Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2021, 5002-5187 [2022-00702]
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Administration, 1800 F Street NW,
Washington, DC 20405.
REGULATORY INFORMATION
SERVICE CENTER
Introduction to the Unified Agenda of
Federal Regulatory and Deregulatory
Actions—Fall 2021
Regulatory Information Service
Center.
ACTION: Introduction to the Regulatory
Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions.
AGENCY:
Publication of the Fall 2021
Unified Agenda of Federal Regulatory
and Deregulatory Actions represents a
key component of the regulatory
planning mechanism prescribed in
Executive Order (‘‘E.O.’’) 12866,
‘‘Regulatory Planning and Review,’’ (58
FR 51735) and reaffirmed in E.O. 13563,
‘‘Improving Regulation and Regulatory
Review,’’ (76 FR 3821). The Regulatory
Flexibility Act requires that agencies
publish semiannual regulatory agendas
in the Federal Register describing
regulatory actions they are developing
that may have a significant economic
impact on a substantial number of small
entities (5 U.S.C. 602).
The Unified Agenda of Regulatory
and Deregulatory Actions (Unified
Agenda), published in the fall and
spring, helps agencies fulfill all of these
requirements. All federal regulatory
agencies have chosen to publish their
regulatory agendas as part of this
publication. The complete Unified
Agenda and Regulatory Plan can be
found online at www.reginfo.gov and a
reduced print version can be found in
the Federal Register. Information
regarding obtaining printed copies can
also be found on the Reginfo.gov
website (or below, VI. How Can Users
Get Copies of the Plan and the
Agenda?).
The Fall 2021 Unified Agenda
publication appearing in the Federal
Register includes the Regulatory Plan
and agency regulatory flexibility
agendas, in accordance with the
publication requirements of the
Regulatory Flexibility Act. Agency
regulatory flexibility agendas contain
only those Agenda entries for rules that
are likely to have a significant economic
impact on a substantial number of small
entities and entries that have been
selected for periodic review under
section 610 of the Regulatory Flexibility
Act.
The complete Fall 2021 Unified
Agenda contains the Regulatory Plans of
27 Federal agencies and 67 Federal
agency regulatory agendas.
ADDRESSES: Regulatory Information
Service Center (MR), General Services
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SUMMARY:
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For
further information about specific
regulatory actions, please refer to the
agency contact listed for each entry. To
provide comment on or to obtain further
information about this publication,
contact: Boris Arratia, Director,
Regulatory Information Service Center
(MR), General Services Administration,
1800 F Street NW, Washington, DC
20405, 703–795–0816. You may also
send comments to us by email at: RISC@
gsa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Table of Contents
Introduction to the Regulatory Plan and the
Unified Agenda of Federal Regulatory and
Deregulatory Actions
I. What are the Regulatory Plan and the
Unified Agenda?
II. Why are the Regulatory Plan and the
Unified Agenda published?
III. How are the Regulatory Plan and the
Unified Agenda organized?
IV. What information appears for each entry?
V. Abbreviations
VI. How can users get copies of the Plan and
the Agenda?
Introduction to the Fall 2021 Regulatory Plan
Agency Regulatory Plans
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of Housing and Urban
Development
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Department of Veterans Affairs
Other Executive Agencies
Architectural and Transportation Barriers
Compliance Board
Environmental Protection Agency
General Services Administration
National Aeronautics and Space
Administration
National Archives and Records
Administration
National Science Foundation
Office of Management and Budget
Office of Personnel Management
Pension Benefit Guaranty Corporation
Small Business Administration
Social Security Administration
Independent Regulatory Agencies
Consumer Product Safety Commission
Federal Trade Commission
National Indian Gaming Commission
Nuclear Regulatory Commission
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Agency Agendas
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of the Interior
Department of Labor
Department of Transportation
Department of the Treasury
Other Executive Agencies
Committee for Purchase From People Who
Are Blind or Severely Disabled
Environmental Protection Agency
General Services Administration
Office of Management and Budget
Office of Personnel Management
Small Business Administration
Joint Authority
Department of Defense/General Services
Administration/National Aeronautics and
Space Administration (Federal Acquisition
Regulation)
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Consumer Product Safety Commission
Federal Communications Commission
Federal Reserve System
National Labor Relations Board
Nuclear Regulatory Commission
Securities and Exchange Commission
Surface Transportation Board
Introduction to the Regulatory Plan and
the Unified Agenda of Federal
Regulatory and Deregulatory Actions
I. What are the Regulatory Plan and the
Unified Agenda?
The Regulatory Plan serves as a
defining statement of the
Administration’s regulatory and
deregulatory policies and priorities. The
Plan is part of the fall edition of the
Unified Agenda. Each participating
agency’s regulatory plan contains: (1) A
narrative statement of the agency’s
regulatory and deregulatory priorities,
and, for the most part, (2) a description
of the most important significant
regulatory and deregulatory actions that
the agency reasonably expects to issue
in proposed or final form during the
upcoming fiscal year. This edition
includes the regulatory plans of 30
agencies.
The Unified Agenda provides
information about regulations that the
Government is considering or
reviewing. The Unified Agenda has
appeared in the Federal Register twice
each year since 1983 and has been
available online since 1995. The
complete Unified Agenda is available to
the public at www.reginfo.gov. The
online Unified Agenda offers flexible
search tools and access to the historic
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Unified Agenda database to 1995. The
complete online edition of the Unified
Agenda includes regulatory agendas
from 65 Federal agencies. Agencies of
the United States Congress are not
included.
The Fall 2021 Unified Agenda
publication appearing in the Federal
Register consists of The Regulatory Plan
and agency regulatory flexibility
agendas, in accordance with the
publication requirements of the
Regulatory Flexibility Act. Agency
regulatory flexibility agendas contain
only those Agenda entries for rules that
are likely to have a significant economic
impact on a substantial number of small
entities and entries that have been
selected for periodic review under
section 610 of the Regulatory Flexibility
Act. Printed entries display only the
fields required by the Regulatory
Flexibility Act. Complete agenda
information for those entries appears, in
a uniform format, in the online Unified
Agenda at www.reginfo.gov.
The following agencies have no
entries for inclusion in the printed
regulatory flexibility agenda. An asterisk
(*) indicates agencies that appear in The
Regulatory Plan. The regulatory agendas
of these agencies are available to the
public at www.reginfo.gov.
Cabinet Departments
Department of Justice*
Department of Housing and Urban
Development*
Department of State*
Department of Veterans Affairs*
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Other Executive Agencies
Agency for International Development
Architectural and Transportation
Barriers Compliance Board
Commission on Civil Rights
Corporation for National and
Community Service
Council on Environmental Quality
Court Services and Offender
Supervision Agency for the District of
Columbia
Federal Mediation Conciliation Service
Institute of Museum and Library
Services
Inter-American Foundation
National Aeronautics and Space
Administration*
National Archives and Records
Administration*
National Endowment for the Arts
National Endowment for the Humanities
National Mediation Board
National Science Foundation
Office of Government Ethics
Office of National Drug Control Policy
Office of Personnel Management*
Peace Corps
Pension Benefit Guaranty Corporation*
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Railroad Retirement Board*
Social Security Administration*
Tennessee Valley Authority
U.S. Agency for Global Media
Independent Agencies
Commodity Futures Trading
Commission
Council of the Inspectors General on
Integrity and Efficiency
Farm Credit Administration
Federal Deposit Insurance Corporation
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Maritime Commission
Federal Mine Safety and Health Review
Commission
Federal Permitting Improvement
Steering Council
Federal Trade Commission*
National Credit Union Administration
National Indian Gaming Commission*
National Labor Relations Board
National Transportation Safety Board
Postal Regulatory Commission
Council of the Inspectors General on
Integrity and Efficiency
Farm Credit Administration
Federal Deposit Insurance Corporation
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Maritime Commission
Federal Mine Safety and Health Review
Commission
Federal Trade Commission*
National Credit Union Administration
National Indian Gaming Commission*
National Labor Relations Board
National Transportation Safety Board
Postal Regulatory Commission
The Regulatory Information Service
Center compiles the Unified Agenda for
the Office of Information and Regulatory
Affairs (OIRA), part of the Office of
Management and Budget. OIRA is
responsible for overseeing the Federal
Government’s regulatory, paperwork,
and information resource management
activities, including implementation of
Executive Order 12866 (incorporated in
Executive Order 13563). The Center also
provides information about Federal
regulatory activity to the President and
his Executive Office, the Congress,
agency officials, and the public.
The activities included in the Agenda
are, in general, those that will have a
regulatory action within the next 12
months. Agencies may choose to
include activities that will have a longer
timeframe than 12 months. Agency
agendas also show actions or reviews
completed or withdrawn since the last
Unified Agenda. Executive Order 12866
does not require agencies to include
regulations concerning military or
foreign affairs functions or regulations
related to agency organization,
management, or personnel matters.
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Agencies prepared entries for this
publication to give the public notice of
their plans to review, propose, and issue
regulations. They have tried to predict
their activities over the next 12 months
as accurately as possible, but dates and
schedules are subject to change.
Agencies may withdraw some of the
regulations now under development,
and they may issue or propose other
regulations not included in their
agendas. Agency actions in the
rulemaking process may occur before or
after the dates they have listed. The
Regulatory Plan and Unified Agenda do
not create a legal obligation on agencies
to adhere to schedules in this
publication or to confine their
regulatory activities to those regulations
that appear within it.
II. Why are the Regulatory Plan and the
Unified Agenda published?
The Regulatory Plan and the Unified
Agenda helps agencies comply with
their obligations under the Regulatory
Flexibility Act and various Executive
orders and other statutes.
Regulatory Flexibility Act
The Regulatory Flexibility Act
requires agencies to identify those rules
that may have a significant economic
impact on a substantial number of small
entities (5 U.S.C. 602). Agencies meet
that requirement by including the
information in their submissions for the
Unified Agenda. Agencies may also
indicate those regulations that they are
reviewing as part of their periodic
review of existing rules under the
Regulatory Flexibility Act (5 U.S.C.
610). Executive Order 13272, ‘‘Proper
Consideration of Small Entities in
Agency Rulemaking,’’ signed August 13,
2002 (67 FR 53461), provides additional
guidance on compliance with the Act.
Executive Order 12866
Executive Order 12866, ‘‘Regulatory
Planning and Review,’’ September 30,
1993 (58 FR 51735), requires covered
agencies to prepare an agenda of all
regulations under development or
review. The Order also requires that
certain agencies prepare annually a
regulatory plan of their ‘‘most important
significant regulatory actions,’’ which
appears as part of the fall Unified
Agenda. Executive Order 13497, signed
January 30, 2009 (74 FR 6113), revoked
the amendments to Executive Order
12866 that were contained in Executive
Order 13258 and Executive Order
13422.
Executive Order 13563
Executive Order 13563, ‘‘Improving
Regulation and Regulatory Review,’’
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January 18, 2011 (76 FR 3821)
supplements and reaffirms the
principles, structures, and definitions
governing contemporary regulatory
review that were established in
Executive Order 12866, which includes
the general principles of regulation and
public participation, and orders
integration and innovation in
coordination across agencies; flexible
approaches where relevant, feasible, and
consistent with regulatory approaches;
scientific integrity in any scientific or
technological information and processes
used to support the agencies’ regulatory
actions; and retrospective analysis of
existing regulations.
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Executive Order 13132
Executive Order 13132, ‘‘Federalism,’’
August 4, 1999 (64 FR 43255), directs
agencies to have an accountable process
to ensure meaningful and timely input
by State and local officials in the
development of regulatory policies that
have ‘‘federalism implications’’ as
defined in the Order. Under the Order,
an agency that is proposing a regulation
with federalism implications, which
either preempt State law or impose nonstatutory unfunded substantial direct
compliance costs on State and local
governments, must consult with State
and local officials early in the process
of developing the regulation. In
addition, the agency must provide to the
Director of the Office of Management
and Budget a federalism summary
impact statement for such a regulation,
which consists of a description of the
extent of the agency’s prior consultation
with State and local officials, a
summary of their concerns and the
agency’s position supporting the need to
issue the regulation, and a statement of
the extent to which those concerns have
been met. As part of this effort, agencies
include in their submissions for the
Unified Agenda information on whether
their regulatory actions may have an
effect on the various levels of
government and whether those actions
have federalism implications.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4, title II) requires
agencies to prepare written assessments
of the costs and benefits of significant
regulatory actions ‘‘that may result in
the expenditure by State, local, and
tribal governments, in the aggregate, or
by the private sector, of $100,000,000 or
more in any 1 year.’’ The requirement
does not apply to independent
regulatory agencies, nor does it apply to
certain subject areas excluded by
section 4 of the Act. Affected agencies
identify in the Unified Agenda those
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regulatory actions they believe are
subject to title II of the Act.
Executive Order 13211
Executive Order 13211, ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use,’’ May 18, 2001 (66
FR 28355), directs agencies to provide,
to the extent possible, information
regarding the adverse effects that agency
actions may have on the supply,
distribution, and use of energy. Under
the Order, the agency must prepare and
submit a Statement of Energy Effects to
the Administrator of the Office of
Information and Regulatory Affairs,
Office of Management and Budget, for
‘‘those matters identified as significant
energy actions.’’ As part of this effort,
agencies may optionally include in their
submissions for the Unified Agenda
information on whether they have
prepared or plan to prepare a Statement
of Energy Effects for their regulatory
actions.
Small Business Regulatory Enforcement
Fairness Act
The Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104–
121, title II) established a procedure for
congressional review of rules (5 U.S.C.
801 et seq.), which defers, unless
exempted, the effective date of a
‘‘major’’ rule for at least 60 days from
the publication of the final rule in the
Federal Register. The Act specifies that
a rule is ‘‘major’’ if it has resulted, or is
likely to result, in an annual effect on
the economy of $100 million or more or
meets other criteria specified in that
Act. The Act provides that the
Administrator of OIRA will make the
final determination as to whether a rule
is major.
III. How are the Regulatory Plan and
the Unified Agenda organized?
The Regulatory Plan appears in part II
in a daily edition of the Federal
Register. The Plan is a single document
beginning with an introduction,
followed by a table of contents, followed
by each agency’s section of the Plan.
Following the Plan in the Federal
Register, as separate parts, are the
regulatory flexibility agendas for each
agency whose agenda includes entries
for rules which are likely to have a
significant economic impact on a
substantial number of small entities or
rules that have been selected for
periodic review under section 610 of the
Regulatory Flexibility Act. Each printed
agenda appears as a separate part. The
sections of the Plan and the parts of the
Unified Agenda are organized
alphabetically in four groups: Cabinet
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departments; other executive agencies;
the Federal Acquisition Regulation, a
joint authority (Agenda only); and
independent regulatory agencies.
Agencies may in turn be divided into
subagencies. Each printed agency
agenda has a table of contents listing the
agency’s printed entries that follow.
Each agency’s part of the Agenda
contains a preamble providing
information specific to that agency.
Each printed agency agenda has a table
of contents listing the agency’s printed
entries that follow.
Each agency’s section of the Plan
contains a narrative statement of
regulatory priorities and, for most
agencies, a description of the agency’s
most important significant regulatory
and deregulatory actions. Each agency’s
part of the Agenda contains a preamble
providing information specific to that
agency plus descriptions of the agency’s
regulatory and deregulatory actions.
The online, complete Unified Agenda
contains the preambles of all
participating agencies. Unlike the
printed edition, the online Agenda has
no fixed ordering. In the online Agenda,
users can select the particular agencies’
agendas they want to see. Users have
broad flexibility to specify the
characteristics of the entries of interest
to them by choosing the desired
responses to individual data fields. To
see a listing of all of an agency’s entries,
a user can select the agency without
specifying any particular characteristics
of entries.
Each entry in the Agenda is associated
with one of five rulemaking stages. The
rulemaking stages are:
1. Prerule Stage—actions agencies
will undertake to determine whether or
how to initiate rulemaking. Such actions
occur prior to a Notice of Proposed
Rulemaking (NPRM) and may include
Advance Notices of Proposed
Rulemaking (ANPRMs) and reviews of
existing regulations.
2. Proposed Rule Stage—actions for
which agencies plan to publish a Notice
of Proposed Rulemaking as the next step
in their rulemaking process or for which
the closing date of the NPRM Comment
Period is the next step.
3. Final Rule Stage—actions for which
agencies plan to publish a final rule or
an interim final rule or to take other
final action as the next step.
4. Long-Term Actions—items under
development but for which the agency
does not expect to have a regulatory
action within the 12 months after
publication of this edition of the Unified
Agenda. Some of the entries in this
section may contain abbreviated
information.
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5. Completed Actions—actions or
reviews the agency has completed or
withdrawn since publishing its last
agenda. This section also includes items
the agency began and completed
between issues of the Agenda.
6. Long-Term Actions—are
rulemakings reported during the
publication cycle that are outside of the
required 12-month reporting period for
which the Agenda was intended.
Completed Actions in the publication
cycle are rulemakings that are ending
their lifecycle either by Withdrawal or
completion of the rulemaking process.
Therefore, the Long-Term and
Completed RINs do not represent the
ongoing, forward-looking nature
intended for reporting developing
rulemakings in the Agenda pursuant to
Executive Order 12866, section 4(b) and
4(c). To further differentiate these two
stages of rulemaking in the Unified
Agenda from active rulemakings, LongTerm and Completed Actions are
reported separately from active
rulemakings, which can be any of the
first three stages of rulemaking listed
above. A separate search function is
provided on www.reginfo.gov to search
for Completed and Long-Term Actions
apart from each other and active RINs.
A bullet (•) preceding the title of an
entry indicates that the entry is
appearing in the Unified Agenda for the
first time.
In the printed edition, all entries are
numbered sequentially from the
beginning to the end of the publication.
The sequence number preceding the
title of each entry identifies the location
of the entry in this edition. The
sequence number is used as the
reference in the printed table of
contents. Sequence numbers are not
used in the online Unified Agenda
because the unique Regulation Identifier
Number (RIN) is able to provide this
cross-reference capability.
Editions of the Unified Agenda prior
to fall 2007 contained several indexes,
which identified entries with various
characteristics. These included
regulatory actions for which agencies
believe that the Regulatory Flexibility
Act may require a Regulatory Flexibility
Analysis, actions selected for periodic
review under section 610(c) of the
Regulatory Flexibility Act, and actions
that may have federalism implications
as defined in Executive Order 13132 or
other effects on levels of government.
These indexes are no longer compiled,
because users of the online Unified
Agenda have the flexibility to search for
entries with any combination of desired
characteristics. The online edition
retains the Unified Agenda’s subject
index based on the Federal Register
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Thesaurus of Indexing Terms. In
addition, online users have the option of
searching Agenda text fields for words
or phrases.
IV. What information appears for each
entry?
All entries in the online Unified
Agenda contain uniform data elements
including, at a minimum, the following
information:
Title of the Regulation—a brief
description of the subject of the
regulation. In the printed edition, the
notation ‘‘Section 610 Review’’
following the title indicates that the
agency has selected the rule for its
periodic review of existing rules under
the Regulatory Flexibility Act (5 U.S.C.
610(c)). Some agencies have indicated
completions of section 610 reviews or
rulemaking actions resulting from
completed section 610 reviews. In the
online edition, these notations appear in
a separate field.
Priority—an indication of the
significance of the regulation. Agencies
assign each entry to one of the following
five categories of significance.
(1) Economically Significant
As defined in Executive Order 12866,
a rulemaking action that will have an
annual effect on the economy of $100
million or more or will adversely affect
in a material way the economy, a sector
of the economy, productivity,
competition, jobs, the environment,
public health or safety, or State, local,
or tribal governments or communities.
The definition of an ‘‘economically
significant’’ rule is similar but not
identical to the definition of a ‘‘major’’
rule under 5 U.S.C. 801 (Pub. L. 104–
121). (See below.)
(2) Other Significant
A rulemaking that is not
Economically Significant but is
considered Significant by the agency.
This category includes rules that the
agency anticipates will be reviewed
under Executive Order 12866 or rules
that are a priority of the agency head.
These rules may or may not be included
in the agency’s regulatory plan.
(3) Substantive, Nonsignificant
A rulemaking that has substantive
impacts, but is neither Significant, nor
Routine and Frequent, nor
Informational/Administrative/Other.
(4) Routine and Frequent
A rulemaking that is a specific case of
a multiple recurring application of a
regulatory program in the Code of
Federal Regulations and that does not
alter the body of the regulation.
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(5) Informational/Administrative/Other
A rulemaking that is primarily
informational or pertains to agency
matters not central to accomplishing the
agency’s regulatory mandate but that the
agency places in the Unified Agenda to
inform the public of the activity.
Major—whether the rule is ‘‘major’’
under 5 U.S.C. 801 (Pub. L. 104–121)
because it has resulted or is likely to
result in an annual effect on the
economy of $100 million or more or
meets other criteria specified in that
Act. The Act provides that the
Administrator of the Office of
Information and Regulatory Affairs will
make the final determination as to
whether a rule is major.
Unfunded Mandates—whether the
rule is covered by section 202 of the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). The Act requires that,
before issuing an NPRM likely to result
in a mandate that may result in
expenditures by State, local, and tribal
governments, in the aggregate, or by the
private sector of more than $100 million
in 1 year, agencies, other than
independent regulatory agencies, shall
prepare a written statement containing
an assessment of the anticipated costs
and benefits of the Federal mandate.
Legal Authority—the section(s) of the
United States Code (U.S.C.) or Public
Law (Pub. L.) or the Executive order
(E.O.) that authorize(s) the regulatory
action. Agencies may provide popular
name references to laws in addition to
these citations.
CFR Citation—the section(s) of the
Code of Federal Regulations that will be
affected by the action.
Legal Deadline—whether the action is
subject to a statutory or judicial
deadline, the date of that deadline, and
whether the deadline pertains to an
NPRM, a Final Action, or some other
action.
Abstract—a brief description of the
problem the regulation will address; the
need for a Federal solution; to the extent
available, alternatives that the agency is
considering to address the problem; and
potential costs and benefits of the
action.
Timetable—the dates and citations (if
available) for all past steps and a
projected date for at least the next step
for the regulatory action. A date
displayed in the form 12/00/19 means
the agency is predicting the month and
year the action will take place but not
the day it will occur. In some instances,
agencies may indicate what the next
action will be, but the date of that action
is ‘‘To Be Determined.’’ ‘‘Next Action
Undetermined’’ indicates the agency
does not know what action it will take
next.
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Regulatory Flexibility Analysis
Required—whether an analysis is
required by the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) because the
rulemaking action is likely to have a
significant economic impact on a
substantial number of small entities as
defined by the Act.
Small Entities Affected—the types of
small entities (businesses, governmental
jurisdictions, or organizations) on which
the rulemaking action is likely to have
an impact as defined by the Regulatory
Flexibility Act. Some agencies have
chosen to indicate likely effects on
small entities even though they believe
that a Regulatory Flexibility Analysis
will not be required.
Government Levels Affected—whether
the action is expected to affect levels of
government and, if so, whether the
governments are State, local, tribal, or
Federal.
International Impacts—whether the
regulation is expected to have
international trade and investment
effects, or otherwise may be of interest
to the Nation’s international trading
partners.
Federalism—whether the action has
‘‘federalism implications’’ as defined in
Executive Order 13132. This term refers
to actions ‘‘that have substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
Independent regulatory agencies are not
required to supply this information.
Included in the Regulatory Plan—
whether the rulemaking was included in
the agency’s current regulatory plan
published in fall 2021.
Agency Contact—the name and phone
number of at least one person in the
agency who is knowledgeable about the
rulemaking action. The agency may also
provide the title, address, fax number,
email address, and TDD for each agency
contact.
Some agencies have provided the
following optional information:
RIN Information URL—the internet
address of a site that provides more
information about the entry.
Public Comment URL—the internet
address of a site that will accept public
comments on the entry.
Alternatively, timely public
comments may be submitted at the
Governmentwide e-rulemaking site,
www.regulations.gov.
Additional Information—any
information an agency wishes to include
that does not have a specific
corresponding data element.
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Compliance Cost to the Public—the
estimated gross compliance cost of the
action.
Affected Sectors—the industrial
sectors that the action may most affect,
either directly or indirectly. Affected
sectors are identified by North
American Industry Classification
System (NAICS) codes.
Energy Effects—an indication of
whether the agency has prepared or
plans to prepare a Statement of Energy
Effects for the action, as required by
Executive Order 13211 ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use,’’ signed May 18,
2001 (66 FR 28355).
Related RINs—one or more past or
current RIN(s) associated with activity
related to this action, such as merged
RINs, split RINs, new activity for
previously completed RINs, or duplicate
RINs.
Statement of Need—a description of
the need for the regulatory action.
Summary of the Legal Basis—a
description of the legal basis for the
action, including whether any aspect of
the action is required by statute or court
order.
Alternatives—a description of the
alternatives the agency has considered
or will consider as required by section
4(c)(1)(B) of Executive Order 12866.
Anticipated Costs and Benefits—a
description of preliminary estimates of
the anticipated costs and benefits of the
action.
Risks—a description of the magnitude
of the risk the action addresses, the
amount by which the agency expects the
action to reduce this risk, and the
relation of the risk and this risk
reduction effort to other risks and risk
reduction efforts within the agency’s
jurisdiction.
V. Abbreviations
The following abbreviations appear
throughout this publication:
ANPRM—An Advance Notice of
Proposed Rulemaking is a preliminary
notice, published in the Federal
Register, announcing that an agency is
considering a regulatory action. An
agency may issue an ANPRM before it
develops a detailed proposed rule. An
ANPRM describes the general area that
may be subject to regulation and usually
asks for public comment on the issues
and options being discussed. An
ANPRM is issued only when an agency
believes it needs to gather more
information before proceeding to a
notice of proposed rulemaking.
CFR—The Code of Federal
Regulations is an annual codification of
the general and permanent regulations
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published in the Federal Register by the
agencies of the Federal Government.
The Code is divided into 50 titles, each
title covering a broad area subject to
Federal regulation. The CFR is keyed to
and kept up to date by the daily issues
of the Federal Register.
E.O.—An Executive order is a
directive from the President to
Executive agencies, issued under
constitutional or statutory authority.
Executive orders are published in the
Federal Register and in title 3 of the
Code of Federal Regulations.
FR—The Federal Register is a daily
Federal Government publication that
provides a uniform system for
publishing Presidential documents, all
proposed and final regulations, notices
of meetings, and other official
documents issued by Federal agencies.
FY—The Federal fiscal year runs from
October 1 to September 30.
NPRM—A Notice of Proposed
Rulemaking is the document an agency
issues and publishes in the Federal
Register that describes and solicits
public comments on a proposed
regulatory action. Under the
Administrative Procedure Act (5 U.S.C.
553), an NPRM must include, at a
minimum: A statement of the time,
place, and nature of the public
rulemaking proceeding.
Legal Authority—A reference to the
legal authority under which the rule is
proposed; and either the terms or
substance of the proposed rule or a
description of the subjects and issues
involved.
Pub. L.—A public law is a law passed
by Congress and signed by the President
or enacted over his veto. It has general
applicability, unlike a private law that
applies only to those persons or entities
specifically designated. Public laws are
numbered in sequence throughout the 2year life of each Congress; for example,
Public Law 112–4 is the fourth public
law of the 112th Congress.
RFA—A Regulatory Flexibility
Analysis is a description and analysis of
the impact of a rule on small entities,
including small businesses, small
governmental jurisdictions, and certain
small not-for-profit organizations. The
Regulatory Flexibility Act (5 U.S.C. 601
et seq.) requires each agency to prepare
an initial RFA for public comment when
it is required to publish an NPRM and
to make available a final RFA when the
final rule is published, unless the
agency head certifies that the rule
would not have a significant economic
impact on a substantial number of small
entities.
RIN—The Regulation Identifier
Number is assigned by the Regulatory
Information Service Center to identify
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each regulatory action listed in the
Regulatory Plan and the Unified
Agenda, as directed by Executive Order
12866 (section 4(b)). Additionally, OMB
has asked agencies to include RINs in
the headings of their Rule and Proposed
Rule documents when publishing them
in the Federal Register, to make it easier
for the public and agency officials to
track the publication history of
regulatory actions throughout their
development.
Seq. No.—The sequence number
identifies the location of an entry in the
printed edition of the Regulatory Plan
and the Unified Agenda. Note that a
specific regulatory action will have the
same RIN throughout its development
but will generally have different
sequence numbers if it appears in
different printed editions of the Unified
Agenda. Sequence numbers are not used
in the online Unified Agenda.
U.S.C.—The United States Code is a
consolidation and codification of all
general and permanent laws of the
United States. The U.S.C. is divided into
50 titles, each title covering a broad area
of Federal law.
VI. How can users get copies of the Plan
and the Agenda?
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Copies of the Federal Register issue
containing the printed edition of The
Regulatory Plan and the Unified Agenda
(agency regulatory flexibility agendas)
are available from the Superintendent of
Documents, U.S. Government
Publishing Office, P.O. Box 371954,
Pittsburgh, PA 15250–7954.
Telephone: (202) 512–1800 or 1–866–
512–1800 (toll-free).
Copies of individual agency materials
may be available directly from the
agency or may be found on the agency’s
website. Please contact the particular
agency for further information.
All editions of The Regulatory Plan
and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
since fall 1995 are available in
electronic form at www.reginfo.gov,
along with flexible search tools.
The Government Publishing Office’s
GPO GovInfo website contains copies of
the Agendas and Regulatory Plans that
have been printed in the Federal
Register. These documents are available
at www.govinfo.gov.
Dated: December 7, 2021.
Boris Arratia,
Director.
Introduction to the Fall 2021
Regulatory Plan
Executive Order 12866, issued in
1993, requires the annual production of
a Unified Regulatory Agenda and
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Regulatory Plan. It does so in order to
promote transparency—or in the words
of the Executive Order itself, ‘‘to have
an effective regulatory program, to
provide for coordination of regulations,
to maximize consultation and the
resolution of potential conflicts at an
early stage, to involve the public and its
State, local, and tribal officials in
regulatory planning, and to ensure that
new or revised regulations promote the
President’s priorities and the principles
set forth in this Executive order.’’ The
requirements of Executive Order 12866
were reaffirmed in Executive Order
13563, issued in 2011.
We are now providing the first
Regulatory Plan of the Biden-Harris
Administration for public scrutiny and
review. The regulatory plans and
agendas submitted by agencies and
included here offer blueprints for how
the Administration plans to continue
delivering on the President’s agenda as
we build back better. This agenda is
fully consistent with the priorities
outlined by the President as reflected in
his executive orders and our previous
regulatory agenda. We are proud to
shine a light on the regulatory agenda as
a way to share with the public how the
themes of equity, prosperity and public
health cut across everything we do to
improve the lives of the American
people.
These new plans build on significant
progress the Administration has already
made advancing our priorities and
proving that our Government can
deliver results—from confronting the
pandemic, to creating a stronger and
fairer economy, to addressing climate
change and advancing equity. For
example, since releasing the spring
regulatory agenda, we have proposed or
finalized regulatory protections to:
• Protect the Public from COVID—
The Centers for Disease Control and
Prevention (CDC) issued orders
requiring all people to wear face masks
while on public transportation and in
transportation hubs. In addition, CDC
issued Global Testing Orders for all
international air travelers, strengthening
protocols to protect travelers and the
health and safety of American
communities.
• Combat Housing Discrimination.
Following President Biden’s
Presidential Memorandum directing his
Administration to address racial
discrimination in the housing market,
the Department of Housing and Urban
Development (HUD) published an
interim final rule requiring HUD
funding recipients to affirmatively
further fair housing, including by
completing an assessment of fair
housing issues, identifying fair housing
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5007
priorities and goals, and then
committing to meaningful actions to
meet those goals and remedy identified
issues.
• Tackle the Climate Crisis. The
Environmental Protection Agency (EPA)
took an important step forward to
advance President Biden’s commitment
to action on climate change and protect
people’s health by proposing
comprehensive new protections to
sharply reduce pollution from the oil
and natural gas industry—including, for
the first time, reductions from existing
sources nationwide. The proposed new
Clean Air Act rule would lead to
significant, cost-effective reductions in
methane emissions and other healthharming air pollutants that endanger
nearby communities.
• Improve Pipeline Safety and
Environmental Standards. In a major
step to enhance and modernize pipeline
safety and environmental standards, the
Department of Transportation issued a
final rule that—for the first time—
applies federal pipeline safety
regulations to tens of thousands of miles
of unregulated gas gathering pipelines.
This rule will improve safety, reduce
greenhouse gas emissions, and result in
more jobs for pipeline workers that are
needed to help upgrade the safety and
operations of these lines.
In addition to these significant
actions, the Administration has also
made key progress advancing another
core objective: Effectively implementing
the American Rescue Plan (ARP). Since
the ARP went into effect in March, the
Administration has promulgated 17
proposed and 32 final rules to get much
needed relief to the communities across
the countries efficiently and equitably.
For example:
• The Department of Education
established requirements to ensure that
state and local educational agencies
consult members of the public in
determining how to use school
emergency relief funds, and develop
plans for a safe return to in-person
instruction.
• The Department of Housing and
Urban Development finalized a rule so
the agency could require that operators
of project-based rental assistance
housing (such as Section 8) notify
tenants of the availability of emergency
rent relief, and give tenants time to
secure that relief.
• The Small Business Administration
finalized a rule to deliver much needed
support to small business by
streamlining forgiveness of small loans
under the Paycheck Protection Program
(a program extended by the ARP Act).
In this agenda, we are adding
important new measures under
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consideration to advance additional
Administration priorities, including:
• Uncovering Hidden Airline Service
Fees. The Department of Transportation
plans to better protect consumers and
improve competition by ensuring that
consumers have ancillary fee
information, including ‘‘baggage fees,’’
‘‘change fees,’’ and ‘‘cancellation fees’’
at the time of ticket purchase. The
Department also plans to examine
whether fees for certain ancillary
services should be disclosed at the first
point in a search process where a fare
is listed.
• Stopping Super-Pollutants. The
EPA is considering restricting—fully,
partially, or on a graduated schedule—
the use of Hydrofluorocarbons (HFCs) in
sectors or subsectors including the
refrigeration, air conditioning, aerosol,
and foam sectors. HFCs are potent
greenhouse gases found in a range of
appliances and substances, including
refrigerators, air conditioners and foams,
and have an impact on warming our
climate that is hundreds to thousands of
times greater than the same amount of
carbon dioxide.
• Transitioning Toward ZeroEmission Technologies. The EPA plans
to strengthen greenhouse gas emission
standards for light- and heavy-duty
vehicles, with an eye towards
encouraging automakers to transition to
zero-emission technologies. If
implemented, the new standards would
save consumers money, cut pollution,
boost public health, advance
environmental justice, and tackle the
climate crisis.
• Lowering Mental Health and
Substance Use Treatment Costs. The
Department of Labor, Department of
Health and Human Services, and
Department of Treasury are considering
changes to clarify health insurance
plans’ and issuers’ obligations to cover
mental health and substance use
treatment in light of new legislative
enactments and experience
implementing the MHPAEA law since
the last relevant rulemaking in 2014.
• Increasing Access for People With
Disabilities. As part of the
Administration’s commitment to equity,
the Department of Justice is exploring a
new rule to ensure that individuals with
disabilities can use sidewalks and other
pedestrian facilities.
Between this regulatory agenda and
the next in spring 2022, agencies will
also be developing plans for
implementing the Infrastructure
Investment and Jobs Act (IIJA), historic
legislation to rebuild crumbling
infrastructure, create good paying jobs,
and grow our economy. These plans
will provide greater detail on how
agencies will administer new IIJA
programs in a manner that delivers
meaningful results to all Americans,
strengthens American manufacturing,
and advances climate resilience. These
plans will provide an opportunity for
the public to be partners in the
implementation of the IIJA—and all
government programs. Public
engagement in IIJA implementation can
only make it better and more responsive
to what our families and communities
most need.
DEPARTMENT OF AGRICULTURE
Regulation
Identifier No.
Sequence No.
Title
1 ........................
2 ........................
3 ........................
Poultry Grower Ranking Systems (AMS–FTPP–21–0044) ......................................
Clarification of Scope of the Packers and Stockyards Act (AMS–FTPP–21–0046)
Unfair Practices in Violation of the Packers and Stockyards Act (AMS–FTPP–21–
0045).
Organic Livestock and Poultry Standards ................................................................
Establishing AWA Standards for Birds .....................................................................
Voluntary Labeling of Meat Products With ‘‘Product of USA’’ and Similar Statements.
Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed.
Prior Label Approval System: Expansion of Generic Label Approval .....................
4 ........................
5 ........................
6 ........................
7 ........................
8 ........................
Rulemaking stage
0581–AE03
0581–AE04
0581–AE05
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
0581–AE06
0579–AE61
0583–AD87
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
0583–AD56
Final Rule Stage.
0583–AD78
Final Rule Stage.
DEPARTMENT OF COMMERCE
Title
9 ........................
Request for Comments Concerning the Imposition of Export Controls on Certain
Brain-Computer Interface (BCI) Emerging Technology.
Foundational Technologies: Proposed Controls; Request for Comments ...............
Removal of Certain General Approved Exclusions (GAEs) Under the Section 232
Steel and Aluminum Tariff Exclusions Process.
Information Security Controls: Cybersecurity Items .................................................
Authorization of Certain ‘‘Items’’ to Entities on the Entity List in the Context of
Specific Standards Activities.
Commerce Control List: Expansion of Controls on Certain Biological Equipment
‘‘Software’’.
Changes To Implement Provisions of the Trademark Modernization Act of 2020 ..
10 ......................
11 ......................
12 ......................
13 ......................
14 ......................
15 ......................
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Regulation
Identifier No.
Sequence No.
0694–AI41
Rulemaking stage
Prerule Stage.
0694–AH80
0694–AH55
Proposed Rule Stage.
Final Rule Stage.
0694–AH56
0694–AI06
Final Rule Stage.
Final Rule Stage.
0694–AI08
Final Rule Stage.
0651–AD55
Final Rule Stage.
DEPARTMENT OF DEFENSE
Regulation
Identifier No.
Sequence No.
Title
16 ......................
Department of Defense (DoD)-Defense Industrial Base (DIB) Cybersecurity (CS)
Activities.
Nondiscrimination on the Basis of Disability in Programs or Activities Assisted or
Conducted by the DoD.
17 ......................
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Rulemaking stage
0790–AK86
Proposed Rule Stage.
0790–AJ04
Final Rule Stage.
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DEPARTMENT OF DEFENSE—Continued
Regulation
Identifier No.
Sequence No.
Title
18 ......................
19 ......................
Federal Voting Assistance Program .........................................................................
Small Business Innovation Research Program Data Rights (DFARS Case 2019–
D043).
Reauthorization and Improvement of Mentor-Protege Program (DFARS Case
2020–D009).
Maximizing the Use of American-Made Goods (DFARS Case 2019–D045) ..........
Policy and Procedures for Processing Requests to Alter US Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408.
Credit Assistance for Water Resources Infrastructure Projects ..............................
Flood Control Cost-Sharing Requirements Under the Ability to Pay Provision .......
Revised Definition of ‘‘Waters of the United States’’—Rule 1 .................................
Revised Definition of ‘‘Waters of the United States’’—Rule 2 (Reg Plan Seq No.
XX).
TRICARE Coverage and Payment for Certain Services in Response to the
COVID–19 Pandemic.
TRICARE Coverage of Certain Medical Benefits in Response to the COVID–19
Pandemic.
TRICARE Coverage of National Institute of Allergy and Infectious Disease
Coronavirus Disease 2019 Clinical Trials.
Expanding TRICARE Access to Care in Response to the COVID–19 Pandemic ..
20 ......................
21 ......................
22 ......................
23
24
25
26
......................
......................
......................
......................
27 ......................
28 ......................
29 ......................
30 ......................
Rulemaking stage
0790–AK90
0750–AK84
Final Rule Stage.
Proposed Rule Stage.
0750–AK96
Proposed Rule Stage.
0750–AK85
0710–AB22
Final Rule Stage.
Proposed Rule Stage.
0710–AB31
0710–AB34
0710–AB40
0710–AB47
Proposed
Proposed
Proposed
Proposed
0720–AB81
Final Rule Stage.
0720–AB82
Final Rule Stage.
0720–AB83
Final Rule Stage.
0720–AB85
Final Rule Stage.
Rule
Rule
Rule
Rule
Stage.
Stage.
Stage.
Stage.
DEPARTMENT OF EDUCATION
Regulation
Identifier No.
Sequence No.
Title
31 ......................
Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance.
Family Educational Rights and Privacy Act .............................................................
Determining the Amount of Federal Education Assistance Funds Received by Institutions of Higher Education (90/10).
Borrower Defense .....................................................................................................
Pell Grants for Prison Education Programs .............................................................
Gainful Employment .................................................................................................
Improving Student Loan Cancellation Authorities ....................................................
Income Contingent Repayment ................................................................................
Public Service Loan Forgiveness .............................................................................
32 ......................
33 ......................
34
35
36
37
38
39
......................
......................
......................
......................
......................
......................
Rulemaking stage
1870–AA16
Proposed Rule Stage.
1875–AA15
1840–AD55
Proposed Rule Stage.
Prerule Stage.
1840–AD53
1840–AD54
1840–AD57
1840–AD59
1840–AD69
1840–AD70
Proposed
Proposed
Proposed
Proposed
Proposed
Proposed
Rule
Rule
Rule
Rule
Rule
Rule
Stage.
Stage.
Stage.
Stage.
Stage.
Stage.
DEPARTMENT OF ENERGY
Regulation
Identifier No.
Sequence No.
Title
40 ......................
41 ......................
42 ......................
Energy Conservation Standards for Commercial Water Heating-Equipment ..........
Backstop Requirement for General Service Lamps .................................................
Energy Efficiency Standards for New Federal Commercial and Multi-Family HighRise Residential Buildings Baseline Standards Update.
Energy Conservation Program for Appliance Standards: Procedures for Use in
New or Revised Energy Conservation Standards and Test Procedures for Consumer Products and Commercial/Industrial Equipment.
43 ......................
Rulemaking stage
1904–AD34
1904–AF09
1904–AE44
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
1904–AF13
Final Rule Stage.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Title
44 ......................
Amendments to Civil Monetary Penalty Law Regarding Grants, Contracts, and Information Blocking.
Rulemaking on Discrimination on the Basis of Disability in Critical Health and
Human Services Programs or Activities.
Confidentiality of Substance Use Disorder Patient Records ...................................
Nondiscrimination in Health Programs and Activities ..............................................
ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement,
and Enhancements to Support Information Sharing.
Treatment of Opioid Use Disorder With Buprenorphine Utilizing Telehealth ..........
Treatment of Opioid use Disorder With Extended Take Home Doses of Methadone.
45 ......................
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Regulation
Identifier No.
Sequence No.
46 ......................
47 ......................
48 ......................
49 ......................
50 ......................
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Rulemaking stage
0936–AA09
Final Rule Stage.
0945–AA15
Proposed Rule Stage.
0945–AA16
0945–AA17
0955–AA03
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
0930–AA38
0930–AA39
Proposed Rule Stage.
Proposed Rule Stage.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES—Continued
Regulation
Identifier No.
Sequence No.
Title
51 ......................
Requirement for Proof of Vaccination or Other Proof of Immunity Against Quarantinable Communicable Diseases.
Nonprescription Drug Product With an Additional Condition for Nonprescription
Use.
Nutrient Content Claims, Definition of Term: Healthy ..............................................
Biologics Regulation Modernization .........................................................................
Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter
Hearing Aids and Aligning Other Regulations.
Tobacco Product Standard for Characterizing Flavors in Cigars ............................
Conduct of Analytical and Clinical Pharmacology, Bioavailability and Bioequivalence Studies.
Tobacco Product Standard for Menthol in Cigarettes ..............................................
340B Drug Pricing Program; Administrative Dispute Resolution .............................
Catastrophic Health Emergency Fund (CHEF) ........................................................
Acquisition Regulations; Buy Indian Act; Procedures for Contracting .....................
Streamlining the Medicaid and Chip Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS–2421).
Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (CMS–9910).
Assuring Access to Medicaid Services (CMS–2442) ...............................................
Implementing Certain Provisions of the Consolidated Appropriations Act and
Other Revisions to Medicare Enrollment and Eligibility Rules (CMS–4199).
Requirements for Rural Emergency Hospitals (CMS–3419) ...................................
Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS–9902).
Coverage of Certain Preventive Services (CMS–9903) ..........................................
Omnibus COVID–19 Health Care Staff Vaccination (CMS–3415) ..........................
Native Hawaiian Revolving Loan Fund Eligibility Requirements .............................
Paternity Establishment Percentage Performance Relief ........................................
ANA Non-federal Share Emergency Waivers ..........................................................
Foster Care Legal Representation ...........................................................................
Separate Licensing Standards for Relative or Kinship Foster Family Homes ........
National Institute for Disability, Independent Living, and Rehabilitation Research
Notice of Proposed Rulemaking.
52 ......................
53 ......................
54 ......................
55 ......................
56 ......................
57 ......................
58
59
60
61
62
......................
......................
......................
......................
......................
63 ......................
64 ......................
65 ......................
66 ......................
67 ......................
68
69
70
71
72
73
74
75
......................
......................
......................
......................
......................
......................
......................
......................
Rulemaking stage
0920–AA80
Final Rule Stage.
0910–AH62
Proposed Rule Stage.
0910–AI13
0910–AI14
0910–AI21
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
0910–AI28
0910–AI57
Proposed Rule Stage.
Proposed Rule Stage.
0910–AI60
0906–AB28
0917–AA10
0917–AA18
0938–AU00
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
0938–AU64
Proposed Rule Stage.
0938–AU68
0938–AU85
Proposed Rule Stage.
Proposed Rule Stage.
0938–AU92
0938–AU93
Proposed Rule Stage.
Proposed Rule Stage.
0938–AU94
0938–AU75
0970–AC84
0970–AC86
0970–AC88
0970–AC89
0970–AC91
0985–AA16
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage
DEPARTMENT OF HOMELAND SECURITY
Title
76 ......................
Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review.
Deferred Action for Childhood Arrivals .....................................................................
Asylum and Withholding Definitions .........................................................................
Rescission of ‘‘Asylum Application, Interview, & Employment Authorization’’ Rule
and Change to ‘‘Removal of 30 Day Processing Provision for Asylum Applicant
Related Form I–765 Employment Authorization’’.
U.S. Citizenship and Immigration Services Fee Schedule ......................................
Bars to Asylum Eligibility and Procedures ...............................................................
Inadmissibility on Public Charge Grounds ...............................................................
Procedures for Credible Fear Screening and Consideration of Asylum, Withholding of Removal and Cat Protection Claims by Asylum Officers.
Electronic Chart and Navigation Equipment Carriage Requirements ......................
Shipping Safety Fairways Along the Atlantic Coast .................................................
MARPOL Annex VI; Prevention of Air Pollution from Ships ....................................
Advance Passenger Information System: Electronic Validation of Travel Documents.
Automation of CBP Form I–418 for Vessels ............................................................
Vetting of Certain Surface Transportation Employees .............................................
Indirect Air Carrier Security ......................................................................................
Flight Training Security .............................................................................................
Surface Transportation Cybersecurity Measures .....................................................
Fee Adjustment for U.S. Immigration and Customs Enforcement Form I–246, Application for a Stay of Deportation or Removal.
RFI National Flood Insurance Program’s Floodplain Management Standards for
Land Management & Use, & an Assessment of the Program’s Impact on
Threatened and Endangered Species & Their Habitats.
National Flood Insurance Program: Standard Flood Insurance Policy, Homeowner Flood Form.
77 ......................
78 ......................
79 ......................
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Regulation
Identifier No.
Sequence No.
80
81
82
83
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84
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Rulemaking stage
1615–AC42
Proposed Rule Stage.
1615–AC64
1615–AC65
1615–AC66
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
1615–AC68
1615–AC69
1615–AC74
1615–AC67
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
1625–AC74
1625–AC57
1625–AC78
1651–AB43
Prerule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
1651–AB18
1652–AA69
1652–AA72
1652–AA35
1652–AA74
1653–AA82
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Long-Term Actions.
Proposed Rule Stage.
1660–AB11
Prerule Stage.
1660–AB06
Proposed Rule Stage.
31JAP2
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DEPARTMENT OF HOMELAND SECURITY—Continued
Regulation
Identifier No.
Sequence No.
Title
96 ......................
Amendment to the Public Assistance Program’s Simplified Procedures Large
Project Threshold.
Individual Assistance Program Equity ......................................................................
Ammonium Nitrate Security Program .......................................................................
97 ......................
98 ......................
Rulemaking stage
1660–AB10
Final Rule Stage.
1660–AB07
1670–AA00
Long-Term Actions.
Proposed Rule Stage.
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Regulation
Identifier No.
Sequence No.
Title
99 ......................
100 ....................
Increased 40-year Term for Loan Modifications (FR–6263) ....................................
Affirmatively Furthering Fair Housing (FR–6250) ....................................................
2502–AJ59
2529–AB05
Rulemaking stage
Proposed Rule Stage.
Proposed Rule Stage.
DEPARTMENT OF JUSTICE
Regulation
Identifier No.
Sequence No.
Title
101 ....................
Nondiscrimination on the Basis of Disability by State and Local Governments and
Places of Public Accommodation; Equipment and Furniture.
Implementation of the ADA Amendments Act of 2008: Federally Conducted (Section 504 of the Rehabilitation Act of 1973).
Nondiscrimination on the Basis of Disability by State and Local Governments;
Public Right-of-Way.
Definition of ‘‘Frame or Receiver’’ and Identification of Firearms ............................
Factoring Criteria for Firearms With an Attached Stabilizing Brace ........................
Bars to Asylum Eligibility and Procedures ...............................................................
Asylum and Withholding Definitions .........................................................................
Procedures for Asylum and Withholding of Removal ..............................................
Appellate Procedures and Decisional Finality in Immigration Proceedings; Administrative Closure.
Professional Conduct for Practitioners—Rules and Procedures, and Representation and Appearances.
Procedures for Credible Fear Screening and Consideration of Asylum, Withholding of Removal and CAT Protection Claims by Asylum Officers.
102 ....................
103 ....................
104
105
106
107
108
109
....................
....................
....................
....................
....................
....................
110 ....................
111 ....................
Rulemaking stage
1190–AA76
Prerule Stage.
1190–AA73
Proposed Rule Stage.
1190–AA77
Proposed Rule Stage.
1140–AA54
1140–AA55
1125–AB12
1125–AB13
1125–AB15
1125–AB18
Final Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
1125–AA83
Final Rule Stage.
1125–AB20
Final Rule Stage.
DEPARTMENT OF LABOR
Title
112 ....................
Proposal to Rescind Implementing Legal Requirements Regarding the Equal Opportunity Clause’s Religious Exemption.
Modification of Procedures to Resolve Potential Employment Discrimination ........
Defining and Delimiting the Exemptions for Executive, Administrative, Professional, Outside Sales and Computer Employees.
Modernizing the Davis-Bacon and Related Acts Regulations .................................
Tip Regulations Under the Fair Labor Standards Act (FLSA) .................................
E.O. 14026, Increasing the Minimum Wage for Federal Contractors .....................
Wagner-Peyser Act Staffing .....................................................................................
Apprenticeship Programs, Labor Standards for Registration, Amendment of Regulations.
Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder
Rights.
Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021.
Requirements Related to Surprise Billing, Part 1 ....................................................
Requirements Related to Surprise Billing, Part 2 ....................................................
Respirable Crystalline Silica .....................................................................................
Safety Program for Surface Mobile Equipment .......................................................
Prevention of Workplace Violence in Health Care and Social Assistance ..............
Heat Illness Prevention in Outdoor and Indoor Work Settings ................................
Infectious Diseases ..................................................................................................
113 ....................
114 ....................
115
116
117
118
119
....................
....................
....................
....................
....................
120 ....................
121 ....................
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123
124
125
126
127
128
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Rulemaking stage
1250–AA09
Proposed Rule Stage.
1250–AA14
1235–AA39
Proposed Rule Stage.
Proposed Rule Stage.
1235–AA40
1235–AA21
1235–AA41
1205–AC02
1205–AC06
Proposed Rule Stage.
Final Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
1210–AC03
Proposed Rule Stage.
1210–AC11
Proposed Rule Stage.
1210–AB99
1210–AC00
1219–AB36
1219–AB91
1218–AD08
1218–AD39
1218–AC46
Final Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Prerule Stage.
Prerule Stage.
Proposed Rule Stage.
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DEPARTMENT OF TRANSPORTATION
Sequence No.
129
130
131
132
133
134
135
136
137
138
139
140
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Regulation
Identifier No.
Title
Processing Buy America and Buy American Waivers Based on Nonavailability ....
Accessible Lavatories on Single-Aisle Aircraft: Part II .............................................
Enhancing Transparency of Airline Ancillary Service Fees .....................................
Registration and Marking Requirements for Small Unmanned Aircraft ...................
Greenhouse Gas Emissions Measure .....................................................................
Manual on Uniform Traffic Control Devices for Streets and Highways ...................
Heavy Vehicle Automatic Emergency Braking .........................................................
Light Vehicle Automatic Emergency Braking (AEB) with Pedestrian AEB ..............
Corporate Average Fuel Economy (CAFE) Preemption ..........................................
Passenger Car and Light Truck Corporate Average Fuel Economy Standards .....
Train Crew Staffing ...................................................................................................
Pipeline Safety: Class Location Requirements ........................................................
2105–AE79
2105–AE89
2105–AF10
2120–AK82
2125–AF99
2125–AF85
2127–AM36
2127–AM37
2127–AM33
2127–AM34
2130–AC88
2137–AF29
Rulemaking stage
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
Final Rule Stage.
Proposed Rule Stage.
Long-Term Actions.
DEPARTMENT OF VETERANS AFFAIRS
Regulation
Identifier No.
Sequence No.
Title
141 ....................
142 ....................
143 ....................
Modifying Copayments for Veterans at High Risk for Suicide .................................
VA Pilot Program on Graduate Medical Education and Residency ........................
Staff Sergeant Parker Gordon Fox Suicide Prevention Grant Program ..................
2900–AQ30
2900–AR01
2900–AR16
Rulemaking stage
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
ENVIRONMENTAL PROTECTION AGENCY
Title
144 ....................
National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Commercial Sterilization and Fumigation Operations.
Control of Air Pollution From New Motor Vehicles: Heavy-Duty Engine and Vehicle Standards.
Amendments to the NSPS for GHG Emissions From New, Modified, Reconstructed Stationary Sources: EGUs.
Emission Guidelines for Greenhouse Gas Emissions from Fossil Fuel-Fired Existing Electric Generating Units.
Renewable Fuel Standard (RFS) Program: RFS Annual Rules ..............................
NESHAP: Coal- and Oil-Fired Electric Utility Steam Generating Units-Revocation
of the 2020 Reconsideration, and Affirmation of the Appropriate and Necessary
Supplemental Finding.
Standards of Performance for New, Reconstructed, and Modified Sources and
Emissions Guidelines for Existing Sources: Oil and Natural Gas Sector Climate
Review.
Review of Final Rule Reclassification of Major Sources as Area Sources Under
Section 112 of the Clean Air Act.
Restrictions on Certain Uses of Hydrofluorocarbons Under Subsection (i) of the
American Innovation and Manufacturing Act.
Review of the National Ambient Air Quality Standards for Particulate Matter ........
Pesticides; Modification to the Minimum Risk Pesticide Listing Program and
Other Exemptions Under FIFRA Section 25(b).
Cyclic Aliphatic Bromide Cluster (HBCD); Rulemaking Under TSCA Section 6(a)
Asbestos (Part 1: Chrysotile Asbestos); Rulemaking under TSCA Section 6(a) ....
Designating PFOA and PFOS as CERCLA Hazardous Substances ......................
Hazardous and Solid Waste Management System: Disposal of Coal Combustion
Residuals From Electric Utilities; Legacy Surface Impoundments.
Accidental Release Prevention Requirements: Risk Management Program Under
the Clean Air Act; Retrospection.
Federal Baseline Water Quality Standards for Indian Reservations .......................
Clean Water Act Section 401: Water Quality Certification ......................................
Revised Definition of ‘‘Waters of the United States’’—Rule 1 .................................
Revised Definition of ‘‘Waters of the United States’’—Rule 2 .................................
Revised 2023 and Later Model Year Light-Duty Vehicle Greenhouse Gas Emissions Standards.
Hazardous and Solid Waste Management System: Disposal of Coal Combustion
Residuals From Electric Utilities; Federal CCR Permit Program.
Hazardous and Solid Waste Management System: Disposal of CCR; A Holistic
Approach to Closure Part B: Implementation of Closure.
Cybersecurity in Public Water Systems ...................................................................
National Primary Drinking Water Regulations for Lead and Copper: Regulatory
Revisions.
145 ....................
146 ....................
147 ....................
148 ....................
149 ....................
150 ....................
151 ....................
152 ....................
153 ....................
154 ....................
155
156
157
158
....................
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159 ....................
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160
161
162
163
164
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165 ....................
166 ....................
167 ....................
168 ....................
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Rulemaking stage
2060–AU37
Proposed Rule Stage.
2060–AU41
Proposed Rule Stage.
2060–AV09
Proposed Rule Stage.
2060–AV10
Proposed Rule Stage.
2060–AV11
2060–AV12
Proposed Rule Stage.
Proposed Rule Stage.
2060–AV16
Proposed Rule Stage.
2060–AV20
Proposed Rule Stage.
2060–AV46
Proposed Rule Stage.
2060–AV52
2070–AK55
Proposed Rule Stage.
Proposed Rule Stage.
2070–AK71
2070–AK86
2050–AH09
2050–AH14
Proposed
Proposed
Proposed
Proposed
2050–AH22
Proposed Rule Stage.
2040–AF62
2040–AG12
2040–AG13
2040–AG19
2060–AV13
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Proposed Rule Stage.
Final Rule Stage.
2050–AH07
Final Rule Stage.
2050–AH18
Final Rule Stage.
2040–AG20
2040–AG16
Final Rule Stage.
Long-Term Actions.
31JAP2
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
ENVIRONMENTAL PROTECTION AGENCY—Continued
Regulation
Identifier No.
Sequence No.
Title
169 ....................
Per- and polyfluoroalkyl Substances (PFAS): Perfluorooctanoic Acid (PFOA) and
Perfluorooctanesulfonic Acid (PFOS) National Primary Drinking Water Regulation Rulemaking.
2040–AG18
Rulemaking stage
Long-Term Actions.
PENSION BENEFIT GUARANTY CORPORATION
Regulation
Identifier No.
Sequence No.
Title
170 ....................
Special Financial Assistance by PBGC ...................................................................
1212–AB53
Rulemaking stage
Final Rule Stage.
SMALL BUSINESS ADMINISTRATION
Regulation
Identifier No.
Sequence No.
Title
171 ....................
Service-Disabled Veteran-Owned Small Business Certification ..............................
3245–AH69
Rulemaking stage
Prerule Stage.
SOCIAL SECURITY ADMINISTRATION
Regulation
Identifier No.
Sequence No.
Title
172 ....................
173 ....................
Omitting Food From In-Kind Support and Maintenance Calculations .....................
$20 Tolerance Rule to Establish That the Individual Meets the Pro-Rata Share of
Household Expenses When Living in the Household of Another.
Inquiry About SSI Eligibility at Application Filing Date Which Will Remove the Requirement for a Signed Written Statement and Will Expand Protective Filing.
174 ....................
Rulemaking stage
0960–AI60
0960–AI68
Proposed Rule Stage
Proposed Rule Stage.
0960–AI69
Proposed Rule Stage.
NUCLEAR REGULATORY COMMISSION
Title
175 ....................
176 ....................
Cyber Security at Fuel Cycle Facilities [NRC–2015–0179] .....................................
Alternative Physical Security Requirements for Advanced Reactors [NRC–2017–
0227].
Revision of Fee Schedules: Fee Recovery for FY 2022 [NRC–2020–0031] ..........
Advanced Nuclear Reactor Generic Environmental Impact Statement [NRC–
2020–0101].
Emergency Preparedness Requirements for Small Modular Reactors and Other
New Technologies [NRC–2015–0225].
NuScale Small Modular Reactor Design Certification [NRC–2017–0029] ..............
American Society of Mechanical Engineers 2019–2020 Code Editions [NRC–
2018–0290].
177 ....................
178 ....................
179 ....................
180 ....................
181 ....................
BILLING CODE 6820–27–P
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The U.S. Department of Agriculture’s
(USDA) fall 2021 Regulatory Agenda
and Plan prioritizes initiatives fostering
21st century innovation, job creation,
economic and market opportunity in
rural America, particularly among
historically underserved people and
communities, and a safe end to the
pandemic. USDA will continue to
leverage existing programs in response
to unforeseen events and national
emergencies affecting the American
farm economy, schools, individual
households, and our National Forests.
All USDA programs, including the
priorities contained in this Regulatory
Plan, will be structured to advance the
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cause of equity by removing barriers and
opening new opportunities.
In 2021, the USDA:
Agricultural Marketing Service (AMS)
implemented a Dairy Donation Program
to reimburse dairy organization for
donated dairy products to non-profit
organizations for distribution to
recipient individuals and families. The
new program was brought about by the
2020 COVID–19 pandemic which
disrupted dairy supply chains and
displaced significant volumes of milk
normally used in food service channels.
This led to milk being dumped or fed to
animals across the United States. The
new program is intended to encourage
the donation of dairy products and to
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3150–AJ64
3150–AK19
Proposed Rule Stage.
Proposed Rule Stage.
3150–AK44
3150–AK55
Proposed Rule Stage.
Proposed Rule Stage.
3150–AJ68
Final Rule Stage.
3150–AJ98
3150–AK22
Final Rule Stage.
Final Rule Stage.
prevent and minimize food waste. Farm
Service Agency (FSA) implemented a
new Heirs’ Property Relending Program
authorized by changes that the
Agriculture Improvement Act of 2018
(2018 Farm Bill) made to the
Consolidated Farm and Rural
Development Act. The relending
program provides revolving loan funds
to eligible intermediary lenders to
resolve ownership and succession on
farmland with multiple owners. The
lenders give loans to qualified
individuals to resolve these ownership
issues. The intermediary lenders
consolidate and coordinate the
ownerships of the land-ownership
interests.
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
Outlined below are some of our most
important upcoming regulatory actions.
These include efforts to restore and
expand economic opportunity amid a
safe end to the pandemic; address the
climate change emergency; and support
agricultural markets that are free, open
and promote competition. This
Regulatory Plan also reflects USDA’s
continued commitments to ensuring a
safe and nutritious food supply and
animal welfare protections. As always,
our Semiannual Regulatory Agenda
contains information on a broadspectrum of USDA’s initiatives and
upcoming regulatory actions.
Restore and Expand Economic
Opportunity Amid a Safe End to the
Pandemic
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Pandemic Assistance Programs
USDA will provide additional direct
financial assistance to producers of
agricultural commodities who suffered
eligible revenue losses in calendar year
2020 during the COVID–19 pandemic;
this will expand on the assistance
USDA provided last year. Payments will
be made using funds under the
Coronavirus Aid, Relief, and Economic
Security Act (CARES Act; Pub. L. 116–
136). The rule will also implement the
expanded Pandemic Cover Crop
Program (PCCP) to help agricultural
producers impacted by the effects of the
COVID–19 outbreak. Given cover crop
cultivation requires sustained, long-term
investments to improve soil health and
gain other agronomic benefits, the
economic challenges due to the
pandemic made maintaining cover
cropping systems financially
challenging for many producers. In
addition, the rule will also update the
regulations for the Emergency
Conservation Program (ECP); the
Emergency Assistance for Livestock,
Honeybees, and Farm-Raised Fish
Program (ELAP); and the Livestock
Forage Disaster Program (LFP);
Livestock Indemnity Program (LIP); and
payment eligibility provisions. For more
information about this rule, see RIN
0503–AA75.
Address the Climate Change Emergency
Special Areas; Roadless Area
Conservation; National Forest System
Lands in Alaska: USDA proposes to
repeal a final rule promulgated in 2020
that exempted the Tongass National
Forest from the 2001 Roadless Area
Conservation Rule (2001 Roadless Rule).
The 2001 Roadless Rule prohibited
timber harvest and road construction or
reconstruction within designated
Inventoried Roadless Areas, with
limited exceptions. This proposal is
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consistent with President Biden’s
Executive Order 13990, Protecting
Public Health and the Environment and
Restoring Science to Tackle the Climate
Crisis, directing action to address
Federal regulations issued during the
previous four years that may conflict
with protecting the environment and to
immediately commence work to
confront the climate crisis. For more
information about this rule, see RIN
0596–AD51.
Support Agricultural Markets That Are
Free, Open and Promote Competition
On July 9, 2021, President Biden
signed Executive Order 14036 to
address the growing concerns over
competition and concentration in the
U.S. economy, including the agriculture
sector. The order includes 72 initiatives
by more than a dozen federal agencies
including USDA to promptly tackle
some of the most pressing competition
problems across the economy.
Specifically, the White House fact sheet
looks to ‘‘empower family farmers and
increase their incomes by strengthening
the Department of Agriculture’s tools to
stop the abusive practices of some meat
processors.’’ One of USDA’s initiatives
is this area will be to revitalize, through
the following rulemakings, the Packers
and Stockyards Act to fight unfair
practices and rebuild a competitive
marketplace:
Poultry Grower Ranking Systems: The
proposal would address the use of
poultry grower ranking systems as a
method of payment and settlement
grouping for poultry growers under
contract in poultry growing
arrangements with live poultry dealers.
The proposal would establish certain
requirements with which a live poultry
dealer must comply if a poultry grower
ranking system is utilized to determine
grower payment. A live poultry dealer’s
failure to comply would be deemed an
unfair, unjustly discriminatory, and
deceptive practice according to factors
outlined in the proposed rule. For more
information about this rule, see RIN
0581–AE03.
Clarification of Scope of the Packers
and Stockyards Act: The proposal
would revise regulations under the
Packers and Stockyards Act (Act),
providing clarity regarding conduct that
may violate the Act. The proposal
would make clear that it is not
necessary to demonstrate harm or likely
harm to competition to establish a
violation of either section 202(a) or (b)
of the Act. For more information about
this rule, see RIN 0581–AE04.
Unfair Practices in Violation of the
Packers and Stockyards Act: The
proposal supplements recent updates to
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the regulations issued under the Act
that provided criteria for the Secretary
to consider when determining whether
certain conduct or actions by packers,
swine contractors, or live poultry
dealers is unduly or unreasonably
preferential or advantageous. The
proposal clarifies the conduct USDA
considers unfair, unjustly
discriminatory, or deceptive and a
violation of the Act, regardless of
whether such action harms or is likely
to harm competition. The proposal also
clarifies the criteria and types of
conduct considered unduly preferential,
advantageous, prejudicial, or
disadvantageous and violations of the
Act. For more information about this
rule, see RIN 0581–AE05.
Ensuring That America’s Food Supply
Is Safe and Nutritious
USDA’s Food Safety and Inspection
Service (FSIS) continues to ensure that
meat, poultry, and egg products are
properly marked, labeled, and packaged,
and prohibits the distribution incommerce of meat, poultry, and egg
products that are adulterated or
misbranded. Consistent with the
President’s priorities of advancing the
country’s economic recovery and
promoting economic resilience, FSIS is
proposing several rules to improve
regulatory certainty, which assure
consumers that meat, poultry, and egg
products are safe and truthfully labeled
and fosters fair competition among the
regulated industry. In a similar vein,
AMS has prepared proposed standards
for organic livestock and poultry
production.
Voluntary Labeling of Meat Products
With ‘‘Product of USA’’ and Similar
Statements: In accordance with
Executive Order 14036, Promoting
Competition in the American Economy,
FSIS will propose to address concerns
that the voluntary ‘‘Product of USA’’
label claim may confuse consumers
about the origin of FSIS regulated
products. FSIS intends to clarify the
voluntary claim so that it is more
meaningful to consumers and ensures a
fair and competitive marketplace for
American farmers and ranchers. For
more information about this rule, see
RIN 0583–AD87.
Revision of the Nutrition Facts Panels
for Meat and Poultry Products and
Updating Certain Reference Amounts
Customarily Consumed; Prior Label
Approval System: Expansion of Generic
Label Approval: FSIS plans to finalize
two rules, one to update nutrition
labeling for meat and poultry products
and another to expand the categories of
meat and poultry product labels deemed
generically approved that may be used
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
in commerce without prior FSIS review
and approval. The rule expanding the
categories of generically approved labels
would reduce labeling costs for meat
and poultry establishments, including
small and very small establishments.
Both rules will provide additional
certainty about what is required for
meat and poultry labeling while
ensuring that consumers have access to
the information they need about the
food they buy. For more information
about these rules, see RINs 0583–AD56
and 0583–AD78.
National Organic Program; Organic
Livestock and Poultry Standards: The
proposal would establish standards that
support additional practice standards
for organic livestock and poultry
production. This proposed action would
add provisions to the USDA organic
regulations to address and clarify
livestock and poultry living conditions
(for example, outdoor access, housing
environment and stocking densities),
health care practices (for example
physical alterations, administering
medical treatment, euthanasia), and
animal handling and transport to and
during slaughter. For more information
about this rule, see RIN 0581–AE06.
Animal Welfare Protections
Standards for the Humane Handling,
Care, Treatment and Transportation of
Birds Not Bred for Use in Research
under the Animal Welfare Act: The
proposal would establish standards for
humane handling, care, treatment, and
transportation of birds not bred for use
in research when those birds are
engaged in any activity covered under
the Animal Welfare Act. For more
information about this rule, see RIN
0579–AE61.
USDA—AGRICULTURAL MARKETING
SERVICE (AMS)
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Proposed Rule Stage
1. Poultry Grower Ranking Systems
(AMS–FTPP–21–0044)
Priority: Other Significant.
Legal Authority: 7 U.S.C. 181 to 229c
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: The U.S. Department of
Agriculture’s Agricultural Marketing
Service proposes to amend the
regulations issued under the Packers
and Stockyards Act (P&S Act) to address
the use of poultry grower ranking
systems as a method of payment and
settlement grouping for poultry growers
under contract in poultry growing
arrangements with live poultry dealers.
The proposed regulation would
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establish certain requirements with
which a live poultry dealer must
comply if a poultry grower ranking
system is utilized to determine grower
payment. A live poultry dealer’s failure
to comply would be deemed an unfair,
unjustly discriminatory, and deceptive
practice.
Statement of Need: Although poultry
grower ranking systems may promote
healthy competition among growers and
the use of improved technologies,
differences in size and imbalances of
power between parties in contractual
poultry growing arrangements can have
detrimental effects on one of the
contracting parties and may result in
marketplace inefficiencies. An oftencited concern is the live poultry dealer’s
full control over inputs, e.g., chick, feed,
medication, etc., to the poultry growing
process. Industry members have asked
the Agricultural Marketing Service
(AMS) to address such imbalances by
specifying the conduct that would be
considered violative of the Packers and
Stockyards Act (Act).
Summary of Legal Basis: The
Agricultural Marketing Service (AMS) is
delegated authority by the Secretary of
Agriculture to enforce the P&S Act.
AMS has received numerous complaints
regarding the imbalance of power in
poultry growing agreements, wherein
one side controls all of the inputs, then
arbitrarily ranks grower performance
against other growers to determine pay.
Alternatives: AMS considered
finalizing a 2016 proposed rule that
would have identified criteria for
determining whether a live poultry
dealer’s use of a grower ranking system
for payment purposes might be
unlawful under the Packers and
Stockyards Act.
Anticipated Cost and Benefits: USDA
estimates the first-year costs associated
with this proposed rule to be $17.37
million. Subsequent year costs are
expected to be significantly less than
first-year costs, resulting in a ten-year
total cost of $34.64 million. USDA
expects the primary benefit of the
regulation will be the increased ability
to protect poultry growers from unfair
practices associated with the use of
poultry grower ranking systems. At the
same time, the rule is expected to
improve efficiencies through the use of
new technologies and to reduce market
failures among poultry growers.
Risks: Extended litigation over legal
challenges from the industry could
result in the rule being struck down by
the courts, hindering the agency’s
ability to enforce the Act for years.
Timetable:
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Action
NPRM ..................
Date
5015
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael V. Durando,
Deputy Administrator, Fair Trade
Practices Program, Department of
Agriculture, Agricultural Marketing
Service, 1400 Independence Avenue
SW, Washington, DC 20250–0237,
Phone: 202 720–0219.
RIN: 0581–AE03
USDA—AMS
2. Clarification of Scope of the Packers
and Stockyards Act (AMS–FTPP–21–
0046)
Priority: Other Significant.
Legal Authority: 7 U.S.C. 181 to 229c
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: USDA proposes to revise the
regulations issued under the Packers
and Stockyards Act (Act) (7 U.S.C. 181
229c) to provide clarity regarding
conduct that may violate the Act. This
action is intended to support market
growth, assure fair trade practices and
competition, and protect livestock and
poultry growers and producers. The
proposed rule addresses long-standing
issues related to competitiveness and
whether all allegations of violations of
the Act must be accompanied by a
showing of harm or likely harm to
competition.
Statement of Need: Revisions to
regulations pertaining to the Packers
and Stockyards Act (Act) that would
clarify the scope of the Act are needed
to establish what conduct or action,
depending on their nature and the
circumstances, violate the Act without a
finding of harm or likely harm to
competition. Such revisions reflect the
Department of Agriculture’s (USDA)
longstanding position in this regard and
complement two concurrent rules
related to poultry grower ranking
systems and conduct that constitutes
unfair trade practices under the Act.
Summary of Legal Basis: The Act
provides USDA with the authority to
assure fair competition and trade
practices and to safeguard farmers
against receiving less than the true
market value of their livestock. Sections
202(c), (d), and (e) of the Act limit the
application of those sections to acts or
practices that have an adverse effect on
competition, such as acts restraining
commerce, creating a monopoly, or
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producing another type of antitrust
injury. However, provisions in sections
202(a) and (b) restrict practices that are
deceptive, unfair, unjust, undue, and
unreasonable; terms that are understood
to encompass more than anticompetitive
conduct. USDA’s position is that
Congress did not intend application of
sections 202(a) and (b) to be limited to
instances in which there is harm to
competition.
Alternatives: USDA considered doing
nothing, not challenging standing court
decisions. However, courts are not
unanimous in their findings. Further,
several courts disagree with USDA’s
position. Lack of clarity hinders the
agency’s ability to consistently
administer and enforce the Act.
Anticipated Cost and Benefits: USDA
estimate annual costs related to this rule
of $9 million for the first five years,
decreasing in subsequent years, for total
ten-year costs of $66 million. We believe
the primary benefit of the proposed
regulation is the increased ability to
protect producers and growers through
enforcement of the Act for violations of
section 202(a) and/or (b) that do not
result in harm, or a likelihood of harm,
to competition.
Risks: Courts have recognized that the
proper analysis of alleged violations of
these two sections depends on the facts
of each case. However, four courts of
appeals have disagreed with USDA’s
interpretation of the Act and have
concluded that plaintiffs could not
prove their claims under those sections
without proving harm to competition or
likely harm to competition. There is a
risk if future legal challenge of USDA
interpretation of sections 202(c), (d),
and (e) of the Act.
Timetable:
Action
Date
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NPRM ..................
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Michael V. Durando,
Deputy Administrator, Fair Trade
Practices Program, Department of
Agriculture, Agricultural Marketing
Service, 1400 Independence Avenue
SW, Washington, DC 20250–0237,
Phone: 202 720–0219.
RIN: 0581–AE04
USDA—AMS
3. Unfair Practices in Violation of the
Packers and Stockyards Act (AMS–
FTPP–21–0045)
Priority: Other Significant.
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Legal Authority: 7 U.S.C. 181 to 229c
CFR Citation: 9 CFR 201.
Legal Deadline: None.
Abstract: USDA proposes to
supplement a recent revision to
regulations issued under the Packers
and Stockyards Act (Act) (7 U.S.C. 181
229c) that provided criteria for the
Secretary to consider when determining
whether certain conduct or action by
packers, swine contractors, or live
poultry dealers is unduly or
unreasonably preferential or
advantageous. The proposed
supplemental amendments would
clarify the conduct the Department
considers unfair, unjustly
discriminatory, or deceptive and a
violation of sections 202(a) and (b) of
the Act. USDA would also clarify the
criteria and types of conduct that would
be considered unduly or unreasonably
preferential, advantageous, prejudicial,
or disadvantageous and violations of the
Act.
Statement of Need: Revisions to
regulations pertaining to the Packers
and Stockyards Act (Act) would clarify
the types of conduct by packers, swine
contractors, or live poultry dealers that
the Agricultural Marketing Service
(AMS) considers unfair, unjustly
discriminatory, or deceptive and a
violation of section 202(a) of the Act,
regardless of whether such action harms
or is likely to harm competition. The
proposed rule would also clarify the
criteria and/or types of conduct that
would be considered unduly or
unreasonably preferential,
advantageous, prejudicial, or
disadvantageous and a violation of
section 202(b) of the Act.
Sections 202(a) and 202(b) of the P&S
Act are broadly written to prohibit
unfair practices and undue preferences
and prejudices. Industry members have
complained that the regulations
effectuating the Act are too vague and
do not provide adequate clarity about
the types of conduct or action that are
likely to violate the Act. This rule is
needed to provide essential clarity about
what would be considered violations of
the Act, regardless of whether such
violations harm or are likely to harm
competition.
Summary of Legal Basis: The Packers
and Stockyards Act (Act) authorizes
AMS to determine if conduct within the
poultry and livestock industries are
unfair, unjustly discriminatory, or
deceptive and, therefore a violation of
the Act.
Alternatives: AMS considered taking
no further action, allowing 100 years of
case law to determine precedent in
making determinations about whether
certain behaviors violate the Act. AMS
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also considered revisiting the
withdrawn 2016 rulemaking approach
that would have identified criteria with
which to determine whether certain
behaviors violate the Act.
Anticipated Cost and Benefits: USDA
estimates first-year costs associated with
this proposed rule to be $27.19 million,
with significantly decreased costs each
year thereafter, resulting in a ten-year
total cost of $54.21 million. AMS
expects this proposed rule to benefit all
segments of the industry, providing
greater clarity about what would be
considered violations of the Act. AMS
expects this proposed rule, coupled
with a concurrent rule on the scope of
the Act, to strengthen enforcement of
the Act, resulting in fairer and more
competitive markets for producers and
poultry growers.
Risks: Industry is divided about
adding lists or examples of specific
prohibited conduct to the regulations.
Some argue such lists would inhibit
freedom to forge contracts that fit
individual situations, while others
contend greater specificity is required so
that affected parties can more readily
identify violative behavior. Industry is
also split on the question of whether
identified prohibited behaviors must be
found to harm or likely harm
competition to be considered violations
of the Act. AMS expects to resolve some
of the controversy by being proactive
and transparent with the industry to
allow for critical discussions and
decisions on the rule.
Timetable:
Action
NPRM ..................
Date
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael V. Durando,
Deputy Administrator, Fair Trade
Practices Program, Department of
Agriculture, Agricultural Marketing
Service, 1400 Independence Avenue
SW, Washington, DC 20250–0237,
Phone: 202 720–0219.
RIN: 0581–AE05
USDA—AMS
4. • Organic Livestock and Poultry
Standards
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 7 U.S.C. 6501–7
U.S.C. 6524
CFR Citation: 7 CFR 205
Legal Deadline: None.
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Abstract: This action would establish
additional practice standards l for
organic livestock and poultry
production. This action would add
provisions to the USDA organic
regulations to address and clarify that
livestock and poultry living conditions
(for example, outdoor access, housing
environment, and stocking densities),
health care practices (for example,
physical alterations, administering
medical treatment, and euthanasia), and
animal handling and transport to and
during slaughter are part of the organic
certification.
Statement of Need: The Organic
Livestock and Poultry Standards (OLPS)
proposed rule is needed to clarify the
USDA organic standards for livestock
and poultry living conditions and health
practices. The current regulations for
livestock production provide general
requirements but some of these
provisions are ambiguous and have led
to inconsistent divergent practices,
particularly in the organic poultry
sector. This rule responds to nine
recommendations from the National
Organic Standards Board and findings
from a USDA Office of Inspector
General (OIG) report. (See USDA, Office
of the Inspector General. March 2010.
Audit Report 01601–03–Hy, Oversight
of the National Organic Program.
Available at: http://www.usda.gov/oig/
rptsauditsams.htm.) This proposed rule
includes provisions to support the
expression of natural behaviors and the
welfare of organic livestock and poultry.
Summary of Legal Basis: OLPS is
authorized by the Organic Foods
Production Act of 1990 (OFPA), 7 U.S.C.
65016524. OFPA authorizes the USDA
to establish national standards
governing the marketing of certain
agricultural products as organically
produced products to assure consumers
that organically produced products meet
a consistent standard and to facilitate
interstate commerce in fresh and
processed food that is organically
produced.
Alternatives: AMS considered several
alternatives and presents these in the
proposed rule. AMS presents two
compliance date alternatives in the
proposed rule that would affect the
costs and benefits of the rule.
Additionally, AMS discusses
alternatives to specific policies included
in the proposed rule, including
alternative indoor and outdoor space
requirements, and non-regulatory
alternatives, including consumer
education or no rule.
Anticipated Cost and Benefits: AMS
estimates an annual cost of
approximately $4 million annually for
layer operations and an associated
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benefit of approximately $14 million
annually. Additionally, AMS estimates
an annual cost to broiler producers of
approximately $12 million annually and
an associated benefit of nearly $100
million annually. The costs of the rule
would primarily affect USDA-certified
organic operations that produce
livestock and poultry. Qualitatively,
AMS also anticipates the rule will
establish a clear standard protecting the
value of the USDA organic seal to
consumers, provide a consistent, level
playing field for organic livestock
producers, and facilitate enforcement of
organic livestock and poultry standards.
Risks: A final rule that is very similar
to this proposed rule was published on
January 19, 2017. That rule was
subsequently withdrawn and never
became effective. The USDA continues
to face two legal challenges related to
the withdrawal of the rule. Publishing a
new proposed rule will indicate that the
USDA is taking steps to advance the
regulations. This could be viewed
favorably by some, although others
would prefer reinstating the January
2017 rule without the associated steps
required to finalize a new rule.
The final rule published in January
2017 elicited mixed responses and was
opposed by a multitude of producer
groups, representing both organic and
non-organic producers. Publication of
this proposed rule is likely to produce
similar responses. Additionally, USDA
argued in its withdrawal of the rule that
USDA had no authority under the
Organic Foods Production Act to
promulgate the rule, so there is legal
risk in reversing direction and
publishing a similar rule.
Finally, AMS plans to seek comment
on providing an extended compliance
date (15 years) for poultry operations
that do not provide birds with access to
soil or vegetation in outdoor spaces (i.e.,
porch systems). AMS’s presentation of
this option is likely to invoke strong
opinions among some stakeholders.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Erin Healy, Director,
Standards Division, National Organic
Program, Department of Agriculture,
Agricultural Marketing Service,
Washington, DC 20024, Phone: 202 617–
4942, Email: erin.healy@usda.gov.
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5017
Related RIN: Related to 0581–AD44,
Related to 0581–AD74, Related to 0581–
AD75.
RIN: 0581–AE06
USDA—ANIMAL AND PLANT HEALTH
INSPECTION SERVICE (APHIS)
Proposed Rule Stage
5. Establishing AWA Standards for
Birds
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2131 to 2159
CFR Citation: 9 CFR 1 to 3.
Legal Deadline: NPRM, Judicial,
February 2022.
Mandated by the U.S. District Court
for the District of Columbia in a May 26,
2020 Stay (Case # 1:18–cv–01138–
TNM).
Abstract: This rulemaking would
extend APHIS enforcement of the
Animal Welfare Act (AWA) to birds,
other than birds bred for use in research.
This would help ensure the humane
care and treatment of such birds.
Statement of Need: Although the
AWA authorizes the regulation of birds
not bred for use in research, APHIS has
not to this date promulgated regulations
and standards for the humane care and
treatment of such birds.
Summary of Legal Basis: 7 U.S.C.
2131 to 2159; 7 CFR 2.22, 2.80, and
371.7.
Alternatives: N/A.
Anticipated Cost and Benefits:
Undetermined.
Risks: Failure to issue the rule would
not comport with the Court’s order in
the Stay, and could place at risk the
humane care and treatment of birds,
other than birds bred for use in research.
Timetable:
Action
NPRM ..................
Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Additional Information: Additional
information about APHIS and its
programs is available on the internet at
http://www.aphis.usda.gov.
Agency Contact: Lance Bassage, DVM,
Director, National Policy Staff, Animal
Care, Department of Agriculture,
Animal and Plant Health Inspection
Service, 4700 River Road, Unit 84,
Riverdale, MD 20737, Phone: 518 218–
7551, Email: lance.h.bassage@usda.gov.
RIN: 0579–AE61
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USDA—FOOD SAFETY AND
INSPECTION SERVICE (FSIS)
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Proposed Rule Stage
6. Voluntary Labeling of Meat Products
With ‘‘Product of USA’’ and Similar
Statements
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601, et seq.
CFR Citation: 9 CFR 317.8.
Legal Deadline: None.
Abstract: The Food Safety and
Inspection Service (FSIS) is proposing
to amend its regulations to define the
conditions under which the labeling of
meat product labels can bear voluntary
statements indicating that the product is
of United States (U.S.) origin, such as
Product of USA, or Made in the USA.
Statement of Need: In 2018 and 2019,
FSIS received two petitions requesting
that it change its policy regarding the
labeling of meat products to indicate
U.S. origin. After considering the
petitions and the public comments
submitted in response to them, FSIS
concluded that adherence to the current
labeling policy guidance may be causing
confusion in the marketplace with
respect to certain imported meat and
that the current labeling policy may no
longer meet consumer expectations of
what the Product of USA claim
signifies. The Agency wants to ensure
that any changes to its current policy are
accomplished by an open and
transparent process. Therefore, FSIS
decided that, instead of changing the
Policy Book entry, it would initiate
rulemaking to define the conditions
under which the labeling of meat
products would be permitted to bear
voluntary statements indicating that the
product is of U.S. origin.
Summary of Legal Basis: The Federal
Meat Inspection Act (21 U.S.C. 601 et
seq.).
Alternatives: FSIS has considered the
current labeling guidance and the
alternatives proposed in the two
petitions: (1) To amend the FSIS Policy
Book to state that meat products may be
labeled as Product of USA only if
significant ingredients having a bearing
on consumer preference such as meat,
vegetables, fruits, dairy products, etc.,
are of domestic origin and; (2) to amend
the FSIS Policy Book to provide that any
beef product labeled as Made in the
USA, Product of the USA, USA Beef or
in any other manner that suggests that
the origin is the United States, be
derived from cattle that have been born,
raised, and slaughtered in the United
States. FSIS will now be conducting a
comprehensive review of origin labeling
claims for meat and conducting a
consumer perception survey pursuant to
developing the proposed regulations.
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Anticipated Cost and Benefits:
Establishments may incur costs
associated with voluntarily changing
their labels as a result of any revised
Product of USA labeling claim
definition. This proposed rule is
expected to benefit consumers by
providing them more specific
information on what Product of USA
means for single-ingredient beef and
pork products.
Risks: N/A.
Timetable:
Action
Date
NPRM ..................
FR Cite
10/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Matthew Michael,
Director, Regulations Development
Staff, Department of Agriculture, Food
Safety and Inspection Service, Office of
Policy and Program Development, 1400
Independence Avenue SW, Washington,
DC 20250–3700, Phone: 202 720–0345,
Fax: 202 690–0486, Email:
matthew.michael@usda.gov.
RIN: 0583–AD87
USDA—FSIS
Final Rule Stage
7. Revision of the Nutrition Facts
Panels for Meat and Poultry Products
and Updating Certain Reference
Amounts Customarily Consumed
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.,
Federal Meat Inspection Act; 21 U.S.C.
451 et seq., Poultry Products Inspection
Act
CFR Citation: 9 CFR 317; 9 CFR 381;
9 CFR 413.
Legal Deadline: None.
Abstract: Consistent with the changes
that the Food and Drug Administration
(FDA) finalized, the Food Safety and
Inspection Service (FSIS) is amending
the Federal meat and poultry products
inspection regulations to update and
revise the nutrition labeling
requirements for meat and poultry
products to reflect recent scientific
research and dietary recommendations
and to improve the presentation of
nutrition information to assist
consumers in maintaining healthy
dietary practices. The final rule will: (1)
Update the list of nutrients that are
required or permitted to be declared; (2)
provide updated Daily Reference Values
(DRV) and Reference Daily Intake (RDI)
values that are based on current dietary
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recommendations from consensus
reports; and (3) amend the requirements
for foods represented or purported to be
specifically for children under the age of
four years and pregnant and lactating
women and establish nutrient reference
values specifically for these population
subgroups. FSIS is also revising the
format and appearance of the Nutrition
Facts Panel; amending the definition of
a single-serving container; requiring
dual-column labeling for certain
containers; and updating and modifying
several reference amounts customarily
consumed (RACCs or reference
amounts). FSIS is also consolidating the
nutrition labeling regulations for meat
and poultry products into a new Code
of Federal Regulations (CFR) part.
Statement of Need: On May 27, 2016,
the Food and Drug Administration
(FDA) published two final rules: (1)
‘‘Food Labeling: Revision of the
Nutrition and Supplement Facts Labels’’
(81 FR 33742); and (2) ‘‘Food Labeling:
Serving Sizes of Foods that Can
Reasonably be Consumed at One Eating
Occasion; Dual-Column Labeling;
Updating, Modifying, and Establishing
Certain Reference Amounts Customarily
Consumed; Serving Size for Breath
Mints; and Technical Amendments’’ (81
FR 34000). FDA finalized these rules to
update the Nutrition Facts label to
reflect new nutrition and public health
research, to reflect recent dietary
recommendations from expert groups,
and to improve the presentation of
nutrition information to help consumers
make more informed choices and
maintain healthy dietary practices. FSIS
has reviewed FDA’s analysis and, to
ensure that nutrition information is
presented consistently across the food
supply, FSIS will propose to amend the
nutrition labeling regulations for meat
and poultry products to parallel, to the
extent possible, FDA’s regulations. This
approach will help increase clarity of
information to consumers and will
improve efficiency in the marketplace.
Summary of Legal Basis: The Federal
Meat Inspection Act (21 U.S.C. 601 et
seq.) and the Poultry Products
Inspection Act (21 U.S.C. 451 et seq.).
Alternatives: FSIS is considering
different alternatives for the compliance
period of the final rule.
Anticipated Cost and Benefits: These
proposed regulations are expected to
benefit consumers by increasing and
improving dietary information available
in the market. An estimate of the
monetary benefits from these market
improvements can be obtained by
calculating the medical cost savings
generated by linking information use to
improved consumer diets. In addition,
FSIS believes that the public would be
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better served by having the regulations
governing nutrition labeling
consolidated in one part of title 9.
Rather than searching through two
separate parts of title 9, CFR parts 317
and 381, to find the nutrition labeling
regulations, interested parties would
only have to survey one, part 413, to be
able to apply nutrition panels to their
meat and poultry products. Firms would
incur a one-time cost for relabeling,
recordkeeping costs, and costs
associated with voluntary
reformulation. Many firms have
voluntarily begun using the FDA format,
which will reduce costs.
Risks: None.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
01/19/17
04/19/17
FR Cite
82 FR 6732
06/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Matthew Michael,
Director, Regulations Development
Staff, Department of Agriculture, Food
Safety and Inspection Service, Office of
Policy and Program Development, 1400
Independence Avenue SW, Washington,
DC 20250–3700, Phone: 202 720–0345,
Fax: 202 690–0486, Email:
matthew.michael@usda.gov.
RIN: 0583–AD56
USDA—FSIS
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8. Prior Label Approval System:
Expansion of Generic Label Approval
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.;
21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 412.2 (a) (1); 9
CFR 317.7; 9 CFR 381.128; 9 CFR 412.2
(b).
Legal Deadline: None.
Abstract: The Food Safety and
Inspection Service (FSIS) is amending
its labeling regulations to expand the
categories of meat and poultry product
labels that it will deem generically
approved and thus not required to be
submitted to FSIS. These reforms will
reduce the regulatory burden on
producers seeking to bring products to
market, as well as the Agency costs
expended to evaluate the labels.
Statement of Need: This action is
needed to reduce the regulatory burden
on producers seeking to bring products
to market, as well as the Agency costs
expended to evaluate the labels. Based
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on FSIS experience evaluating the labels
in question and the ability of inspection
personnel to verify labeling in the field,
FSIS anticipates this action will have no
impact on food safety or the accuracy of
meat and poultry product labeling.
Summary of Legal Basis: The Acts
direct the Secretary of Agriculture to
maintain meat and poultry inspection
programs designed to assure consumers
that these products are safe, wholesome,
not adulterated, and properly marked,
labeled, and packaged. Section 7(d) of
the Federal Meat Inspection Act (21
U.S.C. 607(d)) states: No article subject
to this title shall be sold or offered for
sale by any person, firm, or corporation,
in commerce, under any name or other
marking or labeling which is false or
misleading, or in any container of a
misleading form or size, but established
trade names and other marking and
labeling and containers which are not
false or misleading and which are
approved by the Secretary are
permitted. The Poultry Products
Inspection Act contains similar
language in section 21 U.S.C. 457(c).
Alternatives: FSIS considered three
alternatives to the proposed rule: Taking
no action, adopting the current proposal
except with continued evaluation of
labels that would otherwise be
generically approved, and allowing all
labels to be generically approved.
Anticipated Cost and Benefits: There
are no additional costs to industry, or
the Agency associated with this rule.
FSIS will continue to verify that product
labels, including those that are
generically approved, are truthful and
not misleading and otherwise comply
with FSIS’s requirements.
This rule is expected to reduce the
number of labels industry is required to
submit to FSIS for evaluation by
approximately 35 percent.
Establishments will realize a cost
savings because they will no longer
need to incur costs for submitting
certain types of labels to FSIS for
evaluation (e.g., preparing a printer’s
proof). In addition, streamlining the
evaluation process for specific types of
labels would allow a faster introduction
of products into the marketplace by
reducing wait times for label approvals.
FSIS will also benefit from a
reduction in the number of labels
submitted to it for review. FSIS will be
able to reallocate staff hours from
evaluating labels towards the
development of labeling policy.
Timetable:
Action
Date
NPRM ..................
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FR Cite
85 FR 56538
Action
NPRM Comment
Period End.
Final Rule ............
Date
FR Cite
11/13/20
04/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Matthew Michael,
Director, Regulations Development
Staff, Department of Agriculture, Food
Safety and Inspection Service, Office of
Policy and Program Development, 1400
Independence Avenue SW, Washington,
DC 20250–3700, Phone: 202 720–0345,
Fax: 202 690–0486, Email:
matthew.michael@usda.gov.
RIN: 0583–AD78
BILLING CODE 3410–90–P
DEPARTMENT OF COMMERCE
Statement of Regulatory and
Deregulatory Priorities
Established in 1903, the Department
of Commerce (Commerce or
Department) is one of the oldest
Cabinet-level agencies in the Federal
Government. Commerce’s mission is to
create the conditions for economic
growth and opportunity across all
American communities by promoting
innovation, entrepreneurship,
competitiveness, and environmental
stewardship. Commerce has 12
operating units, which manage a diverse
portfolio of programs and services
ranging from trade promotion and
economic development assistance to
improved broadband access and the
National Weather Service, and from
standards development and statistical
data production, including the
decennial census, to patents and
fisheries management. Across these
varied activities, the Department seeks
to provide a foundation for a more
equitable, resilient, and globally
competitive economy.
To fulfill its mission, Commerce
works in partnership with businesses,
educational institutions, community
organizations, government agencies, and
individuals to:
• Innovate by creating new ideas
through cutting-edge science and
technology, from advances in
nanotechnology to ocean exploration to
broadband deployment, and by
protecting American innovations
through the patent and trademark
system;
• Support entrepreneurship and
commercialization by enabling
community development and
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strengthening minority businesses and
small manufacturers;
• Maintain U.S. economic
competitiveness in the global
marketplace by promoting exports and
foreign direct investment, ensuring a
level playing field for U.S. businesses,
and ensuring that technology transfer is
consistent with our nation’s economic
and security interests;
• Provide effective management and
stewardship of our nation’s resources
and assets to ensure sustainable
economic opportunities; and
• Make informed policy decisions
and enable better understanding of the
economy and our communities by
providing timely, accessible, and
accurate economic and demographic
data.
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Responding to the Administration’s
Regulatory Philosophy and Principles
Commerce’s Regulatory Plan tracks
the most important regulations that the
Department anticipates issuing to
implement these policy and program
priorities and foster sustainable and
equitable growth. Of Commerce’s 12
primary operating units, three bureaus—
the National Oceanic and Atmospheric
Administration (NOAA), the United
States Patent and Trademark Office
(USPTO), and the Bureau of Industry
and Security (BIS)—issue the vast
majority of the Department’s
regulations, and these three bureaus
account for all the planned actions that
are considered the Department’s most
important significant pre-regulatory or
regulatory actions for FY 2022.
National Oceanic and Atmospheric
Administration
NOAA’s mission is built on three
pillars: Science, service, and
stewardship—to understand and predict
changes in climate, weather, oceans,
and coasts; to share that knowledge and
information with others; and to
conserve and manage coastal and
marine ecosystems and resources.
At its core, NOAA is a scientific
agency. It observes, measures, monitors,
and collects data from the depths of the
ocean to the surface of the sun, and it
does so following principles of scientific
integrity. These data are turned into
weather and climate models and
forecasts that are then used for
everything from local weather forecasts
to predicting the movement of wildfire
smoke to identifying the impacts of
climate change on fisheries and living
marine resources.
With respect to service, NOAA not
only collects data but is mandated to
make it operational, and NOAA seeks to
be the authoritative provider of climate
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products and services. By providing
Federal, State, and local government
partners, the private sector, and the
public with actionable environmental
information, NOAA can facilitate
decisions in the face of climate change.
Such decisions can range from
businesses planning the location of
offices; insurance companies trying to
incorporate climate risk into their
insurance policies; and municipalities
looking to ensure that plans for
construction of new housing
developments will be resilient to
increasing sea level risk, flooding, and
heavy precipitation.
The final pillar of NOAA’s mission is
stewardship. NOAA seeks to conserve
our lands, waters, and natural resources,
protecting people and the environment
now and for future generations. As part
of Commerce, moreover, NOAA
recognizes that economic growth must
go hand-in-hand with environmental
stewardship. For example, with respect
to the nation’s fisheries, NOAA looks
simultaneously to optimize productivity
and ensure sustainability in order to
boost long-term economic growth and
competitiveness in this vital sector of
the U.S. economy. Similarly, national
marine sanctuaries both protect
important natural resources and also are
significant drivers of eco-tourism and
local recreation.
Within NOAA, the National Marine
Fisheries Services (NMFS) and the
National Ocean Service (NOS) are the
components that most often exercise
regulatory authority to implement
NOAA’s mission. NMFS oversees the
management and conservation of the
nation’s marine fisheries; protects
marine mammals and Endangered
Species Act (ESA)-listed marine and
anadromous species; and promotes
economic development of the U.S.
fishing industry. NOS assists the coastal
states in their management of land and
ocean resources in their coastal zones,
including estuarine research reserves;
manages national marine sanctuaries;
monitors marine pollution; and directs
the national program for deep-seabed
minerals and ocean thermal energy.
Much of NOAA’s rulemaking is
conducted pursuant to the following key
statutes:
Magnuson-Stevens Fishery Conservation
and Management Act
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act) rulemakings
concern the conservation and
management of fishery resources in the
U.S. Exclusive Economic Zone
(generally 3–200 nautical miles from
shore). As itemized in the Unified
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Agenda, NOAA plans to take several
hundred actions in FY 2022 under
Magnuson-Stevens Act authority, of
which roughly 20 are expected to be
significant rulemakings, as defined in
Executive Order 12866. With certain
exceptions, rulemakings under
Magnuson-Stevens are usually initiated
by the actions of eight regional Fishery
Management Councils (FMCs or
Councils). These Councils are
comprised of representatives from the
commercial and recreational fishing
sectors, environmental groups,
academia, and Federal and State
government, and they are responsible
for preparing fishery management plans
(FMPs) and FMP amendments, and for
recommending implementing
regulations for each managed fishery.
FMPs address a variety of issues,
including maximizing fishing
opportunities on healthy stocks,
rebuilding overfished stocks, and
addressing gear conflicts. After
considering the FMCs’
recommendations in light of the
standards and requirements set forth in
the Magnuson-Stevens Act and in other
applicable laws, NOAA may issue
regulations to implement the proposed
FMPs and FMP amendments.
Marine Mammal Protection Act
The Marine Mammal Protection Act
of 1972 (MMPA) provides the authority
for the conservation and management of
marine mammals under U.S.
jurisdiction. It expressly prohibits, with
certain exceptions, the intentional take
of marine mammals. The MMPA allows,
upon request and subsequent
authorization, the incidental take of
marine mammals by U.S. citizens who
engage in a specified activity (e.g., oil
and gas development, pile driving)
within a specified geographic region.
NMFS authorizes incidental take under
the MMPA if it finds that the taking
would be of small numbers, have no
more than a ‘‘negligible impact’’ on
those marine mammal species or stock,
and would not have an ‘‘unmitigable
adverse impact’’ on the availability of
the species or stock for ‘‘subsistence’’
uses. NMFS also initiates rulemakings
under the MMPA to establish a
management regime to reduce marine
mammal mortalities and injuries as a
result of interactions with fisheries. In
addition, the MMPA allows NMFS to
permit the take or import of wild
animals for scientific research or public
display or to enhance the survival of a
species or stock.
Endangered Species Act
The Endangered Species Act of 1973
(ESA) provides for the conservation of
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species that are determined to be
‘‘endangered’’ or ‘‘threatened,’’ and the
conservation of the ecosystems on
which these species depend. NMFS and
the Department of Interior’s Fish and
Wildlife Service (FWS) jointly
administer the provisions of the ESA:
NMFS manages marine and several
anadromous species, and FWS manages
land and freshwater species. Together,
NMFS and FWS work to protect
critically imperiled species from
extinction. NMFS rulemaking actions
under the ESA are focused on
determining whether any species under
its responsibility is an endangered or
threatened species and whether those
species must be added to the list of
protected species. NMFS is also
responsible for designating, reviewing
and revising critical habitat for any
listed species. In addition, as indicated
in the list of highlighted actions below,
NMFS and FWS may also issue rules
clarifying how particular provisions of
the ESA will be implemented.
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The National Marine Sanctuaries Act
The National Marine Sanctuaries Act
(NMSA) authorizes the Secretary of
Commerce to designate and protect as
national marine sanctuaries areas of the
marine environment with special
national significance due to their
conservation, recreational, ecological,
historical, scientific, cultural,
archeological, educational, or aesthetic
qualities. The primary objective of the
NMSA is to protect marine resources,
such as coral reefs, sunken historical
vessels, or unique habitats.
NOAA’s Office of National Marine
Sanctuaries (ONMS), within NOS, has
the responsibility for management of
national marine sanctuaries. ONMS
regulations, issued pursuant to NMSA,
prohibit specific kinds of activities,
describe and define the boundaries of
the designated national marine
sanctuaries, and set up a system of
permits to allow the conduct of certain
types of activities that would otherwise
not be allowed.
These regulations can, among other
things, regulate and restrict activities
that may injure natural resources,
including all extractive and destructive
activities, consistent with communityspecific needs and NMSA’s purpose to
‘‘facilitate to the extent compatible with
the primary objective of resource
protection, all public and private uses of
the resources of these marine areas.’’ In
FY 2022, NOAA is expected to have at
least three regulatory actions under
NMSA.
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Coastal Zone Management Act
The Coastal Zone Management Act
(CZMA) was passed in 1972 to preserve,
protect, and develop and, where
possible, to restore and enhance the
resources of the nation’s coastal zone.
The CZMA creates a voluntary statefederal partnership, where coastal states
(States in, or bordering on, the Atlantic,
Pacific or Arctic Ocean, the Gulf of
Mexico, Long Island Sound, or one or
more of the Great Lakes), may elect to
develop comprehensive programs that
meet federal approval standards.
Currently, 34 of the 35 eligible entities
are implementing a federally approved
coastal management plan approved by
the Secretary of Commerce.
NOAA’s Regulatory Plan Actions
Of the numerous regulatory actions
that NOAA is planning for this year and
that are included in the Unified Agenda,
there are five, described below, that the
Department considers to be of particular
importance.
1. Illegal, Unreported, and
Unregulated Fishing; Fisheries
Enforcement; High Seas Driftnet Fishing
Moratorium Protection Act (0648–
BG11): The United States is a signatory
to the Port State Measures Agreement
(PSMA). The agreement is aimed at
combating illegal, unreported, and
unregulated (IUU) fishing activities
through increased port inspection of
foreign fishing vessels and by
preventing the products of illegal
fishing from landing and entering into
commerce. The High Seas Driftnet
Fishing Moratorium Act (Fishing
Moratorium Act) implemented
provisions of the PSMA, and NOAA
issued regulations under the Fishing
Moratorium Act in 2011 and 2013.
Since then, the provisions of the Fishing
Moratorium Act have been amended by
the Illegal, Unreported and Unregulated
Fishing Enforcement Act of 2015 (Pub.
L. 114–81) and the Ensuring Access to
Pacific Fisheries Act (Pub. L. 114–327).
This proposed rule would implement
amendments made by these later two
laws. NMFS will also propose changes
to the definition of IUU fishing for the
purposes of identifying and certifying
nations.
2. Amendments to the North Atlantic
Right Whale Vessel Strike Reduction
Rule (0648–BI88): Regulatory
modifications are needed to further
reduce the likelihood of mortalities and
serious injuries to endangered North
Atlantic right whales from vessel
collisions, which are a primary cause of
the species’ decline and greatly
contributing to the ongoing Unusual
Mortality Event (2017–present).
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Following two decades of growth, the
species has been in decline over the past
decade with a population estimate of
only 368 individuals as of 2019. Vessel
strikes are one of the two primary
causes of North Atlantic right whale
mortality and serious injury across their
range, and human-caused mortality to
adult females in particular is limiting
recovery of the species. Entanglement in
fishing gear is the other primary cause
of mortality and serious injury, which is
being addressed by separate regulatory
actions.
3. Endangered and Threatened
Wildlife and Plants; Revision of the
Regulations for Listing Endangered and
Threatened Species and Designation of
Critical Habitat (0648–BJ44): This action
responds to section 2 of the Executive
Order on Protecting Public Health and
the Environment and Restoring Science
to Tackle the Climate Crisis (E.O. 13990)
and the associated Fact Sheet (List of
Agency Actions for Review). This is a
joint rulemaking by NMFS and the FWS
(the Services) to rescind the regulatory
definition of the term ‘‘habitat.’’ This
previously undefined term was defined
by regulation for the first time in 2020
for the purpose of designating critical
habitat under the ESA. Pursuant to
Executive Order 13990, the Services
also considered the alternatives of
retaining the existing habitat definition
or revising the habitat definition and
will be considering any alternatives
provided during the public comment
period on the proposed rule.
4. Endangered and Threatened
Wildlife and Plants; Regulations for
Listing Species and Designating Critical
Habitat (0648–BK47): This action
responds to section 2 of the Executive
Order on Protecting Public Health and
the Environment and Restoring Science
to Tackle the Climate Crisis (E.O. 13990)
and the associated Fact Sheet (List of
Agency Actions for Review). This is a
joint rulemaking by the Services to
revise joint regulations issued in 2019
implementing section 4 of the ESA.
Specifically addressed in this action are
joint regulations that address the
classification of species as threatened or
endangered and the criteria and process
for designating critical habitat for listed
species. Pursuant to Executive Order
13990, the Services reviewed the
specific regulatory provisions that had
been revised in the 2019 final rule.
Following a review of the 2019 rule, the
Services are proposing to revise a
portion of these regulations but are also
soliciting public comments on all
aspects of the 2019 rule before issuing
a final rule.
5. Endangered and Threatened
Wildlife and Plants; Revision of
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Regulations for Interagency Cooperation
(0648–BK48): This action responds to
section 2 of the Executive Order on
Protecting Public Health and the
Environment and Restoring Science to
Tackle the Climate Crisis (E.O. 13990)
and the associated Fact Sheet (List of
Agency Actions for Review). This is a
joint rulemaking by the Services to
revise joint regulations implementing
section 7 of the ESA, which requires
Federal agencies to consult with the
Services whenever any action the
agency undertakes, funds, or authorizes
may affect endangered or threatened
species or their critical habitat, to
ensure that the action does not
jeopardize listed species or adversely
modify critical habitat. In 2019, the
Services revised various aspects of the
regulations governing the consultation
process under ESA Section 7 including,
significantly, how the Services define
the ‘‘effects of the action,’’ which has
importance for determining the scope of
consultation. Pursuant to Executive
Order 13990, the Services reviewed the
specific regulatory provisions that had
been revised in the 2019 final rule.
Following this review of the 2019 rule,
the Services are proposing to revise a
portion of these regulations, including
‘‘effects of the action,’’ but are also
soliciting public comments on all
aspects of the 2019 rule before issuing
a final rule. In addition to revising
provisions from the 2019 rule, the
Services are proposing to clarify the
responsibilities of a Federal agency and
the Services regarding the requirement
to reinitiate consultation.
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The United States Patent and
Trademark Office
The USPTO’s mission is to foster
innovation, competitiveness, and
economic growth, domestically and
abroad, by delivering high quality and
timely examination of patent and
trademark applications, guiding
domestic and international intellectual
property policy, and delivering
intellectual property information and
education worldwide.
Major Programs and Activities
The USPTO is responsible for
granting U.S. patents and registering
trademarks. This system of secured
property rights, which has its
foundation in Article I, Section 8,
Clause 8, of the Constitution (providing
that Congress shall have the power to
‘‘promote the Progress of Science and
useful Arts, by securing for limited
Times to Authors and Inventors the
exclusive Right to their respective
Writings and Discoveries’’) has enabled
American industry to flourish. New
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products have been invented, new uses
for old ones discovered, and
employment opportunities created for
millions of Americans. The continued
demand for patents and trademarks
underscores the importance to the U.S.
economy of effective mechanisms to
protect new ideas and investments in
innovation, as well as the ingenuity of
American inventors and entrepreneurs.
In addition to granting patents and
trademarks, the USPTO advises the
President of the United States, the
Secretary of Commerce, and U.S.
government agencies on intellectual
property (IP) policy, protection, and
enforcement; and promotes strong and
effective IP protection around the world.
The USPTO furthers effective IP
protection for U.S. innovators and
entrepreneurs worldwide by working
with other agencies to secure strong IP
provisions in free trade and other
international agreements. It also
provides training, education, and
capacity building programs designed to
foster respect for IP and encourage the
development of strong IP enforcement
regimes by U.S. trading partners.
As part of its work, the USPTO
administers regulations located at title
37 of the Code of Federal Regulations
concerning its patent and trademark
services and the other functions it
performs.
The USPTO’s Regulatory Plan Actions
1. Final Rule: Changes to Implement
Provisions of the Trademark
Modernization Act of 2020 (0651–
AD55): The USPTO amends the rules of
practice in trademark cases to
implement provisions of the Trademark
Modernization Act of 2020. This rule
establishes ex parte expungement and
reexamination proceedings for
cancellation of a registration when the
required use in commerce of the
registered mark has not been made;
provides for a new nonuse ground for
cancellation before the Trademark Trial
and Appeal Board; establishes flexible
USPTO action response periods; and
amends the existing letter-of-protest rule
to indicate that letter-of-protest
determinations are final and nonreviewable. The rule also sets fees for
petitions requesting institution of ex
parte expungement and reexamination
proceedings, and for requests to extend
USPTO action response deadlines.
The two new ex parte proceedings
created by this rulemaking—one for
expungement and one for
reexamination—are intended to help
ensure the accuracy of the trademark
register by providing a new mechanism
for removing a registered mark from the
trademark register or cancelling the
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registration as to certain goods and/or
services, when the registrant has not
used the mark in commerce. The
proposed changes will give U.S.
businesses new tools to clear away
unused registered trademarks from the
federal trademark register and will give
the USPTO the ability to move
applications through the system more
efficiently.
Bureau of Industry and Security
BIS advances U.S. national security,
foreign policy, and economic objectives
by maintaining and strengthening
adaptable, efficient, and effective export
control and treaty compliance systems
as well as by administering programs to
prioritize certain contracts to promote
the national defense and to protect and
enhance the defense industrial base.
Major Programs and Activities
BIS administers four sets of
regulations. The Export Administration
Regulations (EAR) regulate exports and
reexports to protect national security,
foreign policy, and short supply
interests. The EAR includes the
Commerce Control List (CCL), which
describes commodities, software, and
technology that are subject to licensing
requirements for specific reasons for
control. The EAR also regulates U.S.
persons’ participation in certain
boycotts administered by foreign
governments. The National Security
Industrial Base Regulations provide for
prioritization of certain contracts and
allocations of resources to promote the
national defense, require reporting of
foreign government-imposed offsets in
defense sales, provide for surveys to
assess the capabilities of the industrial
base to support the national defense,
and address the effect of imports on the
defense industrial base. The Chemical
Weapons Convention Regulations
implement declaration, reporting, and
on-site inspection requirements in the
private sector necessary to meet United
States treaty obligations under the
Chemical Weapons Convention treaty.
The Additional Protocol Regulations
implement similar requirements for
certain civil nuclear and nuclear-related
items with respect to an agreement
between the United States and the
International Atomic Energy Agency.
BIS also has an enforcement
component with nine offices covering
the United States, as well as BIS export
control officers stationed at several U.S.
embassies and consulates abroad. BIS
works with other U.S. Government
agencies to promote coordinated U.S.
Government efforts in export controls
and other programs. BIS participates in
U.S. Government efforts to strengthen
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multilateral export control regimes and
promote effective export controls
through cooperation with other
governments.
In FY 2022, BIS plans to publish a
number of proposed and final rules
amending the EAR. These rules will
cover a range of issues, including
emerging and foundational technology,
country specific policies, CCL revisions
based on decisions by the four
multilateral export control regimes
(Australia Group, Missile Technology
Control Regime, Nuclear Suppliers
Group, and Wassenaar Arrangement),
and implementation of any interagency
agreed transfers from the United States
Munitions List to the CCL.
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BIS’s Regulatory Plan Actions
1. Authorization of Certain ‘‘Items’’ to
Entities on the Entity List in the Context
of Specific Standards Activities (0694–
AI06): BIS is amending the EAR to
clarify its applicability to releases of
technology for standards setting or
development to support U.S.
participation in standards efforts.
2. Commerce Control List:
Implementation of Controls on
‘‘Software’’ Designed for Certain
Automated Nucleic Acid Assemblers
and Synthesizers (0694–AI08): BIS is
publishing this final rule to amend the
CCL by adding a new Export Control
Classification Number (ECCN) 2D352 to
control software that is designed for
automated nucleic acid assemblers and
synthesizers controlled under ECCN
2B352.j and capable of designing and
building functional genetic elements
from digital sequence data. These
amendments to the CCL are based upon
a finding, consistent with the emerging
and foundational technologies
interagency process set forth in section
1758 of the Export Control Reform Act
of 2018 (ECRA) (50 U.S.C. 4817), that
such software is capable of being
utilized in the production of pathogens
and toxins and, consequently, the
absence of export controls on such
software could be exploited for
biological weapons purposes.
3. Information Security Controls:
Cybersecurity Items (0694–AH56): In
2013, the Wassenaar Arrangement (WA),
a multilateral export control regime in
which the United States participates,
added cybersecurity items to the WA
List, including a definition for
‘‘intrusion software.’’ In 2015, public
comments on a BIS proposed
implementation rule revealed serious
issues concerning scope and
implementation regarding these
controls. Based on these comments, as
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well as substantial commentary from
Congress, the private sector, academia,
civil society, and others on the potential
unintended consequences of the 2013
controls, the U.S. government returned
to the WA to renegotiate the controls.
This interim final rule outlines the
progress the United States has made in
this area, revises implementation, and
requests from the public information
about the impact of these revised
controls on U.S. industry and the
cybersecurity community. These items
warrant controls because these tools
could be used for surveillance,
espionage, or other actions that disrupt,
deny or degrade the network or devices
on it.
4. Imposition of Export Controls on
Certain Brain-Computer Interface (BCI)
Emerging Technology (0694–AI41):
Section 1758 of ECRA, as codified under
50 U.S.C. 4817, authorizes BIS to
establish appropriate controls on the
export, reexport or transfer (in-country)
of emerging and foundational
technologies. Pursuant to ECRA, BIS has
identified Brain Computer Interface
technology as part of a representative
list of technology categories for which
BIS will seek public comment to
determine whether this is an emerging
technology that is important to U.S.
national security and for which effective
controls can be implemented. In this
Advance Notice of Proposed
Rulemaking, BIS is seeking comments
specifically concerning whether this
technology could provide the United
States, or any of its adversaries, with a
qualitative military or intelligence
advantage. In addition, BIS is seeking
public comments on how to ensure that
the scope of any controls that may be
imposed on this technology in the
future would be effective and
appropriate with respect to their
potential impact on legitimate
commercial or scientific applications.
5. Foundational Technologies:
Proposed Controls (0694–AH80): BIS is
considering expanding controls on
certain foundational technologies.
Foundational technologies may be items
that are currently subject to control for
military end use or military end user
reasons. Additionally, foundational
technologies may be additional items,
for which an export license is generally
not required (except for certain
countries), that also warrant review to
determine if they are foundational
technologies essential to the national
security. For example, such controls
may be reviewed if the items are being
utilized or are required for innovation in
developing conventional weapons or
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enabling foreign intelligence collection
activities or weapons of mass
destruction applications. In an effort to
address this concern, this proposed rule
would amend the CCL by adding
controls on certain aircraft reciprocating
or rotary engines and powdered metals
and alloys. This rule requests public
comments to ensure that the scope of
these proposed controls will be effective
and appropriate, including with respect
to their potential impact on legitimate
commercial or scientific applications.
6. Removal of Certain General
Approved Exclusions (GAEs) Under the
Section 232 Steel and Aluminum Tariff
Exclusions Process (0694–AH55): On
December 14, 2020, BIS published an
interim final rule (the December 14 rule)
that revised aspects of the process for
requesting exclusions from the duties
and quantitative limitations on imports
of aluminum and steel discussed in
three previous Commerce interim final
rules implementing the exclusion
process authorized by the President
under section 232 of the Trade
Expansion Act of 1962, as amended
(232), as well as a May 26, 2020, notice
of inquiry. The December 14 rule added
123 General Approved Exclusions
(GAEs) to the regulations. The addition
of GAEs was an important step in
improving the efficiency and
effectiveness of the 232 exclusions
process for certain Harmonized Tariff
Schedule of the United States (HTSUS)
codes for steel and aluminum that had
not received objections. Commerce
determined it could authorize imports
under GAEs for these specified HTSUS
codes for all importers instead of
requiring each importer to submit an
exclusion request. Subsequently, based
on Commerce’s review of the public
comments received in response to the
December 14 rule and additional
analysis conducted by Commerce of 232
exclusion request submissions,
Commerce determined that a subset of
the GAEs added in the December 14 rule
did not meet the criteria for inclusion as
a GAE and should therefore be removed.
Commerce is removing these GAEs in
this interim final rule to ensure that
only those GAEs that meet the stated
criteria from the December 14 rule will
continue to be included as eligible
GAEs. Lastly, this interim final rule
makes two conforming changes to the
GAE list for a recent change to one
HTSUS classification and adds a
footnote to both GAE supplements to
address future changes to the HTSUS.
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DOC—BUREAU OF INDUSTRY AND
SECURITY (BIS)
Prerule Stage
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9. Request for Comments Concerning
the Imposition of Export Controls on
Certain Brain–Computer Interface (BCI)
Emerging Technology
Priority: Other Significant.
Legal Authority: 50 U.S.C.
4817(a)(2)(C)
CFR Citation: None.
Legal Deadline: None.
Abstract: Section 1758 of the Export
Control Reform Act of 2018 (ECRA), as
codified under 50 U.S.C. 4817,
authorizes BIS to establish appropriate
controls on the export, reexport or
transfer (in-country) of emerging and
foundational technologies. Pursuant to
ECRA, BIS has identified Brain
Computer Interface (BCI) technology as
part of a representative list of
technology categories concerning which
BIS, through an interagency process,
seeks public comment to determine
whether this technology represents an
emerging technology that is important to
U.S. national security and for which
effective controls can be implemented.
Specifically, BIS is seeking comments
concerning whether this technology
could provide the United States, or any
of its adversaries, with a qualitative
military or intelligence advantage. In
addition, BIS is seeking public
comments on how to ensure that the
scope of any controls that may be
imposed on this technology in the
future would be effective and
appropriate (with respect to their
potential impact on legitimate
commercial or scientific applications).
Statement of Need: The Bureau of
Industry and Security (BIS) is
publishing this ANPRM to obtain public
comments on the potential uses of
Brain-Computer Interface (BCI)
technology, which includes, inter alia,
neural-controlled interfaces, mindmachine interfaces, direct neural
interfaces, and brain-machine interfaces.
On November 19, 2018, BIS published
an ANPRM (83 FR 58201) that identified
BCI technology as part of a
representative list of technology
categories concerning which BIS,
through an interagency process, sought
public comments to determine whether
there are specific emerging technologies
that are essential to U.S. national
security and for which effective controls
can be implemented.
Additional input from the public is
needed to assist in the interagency
process of evaluating BCI technology as
a potential emerging technology and to
determine if there are specific BCI
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technologies for which export controls
would be appropriate. The public’s
responses to the questions posed in this
ANPRM will be considered during the
aforementioned interagency process to
evaluate BCI technology as a potential
emerging technology and to ensure that
the scope of any controls that may be
imposed on this technology would be
effective (in terms of protecting U.S.
national security interests) and
appropriate (with respect to minimizing
their potential impact on legitimate
commercial or scientific applications).
Summary of Legal Basis: Section
1758(a) of the Export Control Reform
Act (ECRA) of 2018 (50 U.S.C. 4817(a))
outlines an interagency process for
identifying emerging and foundational
technologies. BCI technology has been
identified as a technology for evaluation
as a potential emerging technology,
consistent with the interagency process
described in section 1758 of ECRA.
Consequently, BIS is publishing this
ANPRM to obtain feedback from the
public and U.S. industry concerning
whether such technology could provide
the United States, or any of its
adversaries, with a qualitative military
or intelligence advantage.
Alternatives: The Secretary of
Commerce must establish appropriate
controls on the export, reexport or
transfer (in-country) of technology
identified pursuant to the section 1758
process. In so doing, the Secretary must
consider the potential end-uses and
end-users of emerging and foundational
technologies, and the countries to which
exports from the United States are
restricted (e.g., embargoed countries).
While the Secretary has discretion to set
the level of export controls, at a
minimum a license must be required for
the export of such technologies to
countries subject to a U.S. embargo,
including those countries subject to an
arms embargo.
If the interagency process results in a
determination that certain BCI
technology constitutes an emerging
technology, for purposes of section 1758
of ECRA, then BIS is required, pursuant
to ECRA to institute export controls on
such technology. However, BIS does
have some flexibility to ensure that the
scope of any controls that may be
imposed on this technology would be
effective (in terms of protecting U.S.
national security interests) and
appropriate (with respect to minimizing
their potential impact on legitimate
commercial or scientific applications).
Anticipated Cost and Benefits: This
ANPRM is being published by BIS to
assist in evaluating, not only whether
certain BCI technology is an emerging
technology, but also to obtain
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information from the public to assist in
evaluating how the implementation of
export controls on such technology
would impact U.S. industry, in terms of
both its economic and technological
competitiveness. In short, this ANPRM
is intended to assist, as part of the
aforementioned interagency process, in
evaluating the anticipated costs and
benefits of imposing export controls on
certain BCI technology.
Risks: The risks of imposing export
controls on certain BCI technology
would be to hurt the economic and
technological competitiveness of U.S.
industry, which is one of the primary
reasons that BIS is soliciting comments
from the public in accordance with this
ANPRM. There are also risks to U.S.
national security and to U.S. industry
should such technology fall into the
hands of our adversaries.
Timetable:
Action
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
Date
10/26/21
12/10/21
FR Cite
86 FR 59070
03/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Willard Fisher,
Export Administration Specialist,
Department of Commerce, Bureau of
Industry and Security, 14th Street and
Pennsylvania Avenue NW, Washington,
DC 20230, Phone: 202 482–2440, Fax:
202 482–3355, Email: willard.fisher@
bis.doc.gov.
RIN: 0694–AI41
DOC—BIS
Proposed Rule Stage
10. Foundational Technologies:
Proposed Controls; Request for
Comments
Priority: Other Significant.
Legal Authority: 50 U.S.C. 4801 to
4852
CFR Citation: 15 CFR 742; 15 CFR
774.
Legal Deadline: None.
Abstract: The Bureau of Industry and
Security (BIS), the Department of
Commerce, maintains controls on the
export, reexport, and transfer (incountry) of dual-use and less sensitive
military items through the Export
Administration Regulations (EAR),
including the Commerce Control List
(CCL). Foundational technologies may
be items that are currently subject to
control for military end use or military
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end user reasons. Additionally,
foundational technologies may be
additional items, for which an export
license is not required (except for
certain countries) that also warrant
review to determine if they are
foundational technologies essential to
the national security. For example, such
controls may be reviewed if the items
are being utilized or required for
innovation in developing conventional
weapons or enabling foreign intelligence
collection activities or weapons of mass
destruction applications. In an effort to
address this concern, this rule proposes
to amend the CCL with identified
foundational technologies. This rule
requests public comments to ensure that
the scope of these proposed controls
will be effective and appropriate,
including with respect to their potential
impact on legitimate commercial or
scientific applications.
Statement of Need: As part of the
National Defense Authorization Act
(NDAA) for Fiscal Year 2019 (Pub. L.
115–232), Congress enacted the Export
Control Reform Act of 2018 (ECRA) (50
U.S.C. 4817). Section 1758 of ECRA
authorizes the Bureau of Industry and
Security (BIS) to establish appropriate
controls on the export, reexport, or
transfer (in-country) of emerging and
foundational technologies. With this
proposed rule, BIS continues to identify
technologies that may warrant more
restrictive controls than they have at
present and establishes a control
framework applicable to certain
unilaterally-controlled emerging and
foundational technologies.
Summary of Legal Basis: There are a
variety of legal authorities under which
BIS operates. However, ECRA (50 U.S.C.
4817) provides the most substantive
legal basis for BIS’s actions under this
proposed rule.
Alternatives: There are not
alternatives to this rule. This rule serves
as the first tranche of controls
specifically outlining foundational
technologies.
Anticipated Cost and Benefits: The
anticipated costs and benefits of this
proposed rule are not applicable.
Risks: There are no applicable risks to
this proposed rule.
Timetable:
Action
Date
ANPRM ...............
ANPRM Correction and Comment Extension.
ANPRM Comment
Period End.
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10/09/20
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85 FR 52934
85 FR 64078
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Action
Date
ANPRM Correction and Comment Extension
Period End.
NPRM ..................
FR Cite
11/09/20
08/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Logan D. Norton,
Department of Commerce, Bureau of
Industry and Security, 1401
Constitution Avenue, Washington, DC
20230, Phone: 202 812–1762, Email:
logan.norton@bis.doc.gov.
RIN: 0694–AH80
DOC—BIS
Final Rule Stage
11. Removal of Certain General
Approved Exclusions (GAEs) Under the
Section 232 Steel and Aluminum Tariff
Exclusions Process
Priority: Other Significant.
Legal Authority: 19 U.S.C. 1862
CFR Citation: 15 CFR 705.
Legal Deadline: None.
Abstract: On December 14, 2020, the
Department of Commerce published an
interim final rule (December 14 rule)
that revised aspects of the process for
requesting exclusions from the duties
and quantitative limitations on imports
of aluminum and steel. The December
14 rule added 123 General Approved
Exclusions (GAEs) to the regulations.
The addition of GAEs was an important
step in improving the efficiency and
effectiveness of the 232 exclusions
process for certain Harmonized Tariff
Schedule of the United States (HTSUS)
codes for steel and aluminum that had
not received objections. Subsequently,
based on Commerce’s review of the
public comments received in response
to the December 14 rule and additional
analysis conducted by Commerce of 232
submissions, Commerce determined
that a subset of the GAEs added in the
December 14 rule did not meet the
criteria for inclusion as a GAE and
should therefore be removed. Commerce
is removing these GAEs in today’s
interim final rule to ensure that only
those GAEs that meet the stated criteria
from the December 14 rule will continue
to be included as eligible GAEs.
Statement of Need: On December 14,
2020, the Department of Commerce
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5025
published an interim final rule (the
December 14 rule) that revised aspects
of the process for requesting exclusions
from the duties and quantitative
limitations on imports of aluminum and
steel discussed in three previous
Department of Commerce (Commerce)
interim final rules implementing the
exclusion process authorized by the
President under section 232 of the Trade
Expansion Act of 1962, as amended
(232), as well as a May 26, 2020 notice
of inquiry. The December 14 rule
included adding 123 General Approved
Exclusions (GAEs) to the regulations.
The addition of GAEs was an important
step in improving the efficiency and
effectiveness of the 232 exclusions
process. Commerce selected certain
steel and aluminum articles under select
Harmonized Tariff Schedule of the
United States (HTSUS) codes as GAEs
on the basis that exclusion requests
submitted for the specified HTSUS
codes had not received objections from
domestic industry in the 232 exclusions
process.
Commerce is publishing this interim
final rule to remove a subset of General
Approved Exclusions (GAEs) added in
the December 14 rule after public
comments on the December 14 rule and
subsequent Commerce analysis of data
in the 232 Exclusions Portal identified
these HTSUS codes as not meeting the
criteria for inclusion as a GAE. These
cases include HTSUS codes with
exclusion requests that recently
received objections and/or denials in
the 232 Exclusions Portal. Commerce is
removing these GAEs in this interim
final rule to ensure that only those GAEs
that meet the stated criteria from the
December 14 rule will continue to be
included as eligible GAEs.
Summary of Legal Basis: The legal
basis of this rule is section 232 of the
Trade Expansion Act of 1962, as
amended (19 U.S.C. 1862) and Reorg.
Plan No. 3 of 1979 (44 FR 69273,
December 3, 1979). This rule is also
implementing the directive included in
Proclamations 9704 and 9705 of March
8, 2018. As explained in the reports
submitted by the Secretary to the
President, steel and aluminum are being
imported into the United States in such
quantities or under such circumstances
as to threaten to impair the national
security of the United States, and
therefore the President is implementing
these remedial actions (as described
Proclamations 9704 and 9705 of March
8, 2018) to protect U.S. national security
interests. That implementation includes
the creation of an effective process by
which affected domestic parties can
obtain exclusion requests based upon
specific national security
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considerations. Commerce started this
process with the publication of the
March 19 rule and refined the process
with the publication of the September
11, June 10, and December 14 rules and
is continuing the process with the
publication of today’s interim final rule.
The revisions to the exclusion request
process are informed by the comments
received in response to the December 14
rule and Commerce’s experience with
managing the 232 exclusions process.
Alternatives: Alternatives to doing
this rule would include not publishing
the rule. The public has the ability to
apply for exclusion requests, so instead
of creating GAEs, the public could be
told to rely on the existing exclusions
process. However, numerous
commenters on the 232 interim final
rules that have been published have
emphasized the need for making
improvements in the efficiency,
transparency, and fairness of the 232
exclusion process and had suggested the
creation of a GAE type of approval as
part of the 232 exclusions process
would benefit the program. Commenters
on the December 14 rule identified
certain GAE eligible items that they
believed did not meet the stated criteria
for what should be eligible for be
authorized under a GAE. Commerce
after reviewing those comments and
conducting its own additional analysis
agrees that certain items identified
under the current GAEs no longer reflect
the GAE criteria and therefore should be
removed, so the alternative of not doing
a rule or the option of removing the
GAE approvals completely are not
viable options for achieving the
intended policy objectives that
Commerce is trying to fulfill with
having a more effective exclusion
process.
Anticipated Cost and Benefits: For the
anticipated costs, this rule is expected
to increase the burden hours for one of
the collections associated with this rule,
OMB control number 0694–0139. This
increase is expected because of the
removal of certain GAEs for steel and
GAEs for aluminum, which is expected
to result in an increase of 1,100
exclusion request submissions per year.
These removals are estimated to result
in a twenty percent reduction in the
burden and costs savings described in
the December 14 rule. These GAE
removals are expected to be an increase
in 1,100 burden hours for a total cost
increase of 162,800 dollars to the public.
There is also expected to be an increase
in 6,600 burden hours for a total cost
increase of 257,000 dollars to the U.S.
Government. As Commerce asserted in
the December 14 rule that the steel and
aluminum articles identified as being
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eligible for GAEs, including those being
removed in today’s rule, had not
received any objections, the addition of
those new GAEs was not estimated to
result in a decrease in the number of
objections, rebuttals, or surrebuttals
received by BIS. As described elsewhere
in this rule, the GAEs removed in
today’s interim final rule did receive
objections and/or denials and therefore
warrant removal at this time. Because
the December 14 rule did not make any
adjustments to the collections for
objections, rebuttals, or surrebuttals, the
removal of these GAEs is estimated to
result in no change in the burden
associated with the other three
collections.
For the anticipated benefits, these
changes will ensure the effectiveness of
the GAEs under the 232 exclusions
process. By ensuring that only those
GAEs that meet the stated criteria for
what should be considered a GAE, will
help improve the effectiveness, fairness
and transparency of the 232 exclusions
process. Importers and other users of
steel and aluminum in the U.S. and U.S.
producers and steel and aluminum have
comments in response to the various
section 232 interim final rules
published that creating an effective 232
exclusion process is key to reduce
burdens on the public. The adoption of
the GAEs was an important step in
improving efficiency, but in order
ensure U.S. national security interests
are protected, only items that meet the
GAE criteria should be eligible and any
other item should be required to be
included in the normal 232 exclusion
process.
Risks: If this interim final rule were to
be delayed, companies in the United
States would be unable to immediately
benefit from the improvements made to
the GAE process and could face
significant economic hardship, which
could potentially create a detrimental
effect on the general U.S. economy and
national security. Comments received
on the December 14 rule that were
critical of the GAEs were clear that the
removal of GAEs that consisted of
HTSUS codes that received objections
and/or denials under the 232 process
was needed. Commenters noted that
failure to provide this additional
improvement could allow the floodgates
to open for imports of those articles, and
that the influx of such articles could
undermine the efficiency of the 232
process. Commenters also noted that if
this specific improvement is not made,
significant economic consequences
could occur. Given the imports of these
articles have already been objected to
and/or denied in exclusion requests
under the 232 process for national
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security reasons, allowing these specific
GAEs to exist could undermine other
critical U.S. national security interests.
Timetable:
Action
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Effective.
Interim Final Rule
Date
03/19/18
03/19/18
FR Cite
83 FR 12106
05/18/18
09/11/18
09/11/18
83 FR 46026
11/13/18
06/10/19
06/13/19
84 FR 26751
08/09/19
12/14/20
12/14/20
85 FR 81060
12/29/20
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Timothy Mooney,
Export Policy Analyst, Department of
Commerce, Bureau of Industry and
Security, 14th Street and Pennsylvania
Avenue NW, Washington, DC 20230,
Phone: 202 482–3371, Fax: 202 482–
3355, Email: timothy.mooney@
bis.doc.gov.
RIN: 0694–AH55
DOC—BIS
12. Information Security Controls:
Cybersecurity Items
Priority: Other Significant.
Legal Authority: 10 U.S.C. 7420; 10
U.S.C. 7430(e); 15 U.S.C. 1824a; 22
U.S.C. 287c; 22 U.S.C. 3201 et seq.; 22
U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; 30 U.S.C. 185(s); 30 U.S.C.
185(u); 42 U.S.C. 2139a; 43 U.S.C. 1354;
50 U.S.C. 1701 et seq.; 50 U.S.C. 4305;
50 U.S.C. 4601 et seq.; E.O. 12058; E.O.
12851; E.O. 12938; E.O. 13026; E.O.
13222; Pub. L. 108–11
CFR Citation: 15 CFR 740; 15 CFR
742; 15 CFR 772; 15 CFR 774.
Legal Deadline: None.
Abstract: In 2013, the Wassenaar
Arrangement (WA) added cybersecurity
items to the WA List, including a
definition for ‘‘intrusion software.’’ On
May 20, 2015, the Bureau of Industry
and Security (BIS) published a proposed
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rule describing how these new controls
would fit into the Export
Administration Regulations (EAR) and
requested information from the public
about the impact on U.S. industry. The
public comments on the proposed rule
revealed serious issues concerning
scope and implementation regarding
these controls. Based on these
comments, as well as substantial
commentary from Congress, the private
sector, academia, civil society, and
others on the potential unintended
consequences of the 2013 controls, the
U.S. government returned to the WA to
renegotiate the controls. This interim
final rule outlines the progress the
United States has made in this area,
revised Commerce Control List (CCL)
implementation, and requests from the
public information about the impact of
these revised controls on U.S. industry
and the cybersecurity community.
Statement of Need: In 2013, the
Wassenaar Arrangement (WA) added
cybersecurity items to the WA List,
including a definition for intrusion
software. On May 20, 2015, the Bureau
of Industry and Security (BIS) published
a proposed rule describing how these
new controls would fit into the Export
Administration Regulations (EAR) and
requested information from the public
about the impact on U.S. industry. The
public comments on the proposed rule
revealed serious issues concerning
scope and implementation regarding
these controls. Based on these
comments, as well as substantial
commentary from Congress, the private
sector, academia, civil society, and
others on the potential unintended
consequences of the 2013 controls, the
U.S. government returned to the WA to
renegotiate the controls. This interim
final rule outlines the progress the
United States has made in this area,
implements revised Commerce Control
List (CCL) text, establishes a new
License Exception Authorized
Cybersecurity Exports (ACE) and
requests from the public information
about the impact of these revised
controls on U.S. industry and the
cybersecurity community.
Summary of Legal Basis: On August
13, 2018, the President signed into law
the John S. McCain National Defense
Authorization Act for Fiscal Year 2019,
which included the Export Control
Reform Act of 2018 (ECRA), 50 U.S.C.
4801–4852. ECRA provides the legal
basis for BIS’s principal authorities and
serves as the authority under which BIS
issues this rule.
Alternatives: As noted above, BIS
does not believe that the amendments in
this rule, will have a significant
economic impact on a substantial
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number of small entities. Nevertheless,
consistent with 5 U.S.C. 603(c), BIS
considered significant alternatives to
these amendments to assess whether the
alternatives would: (1) Accomplish the
stated objectives of this rule (consistent
with the requirements in ECRA); and (2)
minimize any significant economic
impact of this rule on small entities. BIS
could have implemented a much
broader control on software capable of
cybersecurity controlled under ECCNs
4A005, 4D004, 4E001, 4E001, and
5A001 that would have captured a
greater amount of such software and
related technology. That in turn would
have had a greater impact not only on
small businesses, but also on research
and development laboratories (both
academic and corporate), which are
involved in network security. BIS has
determined that implementing focused
controls on specific software and related
technology (i.e., the software controlled
under new ECCN 4A005, 4D004,
4E001.a, 4E001.c, and 5A001.j and
corresponding development technology
in ECCN 5E001) is the least disruptive
alternative for implementing export
controls in a manner consistent with
controlling technology that has been
determined, through the interagency
process authorized under ECRA, to be
essential to U.S. national security. BIS is
not implementing different compliance
or reporting requirements for small
entities. If a small business is subject to
a compliance requirement for the
export, reexport or transfer (in-country)
of this software and related technology,
then it would submit a license
application using the same process as
any other business (i.e., electronically
via SNAPR). The license application
process is free of charge to all entities,
including small businesses. In addition,
as noted above, the resources and other
compliance tools made available by BIS
typically serve to lessen the impact of
any EAR license requirements on small
businesses.
Anticipated Cost and Benefits: For the
existing ECCNs included in this rule
(4D001, 4E001, 5A001, 5A004, 5D001,
5E001), the 2020 data from U.S.
Customs and Border Protection’s
Automated Export System (AES) shows
980 shipments valued at $39,146,164.
Of those shipments, 120 shipments
valued at $1,864,699 went to Country
Group D:1 or D:5 countries, which
would make them ineligible for License
Exception ACE. There were no
shipments to Country Group E:1 or E:2.
Under the provisions of this rule, the
120 shipments require a license
application submission to BIS.
As there is no specific ECCN data in
AES for the new export controls in new
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ECCNs 4A005 and 4D004 or new
paragraph 4E001.c, BIS uses other data
to estimate the number of shipments of
these new ECCNs that will require a
license. Bureau of Economic Analysis
(BEA) data from 2019 show a total
dollar value of $55,657 million for
Telecom, Computer, and Information
Technology Services exports.
Multiplying this value by 12.1% (the
percentage of all exports that are subject
to an EAR license requirement as
determined by using AES data) suggests
that $6,734,497,000 of Telecom/
Computer/IT exports are now subject to
EAR license requirements. Based on
AES data on the existing ECCNs affected
by this rule, BIS estimates the average
value of each shipment for the new
ECCNs at about $40,000, and further
estimates that 0.6% of all new ECCN
shipments (1,010 shipments) are now
eligible for License Exception ACE and
0.03% of all new ECCN shipments (50
shipments) require a license application
submission. Therefore, the annual total
estimated cost associated with the
paperwork burden imposed by this rule
(that is, the projected increase of license
application submissions based on the
additional shipments requiring a
license) is estimated to be 170 new
applications × 29.6 minutes = 5,032/60
min = 84 hours × $30 = $2,520.
There is no paperwork submission to
BIS associated with using License
Exception ACE, and therefore there is
no increase to any paperwork burden or
information collection cost associated
with License Exception ACE
requirements in this rule.
Benefit: Cybersecurity items in the
wrong hands raise both national
security and foreign policy concerns.
The benefit of publishing these
revisions and controlling cybersecurity
items in the way contemplated by this
rule is that national security and foreign
policy concerns are addressed, in that
these regulations assist in keeping such
items out of the hands of those that
would use them for nefarious end uses,
while at the same time not disrupt
legitimate cybersecurity exports.
Risks: The risks of publishing this rule
is that it has unexpected consequences,
which is why there is a 90 day delayed
effective date and 45 day comment
period that will allow the public to
comment on the rule.
Timetable:
Action
Interim Final Rule
Interim Final Rule
Comment Period End.
Interim Final Rule
Effective.
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Date
10/21/21
12/06/21
01/19/22
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Action
Date
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Next Action Undetermined.
FR Cite
02/00/22
Action
Date
Interim Final Rule
Comment Period End.
Final Action .........
FR Cite
08/17/20
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Sharron Cook, Policy
Analyst, Department of Commerce,
Bureau of Industry and Security, 14th
Street and Pennsylvania Avenue NW,
Washington, DC 20230, Phone: 202 482–
2440, Fax: 202 482–3355, Email:
sharron.cook@bis.doc.gov.
Related RIN: Related to 0694–AG49.
RIN: 0694–AH56
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Hillary Hess,
Department of Commerce, Bureau of
Industry and Security, 1401
Constitution Avenue, Washington, DC
20230, Phone: 202 482–4819, Email:
hillary.hess@bis.doc.gov.
RIN: 0694–AI06
DOC—BIS
DOC—BIS
13. Authorization of Certain ‘‘Items’’ to
Entities on the Entity List in the Context
of Specific Standards Activities
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 50 U.S.C. 4801 to
4852; 50 U.S.C. 4601 et seq.; 50 U.S.C.
1701 et seq.; E.O. 12938
CFR Citation: 15 CFR 734.
Legal Deadline: None.
Abstract: The Bureau of Industry and
Security (BIS) is amending the Export
Administration Regulations (EAR) to
clarify the applicability of the Export
Administration Regulations (EAR) to
releases of technology for standards
setting or development in standards
organizations.
Statement of Need: The Bureau of
Industry and Security (BIS) is amending
the Export Administration Regulations
(EAR) to clarify the applicability of the
Export Administration Regulations
(EAR) to releases of technology for
standards setting or development to
support U.S. participation in standards
efforts.
Summary of Legal Basis: There are a
variety of legal authorities under which
BIS operates. However, ECRA (50 U.S.C.
4817) provides the most substantive
legal basis for BIS’s actions under this
rule.
Alternatives: There are not
alternatives to this rule.
Anticipated Cost and Benefits: The
anticipated costs and benefits of this
proposed rule are not applicable.
Risks: There are no applicable risks to
this rule.
Timetable:
14. Commerce Control List: Expansion
of Controls on Certain Biological
Equipment ‘‘Software’’
Priority: Other Significant.
Legal Authority: 50 U.S.C. 4801 to
4852; 50 U.S.C. 4601 et seq.; 50 U.S.C.
1701 et seq.; 10 U.S.C. 8720
CFR Citation: 15 CFR 774.
Legal Deadline: None.
Abstract: BIS is publishing this final
rule to amend the Commerce Control
List (CCL) by adding a new Export
Control Classification Number (ECCN)
2D352 to control ‘‘software’’ that is
designed for automated nucleic acid
assemblers and synthesizers controlled
under ECCN 2B352 and is capable of
designing and building functional
genetic elements from digital sequence
data. These proposed amendments to
the CCL are based upon a finding,
consistent with the emerging and
foundational technologies interagency
process set forth in section 1758 of
ECRA (50 U.S.C. 4817), that such
‘‘software’’ is capable of being utilized
in the production of pathogens and
toxins and, consequently, the absence of
export controls on such software could
be exploited for biological weapons
purposes. In addition, this rule amends
ECCN 2E001 to indicate that this ECCN
controls ‘‘technology’’ for the
‘‘development’’ of ‘‘software’’ described
in the new ECCN 2D352.
Statement of Need: The Bureau of
Industry and Security (BIS) is
publishing this final rule to amend the
Export Administration Regulations
(EAR) to implement the decision made
at the Australia Group (AG) Virtual
Implementation Meeting session held in
May 2021, and later adopted pursuant to
the AG’s silence procedure. This
decision updated the AG Common
Control List for dual-use biological
equipment by adding controls on
Action
Date
Interim Final Rule
Interim Final Rule
Effective.
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06/18/20
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nucleic acid assembler and synthesizer
software that is capable of designing and
building functional genetic elements
from digital sequence data.
Prior to the addition of nucleic acid
assembler/synthesizer software to the
AG biological equipment list, BIS
identified this software as a technology
to be evaluated as an emerging
technology, consistent with the
interagency process described in section
1758 of the Export Control Reform Act
of 2018 (ECRA) (codified at 50 U.S.C.
4817). This identification was based on
a finding that this software is capable of
being used to operate nucleic acid
assemblers and synthesizers controlled
under ECCN 2B352 for the purpose of
generating pathogens and toxins
without the need to acquire controlled
genetic elements and organisms.
Consequently, the absence of export
controls on this software could be
exploited for biological weapons
purposes.
Summary of Legal Basis: Section
1758(a) of the Export Control Reform
Act (ECRA) of 2018 (50 U.S.C. 4817(a))
outlines an interagency process for
identifying emerging and foundational
technologies. Nucleic acid synthesizer
software has been identified as a
technology for evaluation as a potential
emerging technology, consistent with
the interagency process described in
section 1758 of ECRA. Consequently,
BIS published a proposed rule on
November 6, 2020 (85 FR 71012), to
provide the public with notice and the
opportunity to comment on adding a
new ECCN 2D352 to control software for
the operation of nucleic acid assemblers
and synthesizers described in ECCN
2B352.j that is capable of designing and
building functional genetic elements
from digital sequence data. Subsequent
to the publication of this proposed rule,
the Australia Group (AG) added this
software to their biological equipment
Common Control List. This final rule
amends the EAR to reflect the action
taken by the AG.
Alternatives: The Secretary of
Commerce must establish appropriate
controls on the export, reexport or
transfer (in-country) of technology
identified pursuant to the Section 1758
process. In so doing, the Secretary must
consider the potential end-uses and
end-users of emerging and foundational
technologies, and the countries to which
exports from the United States are
restricted (e.g., embargoed countries).
While the Secretary has discretion to set
the level of export controls, at a
minimum a license must be required for
the export of such technologies to
countries subject to a U.S. embargo,
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including those countries subject to an
arms embargo.
If the interagency process results in a
determination that a certain technology
constitutes an emerging technology, for
purposes of section 1758 of ECRA, then
BIS is required, pursuant to ECRA, to
institute export controls on such
technology. However, BIS does have
some flexibility to ensure that the scope
of any controls that may be imposed on
this technology would be effective (in
terms of protecting U.S. national
security interests) and appropriate (with
respect to minimizing their potential
impact on legitimate commercial or
scientific applications). In this
particular instance, the controls on this
technology will be multilateral, because
they have been adopted by the Australia
Group (AG) for inclusion in their
biological equipment Common Control
List.
Anticipated Cost and Benefits: The
changes that would be made by this rule
would only marginally affect the scope
of the EAR controls on chemical
weapons precursors, human and animal
pathogens/toxins, and equipment
capable of use in handling biological
materials.
The number of additional license
applications that would have to be
submitted per year, as a result of the
addition of ECCN 2D352 to the CCL, as
described above, is not expected to
exceed fifteen license applications. This
total represents a relatively insignificant
portion of the overall trade in such
items and is well within the scope of the
information collection approved by the
Office of Management and Budget
(OMB) under control number 06940088.
Risks: This software is capable of
being used to operate nucleic acid
assemblers and synthesizers controlled
under ECCN 2B352 for the purpose of
generating pathogens and toxins
without the need to acquire controlled
genetic elements and organisms.
Consequently, the absence of export
controls on this software could be
exploited for biological weapons
purposes.
Timetable:
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Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
Final Action Effective.
Next Action Undetermined.
FR Cite
11/06/20
12/21/20
85 FR 71012
10/05/21
10/05/21
86 FR 54814
03/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
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Agency Contact: Willard Fisher,
Export Administration Specialist,
Department of Commerce, Bureau of
Industry and Security, 14th Street and
Pennsylvania Avenue NW, Washington,
DC 20230, Phone: 202 482–2440, Fax:
202 482–3355, Email: willard.fisher@
bis.doc.gov.
RIN: 0694–AI08
DOC—PATENT AND TRADEMARK
OFFICE (PTO)
Final Rule Stage
15. Changes To Implement Provisions
of the Trademark Modernization Act of
2020
Priority: Other Significant.
Legal Authority: 15 U.S.C. 1066; 15
U.S.C. 1067; 15 U.S.C. 1113; 15 U.S.C.
1123; 35 U.S.C. 2; Pub. L. 112–29; Pub.
L. 116–260
CFR Citation: 37 CFR 2; 37 CFR 7.
Legal Deadline: Final, Statutory,
December 27, 2021.
Abstract: The United States Patent
and Trademark Office (USPTO or
Office) amends the rules of practice in
trademark cases to implement
provisions of the Trademark
Modernization Act of 2020. The rule
establishes ex parte expungement and
reexamination proceedings for
cancellation of a registration when the
required use in commerce of the
registered mark has not been made;
provides for a new nonuse ground for
cancellation before the Trademark Trial
and Appeal Board; establishes flexible
Office action response periods; and
amends the existing letter-of-protest rule
to indicate that letter-of-protest
determinations are final and nonreviewable. The USPTO also sets fees
for petitions requesting institution of ex
parte expungement and reexamination
proceedings, and for requests to extend
Office action response deadlines.
Amendments are also for the rules
concerning the suspension of USPTO
proceedings and the rules governing
attorney recognition in trademark
matters. Finally, a new rule is to address
procedures regarding court orders
cancelling or affecting registrations.
Statement of Need: The purpose of
this action is to amend the rules of
practice in trademark cases to
implement provisions of the Trademark
Modernization Act of 2020. In addition,
amendments are also proposed for the
rules concerning suspension of USPTO
proceedings and the rules governing
attorney recognition in trademark
matters, and a new rule is proposed to
address procedures regarding court
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orders cancelling or affecting
registrations.
Summary of Legal Basis: The
Trademark Modernization Act of 2020
(TMA) was enacted on December 27,
2020. See Public Law 116260, Div. Q,
Tit. II, Subtit. B, 221228 (Dec. 27, 2020).
The TMA amends the Trademark Act of
1946 (the Act) to establish new ex parte
expungement and reexamination
proceedings to cancel, either in whole
or in part, registered marks for which
the required use in commerce was not
made. Furthermore, the TMA amends
14 of the Act to allow a party to allege
that a mark has never been used in
commerce as a basis for cancellation
before the Trademark Trial and Appeal
Board (TTAB). The TMA also authorizes
the USPTO to promulgate regulations to
set flexible Office action response
periods between 60 days and 6 months,
with an option for applicants to extend
the deadline up to a maximum of 6
months from the Office action issue
date. In addition, the TMA includes
statutory authority for the USPTO’s
letter-of-protest procedures, which
allow third parties to submit evidence to
the USPTO relevant to a trademark’s
registrability during the initial
examination of the trademark
application, and provides that the
decision whether to include such
evidence in the application record is
final and non-reviewable. The TMA
requires the USPTO to promulgate
regulations to implement the provisions
relating to the new ex parte
expungement and reexamination
proceedings, and the letter-of-protest
procedures, within one year of the
TMA’s enactment. The USPTO also
proposes under its authority under the
Trademark Act of 1946, 15 U.S.C. 1051
et seq., to amend the rules regarding
attorney recognition and
correspondence, and to add a new rule
formalizing the USPTO’s longstanding
procedures concerning action on court
orders cancelling or affecting a
registration under section 37 of the Act,
15 U.S.C. 1119.
Alternatives: The TMA mandates the
framework for many of the procedures
in this rulemaking, particularly in
regard to the changes to the letter-ofprotest procedures and most of the
procedures for the new ex parte
expungement and reexamination
proceedings, except for those indicated
below. Thus, the USPTO has little to no
discretion in the rulemaking required to
implement those procedures. For those
provisions for which alternatives were
possible because the TMA provided the
Director discretion to implement
regulations (i.e., fees; limit on petitions
requesting expungement or
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reexamination; reasonable investigation
and evidence; director-initiated
proceedings; response time periods in
new ex parte proceedings; flexible
response periods; suspension of
proceedings; and attorney recognition),
a full discussion of alternatives is
provided in the proposed rule.
Anticipated Cost and Benefits: The
proposed regulations have qualitative
benefits of ensuring a well-functioning
trademark system where the trademark
register accurately reflects trademarks
that are currently in use.
Risks: The risk of taking no action is
that USPTO would not comply with its
statutory mandate under the TMA.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
Final Action Effective.
05/18/21
07/19/21
FR Cite
86 FR 26862
11/00/21
12/00/21
BILLING CODE 3410–12–P
DEPARTMENT OF DEFENSE
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Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is
the largest Federal department,
employing over 1.6 million military
personnel and 750,000 civilians with
operations all over the world. DoD’s
enduring mission is to provide combatcredible military forces needed to deter
war and protect the security of our
nation. In support of this mission, DoD
adheres to a strategy where a more
lethal force, strong alliances and
partnerships, American technological
innovation, and a culture of
performance will generate a decisive
and sustained United States military
advantage. Because of this expansive
and diversified mission and reach, DoD
regulations can address a broad range of
matters and have an impact on varied
17:50 Jan 28, 2022
Retrospective Review of Existing
Regulations
Pursuant to section 6 of Executive
Order 13563 ‘‘Improving Regulation and
Regulatory Review’’ (January 18, 2011),
the Department continues to review
existing regulations with a goal to
eliminate outdated, unnecessary, or
ineffective regulations; account for the
currency and legitimacy of each of the
Department’s regulations; and
ultimately reduce regulatory burden and
costs.
DOD Priority Regulatory Actions
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: None.
Agency Contact: Catherine Cain,
Trademark Manual of Examining
Procedure Editor, Department of
Commerce, Patent and Trademark
Office, P.O. Box 1451, Alexandria, VA
22313, Phone: 571 272–8946, Fax: 751
273–8946, Email: catherine.cain@
uspto.gov.
RIN: 0651–AD55
VerDate Sep<11>2014
members of the public, as well as other
federal agencies.
Pursuant to Executive Order 12866,
‘‘Regulatory Planning and Review’’
(September 30, 1993) and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review’’ (January 18,
2011), the DoD Regulatory Plan and
Agenda provide notice about the DoD’s
regulatory and deregulatory actions
within the Executive Branch.
Jkt 256001
The regulatory and deregulatory
actions identified in this Regulatory
Plan embody the core of DoD’s
regulatory priorities for Fiscal Year (FY)
2022 and help support President
Biden’s regulatory priorities and the
Secretary of Defense’s top priorities,
along with those of the National Defense
Strategy, to defend the Nation. The DoD
prioritization is focused on initiatives
that:
• Promote the country’s economic
resilience, including addressing COVIDrelated issues.
• Support underserved communities
and improve small business
opportunities.
• Promote diversity, equity,
inclusion, and accessibility in the
Federal workforce.
• Support national security efforts,
especially safeguarding Federal
Government information and
information technology systems.
• Support the climate change
emergency; and
• Promote Access to Voting.
Rules That Promote the Country’s
Economic Resilience
Pandemic
Pursuant to Executive Order 13987,
‘‘Organizing and Mobilizing the United
States Government to Provide a Unified
and Effective Response to Combat
COVID–19 and to Provide United States
Leadership on Global Health and
Security,’’ January 20, 2021; Executive
Order 13995, ‘‘Ensuring an Equitable
Pandemic Response and Recovery,’’
January 21, 2021; Executive Order
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13997, ‘‘Improving and Expanding
Access to Care and Treatments for
COVID–19,’’ January 21, 2021; and
Executive Order 13999, ‘‘Protecting
Worker Health and Safety,’’ January 21,
2021, the Department has temporarily
modified its TRICARE regulation so
TRICARE beneficiaries have access to
the most up-to-date care required for the
diagnosis and treatment of COVID–19.
TRICARE continues to reimburse like
Medicare, to the extent practicable, as
required by statute. The Department is
researching the impacts of making some
of those modifications permanent and
may pursue such future action.
These modifications include:
• TRICARE Coverages and Payment for
Certain Services in Response to the
COVID–19 Pandemic. RIN 0720–AB81
DoD is finalizing an interim final rule
that temporarily amended 32 CFR part
199 to revise: (1) 32 CFR part 199.4 to
remove the restriction on audio-only
telemedicine services; (2) 32 CFR part
199.6 to authorize reimbursement for
interstate practice by TRICAREauthorized providers when such
authority is consistent with State and
Federal licensing requirements; and (3)
32 CFR part 199.17 to eliminate
copayments for telemedicine services.
These changes reduce the spread of
COVID–19 among TRICARE
beneficiaries by incentivizing use of
telemedicine services, and aid providers
in caring for TRICARE beneficiaries by
temporarily waiving some licensure
requirements. The final rule adopts this
interim final rule as final with changes.
• TRICARE Coverage of Certain Medical
Benefits in Response to the COVID–19
Pandemic. RIN 0720–AB82
DoD is finalizing an interim final rule
that temporarily amended 32 CFR part
199 to revise certain elements of the
TRICARE program under 32 CFR part
199 to: (1) Waive the three-day prior
hospital qualifying stay requirement for
coverage of skilled nursing facility care;
(2) add coverage for treatment use of
investigational drugs under expanded
access authorized by the United States
(U.S.) Food and Drug Administration
(FDA) when for the treatment of
coronavirus disease 2019 (COVID–19);
(3) waive certain provisions for acute
care hospitals that permitted
authorization of temporary hospital
facilities and freestanding ambulatory
surgical centers providing inpatient and
outpatient hospital services; and,
consistent with similar changes under
the Centers for Medicaid and Medicare
Services; (4) revise diagnosis related
group (DRG) reimbursement by
temporarily reimbursing DRGs at a 20
percent higher rate for COVID–19
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patients; and (5) waive certain
requirements for long term care
hospitals. The final action permanently
adopts Medicare’s New Technology
Add-On Payments adjustment to DRGs
for new medical services and
technologies and adopted Medicare’s
Hospital Value Based Purchasing
Program. The final rule adopts the
interim final rule with changes, except
for the note to section 199.4(g)(15)(i)(A),
published at 85 FR 54923, September 3,
2020, which remains interim.
• TRICARE Coverage of National
Institute of Allergy and Infectious
Disease—Coronavirus Disease 2019
Clinical Trials. RIN 0720–AB83
This interim final rule temporarily
amended section 199.4(e)(26) of 32 CFR
199 to revise certain elements of the
TRICARE program to add coverage for
National Institute of Allergy and
Infectious Disease-sponsored clinical
trials for the treatment or prevention of
coronavirus disease 2019 (COVID–19).
Title 10, U.S.C. 1079(a)(12)
authorizes, pursuant to an agreement
with the Secretary of Health and Human
Services (HHS) and under such
regulations as the Secretary of Defense
may prescribe, a waiver of the
requirement that covered care be
medically or psychologically necessary
in connection with clinical trials
sponsored by the NIH, provided the
Secretary of Defense determines that
such a waiver will promote access by
covered beneficiaries to promising new
treatments and contribute to the
development of such treatments. On
September 19, 2020, the DoD entered
into an agreement with NIH to permit
coverage of such trials. Based on an
agreement with the National Cancer
Institute (NCI) and 32 CFR 199.4(e)(26),
TRICARE currently covers NCI
sponsored clinical trials related to
cancer prevention, screening, and early
detection. The intent of these statutory
and regulatory provisions is to expand
TRICARE beneficiary access to new
treatments and to contribute to the
development of such treatments.
This rule, pursuant to the agreement
with the NIH, temporarily amends the
TRICARE regulation to authorize
coverage of cost-sharing for medical care
and testing of TRICARE-eligible patients
who participate in Phase I, II, III, or IV
clinical trials examining the treatment
or prevention of COVID–19 that are
sponsored by NIAID, enforcing the
provisions within the agreement
between DoD and NIH. Additionally,
this change establishes requirements for
TRICARE cost-sharing care related to
NIAID-sponsored COVID–19 clinical
trials; these new requirements mirror
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the existing requirements set forth in 32
CFR 199.4(e)(26)(ii)(B) for coverage of
cancer clinical trials. This amendment
supports statutory intent by encouraging
participation of TRICARE beneficiaries
in clinical trials studying the prevention
or treatment of COVID–19 and
contributing to the development of
treatments, including vaccines, for
COVID–19.
• Expanding TRICARE Access to Care
in Response to the COVID–19
Pandemic. RIN 0720–AB85
This interim final rule will
temporarily amend the TRICARE
regulation at 32 CFR part 199 by: (1)
Adding freestanding End Stage Renal
Disease facilities as a category of
TRICARE-authorized institutional
provider and modifying the
reimbursement for such facilities; (2)
adding coronavirus 2019 (COVID–19)
Immunizers who are not otherwise an
eligible TRICARE-authorized provider
as providers eligible for reimbursement
for COVID–19 vaccines and vaccine
administration; (3) and adopting
Medicare New COVID–19 Treatments
Add-on Payments (NTCAPs).
Maximizing the Use of American-Made
Goods (DFARS Case 2019–D045). RIN:
0750–AK85
This rule supports Executive Order
14005, ‘‘Ensuring the Future is Made in
All of America by All of America’s
Workers,’’ January 25, 2021, that builds
upon a previous Executive Order 13881,
Maximizing Use of American-Made
Goods, Products, and Materials,’’ July
15, 2019. The rule implements
Executive Order 13881 which requires
an amendment to the FAR to provide
that materials shall be considered of
foreign origin if: (a) For iron and steel
end products, the cost of foreign iron
and steel used in such iron and steel
end products constitutes 5 percent or
more of the cost of all the products used
in such iron and steel end products; or
(b) for all other end products, the cost
of the foreign products used in such end
products constitutes 45 percent or more
of the cost of all the products used in
such end products. The FAR changes
were accomplished under FAR Case
2019–016, published in the Federal
Register at 86 FR 6180.
In addition, the Executive Order
13881 provides that in determining
price reasonableness, the evaluation
factors of 20 percent (for other than
small businesses), or 30 percent (for
small businesses) shall be applied to
offers of materials of foreign origin. The
DFARS currently applies a 50 percent
factor and requires no additional
revisions. This DFARS rule makes
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conforming changes as a result of
implementation of the Executive Order
in the FAR.
Rules That Support Underserved
Communities and Improve Small
Business Opportunities
Executive Order 13985, ‘‘Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government’’ January 20, 2021
Rules of Particular Interest to Small
Business
Small Business Innovation Research
Program Data Rights (DFARS Case
2019–D043). RIN: 0750–AK84
This rule implements changes made
by the Small Business Administration
(SBA) related to data rights in the Small
Business Innovation Research (SBIR)
Program and Small Business
Technology Transfer (STTR) Program
Policy Directive, published in the
Federal Register on April 2, 2019 (84 FR
12794). The SBIR and STTR programs
fund a diverse portfolio of startups and
small businesses across technology
areas and markets to stimulate
technological innovation, meet Federal
research and development (R&D) needs,
and increase commercialization to
transition R&D into impact. The final
SBA Policy Directive includes several
revisions to clarify data rights, which
require corresponding revisions to the
DFARS. These changes include
harmonizing definitions, lengthening
the SBIR/STTR protection period from 5
years to 20 years, and providing for the
granting of Government-purpose rights
license in place of an unlimited rights
license upon expiration of the SBIR/
STTR protection period.
Reauthorization and Improvement of
Mentor-Prote´ge´ Program (DFARS Case
2020–D009). RIN: 0750–AK96
This rule implements section 872 of
the National Defense Authorization Act
for Fiscal Year 2020. Section 872
reauthorizes and modifies the DoD
Mentor-Prote´ge´ Program. The purpose of
the Program is to provide incentives for
DoD contractors to assist eligible small
businesses (prote´ge´s) in enhancing their
capabilities and to increase
participation of such firms in
Government and commercial contracts.
Under this program, prote´ge´s expand
their footprint in the defense industrial
base by partnering with larger
companies (mentors). As a result of this
rule, the date by which new mentorprote´ge´ agreements may be submitted
and approved is extended to September
30, 2024. In addition, mentors incurring
costs prior to September 30, 2026, may
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be eligible for certain credits and
reimbursements. Per the statute, this
rule also establishes additional
performance goals and outcome-based
metrics to measure progress in meeting
those goals.
Rules That Promote Diversity, Equity,
Inclusion, and Accessibility in the
Federal Workforce
Nondiscrimination on the Basis of
Disability in Program or Activities
Assisted or Conducted by the DoD and
in Equal Access to Information and
Communication Technology Used by
DoD, and Procedures for Resolving
Complaints. RIN: 0790–AJ04
Revisions to this regulation: (1)
Update and clarify the obligations that
Section 504 of the Rehabilitation Act of
1973 (section 504) imposes on
recipients of Federal financial assistance
and the Military Departments and
Components (DoD Components); (2)
reflect the most current Federal statutes
and regulations, as well as
developments in Supreme Court
jurisprudence, regarding unlawful
discrimination on the basis of disability
and promotes consistency with
comparable provisions implementing
title II of the Americans with
Disabilities Act (ADA); (3) implement
section 508 of the Rehabilitation Act of
1973 (section 508), requiring DoD make
its electronic and information
technology accessible to individuals
with disabilities; (4) establish and
clarify obligations under the
Architectural Barriers Act of 1968
(ABA), which requires that DoD make
facilities accessible to individuals with
disabilities; and (5) Provide complaint
resolution and enforcement procedures
pursuant to section 504 and the
complaint resolution and enforcement
procedures pursuant to section 508.
These revisions are particularly relevant
in light of Executive Order 14035,
‘‘Diversity, Equity, Inclusion, and
Accessibility in the Federal Workforce.
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Rules That Support National Security
Efforts
Department of Defense (DoD)—Defense
Industrial Base (DIB) Cybersecurity (CS)
Activities. RIN: 0790–AK86
This rule will amend the DoD—
Defense Industrial Base (DIB)
Cybersecurity (CS) activities regulation.
It will allow a broader community of
defense contractors access to relevant
cyber threat information that is critical
in defending unclassified networks and
information systems and protecting DoD
warfighting capabilities. These
amendments seek to address the
increasing cyber threat targeting all
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defense contractors including those in
the vulnerable supply chain by
expanding eligibility to defense
contractors that process, store, develop,
or transmit DoD Controlled Unclassified
Information (CUI). These steps align
with the Administration’s efforts to
provide defense contractors with critical
and real-time cybersecurity resources
needed to safeguard DoD CUI.
Rules That Support the Climate Change
Emergency
Policy and Procedures for Processing
Requests To Alter U.S. Army Corps of
Engineers Civil Works Projects Pursuant
to 33 U.S.C. 408. RIN: 0710–AB22
Where a party other than the USACE
seeks to use or alter a Civil Works
project that USACE constructed, the
proposed use or alteration is subject to
the prior approval of the USACE. Some
examples of such alterations include an
improvement to the project; relocation
of part of the project; or installing
utilities or other non-project features.
This requirement was established in
section 14 of the Rivers and Harbors Act
of 1899 and is codified at 33 U.S.C. 408
(section 408). Section 408 provides that
the USACE may grant permission for
another party to alter a Civil Works
project, upon a determination that the
alteration proposed will not be injurious
to the public interest and will not
impair the usefulness of the Civil Works
project. The USACE is proposing to
convert its policy that governs the
section 408 program to a binding
regulation. This policy, Engineer
Circular 1165–2–220, Policy and
Procedural Guidance for Processing
Requests to Alter U.S. Army Corps of
Engineers Civil Works Projects Pursuant
to 33 U.S.C. 408, was issued in
September 2018.
Credit Assistance for Water Resources
Infrastructure Projects. RIN: 0710–AB31
The USACE proposes to implement a
new credit program for dam safety work
at non-Federal dams. The program is
authorized under the Water
Infrastructure Finance and Innovation
Act of 2014 (WIFIA) and Division D,
Title 1 of the Consolidated
Appropriations Act of 2021. WIFIA
authorizes the USACE to provide
secured (direct) loans and loan
guarantees (Federal Credit instruments)
to eligible water resources infrastructure
projects and to charge fees to recover all
or a portion of the USACE’ cost of
providing credit assistance and the costs
of conducting engineering reviews and
retaining expert firms, including
financial and legal services, to assist in
the underwriting and servicing of
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Federal credit instruments. Projects
would be evaluated and selected by the
Secretary of the Army (the Secretary),
based on the requirements and the
criteria described in this rule.
Flood Control Cost-Sharing
Requirements Under the Ability To Pay
Provision. RIN: 0710–AB34
Section 103(m) of the Water
Resources Development Act (WRDA) of
1986, as amended (33 U.S.C. 2213(m)),
authorizes the USACE to reduce the
non-Federal share of the cost of a study
or project for certain communities that
are not able financially to afford the
standard cost-share. Part 241 of title 33
in the Code of Federal Regulations
provides the criteria that the USACE
uses in making these determinations
where the primary purpose of the study
or project is flood damage reduction.
The proposed rule would update this
regulation, including by broadening the
project purposes for which the USACE
could reduce the non-Federal cost-share
on this basis.
Revised Definition of ‘‘Waters of the
United States’’—Rule 1. RIN: 0710–
AB40
In April 2020, the EPA, and the
Department of the Army (‘‘the
agencies’’) published the Navigable
Waters Protection Rule (NWPR) that
revised the previously codified
definition of ‘‘waters of the United
States’’ (85 FR 22250, April 21, 2020).
The agencies are now initiating this new
rulemaking process that restores the
regulations (51 FR 41206) in place prior
to the 2015 ‘‘Clean Water Rule:
Definition of ‘Waters of the United
States’ ’’ (80 FR 37054, June 29, 2015),
updated to be consistent with relevant
Supreme Court decisions. The agencies
intend to consider further revisions in a
second rule in light of additional
stakeholder engagement and
implementation considerations,
scientific developments, and
environmental justice values. This effort
will also be informed by the experience
of implementing the pre-2015 rule, the
2015 Clean Water Rule, and the 2020
Navigable Waters Protection Rule.
Revised Definition of ‘‘Waters of the
United States’’—Rule 2. RIN: 0710–
AB47
The Department of the Army and the
Environmental Protection Agency
intend to pursue a second rule defining
‘‘Waters of the United States’’ to
consider further revisions to the
agencies’ first rule (RIN 0710–AB40)
which proposes to restore the
regulations in place prior to the 2015
‘‘Clean Water Rule: Definition of ‘Waters
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of the United States’ ’’ (80 FR 37054,
June 29, 2015), updated to be consistent
with relevant Supreme Court Decisions.
This second rule proposes to include
revisions reflecting on additional
stakeholder engagement and
implementation considerations,
scientific developments, and
environmental justice values. This effort
will also be informed by the experience
of implementing the pre-2015 rule, the
2015 Clean Water Rule, and the 2020
Navigable Waters Protection Rule.
Rules Promoting Access to Voting
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Federal Voting Assistant Program
(FVAP). RIN: 0790–AK90
DOD is finalizing an interim final rule
for its Federal Voting Assistance
Program (FVAP). The FVAP assists
overseas service members and other
overseas citizens with exercising their
voting rights by serving as a critical
resource to successfully register to vote.
On March 7, 2021, the White House
released Executive Order 14019 on
Promoting Access to Voting. The
purpose of the Executive Order is to
protect and promote the exercise of the
right to vote, eliminate discrimination
and other barriers to voting, expand
access to voter registration and accurate
election information, and ensure
registering to vote and the act of voting
be made simple and easy for all those
eligible to do so. To accomplish this
purpose, with this final rule DoD is
doing the following:
• Maximizing voter awareness of
Uniformed and Overseas Citizens
Absentee Voting Act (UOCAVA)
eligibility and resources by providing
better coordination with the Federal
Government’s voting assistance services
to improve voter accessibility and
communication.
• Requiring DoD components to
establish component-wide programs to
communicate and disseminate voting
information, with the goal of improving
communication and clarity for the
impacted population.
• Requiring federal agencies to enter
into memorandums of understanding
(MOU) with the DoD to provide
accurate, nonpartisan voting
information and assistance to ensure
military and overseas voters understand
their voting rights, how to register and
apply for an absentee ballot, and how to
return their absentee ballot successfully.
• Promoting opportunities to register
to vote and participate in elections to
include civilians working for the
Department who vote locally.
• Distributing voter information and
use of vote.gov in conjunction with
fvap.gov website and current
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communications to support a
comprehensive approach to voter
awareness.
• Creating innovative solutions to
reduce barriers and increase voter
awareness of their status in the
Uniformed and Overseas Citizens
Absentee Voting Act absentee voting
process, including increased visibility of
overseas ballots.
• Developing materials to support
absentee voting by military and overseas
U.S. citizens with limited English
proficiency.
Federal Register Requests for
Information (RFIs)
In support of Executive Orders 14017,
‘‘America’s Supply Chains,’’ 13985,
‘‘Advancing Racial Equity and Support
for Underserved Communities Through
the Federal Government, and 14036,
Promoting Competition in the American
Economy,’’ DoD published a RFI on
September 8, 2021, titled ‘‘Notice of
Request for Comments on Barriers
Facing Small Businesses in Contracting
with the Department of Defense.’’ The
participation of dynamic, resilient, and
innovative small businesses in the
defense industrial base is critical to the
United States’ efforts to maintain its
technological superiority, military
readiness, and warfighting advantage. In
furtherance of its efforts to maximize
opportunities for small businesses to
contribute to national security, the DoD
sought public input on the barriers that
small businesses face in working with
the DoD.
Additionally, in support of Executive
Order 14017, ‘‘America’s Supply
Chains,’’ DoD published an RFI on
September 28, 2021, titled ‘‘Federal
Register Notice of Request for Written
Comments in Support of the Department
of Defense’s One-Year Response to
Executive Order 14017, ‘‘America’s
Supply Chains.’’ The Executive Order
directs six Federal agencies to conduct
a review of their respective industrial
bases, with the objective to use this
assessment to secure and strengthen
America’s supply chains. One of these
directives is for the Secretary of
Defense, in consultation with the heads
of appropriate agencies, to submit a
report on supply chains for the defense
industrial base, including key
vulnerabilities and potential courses of
action to strengthen the defense
industrial base. The effort will build on
the Executive Order. report, Assessing
and Strengthening the Manufacturing
and Defense Industrial Base and Supply
Chain Resiliency of the United States
(released October 2018) and the Annual
Industrial Capabilities Report, which is
mandated by the Congress.
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DOD—OFFICE OF THE SECRETARY
(OS)
Proposed Rule Stage
16. Department of Defense (DOD)—
Defense Industrial Base (DIB)
Cybersecurity (CS) Activities
Priority: Other Significant.
Legal Authority: 10 U.S.C. 391; 10
U.S.C. 2224; 44 U.S.C. 3541; 10 U.S.C.
393
CFR Citation: 32 CFR 236.
Legal Deadline: None.
Abstract: The DIB CS Program is
currently only permitted to provide
cyber threat information to cleared
defense contractors, per the Program
eligibility requirements within 32 CFR
part 236. However, this proposed
revision to the Federal rule would allow
all defense contractors who process,
store, develop, or transit DoD CUI to be
eligible to participate and begin
receiving critical cyber threat
information. Expanding participation in
the DIB CS Program is part of DoD’s
comprehensive approach to collaborate
with the DIB to counter cyber threats
through information sharing between
the Government and DIB participants.
The expanded eligibility criteria will
allow a broader community of defense
contractors to participate in the DIB CS
Program, in alignment with the National
Defense Strategy.
Statement of Need: Unauthorized
access and compromise of DoD
unclassified information and operations
poses an imminent threat to U.S.
national security and economic security
interests. Defense contractors with this
information are being targeted on a daily
basis. Many of these contractors are
small and medium size contractors that
can benefit from partnering with DoD to
enhance and supplement their
cybersecurity capabilities.
Summary of Legal Basis: This revised
regulation supports the
Administration’s effort to promote
public-private cyber collaboration by
expanding eligibility for the DIB CS
voluntary cyber threat information
sharing program to all defense
contractors. This regulation aligns with
DoD’s statutory responsibilities for
cybersecurity engagement with those
contractors supporting the Department.
Alternatives: (1) No action alternative:
Maintain status quo with the ongoing
voluntary cybersecurity program for
cleared contractors. (2) Next best
alternative: DoD posts generic cyber
threat information and cybersecurity
best practices on a public accessible
website without directly engaging
participating companies.
Anticipated Cost and Benefits:
Participation in the voluntary DIB CS
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Program enables DoD contractors to
access Government Furnished
Information and collaborate with the
DoD Cyber Crime Center (DC3) to better
respond to and mitigate the cyber threat.
To participate in the DIB CS Program,
DoD contractors must have or obtain a
DoD-approved, medium assurance
certificate to enable access to a secure
DoD unclassified web portal. Cost of the
DoD-approved medium assurance
certificate is approximately $175 for
each individual identified by the DoD
contractor. See https://public.cyber.mil/
eca/ for more information about DoDapproved certificates.
Contractors are encouraged to
voluntarily report information to
promote sharing of cyber threat
indicators that they believe are valuable
in alerting the Government and others,
as appropriate, in order to better counter
cyber threat actor activity. This cyber
information may be of interest to the
DIB and DoD for situational awareness
and does not include mandatory cyber
incident reporting included under
DFARS 252.204–7012.
The costs are under review.
Risks: Cyber threats to DIB
unclassified information systems
represent an unacceptable risk of
compromise of DoD information and
mission and pose an imminent threat to
U.S. national security and economic
security interests. This threat is
particularly acute for those small and
medium size companies with less
mature cybersecurity capabilities. The
combination of mandatory cyber
activities under DFARS 252.204–7012,
combined with the voluntary
participation in the DIB CS Program,
will enhance and supplement DoD
contractors capabilities to safeguard
DoD information that resides on, or
transits, DoD contractors unclassified
network or information systems.
Through collaboration with DoD and the
sharing with other contractors in the
DIB CS Program, defense contractors
will be better prepared to mitigate the
cyber risk they face today and in the
future.
Timetable:
Action
Date
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NPRM ..................
FR Cite
06/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Agency Contact: Kevin Dulany,
Director, Cybersecurity Policy and
Partnerships CIO, Department of
Defense, Office of the Secretary, 4800
Mark Center, Alexandria, VA 22311,
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ensure that information and
communication technology is accessible
to and usable by individuals with
disabilities. Title 28, Code of Federal
Regulations, part 41 implementing
Executive Order 12250, which assigns
DOD—OS
the DOJ responsibility to coordinate
Final Rule Stage
implementation of section 504 of the
Rehabilitation Act.
17. Nondiscrimination on the Basis of
Alternatives: The Department
Disability in Programs or Activities
considered taking no new action and
Assisted or Conducted by the DOD
continuing to rely on the existing
Priority: Other Significant.
regulation. The Department considered
Legal Authority: Pub. L. 100–259; Pub. issuing sub-regulatory guidance to
L. 102–569; 29 U.S.C. 791 to 794d; 42
clarify existing regulation. Both options
U.S.C. ch. 51 and 126; E.O. 12250
were rejected because of the need to
CFR Citation: 32 CFR 56.
update and clarify the Department’s
Legal Deadline: None.
obligations pursuant to section 504 and
Abstract: The Department of Defense
section 508 of the Rehabilitation Act of
(DoD) is amending its regulation
1973, as amended.
prohibiting unlawful discrimination on
Anticipated Cost and Benefits:
the basis of disability in programs or
Because
OMB originally determined this
activities receiving Federal financial
rule to not be a significant regulatory
assistance from, or conducted by, DoD.
action, a cost and benefit analysis has
These revisions will update and clarify
not yet been completed.
the obligations that section 504 of the
Risks: Without this final rule, the
Rehabilitation Act of 1973, as amended,
Department’s current regulation is
imposes on recipients of Federal
inconsistent with current Federal
financial assistance and DoD
statutes and regulations, as well as
Components, and the obligations that
developments in Supreme Court
the Architectural Barriers Act imposes
jurisprudence, regarding unlawful
on DoD Components. The updates will
also clarify the procedures for resolving discrimination on the basis of disability.
Consistent with congressional intent,
complaints regarding information and
communication technology accessible to the provisions in the final rule are
consistent with the nondiscrimination
and usable by individuals with
provisions in DOJ regulations
disabilities in accordance with section
implementing title II of the ADA
508 of the Rehabilitation Act, as
amended. This rule promotes the Biden Amendments Act (applicable to state
Administration’s priorities on diversity, and local government entities).
Timetable:
equity, and inclusion.
Statement of Need: Finalization of
Action
Date
FR Cite
this Department-wide rule will clarify
the longstanding policy of the
NPRM ..................
07/16/20 85 FR 43168
Department. It does not change the
NPRM Comment
09/14/20
Department’s practices in addressing
Period End.
Final Action .........
06/00/22
issues of discrimination. This rule
amends the Department’s prior
Regulatory Flexibility Analysis
regulation to include updated
Required: No.
accessibility standards for recipients of
Small Entities Affected: No.
Federal financial assistance to be more
Government Levels Affected: None.
user-friendly and to support individuals
Additional Information: The full title
with disabilities. This update is
of the rule is ‘‘Nondiscrimination on the
particularly relevant in light of
Basis of Disability in Programs or
Executive Order 14035, Diversity,
Activities Assisted or Conducted by the
Equity, Inclusion, and Accessibility in
DoD and in Equal Access to Information
the Federal Workforce.
and Communication Technology Used
Summary of Legal Basis: This rule is
by DoD, and Procedures for Resolving
proposed under the authorities of title
Complaints.’’ That title is too long to
29, U.S.C., chapter 16, subchapter V,
include above, so I am including it here.
sections 794 through 794d, codifying
DoD Instruction 1020.dd (‘‘Unlawful
legislation prohibiting discrimination
Discrimination on the Basis of Disability
on the basis of disability under any
in Programs or Activities Receiving
program or activity receiving Federal
Federal Financial Assistance from, or
financial assistance or under any
Conducted by, the DoD’’) will be
program or activity conducted by any
codified as a rule under 32 CFR part 56.
Federal agency, including provisions
The rule was originally reported as
establishing the United States Access
Board and requiring Federal agencies to being codified under 32 CFR part 195.
Phone: 571 372–4699, Email:
kevin.m.dulany.civ@mail.mil.
RIN: 0790–AK86
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Agency Contact: Randy Cooper,
Director, Department of Defense
Disability EEO Policy and Compliance,
Department of Defense, Office of the
Secretary, 4000 Defense Pentagon, Room
5D641, Washington, DC 20301–4000,
Phone: 703 571–9327, Email:
randy.d.cooper3.civ@mail.mil.
RIN: 0790–AJ04
DOD—OS
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18. Federal Voting Assistance Program
Priority: Other Significant.
Legal Authority: E.O. 12642; 10 U.S.C.
1566a; 52 U.S.C. 20506; 52 U.S.C. ch.
203
CFR Citation: 32 CFR 233.
Legal Deadline: None.
Abstract: The FVAP assists overseas
service members and other overseas
citizens with exercising their voting
rights by serving as a critical resource to
successfully register to vote. It requires
Federal agencies to enter into
Memorandums of Understanding with
the DoD to provide accurate,
nonpartisan voting information and
assistance to ensure military and
overseas voters understand their voting
rights, how to register and apply for an
absentee ballot, and how to return their
absentee ballot successfully.
Statement of Need: This rule
establishes policy and assigns
responsibilities for the Federal Voting
Assistance Program (FVAP). It
establishes policy and assigns
responsibilities for the development and
implementation of installation voter
assistance (IVA) offices as voter
registration agencies. This part
establishes policy to develop and
implement, jointly with States,
procedures for persons to apply to
register to vote at recruitment offices of
the Military Services.
Summary of Legal Basis: This rule is
proposed under the authorities of the
Uniformed and Overseas Citizens
Absentee Voting Act (UOCAVA), 52
U.S.C. chapter 203, on behalf of the
Secretary of Defense, as the Presidential
designee under 53 U.S.C. 20301(a). See
Executive Order No. 12642, Designation
of Secretary of Defense as Presidential
Designee, 53 FR 21975 (June 8, 1988)
and Executive Order 14019, Promoting
Access to Voting.
Alternatives: No Action—If DoD took
no action, decreases in successful voting
by voters covered by the Uniformed and
Overseas Citizens Absentee Voting Act
could occur.
Voters who received assistance from
FVAP or Voting Assistance Officers
were significantly more likely to submit
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a ballot than if they did not receive that
assistance a consistent finding across
the last four General Elections. The
impacted public, without coordinated
FVAP voter assistance, could experience
confusion with the voting registration
process, and may endure inefficient
FVAP assistance leading up to, and on
Election Day. With no purposeful effort
to streamline these regulations, there is
a dire possibility that absentee voter
ballots will not be sent and received in
time to be counted. DoD, as the
presidential designee agency, pursuant
to Executive Order 12642, shoulders the
responsibility and desire to resolve
known issues, better communicate with
the public, and provide a seamless and
uniform voting assistance framework for
the public populations overseas.
Anticipated Cost and Benefits: This
amendment of the current policies seeks
to establish uniform framework within
DoD on how to interact and disseminate
communications with the impacted
public populations overseas. The
changes outlined in this rule improve
the transparency and effectiveness of
communication to the general public,
absent overseas voters, Service member
spouse and dependents, and eligible
voters who seek to register to vote on
Military Service installations. This
includes maximizing awareness of voter
UOCAVA eligibility, and providing
resources to the impacted public
populations. These changes will
maximize voting assistance
effectiveness and outcomes, address
known concerns impacting the public,
ahead of upcoming election cycles.
While the Department estimates that
the public will not incur any costs as a
result of this rule, the public may
receive better voter assistance since DoD
will improve the Government’s
coordination to provide voter assistance
to absent uniformed service voters and
overseas voters and support the
government’s efforts to implement a
comprehensive program to cover all
executive branch agencies and overseas
citizens more broadly.
Risks: This rule seeks to increase the
likelihood of voters protected under
UOCAVA and military voting assistance
laws to receive and return absentee
ballots. It enables FVAP to provide
assistance and information to military
and overseas American voters in an
effective manner based on surveys,
research and historical after action
reports.
Should FVAP become unable to foster
voter awareness through the States and
voter assistance programs, the
Department of Defense will become less
effective to meet military and civilian
voter assistance requirements, thus
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increasing the possible risk of absentee
ballot rejections during federal election
cycles. This may bring unwanted
stakeholder and Congressional scrutiny.
FVAP would cease to provide active
engagement mechanisms to elicit input
and offer recommendations to improve
levels of voter success and effectiveness
for State absentee balloting processes for
absent overseas uniformed voters and
citizens.
Timetable:
Action
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Final Action .........
Date
03/06/20
03/06/20
FR Cite
85 FR 13045
04/06/20
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: David Beirne,
Director, DODHRA FVAP, Department
of Defense, Office of the Secretary, 48
Mark Center Drive, Alexandria, VA
22408, Phone: 571 372–0740, Email:
david.e.beirne.civ@mail.mil.
RIN: 0790–AK90
DOD—DEFENSE ACQUISITION
REGULATIONS COUNCIL (DARC)
Proposed Rule Stage
19. Small Business Innovation Research
Program Data Rights (DFARS Case
2019–D043)
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303
CFR Citation: 48 CFR 227; 48 CFR
252.
Legal Deadline: None.
Abstract: DoD is proposing to amend
the Defense Federal Acquisition
Regulation Supplement (DFARS) to
implement changes related to data rights
in the Small Business Administration’s
Policy Directive for the Small Business
Innovation Research (SBIR) Program,
published in the Federal Register on
April 2, 2019 (84 FR 12794). The final
SBA Policy Directive includes several
revisions to clarify data rights, which
require corresponding revisions to the
DFARS.
Statement of Need: This rule is
necessary to implement the Small
Business Administration (SBA) related
to data rights in the Small Business
Innovation Research (SBIR) Program
and Small Business Technology
Transfer (STTR) Program Policy
Directive, published in the Federal
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Register on April 2, 2019 (84 FR 12794).
The final SBA Policy Directive includes
several revisions to clarify data rights,
which require corresponding revisions
to the DFARS.
Summary of Legal Basis: The legal
basis for this rule is 15 U.S.C. 638,
which provides the authorization,
policy, and framework for SBIR/STTR
programs.
Alternatives: There are no alternatives
that would meet the stated objective of
this rule.
Anticipated Cost and Benefits: While
specific costs and savings have not been
quantified, this rule is expected to have
significant benefit for small businesses
participating in the DoD SBIR/STTR
program. SBIR and STTR enable small
businesses to explore their technological
potential and provide the incentive to
profit from its commercialization. By
including qualified small businesses in
the nation’s R&D arena, high-tech
innovation is stimulated, and the United
States gains entrepreneurial spirit as it
meets its specific research and
development needs.
Risks: The continuous protection of
an awardee’s SBIR/STTR Data while
actively pursuing or commercializing its
technology with the Federal
Government, provides a significant
incentive for innovative small
businesses to participate in these
programs.
Timetable:
Action
Date
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ANPRM ...............
Correction ............
ANPRM Comment
Period End.
Comment Period
Extended.
ANPRM Comment
Period End.
NPRM ..................
FR Cite
08/31/20
09/21/20
10/30/20
85 FR 53758
85 FR 59258
12/04/20
85 FR 78300
01/31/21
04/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Jennifer Johnson,
Defense Acquisition Regulations
System, Department of Defense, Defense
Acquisition Regulations Council, 3060
Defense Pentagon, Room 3B941,
Washington, DC 20301–3060, Phone:
571 372–6100, Email:
jennifer.d.johnson1.civ@mail.mil.
RIN: 0750–AK84
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DOD—DARC
20. Reauthorization and Improvement
of Mentor-Protege Program (DFARS
Case 2020–D009)
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303; Pub.
L. 116–92, sec. 872
CFR Citation: 48 CFR, ch. 2, app. I.
Legal Deadline: None.
Abstract: DoD is proposing to amend
the Defense Federal Acquisition
Regulation Supplement to implement
section 872 of the National Defense
Authorization Act for Fiscal Year 2020,
which reauthorizes and improves the
DoD Mentor-Protege Program.
Statement of Need: This rule is
necessary to amend the DFARS to
implement the reauthorization of and
amendments to the Mentor Prote´ge´
Program provided by section 872 of the
National Defense authorization act
(NDAA) of Fiscal Year (FY) 2020.
Summary of Legal Basis: The legal
basis for this rule is section 872 of the
NDAA for FY 2020 (Pub. L. 116–92).
Alternatives: There are no alternatives
that would meet the requirements of the
statute.
Anticipated Cost and Benefits: This
rule is expected to be of significant
benefit to small businesses accepted as
prote´ge´s under the program, as well as
the firms that mentor such small
businesses, by bringing more small
businesses into DoD’s supply chain.
DoD’s Mentor-Prote´ge´ Program is the
oldest continuously operating Federal
mentor-prote´ge´ program in existence.
DoD’s Mentor-Prote´ge´ Program has
successfully helped more than 190
small businesses fill unique niches and
become part of the military’s supply
chain. Many mentors have made the
Program an integral part of their
sourcing plans. Prote´ge´s have used their
involvement in the Program to develop
technical capabilities. Successful
mentor-prote´ge´ agreements provide a
winning relationship for the prote´ge´, the
mentor, and DoD.
Risks: Failure to implement section
872 and extend DoD’s Mentor-Prote´ge´
Program would significantly inhibit the
Department’s ability to provide
incentives for DoD contractors to assist
small businesses in enhancing their
capabilities and to increase
participation of such firms in
Government and commercial contracts.
Timetable:
Action
Date
NPRM ..................
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12/00/21
Regulatory Flexibility Analysis
Required: Yes.
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Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Jennifer Johnson,
Defense Acquisition Regulations
System, Department of Defense, Defense
Acquisition Regulations Council, 3060
Defense Pentagon, Room 3B941,
Washington, DC 20301–3060, Phone:
571 372–6100, Email:
jennifer.d.johnson1.civ@mail.mil.
RIN: 0750–AK96
DOD—DARC
Final Rule Stage
21. Maximizing the Use of AmericanMade Goods (DFARS Case 2019–D045)
Priority: Other Significant.
Legal Authority: 41 U.S.C. 1303
CFR Citation: 48 CFR 225; 48 CFR
252.
Legal Deadline: None.
Abstract: DoD is issuing a final rule to
amend the Defense Federal Acquisition
Regulation Supplement (DFARS) to
implement Executive Order 13881,
Maximizing Use of American-Made
Goods, Products, and Materials.
Executive Order 13881 requires an
amendment to the Federal Acquisition
Regulation (FAR) to provide that
materials shall be considered of foreign
origin if: (a) For iron and steel end
products, the cost of foreign iron and
steel used in such iron and steel end
products constitutes 5 percent or more
of the cost of all the products used in
such iron and steel end products; or (b)
for all other end products, the cost of
the foreign products used in such end
products constitutes 45 percent or more
of the cost of all the products used in
such end products. The FAR changes
were accomplished under FAR Case
2019–016, published in the Federal
Register at 86 FR 6180. This DFARS
rule will make conforming changes to
the DFARS.
Statement of Need: This rule is
needed to implement Executive Order
13881, Maximizing Use of AmericanMade Goods, Products, and Materials,
dated July 15, 2019, which requires an
amendment to the Federal Acquisition
Regulation (FAR) and the Defense
Federal Acquisition Regulation
Supplement (DFARS) to provide that
under the Buy American statute,
materials shall be considered of foreign
origin if—
(A) For iron and steel products, the
cost of foreign iron and steel used in
such iron and steel products constitutes
5 percent or more of the cost of all the
product’s domestic content; or
(B) For all other products, the cost of
the foreign components used in such
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products constitutes 45 percent or more
of the cost of all the product’s domestic
content.
In addition, the Executive order
provides that in determining price
reasonableness, the evaluation factors of
20 percent (for other than small
businesses), or 30 percent (for small
businesses) shall be applied to offers of
materials of foreign origin. The DFARS
applies a 50 percent factor and requires
no additional revisions. This rule makes
conforming changes to the applicable
clauses as a result of implementation of
the Executive order requirements in the
FAR.
Summary of Legal Basis: The legal
basis for this rule is 41 U.S.C. 1303 and
Executive Order 13881, Maximizing Use
of American-Made Goods, Products, and
Materials, dated July 15, 2019.
Alternatives: There are no alternatives
that would meet the requirements of
Executive Order 13881.
Anticipated Cost and Benefits: This
rule increases the percentages for use in
the domestic content test applied to
offers of products and materials to
determine domestic or foreign origin.
The rule will strengthen domestic
preferences under the Buy American
statute and provide both large and small
businesses the opportunity and
incentive to deliver U.S. manufactured
products from domestic suppliers. It is
expected that this rule will benefit large
and small U.S. manufacturers, including
those of iron or steel.
Risks: N/A.
Timetable:
Action
Date
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NPRM Comment
Period End.
Final Action .........
08/30/21
10/29/21
FR Cite
86 FR 48370
02/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Jennifer Johnson,
Defense Acquisition Regulations
System, Department of Defense, Defense
Acquisition Regulations Council, 3060
Defense Pentagon, Room 3B941,
Washington, DC 20301–3060, Phone:
571 372–6100, Email:
jennifer.d.johnson1.civ@mail.mil.
RIN: 0750–AK85
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DOD—U.S. ARMY CORPS OF
ENGINEERS (COE)
Proposed Rule Stage
22. Policy and Procedures for
Processing Requests To Alter U.S. Army
Corps of Engineers Civil Works Projects
Pursuant to 33 U.S.C. 408
Priority: Other Significant.
Legal Authority: 33 U.S.C. 408
CFR Citation: 33 CFR 350.
Legal Deadline: None.
Abstract: Where a party other than the
U.S. Army Corps of Engineers (Corps)
seeks to use or alter a Civil Works
project that the Corps constructed, the
proposed use or alteration is subject to
the prior approval of the Corps. Some
examples of such alterations include an
improvement to the project; relocation
of part of the project; or installing
utilities or other non-project features.
This requirement was established in
section 14 of the Rivers and Harbors Act
of 1899 and is codified at 33 U.S.C. 408
(section 408). Section 408 provides that
the Corps may grant permission for
another party to alter a Civil Works
project upon a determination that the
alteration proposed will not be injurious
to the public interest and will not
impair the usefulness of the Civil Works
project. The Corps is proposing to
convert its policy that governs the
section 408 program to a binding
regulation. This policy, Engineer
Circular 1165–2–220, Policy and
Procedural Guidance for Processing
Requests to Alter U.S. Army Corps of
Engineers Civil Works Projects Pursuant
to 33 U.S.C. 408, was issued in
September 2018.
Statement of Need: Through the Civil
Works program, the U.S. Army Corps of
Engineers (Corps), in partnership with
stakeholders, has constructed many
Civil Works projects across the Nation’s
landscape. Given the widespread
locations of these projects, there may be
a need for others outside of the Corps
to alter or occupy these projects and
their associated lands. Reasons for
alterations could include activities such
as improvements to the project;
relocation of part of the project; or
installing utilities or other non-project
features. In order to ensure that these
projects continue to provide their
intended benefits to the public,
Congress provided that any use or
alteration of a Civil Works project by
another party is subject to the prior
approval of the Corps. This requirement
was established in section 14 of the
Rivers and Harbors Act of 1899 and is
codified at 33 U.S.C. 408 (section 408).
Specifically, section 408 provides that
the Corps may grant permission for
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another party to alter a Civil Works
project upon a determination that the
alteration proposed will not be injurious
to the public interest and will not
impair the usefulness of the Civil Works
project. The Corps is proposing to
convert its policy that governs the
section 408 program to a binding
regulation. Engineer Circular 1165–2–
220, Policy and Procedural Guidance for
Processing Requests to Alter U.S. Army
Corps of Engineers Civil Works Projects
Pursuant to 33 U.S.C. 408 was issued in
September 2018.
Summary of Legal Basis: The Corps
has legal authority over the section 408
program under 33 U.S.C. 408.
Alternatives: The preferred alternative
would be to conduct rulemaking to
issue the requirements governing the
section 408 review process in the form
of a binding regulation. The current
Corps policy appears in an Engineer
Circular that has expired. The next best
alternative would involve issuing these
requirements in the form of an Engineer
Regulation. That alternative would not
fulfill the intent of the law because it
would not be binding on the regulated
public.
Anticipated Cost and Benefits: The
proposed rule would reduce costs to the
regulated public by clarifying the
applicable requirements and providing
consistent implementation of these
requirements across the Corps program.
Risks: The proposed action is not
anticipated to increase risk to public
health, safety, or the environment
because it outlines the procedures the
Corps will follow when evaluating
requests for section 408 permissions.
The Corps will comply with all
statutory requirements when reviewing
requests.
Timetable:
Action
NPRM ..................
Date
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Virginia Rynk,
Department of Defense, U.S. Army
Corps of Engineers, Attn: CECW–EC,
441 G Street NW, Washington, DC
20314, Phone: 202 761–4741.
RIN: 0710–AB22
DOD—COE
23. Credit Assistance for Water
Resources Infrastructure Projects
Priority: Other Significant.
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Legal Authority: Pub. L. 114–94; Pub.
L. 114–322; Pub. L. 115–270; 33 U.S.C.
3901
CFR Citation: 33 CFR 386.
Legal Deadline: None.
Abstract: The U.S. Army Corps of
Engineers (Corps) proposes to
implement a new credit program for
dam safety work at non-Federal dams.
The program is authorized under the
Water Infrastructure Finance and
Innovation Act of 2014 (WIFIA) and
Division D, title 1 of the Consolidated
Appropriations Act of 2020. WIFIA
authorizes the Corps to provide secured
(direct) loans and loan guarantees
(Federal Credit instruments) to eligible
water resources infrastructure projects
and to charge fees to recover all or a
portion of the Corps’ cost of providing
credit assistance and the costs of
conducting engineering reviews and
retaining expert firms, including
financial and legal services, to assist in
the underwriting and servicing of
Federal credit instruments. Projects
would be evaluated and selected by the
Secretary of the Army (the Secretary)
based on the requirements and the
criteria described in this rule.
Statement of Need: The USACE
WIFIA program is focused on providing
Federal loans, and potentially to also
include loan guarantees, to projects for
maintaining, upgrading, and repairing
dams identified in the National
Inventory of Dams owned by nonfederal entities. These loans will be
repaid with non-Federal funding.
Summary of Legal Basis: The USACE
WIFIA program was authorized under
Subtitle C of Title V of the Water
Resources Reform and Development Act
of 2014 (WRRDA 2014), which
authorizes USACE to provide secured
(direct) loans, and potentially to also
include loan guarantees, to eligible
water resources infrastructure projects
(needed further authorization was
provided by Division D, Title 1 of the
Consolidated Appropriations Act of
2020). The statute also authorizes
USACE to charge fees to recover all or
a portion of USACE’s cost of providing
credit assistance and the costs of
conducting engineering reviews and
retaining expert firms, including
financial and legal services, to assist in
the underwriting and servicing of
Federal credit instruments.
The Fiscal 2021 Consolidated
Appropriations Act, provided USACE
WIFIA appropriations of $2.2M admin,
and $12M credit subsidy and a loan
volume limit of $950M. These
appropriated funds are limited to fund
projects focused on maintaining,
upgrading, and repairing dams
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identified in the National Inventory of
Dams owned by non-federal entities.
Alternatives: The preferred alternative
would be to conduct proposed
rulemaking to implement a new credit
program for dam safety work at nonFederal dams in the form of a binding
regulation in compliance with the Water
Infrastructure Finance and Innovation
Act of 2014 (WIFIA) and Division D,
title 1 of the Consolidated
Appropriations Act of 2020. The next
best alternative would involve issuing
these implementing procedures in the
form of an Engineer Regulation. That
alternative would not fulfill the intent of
the law because it would not be binding
on the regulated public. The no action
alternative would be to not conduct
rulemaking which would not fulfill the
authorization provided by Congress.
Anticipated Cost and Benefits: The
proposed rule would add Corps
procedures to the CFR on the
implementation of a new credit program
for dam safety work at non-Federal
dams to allow for consistent
implementation across the Corps and
clear understanding of the program and
its requirements by the regulated public.
The USACE would incur costs to
administer the loan program while
benefits are expected for the public in
the form of benefits from projects
enabled by WIFIA loans.
Risks: The proposed action is not
anticipated to increase risk to public
health, safety, or the environment
because it outlines the procedures the
Corps will follow for implementing a
federal loan program. The Corps will
comply with all statutory requirements
when reviewing requests.
Timetable:
Action
Date
NPRM ..................
FR Cite
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Aaron Snyder,
Department of Defense, U.S. Army
Corps of Engineers, 441 G Street NW,
Washington, DC 20314, Phone: 651 290–
5489, Email: aaron.m.snyder@
usace.army.mil.
Related RIN: Merged with 0710–
AB32.
RIN: 0710–AB31
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DOD—COE
24. Flood Control Cost-Sharing
Requirements Under the Ability To Pay
Provision
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 2213(m)
CFR Citation: 33 CFR 241.
Legal Deadline: None.
Abstract: Section 103(m) of the Water
Resources Development Act (WRDA) of
1986, as amended (33 U.S.C. 2213(m)),
authorizes the U.S. Army Corps of
Engineers (Corps) to reduce the nonFederal share of the cost of a study or
project for certain communities that are
not able financially to afford the
standard non-Federal cost-share. Part
241 of title 33 in the Code of Federal
Regulations provides the criteria that
the Corps uses in making these
determinations where the primary
purpose of the study or project is flood
damage reduction. The proposed rule
would update this regulation, including
by broadening its applicability by
including projects with other purposes
(instead of just flood damage reduction)
and by including the feasibility study of
a project (instead of just design and
construction).
Statement of Need: The Corps may
conduct a rulemaking to propose
amendments to the Corps’ regulations at
33 CFR part 241 for Corps projects. The
WRDA 2000 modified Section 103(m) to
also include the following mission
areas: Environmental protection and
restoration, flood control, navigation,
storm damage protection, shoreline
erosion, hurricane protection, and
recreation or an agricultural water
supply project which have not yet been
added to the regulation. It also included
the opportunity to cost share all phases
of a USACE project to also include
feasibility in addition to the already
covered design and construction. This
rule would provide a framework for
deciding which projects are eligible for
consideration for a reduction in the nonFederal cost share based on ability to
pay.
Summary of Legal Basis: 33 U.S.C.
2213(m).
Alternatives: The preferred alternative
would be to conduct rulemaking to
amend 33 CFR 241 by broadening the
project purposes for which the Corps
could reduce the non-Federal cost-share
based on ability to pay and by allowing
such a reduction for feasibility studies.
The next best alternative would be to
provide additional guidance instead of
amending the existing regulation. This
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alternative could lead to confusion for
the regulated public.
Anticipated Cost and Benefits: The
proposed rule would add Corps
procedures on the ability to pay
provision allowing for consistent
implementation across the Corps and
clear understanding of the program and
its requirements by the regulated public.
Risks: The proposed action is not
anticipated to increase risk to public
health, safety, or the environment
because it outlines the procedures the
Corps will follow when evaluating the
ability to pay provision for cost-sharing
with the non-Federal sponsor.
Timetable:
Action
Date
NPRM ..................
FR Cite
03/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
Agency Contact: Amy Frantz, Program
Manager, Department of Defense, U.S.
Army Corps of Engineers, CECW–P, 441
G Street NW, Washington, DC 20314,
Phone: 202 761–0106, Email:
amy.k.frantz@usace.army.mil.
Related RIN: Previously reported as
0710–AA91.
RIN: 0710–AB34
2015 Clean Water Rule, and the 2020
Navigable Waters Protection Rule.
Statement of Need: In 2015, the
Environmental Protection Agency and
the Department of the Army (‘‘the
agencies’’) published the ‘‘Clean Water
Rule: Definition of ’Waters of the United
States (80 FR 37054, June 29, 2015).’’ In
April 2020, the agencies published the
Navigable Waters Protection Rule (85 FR
22250, April 21, 2020). The agencies
conducted a substantive re-evaluation of
the definition of ‘‘waters of the United
States’’ in accordance with the
Executive Order 13990 and determined
that they need to revise the definition to
ensure the agencies listen to the science,
protect the environment, ensure access
to clean water, consider how climate
change resiliency may be affected by the
definition of waters of the United States,
and to ensure environmental justice is
prioritized in the rulemaking process.
Summary of Legal Basis: The Clean
Water Act (33 U.S.C. 1251 et seq.).
Alternatives: Please see EPA’s
alternatives. EPA is the lead for this
rulemaking action.
Anticipated Cost and Benefits: Please
see EPA’s statement of anticipated costs
and benefits. EPA is the lead for this
rulemaking action.
Risks: Please see EPA’s risks. EPA is
the lead for this rulemaking action.
Timetable:
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Action
25. Revised Definition of ‘‘Waters of the
United States’’—Rule 1
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 1344
CFR Citation: 33 CFR 328.
Legal Deadline: None.
Abstract: In April 2020, the EPA and
the Department of the Army (‘‘the
agencies’’) published the Navigable
Waters Protection Rule (NWPR) that
revised the previously codified
definition of ‘‘waters of the United
States’’ (85 FR 22250, April 21, 2020).
The agencies are now initiating this new
rulemaking process that restores the
regulations (51 FR 41206) in place prior
to the 2015 ‘‘Clean Water Rule:
Definition of ’Waters of the United
States’’ (80 FR 37054, June 29, 2015),
updated to be consistent with relevant
Supreme Court decisions. The agencies
intend to consider further revisions in a
second rule in light of additional
stakeholder engagement and
implementation considerations,
scientific developments, and
environmental justice values. This effort
will also be informed by the experience
of implementing the pre-2015 rule, the
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Date
NPRM ..................
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Stacey M. Jensen,
Office of the Assistant Secretary of the
Army, Department of Defense, U.S.
Army Corps of Engineers, 108 Army
Pentagon, Washington, DC 22202,
Phone: 703 695–6791, Email:
stacey.m.jensen.civ@mail.mil.
RIN: 0710–AB40
defining ‘‘Waters of the United States’’
to consider further revisions to the
agencies’ first rule (RIN 0710–AB40)
which proposes to restore the
regulations in place prior to the 2015
waters of the United States rule (51 FR
41206), updated to be consistent with
relevant Supreme Court Decisions. This
second rule proposes to include
revisions reflecting on additional
stakeholder engagement and
implementation considerations,
scientific developments, and
environmental justice values. This effort
will also be informed by the experience
of implementing the pre-2015 rule, the
2015 Clean Water Rule, and the 2020
Navigable Waters Protection Rule.
Statement of Need: In 2015, the
Environmental Protection Agency and
the Department of the Army (‘‘the
agencies’’) published the ‘‘Clean Water
Rule: Definition of ’Waters of the United
States (80 FR 37054, June 29, 2015).’’ In
April 2020, the agencies published the
Navigable Waters Protection Rule (85 FR
22250, April 21, 2020). The agencies
conducted a substantive re-evaluation of
the definition of ‘‘waters of the United
States’’ in accordance with the
Executive Order 13990 and determined
that they need to revise the definition to
ensure the agencies listen to the science,
protect the environment, ensure access
to clean water, consider how climate
change resiliency may be affected by the
definition of waters of the United States,
and to ensure environmental justice is
prioritized in the rulemaking process.
Summary of Legal Basis: The Clean
Water Act (33 U.S.C. 1251 et seq.).
Alternatives: Please see EPA’s
alternatives. EPA is the lead for this
rulemaking action.
Anticipated Cost and Benefits: Please
see EPA’s statement of anticipated costs
and benefits. EPA is the lead for this
rulemaking action.
Risks: Please see EPA’s risks. EPA is
the lead for this rulemaking action.
Timetable:
Action
NPRM ..................
DOD—COE
26. • Revised Definition of ‘‘Waters of
the United States’’—Rule 2 (Reg Plan
Seq No. XX)
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 33 U.S.C. 1344
CFR Citation: 33 CFR 328.
Legal Deadline: None.
Abstract: The Department of the Army
and the Environmental Protection
Agency intend to pursue a second rule
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Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Stacey M. Jensen,
Office of the Assistant Secretary of the
Army, Department of Defense, U.S.
Army Corps of Engineers, 108 Army
Pentagon, Washington, DC 22202,
Phone: 703 695–6791, Email:
stacey.m.jensen.civ@mail.mil.
RIN: 0710–AB47
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DOD—OFFICE OF ASSISTANT
SECRETARY FOR HEALTH AFFAIRS
(DODOASHA)
Final Rule Stage
27. Tricare Coverage and Payment for
Certain Services in Response to the
Covid–19 Pandemic
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10
U.S.C. ch. 55
CFR Citation: 32 CFR 199.
Legal Deadline: None.
Abstract: The Department of Defense
is finalizing an interim final rule that
temporarily amended 32 CFR part 199
to revise: (1) 32 CFR part 199.4 to
remove the restriction on audio-only
telemedicine services; (2) 32 CFR part
199.6 to authorize reimbursement for
interstate practice by TRICAREauthorized providers when such
authority is consistent with State and
Federal licensing requirements; and (3)
32 CFR part 199.17 to eliminate
copayments for telemedicine services.
The changes in this rule are effective
from the date published through the end
of the coronavirus 2019 (COVID–19)
pandemic. These changes reduce the
spread of COVID–19 among TRICARE
beneficiaries by incentivizing use of
telemedicine services, and aid providers
in caring for TRICARE beneficiaries by
temporarily waiving some licensure
requirements.
The final rule adopts this interim final
rule as final with changes.
Statement of Need: Pursuant to the
President’s health emergency
declaration and as a result of the
worldwide coronavirus 2019 (COVID–
19) pandemic, the Assistant Secretary of
Defense for Health Affairs hereby
modifies the following regulations, but
in each case, only to the extent
necessary, as determined by the
Director, Defense Health Agency, to
encourage social distancing and prevent
the spread of COVID–19 by
incentivizing the use of telehealth
services, and to allow TRICAREauthorized providers to care for
TRICARE beneficiaries wherever there
is need as a result of the consequences
of the COVID–19 pandemic.
The modifications to section
199.4(g)(52) in this interim final rule
(IFR) will allow TRICARE beneficiaries
to obtain telephonic office visits with
TRICARE-authorized providers for
medically necessary care and treatment
and allow reimbursement to those
providers during the COVID–19
pandemic. It provides an exception to
the regulatory exclusion prohibiting
audio-only telephone services.
The modifications to section
199.6(c)(2)(i) in this IFR will allow
providers to be reimbursed for interstate
practice, both in person and via
telehealth, during the global pandemic
so long as the provider meets the
requirements for practicing in that State
or under Federal law. It removes the
requirement that the provider must be
licensed in the State where practicing,
even if that license is optional. For
providers overseas, this will allow
providers, both in person and via
telehealth, to practice outside of the
nation where licensed when permitted
by the host nation.
The modifications to section
199.17(l)(3) will remove cost-shares and
copayments for telehealth services for
TRICARE Prime and Select beneficiaries
utilizing telehealth services with an innetwork, TRICARE-authorized provider
during the global pandemic. It adds innetwork telehealth services as a special
cost-sharing rule to waive the
beneficiary copay.
Summary of Legal Basis: This rule is
issued under 10 U.S.C. 1073 (a)(2)
giving authority and responsibility to
the Secretary of Defense to administer
the TRICARE program.
Alternatives:
(1) No action.
(2) Only apply the regulatory
modifications to COVID–19-related
diagnoses. This was rejected because the
effects of the COVID–19 pandemic are
causing stress on the entire health care
system. The regulatory modifications in
this IFR will take the pressure off of the
health care system by: (1) Covering
telephone appointments with a
TRICARE-authorized provider and
thereby supporting social distancing
recommendations; (2) covering
TRICARE-authorized providers
practicing across state lines, thereby
increasing the overall access to medical
care and treatment; and (3) waiving all
copayments for in-network telehealth
services, thereby removing the potential
cost barrier to obtaining medical
services remotely and inducing demand
for these services, reducing potential
person-to-person transmission of
COVID–19 during medical
appointments.
Anticipated Cost and Benefits: Health
Care Costs Associated with Removing
Copays for Telehealth.
There are three factors that would
increase Department of Defense (DoD)
health care costs due to this rule. First,
the government would lose cost-sharing
revenue paid by beneficiaries on the
existing level of telehealth visits.
Second, there would be induced
demand costs, as removal of patient
costs will increase patient demand for
these services. Finally, there would be
a substitution effect, as the COVID–19
pandemic and removal of telehealth
cost-shares would encourage a shift
from in-person visits, for which
beneficiaries would pay a copay, to
telehealth visits, which would be free to
beneficiaries.
The below provides a summary of the
combined government health care and
administrative costs of the IFR.
SUMMARY OF GOVERNMENT COSTS OF THE PROPOSED COVID–19 TELEHEALTH IFR
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Government Healthcare Cost (HC)
3-Month scenario
6-Month scenario
9-Month scenario
Loss of copays on existing telehealth .......................................................................
Induced demand ........................................................................................................
Loss of copays on in-person shifting to Telehealth ..................................................
$156,949
117,772
26,673,895
$313,897
235,544
48,611,002
$470,846
353,316
65,459,795
Subtotal, Government HC cost ..........................................................................
26,948,616
49,160,443
66,283,957
Start-up administrative cost .......................................................................................
67,494
67,494
67,494
Total Government Cost increase .......................................................................
27,016,110
49,227,937
66,351,451
Beneficiary Cost Impact
There are two types of savings for
beneficiaries estimated here. First,
beneficiaries would avoid the cost-
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sharing they otherwise would have paid
on existing telehealth visits and on inperson visits that would shift to
telehealth. It is estimated the cost-
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sharing savings to beneficiaries would
be: $26,830,844 for a three-month
scenario; $48,924,899 for a six-month
scenario; and $65,930,641 for a nine-
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month scenario. Second, for the share of
historical visits that is estimated would
shift from in-person to telehealth,
beneficiaries would avoid travel time
and time spent in the provider’s waiting
room. Two parameters were considered
in developing the estimate of the value
of time saved for TRICARE
beneficiaries: (1) The average amount of
time saved per visit, and (2) a monetized
estimate of the value of the time saved,
based on the opportunity cost of that
5041
time. See the below table Estimated
Value to Beneficiaries for the combined
results of avoided cost-sharing and
dollar value of saved time.
ESTIMATED VALUE TO BENEFICIARIES
3-Month scenario
9-Month scenario
Avoided cost-sharing .................................................................................................
Dollar value of time saved .........................................................................................
$26,830,844
17,085,995
$48,924,899
31,089,668
$65,930,641
41,384,466
Total estimated value to beneficiaries ................................................................
43,916,839
80,014,567
107,315,107
An important value to beneficiaries
that is not feasible to estimate but worth
noting is the possibility that shifting
visits from in-person to telehealth might
reduce the risk of COVID–19 exposure,
with all the potential benefits that could
accompany that reduced exposure risk.
This reduced risk of COVID–19
exposure may also result in downstream
reductions in cost to the TRICARE
Program in avoided COVID–19
diagnostics and treatment.
Risks: None. This rule will promote
the efficient functioning of the economy
and markets by temporarily modifying
regulations to ensure that actors in the
health care market (primarily health
care providers) will continue to be
reimbursed despite disruption in the
health care ecosystem by the COVID–19
pandemic. Reimbursing providers
despite changing licensing requirements
and in ways that recognize the critical
role telehealth will play in the coming
months ensures that TRICARE supports
not just its beneficiaries, but the
economy in general.
Timetable:
Action
Date
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Final Action .........
khammond on DSKJM1Z7X2PROD with PROPOSALS2
6-Month scenario
05/12/20
05/12/20
FR Cite
85 FR 27921
06/11/20
02/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Erica Ferron, Defense
Health Agency, Medical Benefits and
Reimbursement Division, Department of
Defense, Office of Assistant Secretary
for Health Affairs, 16401 E Centretech
Parkway, Aurora, CO 80011–9066,
Phone: 303 676–3626, Email:
erica.c.ferron.civ@mail.mil.
RIN: 0720–AB81
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DOD—DODOASHA
28. Tricare Coverage of Certain Medical
Benefits in Response to the Covid–19
Pandemic
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10
U.S.C. ch. 55
CFR Citation: 32 CFR 199.
Legal Deadline: None.
Abstract: The Department of Defense
is finalizing an interim final rule that
temporarily amended 32 CFR part 199
to revise certain elements of the
TRICARE program under 32 CFR part
199 to: (1) Waive the three-day prior
hospital qualifying stay requirement for
coverage of skilled nursing facility care;
(2) add coverage for treatment use of
investigational drugs under expanded
access authorized by the United States
(U.S.) Food and Drug Administration
(FDA) when for the treatment of
coronavirus disease 2019 (COVID–19);
(3) waive certain provisions for acute
care hospitals that permitted
authorization of temporary hospital
facilities and freestanding ambulatory
surgical centers providing inpatient and
outpatient hospital services; and,
consistent with similar changes under
the Centers for Medicaid and Medicare
Services; (4) revise diagnosis related
group (DRG) reimbursement by
temporarily reimbursing DRGs at a 20
percent higher rate for COVID–19
patients; and (5) waive certain
requirements for long term care
hospitals. The final action permanently
adopts Medicare’s New Technology
Add-On Payments adjustment to DRGs
for new medical services and
technologies and adopted Medicare’s
Hospital Value Based Purchasing
Program.
The final rule adopts the interim final
rule with changes, except for the note to
section 199.4(g)(15)(i)(A), published at
85 FR 54923, September 3, 2020, which
remains interim.
Statement of Need: Pursuant to the
President’s emergency declaration and
as a result of the worldwide coronavirus
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disease 2019 (COVID–19) pandemic, the
Assistant Secretary of Defense for
Health Affairs is temporarily modifying
the following regulations, but in each
case, only to the extent necessary to
ensure that TRICARE beneficiaries have
access to the most up-to-date care
required for the diagnosis and treatment
of COVID–19, and that TRICARE
continues to reimburse like Medicare, to
the extent practicable, as required by
statute.
The modification to paragraph
199.4(b)(3)(xiv) waives the requirement
for a minimum three-day prior hospital
stay, not including leave day, for
coverage of a skilled nursing facility
admission. This provision reduces stress
on acute care hospitals.
The modification to paragraph
199.4(g)(15) permits cost-sharing of
investigational new drugs (INDs). This
provision also increases access to
emerging therapies.
The modification to paragraph
199.6(b)(4)(i) waives certain provisions
for acute care hospitals that will permit
authorization of temporary hospital
facilities and freestanding ambulatory
surgical centers. This provision
supports increased access to acute care.
The modifications to paragraph
199.14(a)(1)(iii)(E) increase the
diagnosis related group (DRG) amount
by 20 percent for an individual
diagnosed with COVID–19 and adopt
Medicare’s New Technology Add-On
Payments (NTAPs) and Hospital ValueBased Purchasing (HVBP) Program.
These provisions support the
requirement that TRICARE reimburse
like Medicare. The NTAPs and HVBP
Program are adopted permanently.
The modification to paragraph
199.14(a)(9) waives site neutral payment
provisions by reimbursing all long-term
care hospitals (LTCHs) at the standard
federal rate for claims. This provision
supports the requirement that TRICARE
reimburse like Medicare.
Summary of Legal Basis: This rule is
issued under 10 U.S.C. 1073 (a)(2)
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giving authority and responsibility to
the Secretary of Defense to administer
the TRICARE program.
Alternatives:
(1) No action.
(2) The second alternative the
Department of Defense considered was
implementing a more limited benefit
change for COVID–19 patients by not
covering treatment INDs. While this
would have the benefit of reimbursing
only care that has more established
evidence in its favor, this alternative is
not preferred because early access to
treatments is critical for TRICARE
beneficiaries given the rapid progression
of the disease and the lack of available
approved treatments.
Anticipated Cost and Benefits: Health
Care and Administrative Costs.
The cost estimates related to the
changes discussed in this Interim Final
Rule (IFR) include incremental health
care cost increases as well as
administrative costs to the government.
The duration of the COVID–19 national
emergency and Health and Human
Services Public Health Emergency (PHE)
are uncertain, resulting in a range of
estimates for each provision in this IFR.
Cost estimates are provided for an
approximate nine-month (ending 12/31/
2020) and eighteen-month scenario
(ending 9/30/2021). The nine-month
and 18-month periods would be longer
for those provisions applicable
beginning in January of this year, and
shorter for those effective the date this
IFR publishes. The terms nine-month
and 18-month period are used
throughout this estimate for the sake of
simplicity.
The cost estimates consider whether
the outbreak will have more than one
active stage. The first active stage is
considered to be March through August
2020, based on the Institutes for Health
Metrics and Evaluation data as of May
12, 2020 (https://covid19.healthdata.
org/united-states-of-america). A two-
wave scenario would have a second
stage in winter/spring 2021, while a
three-wave scenario would have
additional waves from September 2020
to December 2020 and from January
2021 to June 2021.
Based on these factors, we estimate
that the total cost estimate for this IFR
will be between $43.6M and $59.4M for
a nine-month period, and $66.3M to
$82.1M for an 18-month period. This
estimate includes just over $1M in
administrative start-up costs and no
ongoing administrative costs. The
primary cost drivers in this analysis are
the reimbursement changes being
adopted under the statutory requirement
that TRICARE reimburse like Medicare;
that is, the 20 percent DRG increase for
COVID–19 patients, the adoption of
NTAPs and HVBP, and the waiver of
LTCH site neutral payment reductions.
A breakdown of costs, by provision, is
provided in the below table. A
discussion of assumptions follows.
Nine-month
scenario
Provision
Paragraph 199.4(b)(3)(xiv) SNF Three-Day Prior Stay Waiver ..............................................................................
Paragraph 199.4(g)(15)(A) INDs for COVID–19 .....................................................................................................
Paragraph 199.6(b)(4)(i) Temporary Hospitals and Freestanding ASCs Registering as Hospitals .......................
Paragraph 199.14(a)(1)(iii)(E)(2) 20 Percent DRG Increase for COVID–19 Patients ............................................
Paragraph 199.14(a)(1)(iii)(E)(5) NTAPs .................................................................................................................
Paragraph 199.14(a)(1)(iii)(E)(6) HVBP ..................................................................................................................
Paragraph 199.14(a)(9) LTCH Site Neutral Payments ...........................................................................................
Administrative Costs ................................................................................................................................................
$0.3M
0.7M–2.2M
0M
27.7M–42M
5.7M
2.5M
5.6M
1.1M
$0.6M
2.7M–4.2M
0M
37.1M–51.4M
11.6M
2.5M
10.6M
1.2M
Estimated Total Cost Impact ............................................................................................................................
43.6M–59.4M
66.3M–82.1M
Benefits to the TRICARE Program
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Eighteenmonth
scenario
Depending on the impact of certain
provisions of this IFR, some cost savings
could be achieved from a reduction in
hospitalization rates (i.e., use of
treatment INDs), estimated from no
savings to $40M over 18 months. The
amount of cost-savings achieved will be
determined by the therapies developed,
how widespread their usage is, the
extent to which the therapies are
authorized as treatment INDs, the
effectiveness of the therapies in
reducing hospitalizations and/or the use
of mechanical ventilators, and how long
the therapies remain as INDs before
transitioning to United States Food and
Drug Administration-approval,
clearance, or emergency use
authorization.
Any benefits achieved in reduced
hospitalizations and/or mechanical
ventilator use are also benefits to
TRICARE beneficiaries, for whom
avoidance of more serious COVID–19
illness is of paramount concern. While
we cannot estimate the value of this
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avoidance in quantitative figures, the
potential long-term consequences of a
serious COVID–19 illness, including
permanent cardiac or lung damage, are
not insignificant. If beneficiaries are
able to access emerging therapies that
prevent long-term consequences
(including death), this will be a benefit
to the beneficiary.
The largest creators of costs under this
IFR (reimbursement changes) are not
anticipated or intended to create any
cost savings. However, these changes
will benefit TRICARE institutional
providers and take stress off the entire
health care system by ensuring adequate
reimbursement during the PHE, at a
time during which hospitals are losing
revenue due to reduced elective
procedures and patients who delay care
due to fears of contracting COVID–19
during health care encounters. Ensuring
a robust health care system is of benefit
to our beneficiaries and the general
public, particularly in rural or
underserved areas, even though this
benefit is not quantifiable.
Risks:
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None. This rule will promote the
efficient functioning of the economy
and markets by modifying the
regulations to better reimburse health
care providers for care provided during
the COVID–19 pandemic, particularly as
strain on the health care economy is
being felt due to reductions in higher
cost elective procedures.
Timetable:
Action
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Final Action .........
Date
09/03/20
09/03/20
FR Cite
85 FR 54915
11/02/20
02/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Erica Ferron, Defense
Health Agency, Medical Benefits and
Reimbursement Division, Department of
Defense, Office of Assistant Secretary
for Health Affairs, 16401 E Centretech
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Parkway, Aurora, CO 80011–9066,
Phone: 303 676–3626, Email:
erica.c.ferron.civ@mail.mil.
RIN: 0720–AB82
DOD—DODOASHA
khammond on DSKJM1Z7X2PROD with PROPOSALS2
29. TRICARE Coverage of National
Institute of Allergy and Infectious
Disease Coronavirus Disease 2019
Clinical Trials
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10
U.S.C. ch 55
CFR Citation: 32 CFR 199.
Legal Deadline: None.
Abstract: The Department of Defense
is finalizing an interim final rule that
temporarily amended 32 CFR 199 to
revise certain elements of the TRICARE
program, to add coverage for National
Institute of Allergy and Infectious
Disease-sponsored clinical trials for the
treatment or prevention of coronavirus
disease 2019 (COVID–19).
Statement of Need: Pursuant to the
President’s national emergency
declaration and as a result of the
worldwide COVID–19 pandemic, the
Assistant Secretary of Defense for
Health Affairs hereby temporarily
modifies the regulation at 32 CFR
199.4(e)(26) to permit TRICARE
coverage for National Institute of
Allergy and Infectious Disease (NIAID)sponsored COVID–19 phase I, II, III, and
IV clinical trials for the treatment or
prevention of coronavirus disease 2019
(COVID–19). This provision supports
increased access to emerging therapies
for TRICARE beneficiaries.
Summary of Legal Basis: This rule is
issued under 10 U.S.C. 1079 giving
authority and responsibility to the
Secretary of Defense to administer the
TRICARE program.
Alternatives:
(1) No action.
(2) The second alternative the DoD
considered was implementing a more
limited benefit change for COVID–19
patients by not covering phase I clinical
trials. Although this would have the
benefit of reimbursing only care that has
more established evidence in its favor,
this alternative is not preferred because
early access to treatments is critical for
TRICARE beneficiaries given the rapid
progression of the disease and the lack
of available approved treatments.
Anticipated Cost and Benefits:
Costs: We estimate the total cost for
TRICARE participation in NIAIDsponsored COVID–19 clinical trials will
be $3.2M for the duration of the national
emergency, with an additional $4.0M
for continued care for beneficiaries
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enrolled in clinical trials prior to
termination of the national emergency.
There were several assumptions we
made in developing this estimate. The
duration of the COVID–19 national
emergency is uncertain; however, for
the purposes of this estimate, we
assumed the national emergency would
expire on September 30, 2021. As of the
drafting of this IFR, there were 27
NIAID-sponsored COVID–19 clinical
trials begun since the start of the
national emergency. We assumed 6.2
new trials every 30 days, for a total of
126 trials by September 2021. We
assumed, based on average trial
enrollment and that TRICARE
beneficiaries would participate in trials
at the same rate as the general
population, that 4,549 TRICARE
beneficiaries would participate through
September 2021. Each of the
assumptions in this estimate is highly
uncertain, and our estimate could be
higher or lower depending on real world
events (more or fewer trials, a longer or
shorter national emergency, and/or
higher or lower participation in clinical
trials by TRICARE beneficiaries).
Benefits: These changes expand the
therapies available to TRICARE
beneficiaries in settings that ensure
informed consent of the beneficiary, and
where the benefits of treatment
outweigh the potential risks.
Participation in clinical trials may
provide beneficiaries with benefits such
as reduced hospitalizations and/or use
of a mechanical ventilator. Although we
cannot estimate the value of avoiding
these outcomes quantitatively, the
potential long-term consequences of
serious COVID–19 illness, including
permanent cardiac or lung damage, are
not insignificant. Beneficiary access to
emerging therapies that reduce these
long-term consequences or even death
can be considered to be high-value for
those able to participate.
TRICARE providers will be positively
affected by being able to provide their
patients with a broader range of
treatment options. The general public
will benefit from an increased pool of
available participants for the
development of treatments and vaccines
for COVID–19, as well as the evidence
(favorable or otherwise) that results
from this participation.
Risks: None. This rule will not
directly affect the efficient functioning
of the economy or private markets.
However, increasing the pool of
available participants for clinical trials
may help speed the development of
treatments or vaccines for COVID–19.
Once effective treatments or vaccines for
COVID–19 exist, individuals are likely
to be more confident interacting in the
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5043
public sphere, resulting in a positive
impact on the economy and private
markets.
Timetable:
Action
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
Final Action .........
Date
10/30/20
10/30/20
FR Cite
85 FR 68753
11/30/20
06/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: Erica Ferron, Defense
Health Agency, Medical Benefits and
Reimbursement Division, Department of
Defense, Office of Assistant Secretary
for Health Affairs, 16401 E Centretech
Parkway, Aurora, CO 80011–9066,
Phone: 303 676–3626, Email:
erica.c.ferron.civ@mail.mil.
RIN: 0720–AB83
DOD—DODOASHA
30. Expanding TRICARE Access to Care
in Response to the COVID–19 Pandemic
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 10
U.S.C. ch. 55
CFR Citation: 32 CFR 199
Legal Deadline: None.
Abstract: This interim final rule with
comment will temporarily amend the
TRICARE regulation at 32 CFR part 199
by: (1) Adding freestanding End Stage
Renal Disease facilities as a category of
TRICARE-authorized institutional
provider and modifying the
reimbursement for such facilities; (2)
adding coronavirus 2019 (COVID–19)
Immunizers who are not otherwise an
eligible TRICARE-authorized provider
as providers eligible for reimbursement
for COVID–19 vaccines and vaccine
administration; (3) and adopting
Medicare New COVID–19 Treatments
Add-on Payments (NTCAPs).
Statement of Need: Pursuant to the
President’s emergency declaration and
as a result of the COVID–19 pandemic,
the Assistant Secretary of Defense for
Health Affairs is temporarily modifying
the following regulations (except for the
modifications to paragraphs
199.6(b)(4)(xxi) and
199.14(a)(1)(iii)(E)(7), which will not
expire), but, in each case, only to the
extent necessary to ensure that
TRICARE beneficiaries have access to
the most up-to-date care required for the
prevention, diagnosis, and treatment of
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COVID–19, and that TRICARE continues
to reimburse like Medicare, to the extent
practicable, as required by statute.
The modifications to paragraphs
199.6(b)(4)(xxi) and
199.14(a)(1)(iii)(E)(7) establish
freestanding End Stage Renal Disease
(ESRD) facilities as a category of
TRICARE-authorized institutional
provider and modify TRICARE
reimbursement of freestanding ESRD
facilities. These provisions will improve
TRICARE beneficiary access to
medically necessary dialysis and other
ESRD services and supplies. These
provisions also support the requirement
that TRICARE reimburse like Medicare,
and will help to alleviate regional health
care shortages due to the COVID–19
pandemic by ensuring access to dialysis
care in freestanding ESRD facilities
rather than hospital outpatient
departments.
The modification to paragraph
199.14(a)(iii)(E) adopts Medicare’s New
COVID–19 Treatments Add-on Payment
(NCTAP) for COVID–19 cases that meet
Medicare’s criteria. This provision
increases access to emerging COVID–19
treatments and supports the
requirement that TRICARE reimburse
like Medicare.
The modification to paragraph
199.6(d)(7) adds providers who
administer COVID–19 vaccinations, but
are not otherwise authorized under
199.6, as TRICARE-authorized
providers. This provision increases
access to COVID–19 vaccinations. This
provision increases access to COVID–19
vaccines for eligible TRICARE
beneficiaries and supports the United
States (U.S.) public health goal of
ending the COVID–19 pandemic.
Summary of Legal Basis: This rule is
issued under 10 U.S.C. 1073(a)(2) giving
authority and responsibility to the
Secretary of Defense to administer the
TRICARE program.
Alternatives:
(1) No action.
(2) The second alternative the
Department of Defense considered was
to adopt Medicare’s ESRD
reimbursement methodology, the ESRD
Prospective Payment System (PPS), in
total. While this would have been
completely consistent with the statutory
provision to pay institutional providers
using the same reimbursement
methodology as Medicare, this
alternative is not preferred because
there is still a relatively low volume of
TRICARE beneficiaries who receive
dialysis services from freestanding
ESRDs and who are not enrolled to
Medicare. The cost of implementing the
full ESRD PPS system is estimated to be
at least $600,000.00 in start-up costs,
plus ongoing administrative costs, to
ensure all adjustments were made for
each claim, plus additional special
pricing software or algorithms. In
contrast, we estimate that the option
provided in this IFR can be
implemented relatively quickly (within
six months of publication), and for
approximately $300,000.00 in start-up
costs with lower ongoing administrative
costs. Further, the flat rate will provide
the ESRD facilities with predictability
with regard to TRICARE payments and
will reduce uncertainty and specialized
coding or case-mix documentation
requirements that may be required by
the ESRD PPS, reducing the
administrative burden on the provider.
To summarize, adopting the ESRD
PPS was considered, but was deemed
impracticable and overly burdensome to
both the Government and providers due
to the relative low volume of claims that
will be priced and paid by TRICARE as
primary under this system.
Anticipated Cost and Benefits: Health
Care and Administrative Costs.
The Independent Cost A by Kennell
and Associates, Inc., estimates a total of
$6.8M. Only the ESRD provisions are
expected to result in recurring
incremental health care costs; the
remaining two provisions are expected
to result in one-time cost increases. For
these temporary changes to the
regulation, our cost estimate assumes
that the majority of adults in the U.S.
will be vaccinated by September 2021,
based on the most recent information
provided by Federal and state agencies,
and, as a result, that the President’s
emergency declaration and the public
health emergency relating to the
COVID–19 pandemic will end by
September 2021. While this estimate
would have the President’s emergency
declaration end shortly after publication
of the rule, the COVID–19 pandemic
contains substantial uncertainty
including the possibility of a virus
variant resistant to current vaccines. As
such, we find it appropriate to make
these regulatory changes despite the
potential short effective period, as the
end of the pandemic is by no means a
certainty.
Based on these factors, as well as the
assumptions for each provision detailed
below, we estimate that the total cost
estimate for this Interim Final Rule (IFR)
will be approximately $6.8M. This
estimate includes approximately $0.9M
in administrative costs and $5.9M in
direct health care costs. $1.8M of the
total cost impact is expected to be a onetime start-up cost for both the temporary
and permanent provisions, while the
permanent ESRD provisions are
expected to result in $5M in
incremental annual costs.
A breakdown of costs, by provision, is
provided in the below table.
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Provision
Costs
Add Freestanding ESRD Facilities as TRICARE-Authorized Institutional Providers and Modify ESRD Reimbursement .................
Temporarily Authorize Immunizers Providing COVID–19 Vaccines ...................................................................................................
Temporarily Adopt DRG Add-On Payment for NCTAPs .....................................................................................................................
$5.3M
0.4M
1.1M
Estimated Total Cost Impact ........................................................................................................................................................
6.8M
Risks: None. This rule will promote
the efficient functioning of the economy
and markets by modifying the
regulations to better reimburse health
care providers for care provided during
the COVID–19 pandemic, particularly as
strain on the health care economy is
being felt due to reductions in higher
cost elective procedures. Additionally,
this rule will increase the access of
TRICARE beneficiaries to more
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providers administering COVID–19
vaccinations, which promotes the
efficient functioning of the U.S.
economy by quickening the pace at
which the public receives COVID–19
vaccinations.
Timetable:
Action
Date
Interim Final Rule
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Jahanbakhsh
Badshah, Healthcare Program
Specialist—Reimbursement, Department
of Defense, Office of Assistant Secretary
for Health Affairs, 16401 E. Centretech
Parkway, Aurora, CO 80011, Phone: 303
676–3881, Email:
jahanbakhsh.badshah.civ@mail.mil.
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RIN: 0720–AB85
BILLING CODE 5001–06–P
DEPARTMENT OF EDUCATION
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Statement of Regulatory Priorities
I. Introduction
The U.S. Department of Education
(Department) supports States, local
communities, institutions of higher
education, and families in improving
education and other services nationwide
to ensure that all Americans, including
those with disabilities and who have
been underserved, receive a high-quality
and safe education and are prepared for
employment that provides a livable
wage. We provide leadership and
financial assistance pertaining to
education and related services at all
levels to a wide range of stakeholders
and individuals, including State
educational and other agencies, local
school districts, providers of early
learning programs, elementary and
secondary schools, institutions of higher
education, career and technical schools,
nonprofit organizations, students,
members of the public, families, and
many others. These efforts are helping
to advance equity, recover from the
COVID–19 pandemic, and ensure that
all children and students from prekindergarten through grade 12 will be
ready for, and succeed in,
postsecondary education, and
employment, and that students
attending postsecondary institutions, or
participating in other postsecondary
education options, are prepared for a
profession or career.
We also vigorously monitor and
enforce the implementation of Federal
civil rights laws in educational
programs and activities that receive
Federal financial assistance from the
Department, and support innovative and
promising programs, research and
evaluation activities, technical
assistance, and the dissemination of
data, research, and evaluation findings
to improve the quality of education.
Overall, the laws, regulations, and
programs that the Department
administers will affect nearly every
American during his or her life. Indeed,
in the 2020–21 school year, about 56
million students attended an estimated
131,000 elementary and secondary
schools in approximately 13,600
districts, and about 20 million students
were enrolled in postsecondary schools.
Many of these students may benefit
from some degree of financial assistance
or support from the Department.
In developing and implementing
regulations, guidance, technical
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assistance, evaluations, data gathering
and reporting, and monitoring related to
our programs, we are committed to
working closely with affected persons
and groups. Our core mission includes
serving the most vulnerable, and
facilitating equal access for all, to ensure
all students receive a high-quality and
safe education, and complete it with a
well-considered and attainable path to a
sustainable career. Toward these ends,
we work with a broad range of
interested parties and the general
public, including families, students, and
educators; State, local, and Tribal
governments; other Federal agencies;
and neighborhood groups, communitybased early learning programs,
elementary and secondary schools,
postsecondary institutions,
rehabilitation service providers, adult
education providers, professional
associations, civil rights, nonprofits,
advocacy organizations, businesses, and
labor organizations.
If we determine that it is necessary to
develop regulations, we seek public
participation at the key stages in the
rulemaking process. We invite the
public to submit comments on all
proposed regulations through the
internet or by regular mail. We also
continue to seek greater public
participation in our rulemaking
activities through the use of transparent
and interactive rulemaking procedures
and new technologies.
To facilitate the public’s involvement,
we participate in the Federal Docket
Management System (FDMS), an
electronic single Government-wide
access point (www.regulations.gov) that
enables the public to submit comments
on different types of Federal regulatory
documents and read and respond to
comments submitted by other members
of the public during the public comment
period. This system provides the public
with the opportunity to submit
comments electronically on any notice
of proposed rulemaking or interim final
regulations open for comment as well as
read and print any supporting
regulatory documents.
II. Regulatory Priorities
The following are the key rulemaking
actions the Department is planning for
the coming year. These rulemaking
actions advance the Department’s
mission of ‘‘promot[ing] student
achievement and preparation for global
competitiveness by fostering
educational excellence and ensuring
equal access.’’ These rulemaking actions
also advance the President’s priorities of
ensuring that every American has access
to a high-quality education, regardless
of background, and that government
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should affirmatively work to expand
educational opportunities for
underserved communities. During his
first year in office, the President has
repeatedly made clear the importance of
advancing equity and opportunity for
those who have historically been
underserved, both as a general matter
and with regard to the education system
in particular. See Executive Order 13985
(On Advancing Racial Equity and
Support for Underserved Communities
Through the Federal Government);
Executive Order 14021 (Guaranteeing an
Educational Environment Free From
Discrimination on the Basis of Sex,
Including Sexual Orientation or Gender
Identity); Executive Order 14041 (White
House Initiative on Advancing
Educational Equity, Excellence, and
Economic Opportunity Through
Historically Black Colleges and
Universities); Executive Order 14045
(White House Initiative on Advancing
Educational Equity, Excellence, and
Economic Opportunity for Hispanics);
Executive Order 14049 (White House
Initiative on Advancing Educational
Equity, Excellence, and Economic
Opportunity for Native Americans and
Strengthening Tribal Colleges and
Universities); and Executive Order
14050 (White House Initiative on
Advancing Educational Equity,
Excellence, and Economic Opportunity
for Black Americans). The rulemaking
actions on the Department’s agenda seek
to advance the President’s priorities, as
set out in these executive orders and
more broadly. The rules below cover a
wide range of topics, and a wide range
of educational institutions—from those
serving our youngest children to
colleges, universities, and adult
education programs. In each of these
contexts, promoting equity and
opportunity for students who have been
historically underserved is central to the
Department’s regulatory plan.
These key rulemakings include Public
Service Loan Forgiveness, Income
Contingent Repayment, Improving
Student Loan Cancellation Authorities,
Pell Grants for Prison Education
Programs, State-Defined Processes for
Ability to Benefit, and Civil Rights, such
as Title IX Nondiscrimination on the
Basis of Sex in Education Program or
Activities Receiving Federal Financial
Assistance. For example, the Pell Grants
for Prison Education Programs rule
would support increased educational
opportunities for individuals who are
incarcerated and provide quality
options for individuals in this
underserved community. Additionally,
the Income Contingent Repayment rule
would make student loan payments
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more affordable for borrowers, with a
particular goal of helping increase
educational opportunities for many lowincome borrowers. The Department has
also dispersed billions of dollars in
funding during the COVID–19 pandemic
to address inequities exacerbated by the
pandemic, which targets resources to
historically underserved groups of
students and those students most
impacted by the pandemic through the
American Rescue Plan and other relief
efforts.
For rulemakings that we are just
beginning now, we have limited
information about their potential costs
and benefits. We note that some policies
that were previously included in the
Spring Unified Agenda, such as policies
impacting the magnet schools and
charter school programs, are still part of
the Department’s plans but do not
require regulation and, therefore, are not
included as items in the Fall regulatory
agenda or in this regulatory plan. We
have also identified the Innovative
Assessment Demonstration Authority
(IADA) rulemaking as a long-term action
because we are waiting for the
forthcoming progress report on the
initial demonstration authority to
inform any potential regulatory
proposal.
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Postsecondary Education/Federal
Student Aid
The Department’s upcoming higher
education regulatory efforts include the
following areas:
• Public Service Loan Forgiveness
• Borrower Defense to Repayment
• Improving Student Loan Cancellation
Authorities
• Income Contingent Repayment
• Pell Grants for Prison Education
Programs
• Gainful Employment
• 90/10 rule
These areas are focused on several
general areas which include improving
the rules governing student loan
repayment and targeted student loan
cancellation authorities and protecting
students and taxpayers from poorperforming programs, among other
topics. These rulemakings reflect the
Department’s commitment to serving
students and borrowers well and
protecting them from harmful programs
and practices that may derail their
postsecondary and career goals.
Through these regulatory efforts, the
Department plans to address gaps in
postsecondary outcomes, particularly
those related to student loan repayment,
affordability, and default. The
Department is also focused on the
disparate impacts by income, race/
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ethnicity, gender, disability status, and
other demographic characteristics that
may affect students’ postsecondary and
career goals. For its higher education
rulemakings, generally the Department
uses a negotiated rulemaking process.
We have selected participants for the
negotiated rulemaking committees from
nominees of the organizations and
groups that represent the interests
significantly affected by the proposed
regulations. To the extent possible, we
selected nominees who reflect the
diversity among program participants.
Specifically, the Department is
currently conducting negotiated
rulemaking addressing, among other
things, student loan repayment and
targeted student loan discharges by
improving Public Service Loan
Forgiveness, Borrower Defense to
Repayment, and other targeted student
loan cancellation authorities. On
Income Contingent Repayment, the
Department plans to create or adjust an
income-contingent repayment plan that
would allow borrowers to more easily
afford their student loan payments. For
Public Service Loan Forgiveness, the
Department plans to streamline the
process for receiving loan forgiveness
after 10 years of qualifying payments on
qualifying loans while engaging in
public service. For Borrower Defense,
the Secretary plans to amend the
regulations that specify the acts or
omissions of an institution of higher
education that a borrower may assert as
a defense to repayment of a loan made
under the Federal Direct Loan Program.
In Improving Student Loan Cancellation
Authorities, the Department plans to
propose improvements in areas where
Congress has provided borrowers with
relief or benefits related to Federal
student loans. This includes authorities
granted under the Higher Education Act
(HEA) that allow the Department to
cancel loans for borrowers who meet
certain criteria, such as having a total
and permanent disability, attending a
school that closed, or having been
falsely certified for a student loan. For
these borrowers, the Secretary plans to
amend the regulations relating to
borrower eligibility and streamline
application requirements and the
application and certification processes.
To increase access to educational
opportunities, the Department also
plans to propose regulations that would
guide correctional facilities and eligible
institutions of higher education that
seek to establish eligibility for the Pell
Grant program for individuals who are
incarcerated.
The Department also plans to conduct
negotiated rulemaking on Gainful
Employment and how to determine the
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amount of Federal educational
assistance received by institutions of
higher education through
implementation of the 90/10 rule. For
Gainful Employment, the Department
plans to propose regulations on program
eligibility under the HEA, including
regulations that determine whether
postsecondary educational programs
prepare students for gainful
employment in recognized occupations,
and the conditions under which
programs remain eligible for student
financial assistance programs under title
IV of the HEA. On the 90/10 rule, in
response to changes to the HEA made by
the American Rescue Plan Act of 2021,
the Department plans to amend
provisions governing whether
proprietary institutions meet
requirements that institutions receive at
least 10 percent of their revenue from
sources other than Federal education
assistance funds.
Civil Rights/Title IX
The Secretary is planning a new
rulemaking to amend its regulations
implementing Title IX of the Education
Amendments of 1972, as amended,
consistent with the priorities of the
Biden-Harris Administration. These
priorities include those set forth in
Executive Order 13988 on Preventing
and Combating Discrimination on the
Basis of Gender Identity or Sexual
Orientation and Executive Order 14021
on Guaranteeing an Educational
Environment Free from Discrimination
on the Basis of Sex, Including Sexual
Orientation and Gender Identity.
Student Privacy
The Department is considering policy
options to amend the Family
Educational Rights and Privacy Act
(FERPA) regulations, to update, clarify,
and improve the current regulations.
The proposed regulations are also
needed to implement statutory
amendments to FERPA contained in the
Uninterrupted Scholars Act of 2013 and
the Healthy, Hunger-Free Kids Act of
2010, to reflect a change in the name of
the office designated to administer
FERPA, and to make changes related to
the enforcement responsibilities of the
office concerning FERPA.
COVID–19 Regulations
As part of the Biden-Harris
Administration’s efforts to combat
COVID–19, safely reopen and support
schools, and implement the American
Rescue Plan Act (ARP), the Department
has issued: Interim final requirements to
promote accountability, transparency,
and the effective use of ARP Elementary
and Secondary School Emergency Relief
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Funds; a request for information
regarding implementation of the
statutory requirements for ARP’s
maintenance of equity (a first-of-its-kind
requirement to protect schools and
districts serving students from lowincome backgrounds from harmful
budget cuts); final requirements to
clarify the requirements applicable to
the ARP Emergency Assistance to NonPublic Schools program; amended
regulations so that an institution of
higher education (IHE) may
appropriately determine which
individuals currently or previously
enrolled at an institution are eligible to
receive emergency financial aid grants
to students under the Higher Education
Emergency Relief programs; and a final
rule regarding the allocations to
Historically Black Colleges and
Universities (HBCUs) awarded under
section 314(a)(2) of the Coronavirus
Response and Relief Supplemental
Appropriations Act, 2021 (CRRSAA).
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III. Principles for Regulating
Over the next year, we may need to
issue other regulations because of new
legislation or programmatic changes. In
doing so, we will follow the Principles
for Regulating, which determine when
and how we will regulate. Through
consistent application of those
principles, we have eliminated
unnecessary regulations and identified
situations in which major programs
could be implemented without
regulations or with limited regulatory
action.
In deciding when to regulate, we
consider the following:
• Whether regulations are essential to
promote quality and equality of
opportunity in education.
• Whether a demonstrated problem
cannot be resolved without regulation.
• Whether regulations are necessary
to provide a legally binding
interpretation to resolve ambiguity.
• Whether entities or situations
subject to regulation are similar enough
that a uniform approach through
regulation would be meaningful and do
more good than harm.
• Whether regulations are needed to
protect the Federal interest, that is, to
ensure that Federal funds are used for
their intended purpose and to eliminate
fraud, waste, and abuse.
In deciding how to regulate, we are
mindful of the following principles:
• Regulate no more than necessary.
• Minimize burden to the extent
possible and promote multiple
approaches to meeting statutory
requirements if possible.
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• Encourage coordination of federally
funded activities with State and local
reform activities.
• Ensure that the benefits justify the
costs of regulating.
• To the extent possible, establish
performance objectives rather than
specify the behavior or manner of
compliance a regulated entity must
adopt.
• Encourage flexibility, to the extent
possible and as needed to enable
institutional forces to achieve desired
results.
Summary of Legal Basis: We are
conducting this rulemaking under 20
U.S.C. 1681 et seq.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
ED—OFFICE FOR CIVIL RIGHTS (OCR)
Proposed Rule Stage
31. Nondiscrimination on the Basis of
Sex in Education Programs or Activities
Receiving Federal Financial Assistance
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1681 et seq.
CFR Citation: 34 CFR 106.
Legal Deadline: None.
Abstract: The Department plans to
propose to amend its regulations
implementing Title IX of the Education
Amendments of 1972, 20 U.S.C. 1681 et
seq., consistent with the priorities of the
Biden-Harris Administration. These
priorities include those set forth in
Executive Order 13988 on Preventing
and Combating Discrimination on the
Basis of Gender Identity or Sexual
Orientation and Executive Order 14021
on Guaranteeing an Educational
Environment Free from Discrimination
on the Basis of Sex, Including Sexual
Orientation and Gender Identity. We
anticipate this rulemaking may include,
but would not be limited to,
amendments to 34 CFR 106.8
(Designation of coordinator,
dissemination of policy, and adoption of
grievance procedures), 106.30
(Definitions), 106.44 (Recipient’s
response to sexual harassment), and
106.45 (Grievance process for formal
complaints of sexual harassment).
Statement of Need: This rulemaking is
necessary to align the Title IX
regulations with the priorities of the
Biden-Harris Administration, including
those set forth in the Executive Order on
Preventing and Combating
Discrimination on the Basis of Gender
Identity or Sexual Orientation (E.O.
13988) and the Executive Order on
Guaranteeing an Educational
Environment Free from Discrimination
on the Basis of Sex, Including Sexual
Orientation and Gender Identity (E.O.
14021).
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NPRM ..................
Date
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04/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Anne Hoogstraten,
Department of Education, Office for
Civil Rights, 400 Maryland Avenue SW,
Room PCP–6148, Washington, DC
20202, Phone: 202 245–7466, Email:
anne.hoogstraten@ed.gov.
RIN: 1870–AA16
ED—OFFICE OF PLANNING,
EVALUATION AND POLICY
DEVELOPMENT (OPEPD)
Proposed Rule Stage
32. Family Educational Rights and
Privacy Act
Priority: Other Significant.
Legal Authority: 20 U.S.C. 1232g; 20
U.S.C. 1221e–3; 20 U.S.C. 3474
CFR Citation: 34 CFR 99.
Legal Deadline: None.
Abstract: The Department plans to
propose to amend the Family
Educational Rights and Privacy Act
(FERPA) regulations, 34 CFR part 99, to
update, clarify, and improve the current
regulations by addressing outstanding
policy issues, such as clarifying the
definition of ‘‘education records’’ and
clarifying provisions regarding
disclosures to comply with a judicial
order or subpoena. The proposed
regulations are also needed to
implement statutory amendments to
FERPA contained in the Uninterrupted
Scholars Act of 2013 and the Healthy,
Hunger-Free Kids Act of 2010, to reflect
a change in the name of the office
designated to administer FERPA, and to
make changes related to the
enforcement responsibilities of the
office concerning FERPA.
Statement of Need: These regulations
are needed to implement amendments
to FERPA contained in the Healthy,
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Hunger-Free Kids Act of 2010 (Pub. L.
111296) and the Uninterrupted Scholars
Act (USA) of 2013 (Pub. L. 112278); to
provide needed clarity regarding the
definitions of terms and other key
provisions of FERPA; and to make
necessary changes identified as a result
of the Department’s experience
administering FERPA and the current
regulations. A number of the proposed
changes reflect the Department’s
existing guidance and interpretations of
FERPA.
Summary of Legal Basis: These
regulations are being issued under the
authority provided in 20 U.S.C. 1221e–
3, 20 U.S.C. 3474, and 20 U.S.C. 1232g.
Alternatives: These are discussed in
the preamble to the proposed
regulations.
Anticipated Cost and Benefits: These
are discussed in the preamble to the
proposed regulations.
Risks: These are discussed in the
preamble to the proposed regulations.
Timetable:
Action
Date
NPRM ..................
FR Cite
08/00/22
institutions meet the requirement in 34
CFR 668.14(b)(16) that institutions
receive at least 10 percent of their
revenue from sources other than Federal
education assistance funds.
Statement of Need: This rulemaking is
necessary to reflect changes to the HEA
made by the American Rescue Plan Act,
governing whether proprietary
institutions meet the requirement in 34
CFR 668.14(b)(16) that these institutions
receive at least 10 percent of their
revenue from sources other than Federal
education assistance funds.
Summary of Legal Basis: We are
conducting this rulemaking under the
following authorities: 20 U.S.C. 1085,
1088, 1091, 1092, 1094, 1099a–3, and
1099c.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Dale King,
Department of Education, Office of
Planning, Evaluation and Policy
Development, 400 Maryland Avenue
SW, Room 6C100, Washington, DC
20202, Phone: 202 453–5943, Email:
dale.king2@ed.gov.
RIN: 1875–AA15
Date
Notice of Intent to
Commence Negotiated Rulemaking.
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07/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Gregory Martin,
Department of Education, Office of
Postsecondary Education, 400 Maryland
Avenue SW, Room 2C136, Washington,
DC 20202, Phone: 202 453–7535, Email:
gregory.martin@ed.gov.
RIN: 1840–AD55
ED—OFFICE OF POSTSECONDARY
EDUCATION (OPE)
Prerule Stage
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33. Determining the Amount of Federal
Education Assistance Funds Received
by Institutions of Higher Education (90/
10)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1085, 1088,
1091, 1092, 1094, 1099a–3, 1099c
CFR Citation: 34 CFR 668.28.
Legal Deadline: None.
Abstract: To reflect changes to the
HEA made by the American Rescue Plan
Act, the Secretary plans to propose to
amend the Student Assistance General
Provisions (34 CFR 668.28 Non-Title IV
revenue) governing whether proprietary
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ED—OPE
Proposed Rule Stage
34. Borrower Defense
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1082(a)(5),
(a)(6); 20 U.S.C. 1087(a); 20 U.S.C.
1087e(h); 20 U.S.C. 1221e–3; 20 U.S.C.
1226a–1; 20 U.S.C. 1234(a); 31 U.S.C.
3711
CFR Citation: 34 CFR 30; 34 CFR 668;
34 CFR 674; 34 CFR 682; 34 CFR 685;
34 CFR 686.
Legal Deadline: None.
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Abstract: The Secretary proposes to
amend regulations that determine what
acts or omissions of an institution of
higher education a borrower may assert
as a defense to repayment of a loan
made under the Federal Direct Loan and
Federal Family Education Loan
Programs and specify the consequences
of such borrower defenses for
borrowers, institutions, and the
Secretary. Further, the Secretary intends
to review the use of class-action
lawsuits and pre-dispute arbitration
agreements for matters pertaining to
borrower defense claims by schools
receiving Title IV assistance under the
Higher Education Act.
Statement of Need: This rulemaking is
necessary to determine what acts or
omissions of an institution of higher
education a borrower may assert as a
defense to repayment of a loan made
under the Federal Direct Loan Program
and specify the consequences of such
borrower defenses for borrowers,
institutions, and the Secretary.
Summary of Legal Basis: We are
conducting this rulemaking under the
following authorities: 20 U.S.C.
1082(a)(5), (a)(6); 20 U.S.C.1087(a); 20
U.S.C. 1087e(h); 20 U.S.C. 1221e–3; 20
U.S.C. 1226a–1; 20 U.S.C. 1234(a); and
31 U.S.C. 3711.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
Notice of Intent to
Commence Negotiated Rulemaking.
NPRM ..................
Date
05/26/21
FR Cite
86 FR 28299
05/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Jennifer Hong,
Director, Policy Coordination Group,
Department of Education, 400 Maryland
Avenue SW, Room 287–23, Washington,
DC 20202, Phone: 202 453–7805, Email:
jennifer.hong@ed.gov.
RIN: 1840–AD53
E:\FR\FM\31JAP2.SGM
31JAP2
Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
DC 20202, Phone: 202 453–7241, Email:
aaron.washington@ed.gov.
RIN: 1840–AD54
ED—OPE
35. Pell Grants for Prison Education
Programs
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1001–1002;
20 U.S.C. 1070a, 1070a–1, 1070b,
1070c–1, 1070c–2, 1070g; 20 U.S.C.
1085, 1087aa–1087hh, 1088, 1091; 1094;
1099b, and 1099c; 42 U.S.C. 2753
CFR Citation: 34 CFR 600.20; 34 CFR
600.21; 34 CFR 668.8.
Legal Deadline: None.
Abstract: The Consolidated
Appropriation Act, 2021 defines prison
education programs for purposes of Pell
Grant eligibility. The Department plans
to propose regulations that would guide
correctional facilities and eligible
institutions of higher education that
seek to establish eligibility for the Pell
Grant program.
Statement of Need: These regulations
are necessary to increase access to
educational opportunities for
individuals who are incarcerated
because research demonstrates that
high-quality prison education programs
increase the knowledge and skills
necessary to obtain high-quality and
stable employment.
Summary of Legal Basis: These
regulations are being issued under the
following authorities: 20 U.S.C. 1001–
1002; 20 U.S.C. 1070a, 1070a–1, 1070b,
1070c–1, 1070c–2, 1070g; 20 U.S.C.
1085, 1087aa–1087hh, 1088, 1091; 1094;
1099b, and 1099c; and 42 U.S.C. 2753.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
Date
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Notice of Intent to
Commence Negotiated Rulemaking.
NPRM ..................
05/26/21
FR Cite
86 FR 28299
36. Gainful Employment
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1001; 20
U.S.C. 1002; 20 U.S.C. 1003; 20 U.S.C.
1088; 20 U.S.C. 1091; 20 U.S.C. 1094; 20
U.S.C. 1099(b); 20 U.S.C. 1099(c); 20
U.S.C. 1082; . . .
CFR Citation: 34 CFR 668; 34 CFR
600.
Legal Deadline: None.
Abstract: The Secretary plans to
propose to amend 34 CFR parts 668 and
600 on institution and program
eligibility under the HEA, including
regulations that determine whether
postsecondary educational programs
prepare students for gainful
employment in recognized occupations,
and the conditions under which
institutions and programs remain
eligible for student financial assistance
programs under Title IV of the HEA.
Statement of Need: This rulemaking is
necessary to determine whether
postsecondary educational programs
prepare students for gainful
employment and the conditions under
which institutions and programs remain
eligible for student financial assistance
programs under Title IV of the HEA.
Summary of Legal Basis: We are
conducting this rulemaking under the
following authorities: 20 U.S.C. 1001; 20
U.S.C. 1002; 20 U.S.C. 1003; 20 U.S.C.
1088; 20 U.S.C. 1091; 20 U.S.C. 1094; 20
U.S.C. 1099(b); 20 U.S.C. 1099(c); and
20 U.S.C. 1082.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
05/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Aaron Washington,
Department of Education, Office of
Postsecondary Education, 400 Maryland
Avenue SW, Room 294–12, Washington,
VerDate Sep<11>2014
ED—OPE
17:50 Jan 28, 2022
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Date
Notice of Intent to
Commence Negotiated Rulemaking.
NPRM ..................
05/26/21
FR Cite
86 FR 28299
07/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
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5049
Federalism: Undetermined.
Agency Contact: Gregory Martin,
Department of Education, Office of
Postsecondary Education, 400 Maryland
Avenue SW, Room 2C136, Washington,
DC 20202, Phone: 202 453–7535, Email:
gregory.martin@ed.gov.
RIN: 1840–AD57
ED—OPE
37. Improving Student Loan
Cancellation Authorities
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1087; 20
U.S.C. 1087e; 20 U.S.C. 1087dd
CFR Citation: 34 CFR 674; 34 CFR
682; 34 CFR 685.
Legal Deadline: None.
Abstract: The Department plans to
propose improvements in areas where
Congress has provided borrowers with
relief or benefits related to Federal
student loans. This includes authorities
granted under the HEA that allow the
Department to cancel loans for
borrowers who meet certain criteria,
such as: (a) Being totally and
permanently disabled; (b) attending a
school that recently closed; or (c) having
been falsely certified as able to benefit
from a program despite not having a
high school diploma or its recognized
equivalent. For these borrowers, the
Secretary plans to amend regulations to
improve borrower eligibility,
application requirements, and
processes.
Statement of Need: This rulemaking is
necessary to improve areas where
Congress has provided borrowers with
relief or benefits related to Federal
student loans, including to improve
borrower eligibility, application
requirements, and processes.
Summary of Legal Basis: We are
conducting this rulemaking under 20
U.S.C. 1087; 20 U.S.C. 1087e; and 20
U.S.C. 1087dd.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
potential cost and benefits and cannot
estimate them at this time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
Notice of Intent to
Commence.
Negotiated Rulemaking.
E:\FR\FM\31JAP2.SGM
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Date
05/26/21
FR Cite
86 FR 28299
5050
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Action
Date
NPRM ..................
FR Cite
05/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Jennifer Hong,
Director, Policy Coordination Group,
Department of Education, 400 Maryland
Avenue SW, Room 287–23, Washington,
DC 20202, Phone: 202 453–7805, Email:
jennifer.hong@ed.gov.
RIN: 1840–AD59
ED—OPE
38. Income Contingent Repayment
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 20 U.S.C. 1087e
CFR Citation: 34 CFR 685.
Legal Deadline: None.
Abstract: Using the incomecontingent repayment (ICR) authority
under the Higher Education Act of 1965,
the Secretary of Education may create or
adjust income-driven repayment plans
to cap borrower payments at a set share
of their income. The Department will
propose improvements to these plans in
34 CFR part 685.
Statement of Need: This rulemaking is
necessary to make improvements to the
income- driven repayment plans created
under the ICR authority in Higher
Education Act of 1965 that allows the
Secretary to cap payments at a set share
of a borrower’s income.
Summary of Legal Basis: The
Department is conducting this
rulemaking under 20 U.S.C. 1087e.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Action
Date
Notice of Intent to
Commence Negotiated Rulemaking.
NPRM ..................
05/26/21
FR Cite
86 FR 28299
05/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
VerDate Sep<11>2014
17:50 Jan 28, 2022
Jkt 256001
Agency Contact: Jennifer Hong,
Director, Policy Coordination Group,
Department of Education, 400 Maryland
Avenue SW, Room 287–23, Washington,
DC 20202, Phone: 202 453–7805, Email:
jennifer.hong@ed.gov.
RIN: 1840–AD69
ED—OPE
39. Public Service Loan Forgiveness
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 20 U.S.C. 1087e
CFR Citation: 34 CFR 685.
Legal Deadline: None.
Abstract: The Higher Education Act of
1965 allows borrowers to receive loan
forgiveness after 10 years of qualifying
payments on qualifying loans while
engaging in public service. The
Department will propose improvements
to this program in 34 CFR part 685.
Statement of Need: This rulemaking is
necessary to make improvements that
more closely align the Public Service
Loan Forgiveness program with the
statute and purpose of the program.
Summary of Legal Basis: We are
conducting this rulemaking under 20
U.S.C. 1087e.
Alternatives: We have limited
information about the alternatives at
this time.
Anticipated Cost and Benefits: We
have limited information about the
anticipated costs and benefits at this
time.
Risks: We have limited information
about the risks at this time.
Timetable:
Action
Date
Notice of Intent to
Commence Negotiating Rulemaking.
NPRM ..................
05/26/21
FR Cite
86 FR 28299
05/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Jennifer Hong,
Director, Policy Coordination Group,
Department of Education, 400 Maryland
Avenue SW, Room 287–23, Washington,
DC 20202, Phone: 202 453–7805, Email:
jennifer.hong@ed.gov.
RIN: 1840–AD70
BILLING CODE 4000–01–P
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DEPARTMENT OF ENERGY
Statement of Regulatory and
Deregulatory Priorities
The Department of Energy
(Department or DOE) makes vital
contributions to the Nation’s welfare
through its activities focused on
improving national security, energy
supply, energy efficiency,
environmental remediation, and energy
research. The Department’s mission is
to:
• Promote dependable, affordable and
environmentally sound production and
distribution of energy;
• Advance energy efficiency and
conservation;
• Provide responsible stewardship of
the Nation’s nuclear weapons;
• Provide a responsible resolution to
the environmental legacy of nuclear
weapons production; and
• Strengthen U.S. scientific
discovery, economic competitiveness,
and improve quality of life through
innovations in science and technology.
The Department’s regulatory activities
are essential to achieving its critical
mission and to implementing the
President’s clean energy and climate
initiatives. Among other things, the
Regulatory Plan and the Unified Agenda
contain the rulemakings the Department
will be engaged in during the coming
year to fulfill the Department’s
commitment to meeting deadlines for
issuance of energy conservation
standards and related test procedures.
The Regulatory Plan and Unified
Agenda also reflect the Department’s
continuing commitment to cut costs,
reduce regulatory burden, and increase
responsiveness to the public.
Review of Regulations Under Executive
Order 13990
Pursuant to Executive Order 13990,
‘‘Protecting Public Health and the
Environment and Restoring Science To
Tackle the Climate Crisis,’’ DOE
reviewed all regulations, orders,
guidance documents and policies
promulgated or adopted between
January 20, 2017, and January 20, 2021,
and determined whether these actions
are consistent with the policy goals of
protecting public health and the
environment, including reducing
greenhouse gas emissions and bolstering
the Nation’s resilience to the impacts of
climate change. DOE identified fourteen
rulemakings that the Department will
review under E.O. 13990.
In response to E.O. 13990, DOE
published ten notices of proposed
rulemakings or technical determinations
re-evaluating rulemakings finalized in
the prior four years. Four of these
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publications were explicitly required to
be published in 2021. First, DOE
published two notices of proposed
rulemaking in 2021 that remove
unnecessary obstacles to DOE’s ability
to develop energy conservation
standards and test procedures for
consumer products and commercial/
industrial equipment. Second, DOE
published two technical determinations
that determined that the latest version of
a commercial building code and
residential building code are more
efficient than the prior versions of these
codes, paving the path for states to
adopt these codes.
Other 2021 proposed Departmental
appliance standards program actions
triggered by E.O. 13990 but based on
DOE statutory authorities included a
rule to revert to the prior, water-saving
definition of showerheads; a rule to
remove a product class for dishwashers,
clothes washers and clothes dryers that
had the effect of removing standards
from these products; a rule to streamline
the test procedure waiver process; a rule
to broaden the definition of general
service lamps; and a rule proposing to
reinterpret a features provision for some
types of consumer products and
commercial equipment.
Energy Efficiency Program for
Consumer Products and Commercial
Equipment
The Energy Policy and Conservation
Act requires DOE to set appliance
efficiency standards at levels that
achieve the maximum improvement in
energy efficiency that is technologically
feasible and economically justified. The
Department continues to follow its
schedule for setting new appliance
efficiency standards by both addressing
its backlog of rulemakings with missed
statutory deadlines and advancing
rulemakings with upcoming statutory
deadlines. In the August 2021 Energy
Policy Act of 2005 Report to Congress,
DOE notes that it plans to publish 31
actions relating to energy conservation
standards, including four final rules,
and 31 actions related to test
procedures, including six final rules,
before the end of 2021. See: https://
www.energy.gov/eere/buildings/reportsand-publications. These rulemakings
are expected to save American
consumers billions of dollars in energy
costs over a 30-year timeframe.
In the Department’s 2021 Fall
Regulatory Plan, DOE is highlighting
three important appliance rules. The
first rule is ‘‘Energy Conservation
Standards for Commercial Water
Heating Equipment.’’ DOE estimates
that the energy conservation standards
rulemaking for commercial water
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heating-equipment will result in energy
savings for combined natural gas and
electricity of up to 1.8 quads over 30
years and the net benefit to the Nation
will be between $2.26 billion and $6.75
billion.
The second rule is ‘‘Procedures,
Interpretations, and Policies for
Consideration in New or Revised Energy
Conservation Standards and Test
Procedures for Consumer Products and
Commercial/Industrial Equipment.’’
This rulemaking is focused on both the
procedural requirements as well as the
methodologies used to establish all DOE
energy conservation standards and their
related test procedures. DOE anticipates
that the contemplated revisions would
allow DOE to eliminate inefficiencies
that lengthen the rulemaking process
and consume DOE and stakeholder
resources without appreciable benefit,
while not affecting the ability of the
public to participate in the agency’s
rulemaking process. Eliminating these
inefficiencies would allow DOE to more
quickly develop energy conservation
standards that deliver benefits to the
Nation, including environmental
benefits such as reductions in
greenhouse gas emissions.
The third rule is ‘‘Backstop
Requirement for General Service
Lamps.’’ This rulemaking would codify
in the Code of Federal Regulations the
45 lumens per watt backstop
requirement for general service lamps
(‘‘GSLs’’) that Congress prescribed in the
Energy Policy and Conservation Act, as
amended. Codifying the statutory
standard, which would also prohibit
sales of GSLs that do not meet a
minimum 45 lumens per watt standard,
is estimated to result in total net
benefits of $3.3 billion to $4.9 billion
per year.
Federal Agency Leadership in Climate
Change
Beyond the appliance program, DOE
is supporting Federal agency leadership
in climate change in various ways,
including in its Federal government
energy efficiency rulemakings. DOE is
highlighting one rule supporting Federal
agency leadership in climate change
under the Energy Conservation and
Production Act. The rule establishes
baseline Federal energy efficiency
performance standards for the
construction of new Federal commercial
and multi-family high-rise residential
buildings. The total incremental first
cost savings under the rule is $32.67
million per year, with a potential cost
reduction in new Federal construction
costs of 0.85%, and life-cycle cost net
savings of $161.9 million. Compared to
the prior building standard, DOE
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5051
expects a 4,472,870 metric ton reduction
in carbon dioxide emissions over 30
years.
DOE—ENERGY EFFICIENCY AND
RENEWABLE ENERGY (EE)
Proposed Rule Stage
40. Energy Conservation Standards for
Commercial Water Heating-Equipment
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: 42 U.S.C.
6313(a)(6)(C)(i) and (vi)
CFR Citation: 10 CFR 429; 10 CFR
431.
Legal Deadline: Other, Statutory,
Subject to 6-year-look-back in 42 U.S.C.
6313(a)(6)(C).
Abstract: Once completed, this
rulemaking will fulfill the U.S.
Department of Energy’s (DOE) statutory
obligation under the Energy Policy and
Conservation Act, as amended, (EPCA)
to either propose amended energy
conservation standards for commercial
water heaters and hot water supply
boilers, or determine that the existing
standards do not need to be amended.
(Unfired hot water storage tanks and
commercial heat pump water heaters are
being considered in a separate
rulemaking.) DOE must determine
whether national standards more
stringent than those that are currently in
place would result in a significant
additional amount of energy savings and
whether such amended national
standards would be technologically
feasible and economically justified.
Statement of Need: DOE is required
under 42 U.S.C. 6313(a)(6)(C) to
consider the need for amended
performance-based energy conservation
standards for commercial water heaters.
This rulemaking is being conducted to
satisfy that requirement by evaluating
potential standards related to certain
classes of commercial water heating
equipment.
Summary of Legal Basis: This
rulemaking is being conducted under
DOE’s authority pursuant to 42 U.S.C.
6311, which establishes the agency’s
legal authority over water heaters as one
type of covered equipment that DOE
may regulate, and 42 U.S.C.
6313(a)(6)(C), which requires DOE to
conduct a rulemaking to consider the
need for amended performance-based
energy conservation standards for this
equipment.
Alternatives: Under EPCA, DOE shall
either establish an amended uniform
national standard for this equipment at
the minimum level specified in the
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amended ASHRAE/IES Standard 90.1,
unless the Secretary determines, by rule
published in the Federal Register, and
supported by clear and convincing
evidence, that adoption of a uniform
national standard more stringent than
the amended ASHRAE/IES Standard
90.1 for this equipment would result in
significant additional conservation of
energy and is technologically feasible
and economically justified (42 U.S.C.
6313(a)(6)(A)–(C)).
Anticipated Cost and Benefits: DOE
preliminarily determined that the
anticipated benefits to the Nation of the
proposed energy conservation standards
for the subject commercial water heating
equipment would outweigh the burdens
DOE estimates that potential amended
energy conservation standards for
commercial water heaters may result in
energy savings for combined natural gas
and electricity of 1.8 quads over 30
years and the net benefit to the Nation
of between $2.26 billion and $6.75
billion.
Timetable:
Action
Date
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Request for Information (RFI).
RFI Comment Period End.
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period Reopened End.
Notice of Data
Availability
(NODA).
NODA Comment
Period End.
Notice of NPRM
Withdrawal.
NPRM ..................
10/21/14
FR Cite
79 FR 62899
11/20/14
05/31/16
08/01/16
81 FR 34440
08/05/16
81 FR 51812
08/30/16
12/23/16
81 FR 94234
01/09/17
01/15/21
86 FR 3873
04/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL For More Information:
www1.eere.energy.gov/buildings/
appliance_standards/product.aspx/
productid/51.
URL For Public Comments:
www.regulations.gov/
#!docketDetail;D=EERE-2014-BT-STD0042.
Agency Contact: Julia Hegarty,
Department of Energy, 1000
Independence Avenue SW, Washington,
DC 20585, Phone: 240 597–6737, Email:
julia.hegarty@ee.doe.gov.
Related RIN: Related to 1904–AE39.
RIN: 1904–AD34
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DOE—EE
Action
41. Backstop Requirement for General
Service Lamps
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C.
6295(i)(6)(A)
CFR Citation: 10 CFR 430.
Legal Deadline: Other, Statutory,
Subject to 7-year-lookback in 42 U.S.C.
6293(b).
Abstract: The U.S. Department of
Energy (DOE) proposes to codify the 45
lumens per watt (‘‘im/W’’) backstop
requirement for general service lamps
(GSLs) that Congress prescribed in the
Energy Policy and Conservation Act, as
amended. DOE proposes this backstop
requirement apply because DOE failed
to complete a rulemaking regarding
general service lamps in accordance
with certain statutory criteria. This
proposal represents a departure from
DOE’s previous determination
published in 2019 that the backstop
requirement was not triggered. DOE reevaluates its previous determination
that the backstop was not triggered in
accordance with the review requirement
under E.O. 13990, ‘‘Protecting Public
Health and the Environment and
Restoring Science To Tackle the Climate
Crisis,’’ 86 FR 7037 (January 25, 2021).
Statement of Need: Under the Energy
Policy and Conservation Act (EPCA), as
amended, if DOE fails to complete a
rulemaking regarding general service
lamps (GSL’s) in accordance with
certain statutory criteria, the Secretary
of Energy (Secretary) must prohibit the
sale of any GSL that does not meet a
minimum efficacy of 45 lumens per
watt. In two final rules published on
September 5, 2019 and December 27,
2019, DOE determined that this
statutory backstop requirement for GSLs
was not triggered. DOE now revisits this
determination and proposes to
determine that the statutory backstop
does not apply, consistent with its
statutory obligations under EPCA. This
action was triggered in part by
Executive order 13990, which
specifically instructed DOE to examine
the GSL rules.
Anticipated Cost and Benefits:
Codifying the statutory standard, which
would also prohibit sales of GSLs that
do not meet a minimum 45 lumens per
watt standard, is estimated to result in
total net benefits of 3.3 billion to $4.9
billion per year.
Timetable:
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Request for Information (RFI);
Early Assessment Review.
RFI Comment Period End.
NPRM ..................
Date
05/25/21
FR Cite
86 FR 28001
06/24/21
01/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: Stephanie Johnson,
General Engineer, Department of
Energy, Energy Efficiency and
Renewable Energy, 1000 Independence
Avenue SW, Building Technologies
Office, EE5B, Washington, DC 20585,
Phone: 202 287–1943, Email:
stephanie.johnson@ee.doe.gov.
RIN: 1904–AF09
DOE—EE
Final Rule Stage
42. Energy Efficiency Standards for
New Federal Commercial and MultiFamily High-Rise Residential Buildings
Baseline Standards Update
Priority: Other Significant.
Legal Authority: 42 U.S.C. 6834
CFR Citation: 10 CFR 433.
Legal Deadline: Final, Statutory,
October 31, 2020, 42 U.S.C.
6834(a)(3)(B).
Abstract: The U.S. Department of
Energy (DOE) is working on a final rule
to implement provisions in the Energy
Conservation and Production Act
(ECPA) that require DOE to update the
baseline Federal energy efficiency
performance standards for the
construction of new Federal commercial
and multi-family high-rise residential
buildings. This rule would update the
baseline Federal commercial standard to
the American Society of Heating,
Refrigerating, and Air-Conditioning
Engineers (ASHRAE) Standard 90.1–
2019, if the Secretary determines that
the baseline Federal energy efficiency
performance standards should be
updated to reflect the new standard,
based on the cost-effectiveness of the
requirements under the amendment.
Statement of Need: This rule
addresses DOE’s statutory obligation
under ECPA to review the newest
version of ASHRAE 90.1, that is,
ASHRAE 90.1–2019, and update the
energy efficiency performance standards
for federal commercial and multifamily, high-rise buildings to reflect the
new version of this industry standard.
the rule will also support federal agency
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leadership in addressing climate change
by reducing energy use in Federal
buildings and reducing emissions.
Anticipated Cost and Benefits: This
rule is expected to result in 432.67
million annual incremental first-cost
savings and annual life-cycle cost net
savings of $161.9 million. Furthermore,
compared to the prior Federal buildings
standard, DOE expects a 4,472,870
metric ton reduction in carbon dioxide
emissions over 30 years.
Timetable:
Action
Date
Final Rule ............
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Federal.
Agency Contact: Nicolas Baker, Office
of Federal Energy Management Program,
EE–2L, Department of Energy, Energy
Efficiency and Renewable Energy, 1000
Independence Avenue SW, Washington,
DC 20585, Phone: 202 586–8215, Email:
nicolas.baker@ee.doe.gov.
RIN: 1904–AE44
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DOE—EE
43. Energy Conservation Program for
Appliance Standards: Procedures for
Use in New or Revised Energy
Conservation Standards and Test
Procedures for Consumer Products and
Commercial/Industrial Equipment
Priority: Other Significant.
Legal Authority: 42 U.S.C. 6191 to
6317
CFR Citation: 10 CFR 430, subpart C,
App. A; 10 CFR 431.
Legal Deadline: None.
Abstract: The U.S. Department of
Energy (‘‘DOE’’ or ‘‘the Department’’) is
finalizing its revisions to the
Department’s current rulemaking
guidance titled ‘‘Procedures,
Interpretations, and Policies for
Consideration of New or Revised Energy
Conservation Standards and Test
Procedures for Consumer Products and
Certain Commercial/Industrial
Equipment’’ (‘‘Process Rule’’), which
was last modified in 2020. These
proposed revisions, which are the first
of two sets of revisions to the Process
Rule that DOE intends to propose, are
consistent with longstanding DOE
practice prior to the 2020 amendment
and would remove unnecessary
obstacles to DOE’s ability to meet its
statutory obligations under the Energy
Policy and Conservation Act (‘‘EPCA’’)
and other applicable law. These
proposed changes would include
modifying the Process Rule to remove
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its mandatory application, removing its
recently-added threshold for
determining when significant energy
savings is met, removing the current
provision regarding the use of a
comparative analysis when selecting
potential energy conservation standards,
and reverting to its prior guidance for
determining whether a trial standard
level is economically justified, among
other changes. DOE is undertaking this
action as required by E.O. 13990,
‘‘Protecting Public Health and the
Environment and Restoring Science to
Tackle the Climate Crisis’’, 86 FR 7037
(January 25, 2021).
Statement of Need: On February 14,
2020 and August 19, 2020, DOE
published two final rules (‘‘Process Rule
Amendment Final Rules’’) that made
significant revisions to the existing
Process Rule. DOE is reconsidering the
merits of the approach taken by these
2020 revisions to the Process Rule—
specifically, the one-fits-all rulemaking
approach and the added rulemaking
steps now required under the Process
Rule. In its proposed revisions, the
Department seeks to ensure that the
document remains consistent with
DOE’s legal obligations under the
Energy Policy and Conservation Act, as
amended. DOE’s action in examining
the current Process Rule was triggered
in part by Executive Order 13990, which
specifically instructed DOE to examine
the Process Rule.
Anticipated Cost and Benefits: DOE
anticipates that the contemplated
revisions would allow DOE to eliminate
inefficiencies that lengthen the
rulemaking process and consume DOE
and stakeholder resources without
appreciable benefit, while not affecting
the ability of the public to participate in
the agency’s rulemaking process.
Eliminating these inefficiencies would
allow DOE to more quickly develop
energy conservation standards that
deliver benefits to the Nation, including
environmental benefits, such as
reductions in greenhouse gas emissions,
that DOE is directed to pursue under
E.O. 13990. DOE notes that these
revisions would not dictate any
particular rulemaking outcome in an
energy conservation standard or test
procedure rulemaking.
Timetable:
Action
Date
NPRM (Round 1)
NPRM (Round 1)
Comment Period End.
NPRM (Round 2)
NPRM (Round 2)
Comment Period Extended.
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05/27/21
86 FR 18901
07/07/21
08/09/21
86 FR 35668
86 FR 43429
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Action
NPRM (Round 2)
Comment Period Extended
End.
Final Rule ............
Date
FR Cite
09/13/21
12/00/21
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: John Cymbalsky,
Building Technologies Office, EE–5B,
Department of Energy, Energy Efficiency
and Renewable Energy, 1000
Independence Avenue SW, Washington,
DC 20585, Phone: 202 287–1692, Email:
john.cymbalsky@ee.doe.gov.
RIN: 1904–AF13
BILLING CODE 6450–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Regulatory Priorities for
Fiscal Year 2022
As the federal agency with principal
responsibility for protecting the health
of all Americans and for providing
essential human services, the
Department of Health and Human
Services (HHS or the Department)
implements programs that strengthen
the health care system; advance
scientific knowledge and innovation;
and improve the health, safety, and
wellbeing of the American people.
The Department’s Regulatory Plan for
Fiscal Year 2022 delivers on the BidenHarris Administration’s commitment to
tackle the COVID–19 pandemic, build,
and expand access to affordable health
care, address health disparities, increase
health equity, and promote the
wellbeing of children and families:
• This agenda expands access to
quality, affordable health care for all
Americans, with rules to provide
evidence-based behavioral health
treatment via telehealth and rules to
streamline enrollment and improve
access to care in Medicaid and the
Children’s Health Insurance Program
(CHIP) to ensure that children and
families eligible for these programs are
able to maintain coverage and obtain
needed care.
• As we work to expand access to
affordable health care, we will
simultaneously tackle disparities that
persist in who gain access to care.
Forthcoming rules—including one
designed to prevent discrimination in
accessing care and coverage—serve to
protect every person’s right to access the
health care they need, no matter where
they live or who they are.
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• Building on recent rules requiring
COVID–19 vaccinations for staff at most
Medicare- and Medicaid-participating
health care providers and in Head Start
programs, our Regulatory Plan augments
our fight against COVID–19 and future
pandemics by including new rules that
permit CDC to set vaccination
requirements for airline passengers
entering the U.S. and increase the
resilience of HHS programs to deal with
COVID–19 and future public health
emergencies.
• Our work to promote the health and
wellbeing of every person includes
extending additional support and
resources to children and families.
Whether we are providing flexibility to
ensure more children in foster care are
placed in homes with their relatives or
reimbursing state foster care agencies for
the cost of providing independent legal
representation for children and parents,
we are working to support our next
generation of leaders—and the people
who help raise them.
In short, this agenda allows the
Department to support governmentwide efforts to build a healthy America
by charting a course to Build Back
Better with rules designed to help
protect public health and improve the
health and wellbeing of every person
touched by our programs.
I. Building and Expanding Access to
Affordable Health Care
Since its enactment, the Affordable
Care Act (ACA) has dramatically
reduced the number of uninsured
Americans while strengthening
consumer protections and improving
our nation’s health care system. Yet
high uninsured rates and other barriers
to care continue to persist, compounded
by the health and economic challenges
facing Americans nationwide due to the
COVID–19 pandemic. From day one, the
Biden-Harris Administration has been
focused on closing these gaps in
coverage and access. The American
Rescue Plan (ARP) alongside the ACA
and executive actions by the BidenHarris Administration have already led
to lower premiums for consumers and
more opportunities to gain coverage,
achieving record-high enrollment in
ACA Marketplace and Medicaid
coverage.
The Department plans to continue
expanding access to affordable health
care over the next year, including
through its regulatory actions. Secretary
Becerra’s regulatory priorities in this
area include: Enhancing coverage and
access for Americans in the ACA
Marketplace, Medicaid, CHIP, and
Medicare; expanding the accessibility
and affordability of drugs and medical
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products; addressing behavioral health
needs; and streamlining the secure
exchange of health information.
Enhancing Coverage and Access in the
ACA Marketplace, Medicaid, CHIP, and
Medicare
The Department will take several
regulatory actions in the next year
building on the success of the ACA and
improving access to care for Americans.
In his Executive Order on Strengthening
Medicaid and the Affordable Care Act
(E.O. 14009), President Biden asked the
Department to consider a range of
actions, including actions that would
protect and strengthen Medicaid.
Following this regulatory review, the
Department is issuing two rules. First,
the Department will issue a proposed
rule on Assuring Access to Medicaid
and Children’s Health Insurance
Program (CHIP) Services. Together,
Medicaid and CHIP cover nearly one in
four Americans and provide for access
to a broad array of health benefits and
services critical to underserved
populations, including low-income
adults, children, pregnant women,
elderly, and people with disabilities.
This rule would empower the
Department to assure and monitor
equitable access to services in Medicaid
and CHIP.
Additionally, the Department will
issue a proposed rule on Streamlining
the Medicaid and CHIP Application,
Eligibility Determination, Enrollment,
and Renewal Processes. Although
considerable progress has been made in
these areas, gaps remain in states’ ability
to seamlessly process beneficiaries’
eligibility and enrollment. This rule
would streamline eligibility and
enrollment processes for all Medicaid
and CHIP populations and create new
enrollment pathways to maximize
enrollment and retention of eligible
individuals. The first step to ensuring
access to services is making certain that
people can maintain a consistent source
of high-quality coverage.
The Department also plans to issue a
proposed rule on Requirements for
Rural Emergency Hospitals. This rule
would establish health and safety
requirements as Conditions of
Participation (CoPs) for Rural
Emergency Hospitals (REHs)
participating in Medicare or Medicaid,
in accordance with Section 125 of the
Consolidated Appropriations Act, 2021,
and will establish payment policies and
payment rates for REHs. This rule will
aim to address barriers to health care,
unmet social needs, and other health
challenges and risks faced by rural
communities.
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Improving access to care for
populations with ACA Marketplace
coverage is also a regulatory priority of
the Department. For instance, the
Department will issue a proposed rule
to protect patients’ access to care and
promote competition by ensuring that
plans do not engage in unlawful
discrimination against health care
providers. While the ACA’s provider
nondiscrimination protections are
currently set forth in guidance, the No
Surprises Act directs the Department to
implement these protections through
regulation.
The Department will also work to
ensure access to benefits and services
afforded under the law. A critical part
of this work will include amending
regulations on contraceptive coverage
which guarantee cost-free coverage to
the consumer under the ACA. In
addition to the actions described above,
the Department’s regulatory agenda
includes several payment rules and
notices issued annually by the Centers
for Medicare & Medicaid Services (CMS)
that affect Medicare, Medicaid, and the
ACA Marketplace. These rules, though
they are not included in the HHS
Regulatory Plan, will include policies in
service of the Secretary’s priority of
expanding access to affordable, highquality health care.
Expanding the Accessibility and
Affordability of Drugs and Medical
Products
The Department is committed to
improving Americans’ access to
affordable drugs and medical products.
Earlier this year, the Department issued
a proposed rule entitled Medical
Devices; Ear, Nose and Throat Devices;
Establishing Over-the-Counter Hearing
Aids and Aligning Other Regulations.
Consistent with President Biden’s
Executive Order on Promoting
Competition in the American Economy
(E.O. 14036), this rule proposes to
establish a new category of over the
counter of hearing aids. If finalized, the
rule would allow hearing aids within
this category to be sold directly to
consumers in stores or online without a
medical exam or a fitting by an
audiologist. This action will address
existing barriers on access to hearing
aids, improve consumer choice, and
have a direct impact on quality of life.
Over the next year, the Department
will continue pursuing greater
accessibility and affordability for
Americans in need of drugs and medical
products, consistent with the
Department’s Comprehensive Plan for
Addressing High Drug Prices, released
in September 2021. For example, the
Department plans to issue a proposed
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rule entitled Nonprescription Drug
Product With an Additional Condition
for Nonprescription Use. This rule
would establish requirements for drug
products that could be marketed as
nonprescription drug products with an
additional condition that a
manufacturer must implement to ensure
appropriate self-selection or appropriate
actual use or both for consumers. The
rule is expected to increase consumer
access to drug products, which could
translate into a reduction in undertreatment of certain diseases and
conditions. The Department also plans
to issue a proposed rule on Biologics
Regulation Modernization, which would
update Food and Drug Administration
(FDA) biologics regulations to account
for the existence of biosimilar and
interchangeable biological products.
This rule is intended to support
competition and enhance consumer
choice by preventing efforts to delay or
block competition from biosimilars and
interchangeable products.
In addition, the Department will issue
a proposed rule entitled 340B Drug
Pricing Program; Administrative
Dispute Resolution. The 340B Drug
Pricing Program, which requires drug
manufacturers to provide discounts on
outpatient prescription drugs to certain
safety net providers, is critical to the
ability of safety net providers to stretch
scarce federal resources and reach
patients with low incomes or without
insurance. The rule would establish
new requirements and procedures for
the Program’s Administrative Dispute
Resolution (ADR) process, making the
process more equitable and accessible
for participation by program
participants. This is intended to replace
the previous administration’s
rulemaking on the same subject, which
was finalized in December 2020.
Addressing Behavioral Health Needs
The COVID–19 pandemic has made
clear that too many Americans have
unmet behavioral health needs, which
have seen an alarming rise during the
pandemic due to illness, grief, job loss,
food insecurity, and isolation. The
Secretary is committed to addressing the
behavioral health effects of the COVID–
19 pandemic—including mental health
conditions and substance use
disorders—especially in underserved
communities. This commitment informs
the Department’s regulatory priorities
over the next year.
The Department is proposing two
rules intended to extend telehealth
flexibilities for substance use disorder
treatments that were granted during the
COVID–19 public health emergency.
First, the Department will issue a
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proposed rule on Treatment of Opioid
use Disorder With Extended Take Home
Doses of Methadone. This rule would
propose revisions to Substance Abuse
and Mental Health Services
Administration (SAMHSA) regulations
to make permanent regulatory
flexibilities for opioid treatment
programs to provide extended takehome doses of methadone to patients
when it is safe and appropriate to do so.
Likewise, the Department also plans to
issue a proposed rule on Treatment of
Opioid Use Disorder with
Buprenorphine Utilizing Telehealth.
This rule would propose revisions to
SAMHSA regulations to permanently
allow opioid treatment programs and
certain other providers to provide
buprenorphine via telehealth. Both
changes would allow more patients to
receive comprehensive opioid use
disorder treatment and could address
barriers to treatment such as
transportation, geographic proximity,
employment, or other required activities
of daily living.
Furthermore, the Department,
working closely with the Department of
Labor, will issue a proposed rule on the
Mental Health Parity and Addiction
Equity Act (MHPAEA) and the
Consolidated Appropriations Act, 2021.
The MHPAEA is a federal law that
prevents group health plans and health
insurance issuers that provide mental
health or substance use disorder
benefits from imposing less favorable
benefit limitations on those benefits
than on medical and surgical benefits.
This rule would clarify group health
plans and health insurance issuers’
obligations under the MHPAEA and
promote compliance with MHPAEA,
among other improvements.
Finally, the Department also plans to
issue a proposed rule on the
Confidentiality of Substance Use
Disorder Patient Records. Section 3221
of the CARES Act modifies the statute
that establishes protections for the
confidentiality of substance use disorder
treatment records and directs the
Department to work with other federal
agencies to update the regulations at 42
CFR part 2 (part 2). As required by the
CARES Act, this rule would align
certain provisions of part 2 with aspects
of the HIPAA Privacy, Breach
Notification, and Enforcement Rules;
strengthen part 2 protections against
uses and disclosures of patients’
substance use disorder records for civil,
criminal, administrative, and legislative
proceedings; and require that a HIPAA
Notice of Privacy Practices address
privacy practices with respect to Part 2
records.
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Streamlining the Secure Exchange of
Health Information
The secure exchange of health
information among health care
providers and other entities improves
patient care, reduces costs, and provides
more accurate public health data. The
21st Century Cures Act (Cures Act)
included important provisions related to
improving the interoperability and
transparency of health information.
Two of the Department’s planned
rulemakings directly address and
implement these statutory provisions.
First, the Department plans to finalize
the implementation of the Cures Act
provision that authorizes the
Department to impose civil monetary
penalties, assessments, and exclusions
upon individuals and entities that
engage in fraud and other misconduct
related to HHS grants, contracts, and
other agreements. It would also
implement Cures Act provisions on
information blocking, which authorize
the Office of Inspector General (OIG) to
investigate claims of information
blocking and grant the Department the
power to impose civil monetary
penalties (CMPs) for information
blocking. The Department’s regulations
would also be updated to include the
increased civil monetary penalties
provided in the Bipartisan Budget Act of
2018.
Additionally, the Department will
issue a proposed rule entitled Health
Information Technology: Updates to the
ONC Health IT Certification Program,
Establishment of the Trusted Exchange
Framework and Common Agreement
Attestation Process, and Enhancements
to Support Information Sharing. This
rule would implement certain
provisions of the Cures Act, including
the Electronic Health Record (EHR)
Reporting Program condition and
maintenance of certification
requirements under the ONC Health IT
Certification Program (Certification
Program); a process for health
information networks that voluntarily
adopt the Trusted Exchange Framework
and Common Agreement to attest to the
agreed upon interoperable data
exchange; and enhancements to support
information sharing under the
information blocking regulations.
II. Addressing Health Disparities and
Promoting Equity
Equity is the focus of over a dozen
Executive Orders issued by President
Biden, and it remains a cornerstone of
the Biden-Harris Administration’s
agenda. The Department recognizes that
people of color, people with disabilities,
lesbian, gay, bisexual, transgender, and
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queer (LGBTQ+) people, and other
underserved groups in the U.S. have
been systematically denied a full and
fair opportunity to participate in
economic, social, and civic life. Among
its other manifestations, this history of
inequality shows up as persistent
disparities in health outcomes and
access to care. As the federal agency
responsible for ensuring the health and
wellbeing of Americans, the Department
under Secretary Becerra’s leadership is
committed to tackling these entrenched
inequities and their root causes
throughout its programs and policies.
This regulatory priority includes
promoting equity in health care,
strengthening health and safety
standards for consumer products that
impact underserved communities,
preventing and combatting
discrimination, and ensuring the
equitable administration of HHS
programs. The Department is also
systematically reviewing existing
regulations to make certain they
adequately address the needs of those
most vulnerable to climate change
related impacts.
Promoting Equity in Health Care
The Department is taking action to
promote equity in health care programs
and delivery. Earlier this year, the
Department finalized a rule on Ensuring
Access to Equitable, Affordable, Clientcentered, Quality Family Planning
Services. This rule revoked the previous
administration’s harmful restrictions on
the use of Title X family planning funds,
which had a disproportionate impact on
low-income clients and caused
substantial decreases in utilization
among clients of color. Revoking the
previous rule will allow the Title X
service network to expand in size and
capacity to provide quality family
planning services to more clients.
In addition, the rule updates the Title
X regulations to ensure access to
equitable, affordable, client-centered,
quality family planning services.
The Department is also committed to
improving the effectiveness of federal
health programs that constitute an
important source of care for
underserved communities. For instance,
the Department plans to issue a
proposed rule on the Catastrophic
Health Emergency Fund (CHEF). CHEF
was established to reimburse tribally
operated Indian Health Service (IHS)
Purchased/Referred Care programs,
which serve American Indian/Alaska
Native patients, for medical expenses
related to high-cost illnesses and events
after a threshold cost has been met. This
rule would establish regulations
governing CHEF, set the threshold cost
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that must be reached before CHEF
reimbursement can be paid, and
establish the procedures for
reimbursement under the program.
Strengthening Health and Safety
Standards for Consumer Products That
Impact Underserved Communities
The Department recognizes that
people of color, LGBTQ+ people, people
with disabilities, people with low
incomes, and other underserved
populations experience longstanding
disparities in leading public health
indicators—including obesity and the
use of certain tobacco products. To
protect the public health and advance
equity, the Department is pursuing
regulatory action with respect to
consumer products that have a
disproportionate impact on the health of
underserved groups.
For instance, the Department plans to
propose two rules on tobacco product
standards. First, the Department will
issue a proposed rule on Tobacco
Product Standard for Menthol in
Cigarettes, which would ban menthol as
a characterizing flavor in cigarettes.
Menthol cigarettes are marketed to and
disproportionately used by Black
smokers and increase the appeal of
smoking for youth and young adults.
This standard would reduce the
availability of menthol cigarettes. By
likely decreasing consumption and
increasing the likelihood of cessation,
the standard would likely improve the
health of current menthol cigarette
smokers. Similarly, the Department
plans to issue a proposed rule on
Tobacco Product Standard for
Characterizing Flavors in Cigars. This
rule is a tobacco product standard that
would ban characterizing flavors—such
as strawberry, grape, orange, and
cocoa—in all cigars. As with menthol
cigarettes, flavored cigars appeal to
youth and disproportionately affect
underserved communities. This product
standard would likely reduce the appeal
of cigars, particularly to youth and
young adults, and is intended to
decrease the likelihood of
experimentation, progression to regular
use, and the potential for addiction to
nicotine.
Furthermore, the Department will
issue a proposed rule entitled Nutrient
Content Claims, Definition of Term:
Healthy. This rule would update the
definition for the implied nutrient
content claim ‘‘healthy’’ to be consistent
with current nutrition science and
federal dietary guidelines. This would
ensure that foods labeled ‘‘healthy’’ can
help consumers build more healthful
diets to help reduce their risk of dietrelated chronic disease. This action is
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necessary to improve the public health
and reduce disparities in health
outcomes, particularly among people of
color and people with low incomes in
the U.S., who are disproportionately
affected by obesity and diet-related
chronic illness.
Preventing and Remedying
Discrimination
The Department is taking actions to
eliminate discrimination as a barrier for
historically marginalized communities
seeking access to HHS programs and
activities. This includes two proposed
rules in the Department’s Regulatory
Plan for the coming year. First, the
Department will issue a proposed rule
on Nondiscrimination in Health
Programs and Activities, which would
make changes to the previous
administration’s final rule
implementing the nondiscrimination
provisions in section 1557 of the ACA.
The current section 1557 regulations
significantly narrow the scope of section
1557’s protections. Because
discrimination in the U.S. health care
system is a driver of health disparities,
the Section 1557 regulations present a
key opportunity for the Department to
promote equity and ensure protection of
health care as a right. Additionally, the
Department will issue a proposed rule
entitled Rulemaking on Discrimination
on the Basis of Disability in Critical
Health and Human Services Programs or
Activities. This rule would revise
regulations under section 504 of the
Rehabilitation Act of 1973 to address
unlawful discrimination on the basis of
disability in certain vital HHS-funded
health and human services programs.
Covered topics include
nondiscrimination in life-sustaining
care, organ transplantation, suicide
prevention services, child welfare
programs and services, health care value
assessment methodologies, accessible
medical equipment, auxiliary aids and
services, Crisis Standards of Care and
other relevant health and human
services activities.
Ensuring the Equitable Administration
of HHS Programs
Consistent with President Biden’s
Executive Order on Advancing Racial
Equity and Support for Underserved
Communities Through the Federal
Government (E.O. 13985), the
Department is working to embed equity
throughout HHS programs and policies,
including in the awarding of grants,
loans, and procurement contracts.
For instance, the Department plans to
issue a proposed rule on the National
Institute for Disability, Independent
Living, and Rehabilitation Research
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(NIDILRR), which would propose
revisions to the NIDILRR regulations to
advance equity in the peer review
criteria used to evaluate disability
research applications across all of its
research programs, in addition to
making other changes. The Department
will also issue a proposed rule on the
Native Hawaiian Revolving Loan Fund
(NHRLF). The Native Hawaiian
Revolving Loan Fund (NHRLF) was
established to provide loans and loan
guarantees to Native Hawaiians who are
unable to obtain loans from private
sources on reasonable terms and
conditions for the purpose of promoting
economic development in Hawaii. This
rule proposes to reduce the required
Native Hawaiian ownership or control
for an eligible applicant to NHRLF
program from 100 percent, as the 100
percent Native Hawaiian ownership
requirement prevents many Native
Hawaiian family-owned businesses and
families from obtaining a loan.
Additionally, the Department plans to
issue a proposed rule entitled
Acquisition Regulations; Buy Indian
Act; Procedures for Contracting. This
rule would establish regulations guiding
implementation of the Buy Indian Act,
which allows the Department to set
aside procurement contracts for Indianowned and controlled businesses. This
would promote the growth and
development of Indian industries and in
turn, foster economic development and
sustainability in Indian Country.
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III. Tackling the COVID–19 Pandemic
As the federal agency charged with
protecting the health of all Americans,
the Department plays a central role in
the Biden-Harris Administration’s
whole-of-government response to the
COVID–19 pandemic. From ensuring
access to COVID–19 testing, treatment,
and vaccines, to bolstering the capacity
of the health care system in a public
health emergency, to addressing the
effects of the pandemic on the
behavioral health of Americans,
Secretary Becerra has leveraged the
Department’s full resources to pursue a
comprehensive strategy to combat
COVID–19. Over the last several
months, the Secretary has pursued this
regulatory priority by issuing a number
of critical rules requiring COVID–19
vaccinations to keep schools,
workplaces, and communities safe and
increasing regulatory oversight of
SARS–CoV–2 laboratory
experimentation. Over the next year, the
Department plans to continue its work
to address COVID–19 through new
regulations.
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Building on COVID–19 Vaccine
Requirements To Keep Schools,
Workplaces, and Communities Safe
Despite tremendous gains over the
course of 2021, tens of millions of
people remain unvaccinated against
COVID–19. Reaching this population is
an essential component of the BidenHarris Administration’s strategy to
accelerate our nation’s path out of the
pandemic. For this reason, vaccine
requirements are one of the
Department’s most impactful regulatory
options in combatting COVID–19.
Accordingly, the Department has
recently issued rules expanding COVID–
19 vaccine requirements. For example,
the Department issued an interim final
rule requiring COVID–19 vaccinations
for staff at most Medicare- and
Medicaid-participating providers and
suppliers.
Additionally, the Department issued
an interim final rule with comment
period to add new provisions to the
Head Start Program Performance
Standards to mitigate the spread of the
COVID–19 in Head Start programs
through COVID–19 vaccine
requirements.
Building on these accomplishments,
in the coming months, the Department
plans to issue an interim final rule that
will provide CDC with authority to
require individuals entering the U.S. at
any port of entry to present proof of
vaccination or other proof of immunity
against any quarantinable
communicable diseases for which the
Centers for Disease Control and
Prevention (CDC) determines that a
public health need exists. This rule will
provide CDC with authority to require
travelers to be fully vaccinated upon
arrival and will reduce the number of
international travelers arriving while
infected.
Increasing the Resilience of HHS
Programs To Deal With COVID–19 and
Future Public Health Emergencies
The Department is planning to
introduce new flexibilities in HHS
programs to minimize disruptions and
alleviate burdens that may be caused by
COVID–19 or future emergencies. For
example, the Department issued a final
rule on Flexibility for Head Start
Designation Renewals in Certain
Emergencies. This rule adds a new
provision to the Head Start Program
Performance Standards to establish
parameters by which the Administration
for Children and Families (ACF) may
make designation renewal
determinations during widespread
disasters or emergencies and in the
absence of all normally required data.
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The Department also plans to issue a
proposed rule on Administration for
Native Americans (ANA) Non-federal
Share Emergency Waivers. The rule will
propose the ability for current grantees
to request an emergency waiver for the
non-federal share match. This update to
ANA’s regulation would provide a new
provision for recipients to request an
emergency waiver in the event of a
natural or man-made emergency such as
a public health pandemic.
Additionally, the Department issued a
proposed rule on Paternity
Establishment Percentage Performance
Relief. This rule proposes to modify the
Paternity Establishment Percentage
performance requirements in child
support regulations to provide relief
from financial penalties to states
impacted by the COVID–19 pandemic.
Without regulatory relief, 20 out of the
54 child support programs may be
subject to financial penalties associated
with their failure to achieve
performance for the Paternity
Establishment Percentage (PEP). PEPrelated financial penalties, which are
imposed as reductions in the state’s
Temporary Assistance for Needy
Families (TANF) program funding,
place an undue burden on state budgets
and threaten funding that supports the
very families who are most in need
during this time of crisis.
IV. Boosting the Wellbeing of Children
and Families
The Department’s mission to provide
effective human services to Americans
includes a focus on protecting the
wellbeing of children and families. This
focus has special significance given the
COVID–19 pandemic and its economic
consequences, which have deeply
affected the lives of children and youth,
especially those who are in foster care
or otherwise involved in the child
welfare system. Secretary Becerra has
therefore prioritized children and youth
that are in, or candidates for, foster care
in the HHS Regulatory Plan.
In support of this priority, the
Department will issue a proposed rule
to allow Licensing Standards for
Relative or Kinship Foster Family
Homes that are different from nonrelative homes. Currently, in order to
claim Title IV–E funding, federal
regulations require that all foster family
homes meet the same licensing
standards, regardless of whether the
foster family home is a relative or nonrelative placement. The proposed
change would address barriers to
licensing relatives and kin who can
provide continuity and a safe and loving
home for children when they cannot be
with their parents.
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The Department will also issue a
proposed rule to reimburse agencies for
Title IV–E Administrative Expenditures
for Independent Legal Representation in
Foster Care and other Related Civil
Legal Issues. This rule would make it
easier for Title IV–E agencies to
facilitate the provision of independent
legal representation to a child who is a
candidate for foster care or in foster care
and to a parent preparing for
participation in foster care legal
proceedings. Improving access to
independent legal representation may
help prevent the removal of a child from
the home or, for a child in foster care,
achieve permanence faster.
HHS—OFFICE OF THE INSPECTOR
GENERAL (OIG)
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Final Rule Stage
44. Amendments to Civil Monetary
Penalty Law Regarding Grants,
Contracts, and Information Blocking
Priority: Other Significant.
Legal Authority: 21st Century Cures
Act; Pub. L. 114–255; secs. 4004 and
5003; Bipartisan Budget Act of 2018
(BBA 2018), Pub. L. 115–123. sec. 50412
CFR Citation: 42 CFR 1003; 42 CFR
1005.
Legal Deadline: None.
Abstract: The final regulation
modifies 42 CFR 1003 and 1005 by
addressing three issues. First, the 21st
Century Cures Act (Cures Act) provision
that authorizes the Department of
Health and Human Services (HHS) to
impose civil monetary penalties,
assessments, and exclusions upon
individuals and entities that engage in
fraud and other misconduct related to
HHS grants, contracts, and other
agreements. Second, the Cures Act
information blocking provisions that
authorize the Office of Inspector General
to investigate claims of information
blocking and provide HHS the authority
to impose CMPs for information
blocking. Third, the Bipartisan Budget
Act of 2018 increases in penalty
amounts in the Civil Monetary Penalties
Law.
Statement of Need: The 21st Century
Cures Act (Cures Act) set forth new
authorities which need to be added to
HHS’s existing civil monetary penalty
authorities. This final rule seeks to add
the new authorities to the existing civil
monetary penalty regulations and to set
forth the procedural and appeal rights
for individuals and entities. The
Bipartisan Budget Act of 2018 (BBA)
amended the Civil Monetary Penalties
Law (CMPL) to increase the amounts of
certain civil monetary penalties which
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requires amending the existing
regulations for conformity. The final
rule seeks to ensure alignment between
the increased civil monetary penalties
in the statute and the civil monetary
penalties set forth in the OIG’s rules.
Summary of Legal Basis: The legal
authority for this regulatory action is
found in: (1) Section 1128A(a)–(b) of the
Social Security Act, the Civil Monetary
Penalties Law (42 U.S.C. 1320a-7a),
which provides for civil monetary
penalty amounts; (2) section 1128A(o)–
(s) of the Social Security Act, which
provides for civil monetary penalties for
fraud and other misconduct related to
grants, contracts, and other agreements;
and (3) section 3022(b) of the Public
Health Service Act (42 U.S.C. 300jj–52),
which provides for investigation and
enforcement of information blocking.
Alternatives: The regulations
incorporate the statutory changes to
HHS’ authority found in the Cures Act
and the BBA. The alternative would be
to rely solely on the statutory authority
and not align the regulations
accordingly. However, we concluded
that the public benefit of providing
clarity by placing the new civil
monetary penalties and updated civil
monetary penalty amounts within the
existing regulatory framework
outweighed any burdens of additional
regulations promulgated.
Anticipated Cost and Benefits: We
believe that there are no significant
costs associated with these proposed
revisions that would impose any
mandates on State, local, or Tribal
governments or the private sector. The
regulation will provide a disincentive
for bottlenecks to the flow of health data
that exist, in part, because parties are
reticent to share data across the
healthcare system or prefer not to do so.
The final rule will help foster
interoperability, thus improving care
coordination, access to quality
healthcare, and patients’ access to their
healthcare data.
Risks: We believe the risks of this
regulatory action are minimal because
we are relying upon statutory
authorities and placing the regulation
within our existing regulatory
framework.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
04/24/20
06/23/20
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
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Government Levels Affected: None.
Agency Contact: Chris Hinkle, Senior
Advisor, Department of Health and
Human Services, Office of the Inspector
General, 330 Independence Avenue SW,
Washington, DC 20201, Phone: 202 891–
6062, Email: christina.hinkle@
oig.hhs.gov.
RIN: 0936–AA09
HHS—OFFICE FOR CIVIL RIGHTS
(OCR)
Proposed Rule Stage
45. Rulemaking on Discrimination on
the Basis of Disability in Critical Health
and Human Services Programs or
Activities (Rulemaking Resulting From
a Section 610 Review)
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Sec. 504 of the
Rehabilitation Act of 1973
CFR Citation: 45 CFR 84.
Legal Deadline: None.
Abstract: This proposed rule would
revise regulations under section 504 of
the Rehabilitation Act of 1973 to
address unlawful discrimination on the
basis of disability in certain vital HHSfunded health and human services
programs. Covered topics include nondiscrimination in life-sustaining care,
organ transplantation, suicide
prevention services, child welfare
programs and services, health care value
assessment methodologies, accessible
medical equipment, auxiliary aids and
services, Crisis Standards of Care and
other relevant health and human
services activities.
Statement of Need: To robustly
enforce the prohibition of
discrimination on the basis of disability,
OCR will update the section 504 of the
Rehabilitation Act regulations to clarify
obligations and address issues that have
emerged in our enforcement experience
(including complaints OCR has
received), caselaw, and statutory
changes under the Americans with
Disabilities Act and other relevant laws,
in the forty-plus years since the
regulation was promulgated. OCR has
heard from complainants and many
other stakeholders, as well as federal
partners, including the National Council
on Disability, on the need for updated
regulations in a number of important
areas, including non-discrimination in
life-sustaining care, organ
transplantation, suicide prevention
services, child welfare programs and
services, health care value assessment
methodologies, accessible medical
equipment, auxiliary aids and services,
Crisis Standards of Care and other
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relevant health and human services
activities.
Summary of Legal Basis: These
regulations are required by law. The
current regulations have not been
updated to be consistent with the
Americans with Disabilities Act, the
Americans with Disabilities
Amendments Act, or the 1992
Amendments to the Rehabilitation Act,
all of which made changes that should
be reflected in the HHS section 504
regulations. Under Executive Order
12250, the Department of Justice has
provided a template for HHS to update
this regulation.
Alternatives: OCR considered issuing
guidance, and/or investigating
individual complaints and compliance
reviews. However, we concluded that
not taking regulatory action could result
in continued discrimination, inequitable
treatment and even untimely deaths of
people with disabilities. OCR continues
to receive complaints alleging serious
acts of disability discrimination each
year. While we continue to engage in
enforcement, we believe that our
enforcement and recipients’ overall
compliance with the law will be better
supported by the presence of a clearly
articulated regulatory framework than
continuing the status quo. Continuing to
conduct case-by-case investigations
without a broader framework risks lack
of clarity on the part of providers and
violations of section 504 that could have
been avoided and may go unaddressed.
By issuing a proposed rule, we are
undertaking the most efficient and
effective means of promoting
compliance with section 504.
Anticipated Cost and Benefits: The
Department anticipates that this
rulemaking will result in significant
benefits, namely by providing clear
guidance to the covered entity
community regarding requirements to
administer their health programs and
activities in a non-discriminatory
manner. In turn, the Department
anticipates cost savings as individuals
with disabilities can access a range of
health care services. The Department
expects that the rule, when finalized,
will generate some changes in action
and behavior that may generate some
costs. The rule will address a wide
range of issues, with varying impacts
and a comprehensive analysis is
underway.
Risks: To be determined.
Timetable:
Action
Date
NPRM ..................
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Regulatory Flexibility Analysis
Required: No.
Government Levels Affected:
Undetermined.
Agency Contact: Molly Burgdorf,
Section Chief, Civil Rights Division,
Department of Health and Human
Services, Office for Civil Rights, 200
Independence Avenue SW, Washington,
DC 20201, Phone: 202 357–3411, Email:
ocrmail@hhs.gov.
RIN: 0945–AA15
HHS—OCR
46. Confidentiality of Substance Use
Disorder Patient Records
Priority: Other Significant.
Legal Authority: 42 U.S.C. 290dd–2
amended by the Coronavirus Aid,
Relief, and Economic Security Act (the
CARES Act), Pub. L. 116–136, sec. 3221
(March 27, 2020); Health Information
Technology for Economic and Clinical
Health (HITECH) Act, Pub. L. 111–5,
sec. 13402 and 13405 (February 17,
2009); Health Insurance Portability and
Accountability Act of 1996 (HIPAA)
Pub. L. 104–191, sec. 264 (August 21,
1996); Social Security Act, Pub. L. 74–
271 (August 14, 1935) (see secs. 1171 to
1179 of the Social Security Act, 42
U.S.C. 1320d to 1320d–8)
CFR Citation: 42 CFR 2; 45 CFR 160;
45 CFR 164.
Legal Deadline: NPRM, Statutory,
March 27, 2021.
The CARES Act requires the revisions
to regulations with respect to uses and
disclosures of information occurring on
or after the date that is 12 months after
the date of enactment of the Act (March
27, 2021); and not later than one year
after the date of enactment, an update to
the Notice of Privacy Practices (NPP)
provisions of the HIPAA Privacy Rule at
45 CFR 164.520.
Abstract: This rulemaking, to be
issued in coordination with the
Substance Abuse and Mental Health
Services Administration (SAMHSA),
would implement provisions of section
3221 of the CARES Act. Section 3221
amended 42 U.S.C. 290dd–2 to better
harmonize the 42 CFR part 2 (part 2)
confidentiality requirements with
certain permissions and requirements of
the HIPAA Rules and the HITECH Act.
This rulemaking also would implement
the requirement in section 3221 of the
CARES Act to modify the HIPAA
Privacy Rule NPP provisions so that
HIPAA covered entities and part 2
programs provide notice to individuals
regarding part 2 records, including
patients’ rights and uses and disclosures
permitted or required without
authorization.
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Statement of Need: Rulemaking is
needed to implement section 3221 of
the CARES Act, which modified the
statute that establishes protections for
the confidentiality of substance use
disorder (SUD) treatment records and
authorizes the implementing regulations
at 42 CFR part 2 (part 2). As required by
the CARES Act, this NPRM proposes
regulatory modifications to: (1) Align
certain provisions of part 2 with aspects
of the HIPAA Privacy, Breach
Notification, and Enforcement Rules. (2)
Strengthen part 2 protections against
uses and disclosures of patients’ SUD
records for civil, criminal,
administrative, and legislative
proceedings. (3) Require that a HIPAA
Notice of Privacy Practices address
privacy practices with respect to part 2
records.
Summary of Legal Basis: Section
3221(i) of the CARES Act requires
rulemaking as may be necessary to
implement and enforce section 3221.
Alternatives: HHS considered whether
the CARES Act provisions could be
implemented through guidance.
However, rulemaking is required
because the current part 2 regulations
are inconsistent with the authorizing
statute, as amended by the CARES Act.
HHS considered whether to include the
anti discrimination provisions of section
3221(g) in this rulemaking. However,
because implementation of the anti
discrimination provisions implicates
numerous civil rights authorities, which
require collaboration with the
Department of Justice, HHS will address
the anti discrimination provisions in a
separate rulemaking. HHS considered
whether to propose additional changes
to part 2 that are not required by section
3221 of the CARES Act. However,
adding more proposals would delay
publication of the proposed rule and
eventual implementation of the CARES
Act requirements.
Anticipated Cost and Benefits: HHS
estimates that the effects of the
proposed requirements for regulated
entities would result in new costs of
$16,872,779 within 12 months of
implementing the final rule. HHS
estimates these first-year costs would be
partially offset by $11,182,618 of first
year cost savings, followed by net
savings of $9,612,567 annually in years
two through five, resulting in overall net
cost savings of $32,760,108 over 5 years.
Risks: To be determined.
Timetable:
Action
NPRM .............
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Marissa GordonNguyen, Senior Advisor for Health
Information Privacy Policy, Department
of Health and Human Services, Office
for Civil Rights, 200 Independence
Avenue SW, Washington, DC 20201,
Phone: 800 368–1019, TDD Phone: 800
537–7697, Email: ocrprivacy@hhs.gov.
RIN: 0945–AA16
HHS—OCR
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47. Nondiscrimination in Health
Programs and Activities
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Sec. 1557 of the
Patient Protection and Affordable Care
Act (42 U.S.C. 18116)
CFR Citation: 42 CFR 92.
Legal Deadline: None.
Abstract: This proposed rulemaking
would propose changes to the 2020
Final Rule implementing section 1557
of the Patient Protection and Affordable
Care Act (PPACA). Section 1557 of
PPACA prohibits discrimination on the
basis of race, color, national origin, sex,
age, or disability under any health
program or activity, any part of which
is receiving Federal financial assistance,
including credits, subsidies, or contracts
of insurance, or under any program or
activity that is administered by an
Executive Agency, or any entity
established under title I of the PPACA.
Statement of Need: The Biden
Administration has made advancing
health equity a cornerstone of its policy
agenda. The current section 1557
implementing regulation significantly
curtails the scope of application of
section 1557 protections and creates
uncertainty and ambiguity as to what
constitutes prohibited discrimination in
covered health programs and activities.
Issuance of a revised section 1557
implementing regulation is important
because it would provide clear and
concise regulations that protect
historically marginalized communities
as they seek access to health programs
and activities.
Summary of Legal Basis: The
Secretary of the Department is
statutorily authorized to promulgate
regulations to implement section 1557.
42 U.S.C. 18116(c). The current section
1557 Final Rule is pending litigation.
Alternatives: The Department has
considered the alternative of
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maintaining the section 1557
implementing regulation in its current
form; however, the Department believes
it is appropriate to undertake
rulemaking given the Administration’s
commitment to advancing equity and
access to health care and in light of the
issues raised in litigation challenges to
the current rule.
Anticipated Cost and Benefits: In
enacting section 1557 of the ACA,
Congress recognized the benefits of
equal access to health services and
health insurance that all individuals
should have, regardless of their race,
color, national origin, sex, age, or
disability. The Department anticipates
that this rulemaking will result in
significant benefits, namely by
providing clear guidance to the covered
entity community regarding
requirements to administer their health
programs and activities in a nondiscriminatory manner. In turn, the
Department anticipates cost savings as
individuals are able to access a range of
health care services that will result in
decreased health disparities among
historically marginalized groups and
increased health benefits. The
Department does not yet have an
anticipated cost for this proposed
rulemaking; however, it is important to
recognize that this NPRM applies preexisting nondiscrimination
requirements in Federal civil rights laws
to various entities, the great majority of
which have been covered by these
requirements for years.
Risks: To be determined.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Dylan Nicole de
Kervor, Section Chief, Civil Rights
Division, Department of Health and
Human Services, Office for Civil Rights,
200 Independence Avenue SW,
Washington, DC 20201, Phone: 800 368–
1019, TDD Phone: 800 537–7697, Email:
ocrmail@hhs.gov.
RIN: 0945–AA17
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HHS—OFFICE OF THE NATIONAL
COORDINATOR FOR HEALTH
INFORMATION TECHNOLOGY (ONC)
Proposed Rule Stage
48. • ONC Health IT Certification
Program Updates, Health Information
Network Attestation Process for the
Trusted Exchange Framework and
Common Agreement, and
Enhancements To Support Information
Sharing
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj–11;
42 U.S.C. 300jj–14; 42 U.S.C. 300jj–19a;
42 U.S.C. 300jj–52; 5 U.S.C. 552; Pub. L.
114–255; Pub. L. 116–260
CFR Citation: 45 CFR 170; 45 CFR
171; 45 CFR 172.
Legal Deadline: Final, Statutory,
December 13, 2017, Conditions of
certification and maintenance of
certification.
Final, Statutory, July 24, 2019,
Publish a list of the health information
networks that have adopted the
common agreement and are capable of
trusted exchange pursuant to the
common agreement.
Abstract: The rulemaking implements
certain provisions of the 21st Century
Cures Act, including: the Electronic
Health Record Reporting Program
condition and maintenance of
certification requirements under the
ONC Health IT Certification Program; a
process for health information networks
that voluntarily adopt the Trusted
Exchange Framework and Common
Agreement to attest to such adoption of
the framework and agreement; and
enhancements to support information
sharing under the information blocking
regulations. The rulemaking would also
include proposals for new standards
and certification criteria under the
Certification Program related to realtime benefit tools and electronic prior
authorization and potentially other
revisions to the Certification Program.
Statement of Need: The rulemaking
would implement certain provisions of
the 21st Century Cures Act, including:
the Electronic Health Record (EHR)
Reporting Program condition and
maintenance of certification
requirements under the (Certification
Program); a process for health
information networks that voluntarily
adopt the Trusted Exchange Framework
and Common Agreement to attest to
such adoption of the framework and
agreement; and enhancements to
support information sharing under the
information blocking regulations. The
rulemaking would also include
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proposals for new standards and
certification criteria under the
Certification Program related to realtime benefit tools and electronic prior
authorization. These proposals would
fulfill statutory requirements, provide
transparency, advance interoperability,
and support the access, exchange, and
use of electronic health information.
Transparency regarding health care
information and activities as well as the
interoperability and electronic exchange
of health information are central to the
efforts of the Department of Health and
Human Services to enhance and protect
the health and well-being of all
Americans.
Summary of Legal Basis: The
provisions would be implemented
under the authority of the Public Health
Service Act, as amended by the HITECH
Act and the 21st Century Cures Act.
Alternatives: ONC will consider
different options and measures to
improve transparency, and the
interoperability and access to electronic
health information so that the benefits
to providers, patients, and payers are
maximized and the economic burden to
health IT developers, providers, and
other stakeholders is minimized.
Anticipated Cost and Benefits: The
majority of costs for this proposed rule
would be incurred by health IT
developers in terms of meeting new
requirements and continual compliance
with the EHR Reporting Program
condition and maintenance of
certification requirements. We also
expect that implementation of new
standards and information sharing
requirements may also account for some
costs. We expect that through
implementation and compliance with
the regulations, the market (particularly
patients, payers, and providers) will
benefit greatly from increased
transparency, interoperability, and
streamlined, lower cost access to
electronic heath information.
Risks: At this time, ONC has not been
able to identify any substantial risks that
would undermine likely proposals in
the proposed rule. ONC will continue to
consider and deliberate regarding any
identified potential risks and will be
sure to identify them for stakeholders
and seek comment from stakeholders
during the comment period for the
proposed rule.
Timetable:
Action
Date
NPRM ..................
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Agency Contact: Michael Lipinski,
Director, Regulatory & Policy Affairs
Division, Department of Health and
Human Services, Office of the National
Coordinator for Health Information
Technology, Mary E. Switzer Building,
330 C Street SW, Washington, DC
20201, Phone: 202 690–7151, Email:
michael.lipinski@hhs.gov.
RIN: 0955–AA03
HHS—SUBSTANCE ABUSE AND
MENTAL HEALTH SERVICES
ADMINISTRATION (SAMHSA)
Proposed Rule Stage
49. • Treatment of Opioid Use Disorder
With Buprenorphine Utilizing
Telehealth
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: The Controlled
Substances Act, as amended by the
Ryan Haight Act (21 U.S.C. 802(54)(G))
CFR Citation: 42 CFR 8.11(h).
Legal Deadline: None.
Abstract: In the face of an escalating
overdose crisis and an increasing need
to reach remote and underserved
communities, extending the
buprenorphine telehealth flexibility is
of paramount importance. To
permanently continue this flexibility
among OTPs after the COVID–19 public
health emergency ends, SAMHSA
proposes to revise OTP regulations
under 42 CFR part 8.
Statement of Need: This change will
help facilitate access to Medications for
Opioid Use Disorder (MOUD) in
SAMHSA-regulated opioid treatment
programs (https://www.samhsa.gov/
medication-assisted-treatment/becomeaccredited-opioid-treatment-program).
Research details that many patients are
unable to regularly access OTPs due to
unreliable transportation, geographic
disparity, employment or required
activities of daily living. Providing
buprenorphine via telehealth will allow
more patients to receive comprehensive
treatment.
Summary of Legal Basis: To be
determined.
Alternatives: In the absence of
congressional action, rulemaking is
required.
Anticipated Cost and Benefits: This
change will help facilitate access to and
ensure continuity of medication
treatment for opioid use disorder in
SAMHSA-regulated opioid treatment
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programs. The change will likely reduce
long-term costs at the practice level,
while also facilitating access to
treatment. However, a minority of
providers may face upfront technology
costs as they scale-up the provision of
treatment via telehealth. We expect that
since many providers have now shifted
in part to telehealth services during the
COVID–19 Public Health Emergency,
their costs should now be related to
equipment upgrades and software
updates. The cost to patients would
involve either use of Wi-Fi, data usage
with their respective cellular devices or
landline telephone service. We expect
that many patients already have
acquired some of these services, so the
cost would be monthly maintenance of
such services.
Risks: Patients seeking this care might
still be required to have an in person
visit, as specified by their provider’s
plan of care, so to receive
comprehensive treatment. Without this
provision, there is risk of patients
receiving a lower standard of care and
increased risk of diversion of the
prescribed medications.
Timetable:
Action
NPRM ..................
Date
FR Cite
09/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Neeraj Gandotra,
Chief Medical Officer, Department of
Health and Human Services, Substance
Abuse and Mental Health Services
Administration, 5600 Fishers Lane,
18E67, Rockville, MD 20857, Phone: 202
823–1816, Email: neeraj.gandotra@
samhsa.hhs.gov.
RIN: 0930–AA38
HHS—SAMHSA
50. • Treatment of Opioid Use Disorder
With Extended Take Home Doses of
Methadone
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 21 U.S.C. 823(g)(1)
CFR Citation: 42 CFR 8.
Legal Deadline: None.
Abstract: SAMHSA will revise 42 CFR
part 8 to make permanent some
regulatory flexibilities for opioid
treatment programs to provide extended
take home doses of methadone. To
facilitate this new treatment paradigm,
sections of 42 CFR part 8 will require
updating to reflect current treatment
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practice. SAMHSA’s changes will
impact roughly 1,800 opioid treatment
programs and state opioid treatment
authorities.
Statement of Need: This change will
help ensure continuity of access to
Medications for Opioid Use Disorder
(MOUD) in SAMHSA-regulated opioid
treatment programs (https://
www.samhsa.gov/medication-assistedtreatment/become-accredited-opioidtreatment-program). Research and
stakeholder feedback details that the
take home flexibilities have been well
received by treatment programs and
patients. There are very few reports of
diversion or overdose, and the provision
of extended take home doses facilitates
patient engagement in activities, such as
employment, that support recovery.
Moreover, those with limited access to
transportation benefit from extended
take home doses since they are not
required to attend the OTP almost each
day of the week to receive Methadone.
In this way, making permanent the
methadone extended take home
flexibility will facilitate treatment
engagement.
Summary of Legal Basis: The current
OTP exemption at issue allows OTPs to
operate in a manner that is otherwise
inconsistent with existing OTP
regulations, and therefore, a permanent
extension of such exemptions would
necessitate revisions of the OTP
regulations.
Alternatives: In the absence of
congressional action, rulemaking is
required.
Anticipated Cost and Benefits: This
change will help facilitate and ensure
continuity of access to medication
treatment for opioid use disorder in
SAMHSA-regulated opioid treatment
programs. Programs have already
incorporated this flexibility into
practice and have systems in place that
support its delivery in a cost effective
and patient centered manner. This
proposed rule is not expected to impart
a cost to patients. In fact, the proposed
rule allows patients to engage in
employment and necessary daily
activities. This supports income
generation and also recovery. The
increased number of take homes
allowed may affect OTP clinic visit and
thereby reduce revenue derived from
clinical encounters and medication
visits. Conversely patients may
experience more convenient
engagement with OTPs as the visits to
clinic would be decreased.
Risks: Patients seeking this care
should still be required to have an inperson visit at the OTP in between
provision of take-home doses, as
directed by their treating physician’s
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plan of care. Without this provision,
there is risk of patients receiving a lower
standard of care and increased risk of
diversion of the prescribed medications.
Timetable:
Action
Date
NPRM ..................
FR Cite
09/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: State.
Agency Contact: Dr. Neeraj Gandotra,
Chief Medical Officer, Department of
Health and Human Services, Substance
Abuse and Mental Health Services
Administration, 5600 Fishers Lane,
18E67, Rockville, MD 20857, Phone: 202
823–1816, Email: neeraj.gandotra@
samhsa.hhs.gov.
RIN: 0930–AA39
HHS—CENTERS FOR DISEASE
CONTROL AND PREVENTION (CDC)
Final Rule Stage
51. • Requirement for Proof of
Vaccination or Other Proof of Immunity
Against Quarantinable Communicable
Diseases
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: secs. 215 and 311 of
the Public Health Service (PHS) Act, as
amended (42 U.S.C. 216, 243); sec. 361
to 369, PHS Act, as amended (42 U.S.C.
264 to 272)
CFR Citation: 42 CFR 71.
Legal Deadline: None.
Abstract: This Interim Final Rule
(IFR) will amend current regulations to
permit CDC to require proof of
vaccination or other proof of immunity
against quarantinable communicable
diseases. When CDC exercises this
authority, persons arriving at a U.S. port
of entry will be required to provide
proof of immunity against quarantinable
communicable diseases or proof of
having been fully vaccinated against
quarantinable communicable diseases.
Additionally, as a condition of
controlled free pratique under 42 CFR
71.31(b), carriers destined for the United
States must also comply with
requirements of any order issued
pursuant to the IFR.
Statement of Need: In response to the
COVID–19 pandemic, CDC is amending
current regulations to require proof of
vaccination or other proof of immunity
against quarantinable communicable
diseases for persons arriving at a U.S.
port of entry.
Summary of Legal Basis: HHS/CDC is
promulgating this rule under sections
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215 and 311 of the Public Health
Service Act, as amended (42 U.S.C. 216,
243); section 361 to 369, PHS Act, as
amended (42 U.S.C 264 to 272).
Alternatives: An alternative
considered would allow non-U.S.
nationals to submit accurate contact
information, complete post-arrival
testing, and self-quarantine after arrival
in the United States in lieu of the
vaccination requirement.
Anticipated Cost and Benefits: HHS/
CDC believes it is likely that this
rulemaking will be determined to be
economically significant under E.O.
12866.
Risks: This rulemaking addresses the
risk of introduction of communicable
diseases by international travelers into
the United States. By implementing this
rulemaking, CDC can reduce the risk of
importation of new COVID–19 variants
into the United States. This rulemaking
is expected to increase the number of
travelers who are fully vaccinated upon
arrival and reduce the number of
international travelers arriving while
infected.
Timetable:
Action
Interim Final Rule
Date
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
Local, State.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Ashley C.
Altenburger JD, Public Health Analyst,
Department of Health and Human
Services, Centers for Disease Control
and Prevention, 1600 Clifton Road NE,
MS: H 16–4, Atlanta, GA 30307, Phone:
800 232–4636, Email:
dgmqpolicyoffice@cdc.gov.
RIN: 0920–AA80
HHS—FOOD AND DRUG
ADMINISTRATION (FDA)
Proposed Rule Stage
52. Nonprescription Drug Product With
an Additional Condition for
Nonprescription Use
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 21 U.S.C. 321; 21
U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 371;
42 U.S.C. 262; 42 U.S.C. 264; . . .
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CFR Citation: 21 CFR 201.67; 21 CFR
314.56; 21 CFR 314.81; 21 CFR 314.125;
21 CFR 314.127.
Legal Deadline: None.
Abstract: The proposed rule is
intended to increase access to
nonprescription drug products. The
proposed rule would establish
requirements for a drug product that
could be marketed as a nonprescription
drug product with an additional
condition that an applicant must
implement to ensure appropriate selfselection, appropriate actual use, or
both by consumers.
Statement of Need: Nonprescription
products have traditionally been limited
to drugs that can be labeled with
information for consumers to safely and
appropriately self-select and use the
drug product without supervision of a
health care provider. There are certain
prescription medications that may have
comparable risk-benefit profiles to overthe-counter medications in selected
populations. However, appropriate
consumer selection and use may be
difficult to achieve in the
nonprescription setting based solely on
information included in labeling. FDA
is proposing regulations that would
establish the requirement for a drug
product that could be marketed as a
nonprescription drug product with an
additional condition that an applicant
must implement to ensure appropriate
self-selection or appropriate actual use
or both for consumers.
Summary of Legal Basis: FDA’s
proposed revisions to the regulations
regarding labeling and applications for
nonprescription drug products labeling
are authorized by the FD&C Act (21
U.S.C. 321 et seq.) and by the Public
Health Service Act (42 U.S.C. 262 and
264).
Alternatives: FDA evaluated various
requirements for new drug applications
to assess flexibility of nonprescription
drug product design through drug
labeling for appropriate self-selection
and appropriate use.
Anticipated Cost and Benefits: The
benefits of the proposed rule would
include increased consumer access to
drug products, which could translate to
a reduction in under treatment of
certain diseases and conditions. Benefits
to industry would arise from the
flexibility in drug product approval. The
proposed rule would impose costs
arising from the development of an
innovative approach to assist consumers
with nonprescription drug product selfselection or use.
Risks: None.
Timetable:
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Action
Date
NPRM ..................
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Chris Wheeler,
Supervisory Project Manager,
Department of Health and Human
Services, Food and Drug
Administration, 10903 New Hampshire
Avenue, Building 51, Room 3330, Silver
Spring, MD 20993, Phone: 301 796–
0151, Email: chris.wheeler@fda.hhs.gov.
RIN: 0910–AH62
HHS—FDA
53. Nutrient Content Claims, Definition
of Term: Healthy
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 321; 21
U.S.C. 331; 21 U.S.C. 343; 21 U.S.C. 371
CFR Citation: 10 CFR 101.65
(revision).
Legal Deadline: None.
Abstract: The proposed rule would
update the definition for the implied
nutrient content claim ‘‘healthy’’ to be
consistent with current nutrition
science and federal dietary guidelines.
The proposed rule would revise the
requirements for when the claim
‘‘healthy’’ can be voluntarily used in the
labeling of human food products so that
the claim reflects current science and
dietary guidelines and helps consumers
maintain healthy dietary practices.
Statement of Need: FDA is proposing
to redefine ‘‘healthy’’ to make it more
consistent with current public health
recommendations, including those
captured in recent changes to the
Nutrition Facts label. The existing
definition for ‘‘healthy’’ is based on
nutrition recommendations regarding
intake of fat, saturated fat, and
cholesterol, and specific nutrients
Americans were not getting enough of in
the early 1990s. Nutrition
recommendations have evolved since
that time; recommended diets now
focus on dietary patterns, which
includes getting enough of certain food
groups such as fruits, vegetables, low-fat
dairy, and whole grains. Chronic
diseases, such as heart disease, cancer,
and stroke, are the leading causes of
death and disability in the United States
and diet is a contributing factor to these
diseases. Claims on food packages such
as ‘‘healthy’’ can provide quick signals
to consumers about the healthfulness of
a food or beverage, thereby making it
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easier for busy consumers to make
healthy choices.
FDA is proposing to update the
existing nutrient content claim
definition of ‘‘healthy’’ based on the
food groups recommended by the
Dietary Guidelines for Americans and
also require a food product to be limited
in certain nutrients, including saturated
fat, sodium, and added sugar, to ensure
that foods bearing the claim can help
consumers build more healthful diets to
help reduce their risk of diet-related
chronic disease.
Summary of Legal Basis: FDA is
issuing this proposed rule under
sections 201(n), 301(a), 403(a), 403(r),
and 701(a) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
321(n), 331(a), 343(a), 343(r), and
371(a)). These sections authorize the
agency to adopt regulations that prohibit
labeling that bears claims that
characterize the level of a nutrient
which is of a type required to be
declared in nutrition labeling unless the
claim is made in accordance with a
regulatory definition established by
FDA. Pursuant to this authority, FDA
issued a regulation defining the
‘‘healthy’’ implied nutrient content
claim, which is codified at 21 CFR
101.65. This proposed rule would
update the existing definition to be
consistent with current federal dietary
guidance.
Alternatives:
Alternative 1: Codify the policy in the
current enforcement discretion
guidance.
In 2016, FDA published ‘‘Use of the
Term ‘Healthy’ in the Labeling of
Human Food Products: Guidance for
Industry.’’ This guidance was intended
to advise food manufacturers of FDA’s
intent to exercise enforcement
discretion relative to foods that use the
implied nutrient content claim
‘‘healthy’’ on their labels which: (1) Are
not low in total fat, but have a fat profile
makeup of predominantly mono and
polyunsaturated fats; or (2) contain at
least 10 percent of the Daily Value (DV)
per reference amount customarily
consumed (RACC) of potassium or
vitamin D.
One alternative is to codify the policy
in this guidance. Although guidance is
non-binding, we assume that most
packaged food manufacturers are aware
of the guidance and, over the past 2
years, have already made any
adjustments to their products or product
packaging. Therefore, we assume that
this alternative would have no costs to
industry and no benefits to consumers.
Alternative 2: Extend the compliance
date by 1 year.
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Extending the anticipated proposed
compliance date on the rule updating
the definition by 1 year would reduce
costs to industry as they would have
more time to change products that may
be affected by the rule or potentially
coordinate label changes with already
scheduled label changes. On the other
hand, a longer compliance date runs the
risk of confusing consumers that may
not understand whether a packaged
food product labeled ‘‘healthy’’ follows
the old definition or the updated one.
Anticipated Cost and Benefits: Food
products bearing the ‘‘healthy’’ claim
currently make up a small percentage
(5%) of total packaged foods. Quantified
costs to manufacturers include labeling,
reformulating, and recordkeeping.
Discounted at seven percent over 20
years, the mean present value of costs of
the proposed rule is $237 million, with
a lower bound of $110 million and an
upper bound of $434 million.
Updating the definition of ‘‘healthy’’
to align with current dietary
recommendations can help consumers
build more healthful diets to help
reduce their risk of diet-related chronic
diseases. Discounted at seven percent
over 20 years, the mean present value of
benefits of the proposed rule is $260
million, with a lower bound estimate of
$17 million and an upper bound
estimate of $700 million.
Risks: None.
Timetable:
Action
Date
NPRM ..................
FR Cite
12/00/21
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Agency Contact: Vincent De Jesus,
Nutritionist, Department of Health and
Human Services, Food and Drug
Administration, Center for Food Safety
and Applied Nutrition, (HFS–830),
Room 3D–031, 5100 Paint Branch
Parkway, College Park, MD 20740,
Phone: 240 402–1774, Fax: 301 436–
1191, Email: vincent.dejesus@
fda.hhs.gov.
RIN: 0910–AI13
HHS—FDA
Abstract: FDA’s biologics regulations
will be updated to clarify existing
requirements and procedures related to
Biologic License Applications and to
promote the goals associated with FDA’s
implementation of the abbreviated
licensure pathway created by the
Biologics Price Competition and
Innovation Act of 2009.
Statement of Need: As biologics
regulations were primarily drafted in
the 1970s, before passage of the BPCI
Act, the regulations need to be updated
and modernized to account for the
existence of biosimilar and
interchangeable biological products.
The intent of this rulemaking is to make
high priority updates to FDA’s biologics
regulations with the goals of (1)
providing enhanced clarity and
regulatory certainty for manufacturers of
both originator and biosimilar/
interchangeable products and (2) help
prevent the gaming of FDA regulatory
requirements to prevent or delay
competition from biosimilars and
interchangeable products.
Summary of Legal Basis: FDA’s
authority for this rule derives from the
biological product provisions in section
351 of the PHS Act (42 U.S.C. 262), and
the provisions of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 301, et seq.) applicable to
biological products.
Alternatives: FDA would continue to
rely on guidance and one-on-one
communications with sponsors through
formal meetings and correspondence to
provide clarity on existing requirements
and procedures related to Biologic
License Applications, increasing the
risk of potential confusion and burden.
Anticipated Cost and Benefits: This
proposed rule would impose
compliance costs on affected entities to
read and understand the rule and to
provide certain information relevant to
the regulation. The provisions in this
proposed rule would reduce regulatory
uncertainty for manufacturers of
originator and biosimilar and
interchangeable products. This
reduction of uncertainty may lead to
time-savings to industry and costsavings to government due to better
organized and more complete BLAs and
increased procedural clarity and
predictability.
Risks: None.
Timetable:
Action
54. Biologics Regulation Modernization
Priority: Other Significant.
Legal Authority: 42 U.S.C. 262; 42
U.S.C. 301, et seq.
CFR Citation: 21 CFR 601.
Legal Deadline: None.
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Date
NPRM ..................
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08/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
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Federalism: Undetermined.
Agency Contact: Sandra Benton,
Senior Policy Coordinator, Department
of Health and Human Services, Food
and Drug Administration, 10903 New
Hampshire Avenue, Building 22, Room
1132, Silver Spring, MD 20993, Phone:
301 796–1042, Email: sandra.benton@
fda.hhs.gov.
RIN: 0910–AI14
HHS—FDA
55. Medical Devices; Ear, Nose and
Throat Devices; Establishing Over-theCounter Hearing Aids and Aligning
Other Regulations
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 321; 21
U.S.C. 331 to 334; 21 U.S.C. 351 and
352; 21 U.S.C. 360; 21 U.S.C. 360c to
360e; Pub. L. 115–52, 131 Stat. 1065–67;
21 U.S.C. 360i to 360k; 21 U.S.C. 360l;
21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C.
381; . . .
CFR Citation: 21 CFR 800; 21 CFR
801; 21 CFR 808; 21 CFR 874.
Legal Deadline: NPRM, Statutory,
August 18, 2020.
Abstract: FDA is proposing to
establish an over-the-counter category of
hearing aids to promote the availability
of additional kinds of devices that
address mild to moderate hearing loss,
and proposing related amendments to
the current hearing aid regulations, the
regulations codifying FDA decisions on
State applications for exemption from
preemption, and the hearing aid
classification regulations.
Statement of Need: Hearing loss
affects an estimated 30 million people
in the United States and can have a
significant impact on communication,
social participation, and overall health
and quality of life. However, only about
one-fifth of people who could benefit
from a hearing aid seek intervention.
Several barriers likely impede the use of
hearing aids, and FDA is proposing
rules to address some of these concerns.
Summary of Legal Basis: The Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) establishes a comprehensive
system for the regulation of devices
intended for human use, and hearing
aids are subject to those provisions.
Furthermore, the FDA Reauthorization
Act of 2017 (Pub. L. 115–52, 131 Stat.
1005, 1066) directs FDA to establish by
regulation a category of over-the-counter
hearing aids. This rulemaking
establishes requirements for the safe and
effective use of hearing aids, including
for the over-the-counter category of
hearing aids.
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Alternatives: FDA must establish the
category of over-the-counter hearing
aids as well as requirements that
provide for reasonable assurance of
safety and effectiveness of these hearing
aids. However, FDA will consider
different specific options to maximize
the health benefits to hearing aid users
while minimizing the economic burdens
of the final rules.
Anticipated Cost and Benefits: FDA
expects benefits of the rule to include
cost savings to consumers who wish to
buy lower-cost hearing aids, in part by
enabling consumers to cross-compare
and purchase the devices more easily.
Other benefits may include improving
health equity, especially for Americans
living in rural areas, those with limited
mobility, or those with limited means.
Individual benefits may include
improved health outcomes, and
therefore improved social and economic
participation. FDA expects costs to
include those costs to manufacturers for
changing labeling and updating existing
processes.
Risks: None.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
10/20/21
01/18/22
FR Cite
86 FR 58150
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: Ian Ostermiller,
Regulatory Counsel, Center for Devices
and Radiological Health, Department of
Health and Human Services, Food and
Drug Administration, 10903 New
Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993, Phone: 301
796–5678, Email: ian.ostermiller@
fda.hhs.gov.
RIN: 0910–AI21
HHS—FDA
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56. Tobacco Product Standard for
Characterizing Flavors in Cigars
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 331; 21
U.S.C. 333; 21 U.S.C. 371(a); 21 U.S.C.
387b and 387c; 21 U.S.C. 387f(d) and
387g; . . .
CFR Citation: 21 CFR 1166.
Legal Deadline: None.
Abstract: Evidence shows that
flavored tobacco products appeal to
youth and also shows that youth may be
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more likely to initiate tobacco use with
such products. Characterizing flavors in
cigars, such as strawberry, grape,
orange, and cocoa, enhance taste and
make them easier to use. Over a half
million youth in the United States use
flavored cigars, placing these youth at
risk for cigar-related disease and death.
This proposed rule is a tobacco product
standard that would ban characterizing
flavors (other than tobacco) in all cigars.
We are taking this action with the
intention of reducing the tobaccorelated death and disease associated
with cigar use.
Statement of Need: The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), authorizes FDA
to adopt tobacco product standards
under section 907 if the Secretary finds
that a tobacco product standard is
appropriate for the protection of the
public health. This product standard
would ban characterizing flavors (other
than tobacco) in all cigars.
Characterizing flavors in cigars, such as
strawberry, grape, cocoa, and fruit
punch, increase appeal and make the
cigars easier to use, particularly among
youth and young adults. This product
standard would reduce the appeal of
cigars, particularly to youth and young
adults, and is intended to decrease the
likelihood of experimentation,
progression to regular use, and potential
for addiction to nicotine. In addition,
most of the users of flavored cigars are
from under served communities and/or
at risk populations, including racial/
ethnic minorities, lesbian, gay, bisexual,
transgender and queer (LGBTQ+)
persons, those of lower socioeconomic
status, and youth. As such, reducing the
appeal and use of cigars by eliminating
characterizing flavors is also expected to
decrease tobacco-related disparities and
promote health equity across population
groups.
Summary of Legal Basis: Section 907
of the FD&C Act authorizes the adoption
of tobacco product standards if the
Secretary finds that a tobacco product
standard is appropriate for the
protection of the public health. Section
907 also authorizes FDA to include in
a product standard a provision that
restricts the sale and distribution of a
tobacco product to the extent that it may
be restricted by a regulation under
section 906(d) of the FD&C Act. Section
701(a) of the FD&C Act authorizes the
promulgation of regulations for the
efficient enforcement of the FD&C Act.
Alternatives: In addition to the costs
and benefits of the proposed rule, FDA
will assess the costs and benefits of
changing the effective date of the rule,
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and including pipe tobacco in the
proposed standard.
Anticipated Cost and Benefits: The
anticipated benefits of the proposed rule
stem from diminished exposure to
tobacco smoke for users of cigars from
decreased experimentation, progression
to regular use, and consumption of
cigars with characterizing flavors other
than tobacco. The diminished exposure
and use is expected to reduce illness
and improve health.
Risks: None.
Timetable:
Action
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
Date
03/21/18
07/19/18
FR Cite
83 FR 12294
04/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Samantha
LohColladom, Regulatory Counsel,
Department of Health and Human
Services, Food and Drug
Administration, Center for Tobacco
Products, 10903 New Hampshire
Avenue, Document Control Center,
Building 71, Room G335, Silver Spring,
MD 20993, Phone: 877 287–1373, Email:
ctpregulations@fda.hhs.gov.
RIN: 0910–AI28
HHS—FDA
57. Conduct of Analytical and Clinical
Pharmacology, Bioavailability and
Bioequivalence Studies
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 21 U.S.C. 355; 21
U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 262
CFR Citation: 21 CFR 16; 21 CFR 314;
21 CFR 320; 21 CFR 321; 21 CFR 601;
. . .
Legal Deadline: None.
Abstract: FDA is proposing to amend
21 CFR 320, in certain parts, and
establish a new 21 CFR 321 to clarify
FDA’s study conduct expectations for
analytical and clinical pharmacology,
bioavailability (BA) and bioequivalence
(BE) studies that support marketing
applications for human drug and
biological products. The proposed rule
would specify needed basic study
conduct requirements to enable FDA to
ensure those studies are conducted
appropriately and to verify the
reliability of study data from those
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studies. This regulation would align
with FDA’s other good practice
regulations, would also be consistent
with current industry best practices, and
would harmonize the regulations more
closely with related international
regulatory expectations.
Statement of Need: FDA receives
clinical pharmacology and clinical and
analytical bioavailability (BA) and
bioequivalence (BE) study data in
support of new and abbreviated new
drug applications, and biological license
applications. Our ability to ensure
studies supporting those applications
are reliable and valid, including data
reliability and human subject
protection, is severely limited because
our regulations governing BA and BE
studies at 21 CFR part 320 lack basic
study conduct requirements necessary
for the Agency to verify study data
reliability. Current part 320 does not
describe specific responsibilities for
persons involved in the conduct of
clinical and analytical BA and BE
studies, recordkeeping and record
retention requirements, standing
operating procedures, or compliance
provisions. The proposed rule would
revise part 320 and establish a new part
321 to codify the Agency’s expectations,
and industry best practices, for the
conduct of clinical pharmacology and
clinical and analytical BA and BE
studies for human drug and biological
product marketing applications.
Summary of Legal Basis: FDA’s
proposed revisions to the regulations
regarding the conduct of clinical
pharmacology and clinical and
analytical BA and BE are authorized by
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355, 371 and 374) and by
the Public Health Service Act (42 U.S.C.
262).
Alternatives: FDA considered
providing guidance to applicants and
their contractors that conduct and
submits clinical pharmacology and
clinical and analytical BA and BE
studies to the Agency in support of
marketing applications.
Anticipated Cost and Benefits: The
benefits of the proposed rule would be
increased clarity to industry on study
conduct expectations that should
improve study quality and thereby, to
the extent possible, result in fewer study
rejections due to deficiencies identified
by Agency inspections, and thus
promote faster application approvals.
Also, potential benefit to patients by
increasing the speed in which new
human drug and biological products are
approved to market. The costs would
stem from the proposed rule
establishing recordkeeping requirements
and procedures and processes
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requirements that applicants and their
contractors would need to meet. These
proposed requirements are in-line with
current industry best practices.
Risks: The current regulatory
framework does not adequately describe
FDA’s expectations for the conduct
clinical pharmacology and clinical and
analytical BA and BE studies to ensure
industry performs those studies in a
consistent and reliable manner. The
proposed rule would establish basic
study conduct expectations to ensure
study reliability, including data
reliability and human subject
protection.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Brian Joseph Folian,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, 10903 New
Hampshire Avenue, Building 51, Room
5215, Silver Spring, MD 20993–0002,
Phone: 240 402–4089, Email:
brian.folian@fda.hhs.gov.
RIN: 0910–AI57
HHS—FDA
58. Tobacco Product Standard for
Menthol in Cigarettes
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 21 U.S.C. 387g
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This proposed rule is a
tobacco product standard to prohibit the
use of menthol as a characterizing flavor
in cigarettes.
Statement of Need: The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), authorizes FDA
to adopt tobacco product standards
under section 907 if the Secretary finds
that a tobacco product standard is
appropriate for the protection of the
public health. This product standard
would ban menthol as a characterizing
flavor in cigarettes. The standard would
reduce the availability of menthol
cigarettes and thereby decrease the
likelihood that nonusers who would
experiment with these products would
progress to regular cigarette smoking. In
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addition, among current menthol
cigarette smokers, the proposed tobacco
product standard is likely to improve
the health of current menthol cigarette
smokers by decreasing consumption and
increasing the likelihood of cessation.
Summary of Legal Basis: Section 907
of the FD&C Act authorizes the adoption
of tobacco product standards if the
Secretary finds that a tobacco product
standard is appropriate for the
protection of public health.
Alternatives: In addition to the costs
and benefits of the proposed rule, FDA
will assess the costs and benefits of
extending the effective date of the rule,
creating a process by which some
products may apply for an exemption or
variance from the proposed product
standard, and prohibiting menthol as an
additive in cigarette products rather
than prohibiting menthol as a
characterizing flavor.
Anticipated Cost and Benefits: The
proposed rule is expected to generate
compliance costs on affected entities,
such as one-time costs to read and
understand the rule and alter
manufacturing/importing practices. The
quantified benefits of the proposed rule
stem from improved health and
diminished exposure to tobacco smoke
for users of cigarettes from decreased
experimentation, progression to regular
use, and consumption of menthol
cigarettes. The qualitative benefits of the
proposed rule include impacts such as
reduced illness for smokers.
Risks: None.
Timetable:
Action
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
Date
07/24/13
09/23/13
FR Cite
78 FR 44484
04/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Beth Buckler, Senior
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, Center for
Tobacco Products, 10903 New
Hampshire Avenue, Document Control
Center, Building 71, Room G335, Silver
Spring, MD 20993, Phone: 877 287–
1373, Email: ctpregulations@
fda.hhs.gov.
RIN: 0910–AI60
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HHS—HEALTH RESOURCES AND
SERVICES ADMINISTRATION (HRSA)
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59. • 340B Drug Pricing Program;
Administrative Dispute Resolution
Priority: Other Significant.
Legal Authority: Not Yet Determined
CFR Citation: 42 CFR 10.
Legal Deadline: None.
Abstract: This proposed rule would
replace the Administrative Dispute
Resolution (ADR) final rule currently in
effect and apply to all drug
manufacturers and covered entities that
participate in the 340B Drug Pricing
Program (340B Program), It would
establish new requirements and
procedures for the 340B Program’s ADR
process. This administrative process
would allow covered entities and
manufacturers to file claims for specific
compliance areas outlined in the statute
after good faith efforts have been
exhausted by the parties.
Statement of Need: This NPRM
proposes to replace the 340B
Administrative Dispute Resolution
(ADR) final rule, which was published
in December 2020 and became effective
January 13, 2021. This new rule will
propose new requirements and
procedures for the 340B Program’s ADR
process. The proposed rule applies to
drug manufacturers and covered entities
participating in the 340B Drug Pricing
Program (340B Program) by allowing
these entities to file claims for specific
compliance areas outlined in the 340B
statute after good faith efforts have been
exhausted by the parties. This NPRM
better aligns with the President’s
priorities on drug pricing, better reflects
the current state of the 340B Program,
and seeks to correct procedural
deficiencies in the 340B ADR process.
Summary of Legal Basis: Section
340B(d)(3) of the Public Health Service
Act (PHS Act) requires the Secretary to
promulgate regulations establishing and
implementing an ADR process for
certain disputes arising under the 340B
Program. Under the 340B statute, the
purpose of the ADR process is to resolve
(1) Claims by covered entities that they
have been overcharged for covered
outpatient drugs by manufacturers and
(2) claims by manufacturers, after a
manufacturer has conducted an audit as
authorized by section 340B(a)(5)(C) of
the PHS Act, that a covered entity has
violated the prohibition on diversion or
duplicate discounts.
Alternatives: N/A.
Anticipated Cost and Benefits: N/A.
Risks: None.
Timetable:
17:50 Jan 28, 2022
Date
NPRM ..................
Proposed Rule Stage
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01/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Michelle Herzog,
Deputy Director, Office of Pharmacy
Affairs, Department of Health and
Human Services, Health Resources and
Services Administration, 5600 Fishers
Lane, 08W12, Rockville, MD 20857,
Phone: 301 443–4353, Email: mherzog@
hrsa.gov.
RIN: 0906–AB28
HHS—INDIAN HEALTH SERVICE (IHS)
Proposed Rule Stage
60. Catastrophic Health Emergency
Fund (Chef)
Priority: Other Significant.
Legal Authority: Pub. L. 94–437, sec.
202(d), IHCI Act, as amended by Pub. L.
111–148, sec. 10221
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Catastrophic Health
Emergency Fund (CHEF) pays for
extraordinary medical costs associated
with treatment of victims of disasters or
catastrophic illnesses. CHEF is used to
reimburse PRC programs for high cost
cases (e.g., burn victims, motor vehicle
accidents, high risk obstetrics,
cardiology, etc.). The proposed rule
establishes conditions and procedures
for payment from the fund. During the
comment period for the NPRM, several
Tribes and Tribal Organizations
expressed concern about provisions in
the NRPM related to coordination with
Tribal self-insurance as an alternate
resource. In response to those concerns,
the IHS engaged in additional Tribal
consultation and decided to delay
moving forward with the NPRM
pending the resolution of relevant
litigation. IHS intends to proceed with
developing the NPRM consistent with
how Tribal self-insurance is currently
recognized in agency policy at https://
www.ihs.gov/ihm/pc/part-2/chapter-3purchased-referred-care/. On January
29, 2021, IHS issued a Dear Tribal
Leader Letter to clarify that the
proposed rule should not be relied upon
and that IHS will be moving forward by
publishing a new proposed rule in the
near future. A copy of the Dear Tribal
Leader Letter concerning next steps for
the CHEF regulations is available on the
IHS website at: https://www.ihs.gov/
sites/newsroom/themes/
responsive2017/display_objects/
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documents/2021_Letters/DTLL_
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Statement of Need: These regulations
propose to (1) establish definitions
governing CHEF, including definitions
of disasters and catastrophic illnesses;
(2) establish that a service unit shall not
be eligible for reimbursement for the
cost of treatment from CHEF until its
cost of treating any victim of such
catastrophic illness or disaster has
reached a certain threshold cost; (3)
establish a procedure for reimbursement
of the portion of the costs for authorized
services that exceed such threshold
costs; (4) establish a procedure for
payment from CHEF for cases in which
the exigencies of the medical
circumstances warrant treatment prior
to the authorization of such treatment;
and (5) establish a procedure that will
ensure no payment will be made from
CHEF to a service unit to the extent that
the provider of services is eligible to
receive payment for the treatment from
any other Federal, State, local, or private
source of reimbursement for which the
patient is eligible.
Summary of Legal Basis: Section
202(d) of the Indian Health Care
Improvement Act (IHCIA), Public Law
94–437 (1976), as amended by the
Patient Protection and Affordable Care
Act, Public Law 111–148, section 10221
(2010) requires the Secretary of the
Department of Health and Human
Services, acting through the Indian
Health Service (IHS), to promulgate
regulations to implement section 202(d).
Section 202(d) of the IHCIA amends the
IHS Catastrophic Health Emergency
Fund (CHEF) by establishing the CHEF
threshold cost to the 2000 level of
$19,000; maintains requirements in
current law to promulgate regulations
consistent with the provisions of the
CHEF to establish a definition of
disasters and catastrophic illnesses for
which the cost of the treatment
provided under contract would qualify
for payment under CHEF; provides that
a service unit shall not be eligible for
reimbursement for the cost of treatment
from CHEF until its cost of treating any
victim of such catastrophic illness or
disaster has reached a certain threshold
cost which the Secretary shall establish
at the 2000 level of $19,000; and for any
subsequent year, not less than the
threshold cost of the previous year
increased by the percentage increase in
medical care expenditure category of the
consumer price index for all urban
consumers; establish a procedure that
will ensure no payment will be made
from CHEF to a service unit to the
extent that the provider of services is
eligible to receive payment for the
treatment from any other Federal, State,
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local, or private source of
reimbursement for which the patient is
eligible.
Alternatives: None.
Anticipated Cost and Benefits:
Reducing the threshold to $19,000 will
allow for more purchased/referred care
cases to be eligible for CHEF. Tribal and
Federal PRC programs with limited
budgets would have more of an
opportunity to access the CHEF.
Risks: The increase in cases will
deplete the CHEF earlier in the fiscal
year unless CHEF funding is increased.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
NPRM ..................
01/26/16
03/11/16
FR Cite
81 FR 4339
02/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected:
Undetermined.
Agency Contact: CAPT John E. Rael,
Director, Office of Resource Access and
Partnerships, Department of Health and
Human Services, Indian Health Service,
5600 Fishers Lane, Suite 10E73,
Rockville, MD 20857, Phone: 301 443–
0969, Email: john.rael@ihs.gov.
RIN: 0917–AA10
HHS—IHS
Final Rule Stage
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61. Acquisition Regulations; Buy Indian
Act; Procedures for Contracting
Priority: Other Significant.
Legal Authority: Transfer Act of 1954
(42 U.S.C. 2001 et seq.); Transfer Act (42
U.S.C. 2003); 25 U.S.C. 1633; Buy
Indian Act 1910; Indian Community
Economic Enhancement Act of 2020
(Pub. L. 116–261); . . .
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Indian Health Service
(IHS) is proposing to issue regulations
guiding implementation of the Buy
Indian Act, which provides IHS with
authority to set-aside procurement
contracts for Indian-owned and
controlled businesses. This rule
supplements the Federal Acquisition
Regulation (FAR) and the current HHS
Acquisition Regulations (HHSAR). IHS
may use the Buy Indian Act
procurement authority for acquisitions
in connection with those functions. This
rule is proposed to describe
administration procedures that the IHS
will use in all of its locations to
encourage procurement relationships
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with eligible Indian Economic
Enterprises in the execution of the Buy
Indian Act. These proposed rules are
intended to be consistent with Buy
Indian Act rules previously
promulgated by the Department of
Interior. IHS published the proposed
rule on November 10, 2020, with a 60day comment period ending January 11,
2021 (85 FR 71596). Comments were
received from tribes and tribal entities
requesting an extension of the comment
period due to the encompassing of the
holiday season during the original
comment period, as well as the
disproportionately high impact of the
pandemic on Indian Country. Both of
these events delayed stakeholders from
being able to perform a complete and
full review and provide comments
within the initial 60-day comment
period. On April 21, 2021, HHS
reopened the NPRM and extended the
comment period for 60 days. The
comment period closed on June 21,
2021.
Statement of Need: Due to the unique
legal and political relationship with
Indian Tribes, the Federal government
has a number of programs and
authorities to support and expand the
economic development of tribal entities
and their individual members. The Buy
Indian Act of 1910 is one of these
programs that allows for the Department
of Health and Human Services’ IHS and
the Department of the Interior’s BIA to
award federal contracts to Indian-owned
businesses without using the standard
competitive process. The IHS annually
obligates over $1 billion in commercial
contracts. Much of this can be set-aside
under the Buy Indian Act. The
established use of this rule will promote
the growth and development of Indian
industries and in turn, foster economic
development and sustainability in
Indian Country.
Summary of Legal Basis: This rule
proposes to amend the HHSAR, which
is maintained by Assistant Secretary for
Financial Resources (ASFR) pursuant to
48 CFR 301.103, to establish Buy Indian
Act acquisition policies and procedures
for IHS that are consistent with rules
proposed and/or adopted by the
Department of the Interior. This rule is
to provide uniform administration
procedures that the IHS will use in all
of its locations to encourage
procurement relationships with Indian
labor and industry in the execution of
the Buy Indian Act. IHS’ current rules
are codified at HHSAR, 48 CFR part 326,
subpart 326.6. The Transfer Act
authorizes the Secretary of HHS to make
such other regulations as he deems
desirable to carry out the provisions of
the [Transfer Act]. 42 U.S.C. 2003. The
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Secretary’s authority to carry out
functions under the Transfer Act has
been vested in the Director of the Indian
Health Service under 25 U.S.C. 1661.
Because of these authorities, use of the
Buy Indian Act is reserved to IHS and
is not available for use by any other
HHS component. IHS authority to use
the Buy Indian Act is further governed
by 25 U.S.C.1633, which directs the
Secretary to issue regulations governing
the application of the Buy Indian Act to
construction activities. Additionally,
when Congress amended the Buy Indian
Act, they added a requirement to
harmonize the Buy Indian Act
regulations. As such, the Secretaries
shall promulgate regulations to
harmonize the procurement procedures
of the Department of the Interior and the
Department of Health and Human
Services, to the maximum extent
practicable.
Alternatives: There are no apparent
alternatives to ensure compliance with
this law.
Anticipated Cost and Benefits: The
benefits of this rule include, policy and
compliance objectives such as:
Supporting procurement relationships
with Indian labor and industry as well
as overall Tribal relationships, in the
execution of the Buy Indian Act;
consistent IHS use with the DOI/BIA
regulations; and fostering economic
development and sustainability in
Indian Country. To avoid additional
costs, the rule supports utilization of
fair and reasonable price requirements,
pursuant to the Federal Acquisition
Regulations (FAR). Additionally, IHS
intends to conduct all training on the
Buy Indian Act in-house and/or in
collaboration with the DOI/BIA.
Risks: IHS foresees minimal risks in
the implementation of this rule. One
potential risk is an increased number of
Buy Indian Act challenges to
representation requirement but IHS
views this more as a benefit in ensuring
Buy Indian Act set-aside commercial
contracts are appropriately awarded to
confirmed Indian Economic Enterprises.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
NPRM Comment
Period Reopened.
NPRM Comment
Period Reopened End.
Final Action .........
Date
FR Cite
11/11/20
01/11/21
85 FR 71596
04/21/21
86 FR 20648
06/21/21
02/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
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Small Entities Affected: Businesses.
Government Levels Affected:
Undetermined.
Agency Contact: Santiago Almaraz,
Acting Director, Office of Management
Service, Department of Health and
Human Services, Indian Health Service,
5600 Fishers Lane, Suite 09E45,
Rockville, MD 20857, Phone: 301 443–
4872, Email: santiago.almaraz@ihs.gov.
RIN: 0917–AA18
HHS—CENTERS FOR MEDICARE &
MEDICAID SERVICES (CMS)
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Proposed Rule Stage
62. Streamlining the Medicaid and Chip
Application, Eligibility Determination,
Enrollment, and Renewal Processes
(CMS–2421)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302
CFR Citation: 42 CFR 431; 42 CFR
435; 42 CFR 457.
Legal Deadline: None.
Abstract: This proposed rule would
streamline eligibility and enrollment
processes for all Medicaid and CHIP
populations and create new enrollment
pathways to maximize enrollment and
retention of eligible individuals.
Statement of Need: Since the
implementation of the Affordable Care
Act (ACA), CMS has made
improvements in streamlining the
Medicaid and CHIP application,
eligibility determination, enrollment,
and renewal processes. Simplifying
enrollment in Medicaid and CHIP
coverage is a foundational step in efforts
to address health disparities for lowincome individuals. However, gaps
remain in States’ ability to seamlessly
process beneficiaries’ eligibility and
enrollment in order to maximize
coverage. This proposed rule will
provide States with the tools they need
to reduce unnecessary barriers to
enrollment in Medicaid and CHIP and
to keep eligible beneficiaries covered.
Summary of Legal Basis: This rule
responds to the January 28, 2021,
Executive Order on Strengthening
Medicaid and the Affordable Care Act.
It addresses components of title XIX and
title XXI of the Social Security Act and
several sections of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) and the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152), which amended and revised
several provisions of the Patient
Protection and Affordable Care Act.
Alternatives: In developing the
policies contained in this rule, we
considered numerous alternatives to the
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presented proposals, including
maintaining existing requirements.
These alternatives will be described in
the rule.
Anticipated Cost and Benefits: The
provisions in this rule would streamline
Medicaid and CHIP enrollment
processes and ensure that eligible
beneficiaries can maintain coverage.
While states and the Federal
Government may incur some initial
costs to implement these changes, this
rule aims to reduce administrative
barriers to enrollment, which is
expected to reduce administrative costs
over time. The provisions in this rule
are designed to increase access to
affordable health coverage, and we
believe that the benefits will justify any
costs. Additionally, through clear and
consistent requirements for the timely
renewal of eligibility for all
beneficiaries, this rule promotes
program integrity, thereby protecting
taxpayer funds at both the state and
federal levels. As we move toward
publication, estimates of the cost and
benefits of these provisions will be
included in the rule.
Risks: We anticipate that the
provisions of this rule would further the
administration’s goal of strengthening
Medicaid and making high-quality
health care accessible and affordable for
every American. At the same time,
through clear and consistent
requirements for conducting regular
renewals of eligibility, acting on
changes reported by beneficiaries and
maintaining thorough recordkeeping on
these activities, this rule would reduce
the risk of improper payments.
Timetable:
Action
Date
NPRM ..................
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Local,
State.
Agency Contact: Sarah Delone,
Deputy Director, Children and Adults
Health Programs Group, Department of
Health and Human Services, Centers for
Medicare & Medicaid Services, Center
for Medicaid and CHIP Services, MS:
S2–01–16, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786–
5647, Email: sarah.delone2@
cms.hhs.gov.
RIN: 0938–AU00
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HHS—CMS
63. Provider Nondiscrimination
Requirements for Group Health Plans
and Health Insurance Issuers in the
Group and Individual Markets (CMS–
9910)
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 116–260,
Division BB, title I; 42 U.S.C. 300gg–5(a)
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory,
January 1, 2022, Section 108 of the No
Surprises Act requires proposed
rulemaking by January 1, 2022.
Abstract: This proposed rule would
implement section 108 of the No
Surprises Act.
Statement of Need: Not yet
determined.
Summary of Legal Basis: The
Department of Health and Human
Services regulations are adopted
pursuant to the authority contained in
sections 2701 through 2763, 2791, 2792,
2794, 2799A–1 through 2799B–9 of the
PHS Act (42 U.S.C. 300gg–63, 300gg–91,
300gg–92, 300gg–94, 300gg–139), as
amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
NPRM ..................
Date
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal,
State.
Federalism: Undetermined.
Agency Contact: Lindsey Murtagh,
Director, Market-Wide Regulation
Division, Department of Health and
Human Services, Centers for Medicare &
Medicaid Services, Center for Consumer
Information and Insurance Oversight,
7500 Security Boulevard, Baltimore, MD
21244, Phone: 301 492–4106, Email:
lindsey.murtagh@cms.hhs.gov.
RIN: 0938–AU64
HHS—CMS
64. Assuring Access to Medicaid
Services (CMS–2442)
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 1302
CFR Citation: 42 CFR 438; 42 CFR
447.
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Legal Deadline: None.
Abstract: This rule proposes to assure
and monitor equitable access in
Medicaid and the Children’s Health
Insurance Program (CHIP). These
activities could include actions that
support the implementation of a
comprehensive access strategy as well
as payment specific requirements
related to particular delivery systems.
Statement of Need: In order to assure
equitable access to health care for all
Medicaid and Children’s Health
Insurance Program (CHIP) beneficiaries
across all delivery systems, access
regulations need to be multi-factorial
and focus beyond payment rates.
Barriers to accessing health care services
can be as heterogeneous as Medicaid
and CHIP populations ranging from
potential barriers to access which can be
measured through provider availability
and provider accessibility -to- realized
or perceived access barriers which can
be measured through utilization and
satisfaction with services. CMCS is
developing a comprehensive access
strategy that will address not only FeeFor-Service (FFS) payment, but also
access in managed care and Home and
Community-Based Services (HCBS). The
scope of this rule is unknown at this
time, but will seek to assure and
monitor equitable access in Medicaid
and CHIP.
Summary of Legal Basis: At this time,
the scope of the rule is unknown.
However, there are no broad access
requirements specified in the statute
beyond payment: Section 1902(a)(30)(A)
of the Act requires states to ‘‘assure that
payments are consistent with efficiency,
economy, and quality of care and are
sufficient to enlist enough providers so
that care and services are available
under the plan at least to the extent that
such care and services are available to
the general population in the geographic
area.’’
Alternatives: In developing the
policies contained in this rule, we will
consider numerous alternatives to the
presented proposals, including
maintaining existing requirements.
These alternatives will be described in
the rule.
Anticipated Cost and Benefits: This
proposed rule would be expected to
result in potential costs for states to
come into and remain in compliance.
Estimates for associated costs are
unknown at this time and may vary by
state. Information about anticipated
costs will be included in the proposed
rule.
Risks: At this time, we are still at
work developing a comprehensive
access strategy. We have not yet
concluded which pieces are best done
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through rulemaking versus other
guidance.
Timetable:
Action
Date
NPRM ..................
FR Cite
10/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: State.
Federalism: Undetermined.
Agency Contact: Karen Llanos,
Director, Medicaid Innovation
Accelerator Program and Strategy
Support, Department of Health and
Human Services, Centers for Medicare &
Medicaid Services, Center for Medicaid
and CHIP Services, MS: S2–04–28, 7500
Security Boulevard, Baltimore, MD
21244, Phone: 410 786–9071, Email:
karen.llanos@cms.hhs.gov.
RIN: 0938–AU68
HHS—CMS
65. • Implementing Certain Provisions
of the Consolidated Appropriations Act
and Other Revisions to Medicare
Enrollment and Eligibility Rules (CMS–
4199)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 116–260,
secs. 120 & 402; 42 U.S.C 1395i–2
CFR Citation: 42 CFR 400; 42 CFR
406; 42 CFR 407; 42 CFR 408; . . .
Legal Deadline: Final, Statutory,
October 1, 2022, Enrollments under
section 402 of the CAA start on 10/1/22.
Final, Statutory, January 1, 2023,
Provisions under sections 120 and 402
of the CAA must be effective 1/1/23.
Abstract: This proposed rule would
implement certain Medicare-related
provisions of the Consolidated
Appropriations Act, 2021 (CAA).
Specifically, section 120 of the CAA
allows for Medicare coverage to take
effect earlier for people who enroll in
the General Enrollment Period (GEP) or
within the last three months of their
Initial Enrollment Period (IEP). Section
120 also gives the Secretary the
authority to establish special enrollment
periods for exceptional circumstances.
Section 402 of the CAA extends
immunosuppressive drug coverage for
Medicare kidney transplant recipients
beyond the current law 36-month limit
following a transplant by providing
immunosuppressive drug coverage
under Medicare Part B for these
individuals. Separately, this rule would
address enrollment in Medicare Part A
for applicants who are eligible for Social
Security benefits, but are not yet
receiving them, and make certain
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updates related to state payment of
Medicare premiums.
Statement of Need: This rule is
necessary to implement section 120 of
the Consolidated Appropriations Act,
2021 (CAA) that revises effective dates
of coverage for individuals enrolling in
Medicare and gives the Secretary of the
Department of Health and Human
Services the authority to establish
special enrollment periods (SEPs) for
exceptional circumstances beginning
January 1, 2023. This rule also
implements section 402 of the CAA that,
beginning January 1, 2023, provides for
coverage of immunosuppressive drugs
under part B for certain individuals
whose Medicare entitlement based on
end-stage renal disease (ESRD) would
otherwise end 36-months after the
month in which they received a
successful kidney transplant.
Summary of Legal Basis: The legal
basis of this rule is the Consolidated
Appropriations Act, 2021 (sections 120
and 402).
Alternatives: The provisions of this
rule are primarily established in statute.
Where there is discretion, alternatives
will be discussed within the text of the
rule. Public comments will also be
considered in the development of the
final rule.
Anticipated Cost and Benefits: We
believe that this rule will have a
positive impact on health outcomes of
beneficiaries because it provides for
Medicare coverage to begin earlier and
provides for coverage of
immunosuppressive drugs in situations
where, currently, they are not covered.
Risks: The risks associated with not
publishing this regulation would be not
establishing the regulatory authority
under which immunosuppressive drug
benefits and effective dates of coverage
will be based upon beginning January
2023.
Timetable:
Action
NPRM ..................
Date
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
Agency Contact: Kristy Nishimoto,
Health Insurance Specialist, Department
of Health and Human Services, Centers
for Medicare & Medicaid Services,
Center for Medicare, MS: 100, 7500
Security Boulevard, Baltimore, MD
21244, Phone: 206 615–2367, Email:
kristy.nishimoto@cms.hhs.gov.
RIN: 0938–AU85
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HHS—CMS
66. • Requirements for Rural
Emergency Hospitals (CMS–3419)
(Section 610 Review)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 1395x
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory,
January 1, 2023, Per statute,
amendments made by this section apply
to items and services furnished on or
after January 1, 2023.
Abstract: This proposed rule would
establish health and safety requirements
for a new provider type, Rural
Emergency Hospitals, in accordance
with section 125 of the Consolidated
Appropriations Act, 2021.
Statement of Need: This rule proposes
health and safety standards for Rural
Emergency Hospitals (REHs).
Summary of Legal Basis: This rule
addresses section 125 of the
Consolidated Appropriations Act (Pub.
L. No: 116–260), which establishes
REHs as a new provider type eligible for
Medicare payment.
Alternatives: We understand that the
policies that will be included in this
proposed rule will have impacts on
rural communities and providers of
health care services in these
communities. These impacts will be
taken into consideration as we evaluate
policy alternatives in the development
of this proposed rule. These alternatives
will be included in the rule.
Anticipated Cost and Benefits: This
proposed rule aims to increase access to
health care services, including
emergency services, to rural
communities. Many rural Americans
face healthcare inequities resulting in
worse outcomes overall in rural areas.
Increasing access to key health care
services in these communities will help
address such healthcare inequities.
Estimates of the cost and benefits of the
developed provisions will be included
in the proposed rule.
Risks: Although there are some risks
associated with the potential loss of
inpatient services in rural communities
as providers convert to an REH, we
anticipate that only eligible rural
hospitals and critical access hospitals
with very low average daily inpatient
censuses will convert to an REH. We
anticipate that the provisions of this
proposed rule would help further HHS’s
goal of increasing rural access to care.
Timetable:
Action
Date
NPRM ..................
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67. • Mental Health Parity and
Addiction Equity Act and the
Consolidated Appropriations Act, 2021
(CMS–9902)
Priority: Other Significant.
Legal Authority: Pub. L. 116–260,
Division BB, title II; Pub. L. 110–343,
secs. 511 to 512
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule would propose
amendments to the final rules
implementing the Mental Health Parity
and Addiction Equity Act, taking into
account the amendments to the law
enacted by the Consolidated
Appropriations Act, 2021.
Statement of Need: There have been
a number of legislative enactments
related to MHPAEA since issuance of
the 2014 final rules, including the 21st
Century Cures Act, the Support Act, and
the Consolidated Appropriations Act,
2021. This rule would propose
amendments to the final rules and
incorporate examples and modifications
to account for this legislation and
previously issued guidance.
Summary of Legal Basis: The
Department of Health and Human
Services regulations are adopted
pursuant to the authority contained in
sections 2701 through 2763, 2791, 2792,
2794, 2799A–1 through 2799B–9 of the
PHS Act (42 U.S.C. 300gg–63, 300gg–91,
300gg–92, 300gg–94, 300gg–139), as
amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
Date
NPRM ..................
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Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal,
State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: Lindsey Murtagh,
Director, Market–Wide Regulation
Division, Department of Health and
Human Services, Centers for Medicare &
Medicaid Services, Center for Consumer
Information and Insurance Oversight,
7500 Security Boulevard, Baltimore, MD
21244, Phone: 301 492–4106, Email:
lindsey.murtagh@cms.hhs.gov.
RIN: 0938–AU93
HHS—CMS
HHS—CMS
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Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal,
Local, State.
Federalism: Undetermined.
Agency Contact: Kianna Banks,
Technical Advisor, Department of
Health and Human Services, Centers for
Medicare & Medicaid Services, Center
for Clinical Standards and Quality, MS:
S3–02–01, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786–
8486, Email: kianna.banks@
cms.hhs.gov.
RIN: 0938–AU92
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68. • Coverage of Certain Preventive
Services (CMS–9903)
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 111–148, sec.
1001
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule would propose
amendments to the final rules regarding
religious and moral exemptions and
accommodations regarding coverage of
certain preventive services under title I
of the Patient Protection and Affordable
Care Act.
Statement of Need: Not yet
determined.
Summary of Legal Basis: The
Department of Health and Human
Services regulations are adopted
pursuant to the authority contained in
sections 2701 through 2763, 2791, 2792,
2794, 2799A–1 through 2799B–9 of the
PHS Act (42 U.S.C. 300gg–63, 300gg–91,
300gg–92, 300gg–94, 300gg–139), as
amended.
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
Timetable:
Action
NPRM ..................
Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal,
Local, State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: Lindsey Murtagh,
Director, Market–Wide Regulation
Division, Department of Health and
Human Services, Centers for Medicare &
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Medicaid Services, Center for Consumer
Information and Insurance Oversight,
7500 Security Boulevard, Baltimore, MD
21244, Phone: 301 492–4106, Email:
lindsey.murtagh@cms.hhs.gov.
RIN: 0938–AU94
HHS—CMS
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Final Rule Stage
69. • Omnibus COVID–19 Health Care
Staff Vaccination (CMS–3415) (Section
610 Review)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1395hh; 42
U.S.C. 1302
CFR Citation: 42 CFR 483.
Legal Deadline: None.
Abstract: This interim final rule with
comment period revises the infection
control requirements that most
Medicare- and Medicaid-participating
providers and suppliers must meet to
participate in the Medicare and
Medicaid programs. These changes are
necessary to protect the health and
safety of residents, clients, patients, and
staff and reflect lessons learned as result
of the COVID–19 public health
emergency. The revisions to the
infection control requirements establish
COVID–19 vaccination requirements for
staff at the included Medicare- and
Medicaid-participating providers and
suppliers.
Statement of Need: The rule
establishes COVID–19 vaccination
requirements for staff at the included
Medicare-and Medicaid-participating
providers and suppliers. These changes
are necessary to protect the health and
safety of residents, clients, patients, and
staff.
Summary of Legal Basis: CMS has
broad statutory authority to establish
health and safety regulations, which
includes authority to establish health
and safety standards for Medicare and
Medicaid certified facilities. We believe
requiring staff vaccinations for COVID–
19 is critical to safeguarding the health
and safety of all individuals seeking
health care in Medicare and Medicaid
certified facilities. Sections 1102 and
1871 of the Social Security Act (the Act)
grant the Secretary of Health and
Human Services authority to make and
publish such rules and regulations, not
inconsistent with the Act, as may be
necessary to the efficient administration
of the functions with which the
Secretary is charged under this Act.
Alternatives: In developing the
policies contained in this rule, we
considered numerous alternatives to the
final provisions including limiting
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vaccination requirements to direct care
employees, additional requirements,
and different implementation time
frames. These alternatives are discussed
in further detail in the rule.
Anticipated Cost and Benefits: We
estimate costs associated with this
rulemaking including those costs
associated with information collection
requirements, additional recordkeeping,
and costs associated with vaccination.
We anticipate benefits of the rule to
include reduction in the transmission of
infections and decreases in
hospitalizations and mortality.
Risks: Although there is some
uncertainty about the effects of this rule
on health care staffing, we believe that
the wide application of these
requirements will reduce the likelihood
of individual workers seeking new
employment in order to avoid
vaccination.
Timetable:
Action
Date
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
11/05/21
11/05/21
FR Cite
86 FR 61555
01/04/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal,
Local, State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: Kim Roche, Nurse,
Department of Health and Human
Services, Centers for Medicare &
Medicaid Services, Center for Clinical
Standards and Quality, MS: C2–21–16,
7500 Security Boulevard, Baltimore, MD
21244, Phone: 410 786–3524, Email:
kim.roche@cms.hhs.gov.
RIN: 0938–AU75
HHS—ADMINISTRATION FOR
CHILDREN AND FAMILIES (ACF)
Proposed Rule Stage
70. Native Hawaiian Revolving Loan
Fund Eligibility Requirements
Priority: Other Significant.
Legal Authority: 42 U.S.C. 2991
CFR Citation: 45 CFR 1336.
Legal Deadline: None.
Abstract: This regulation proposes to
reduce the required Native Hawaiian
ownership or control for an eligible
applicant to the Native Hawaiian
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Revolving Loan Fund program under 45
CFR 1336.62.
Statement of Need: The Native
Hawaiian Revolving Loan Fund
(NHRLF) was established to provide
loans and loan guarantees to Native
Hawaiians who are unable to obtain
loans from private sources on
reasonable terms and conditions for the
purpose of promoting economic
development in the State of Hawaii.
Since many Native Hawaiians reside on
leasehold interests that cannot be
collateralized (Hawaiian Homelands),
the NHRLF serves as an important
lender of last resort for Native Hawaiian
borrowers. Applicants for an NHRLF
loan must be an individual Native
Hawaiian or a 100 percent Native
Hawaiian owned organization. To
qualify for an NHRLF loan when one
spouse is not Native Hawaiian, Native
Hawaiian borrowers must establish or
reorganize their business’ legal structure
to exclude a non-Native Hawaiian
spouse from ownership. As the 100
percent Native Hawaiian ownership
requirement prevents many Native
Hawaiian family-owned businesses and
families from obtaining a loan, the
Administration for Children and
Families (ACF) proposes to reduce the
eligibility requirement to maximize loan
funds and spur further economic
development. This proposed change
will likely increase the applicant pool
and availability of loan proceeds to
small Native Hawaiian-owned
businesses and families whose credit
would be deemed too risky for
traditional lenders as businesses recover
from the COVID–19 pandemic. As a
lender of last resort, this revolving loan
fund has filled and will continue to fill
a unique credit niche for Native
Hawaiian-owned businesses.
Summary of Legal Basis: This NPRM
is under the authority granted by section
803A of Native Americans Programs
Act. That section directed ACF’s
Administration for Native Americans
(ANA) to develop the regulations that
set forth the procedures and criteria for
making loans under the NHRLF. Section
803A also permits the ANA
Commissioner to prescribe any other
regulations that the Commissioner
determines are necessary to carry out
the purposes of NHRLF.
Alternatives: ACF reviewed
alternatives to providing greater
flexibility to NHRLF applicants that
directly respond to barriers for accessing
loans and other viable options were not
identified.
Anticipated Cost and Benefits: ANA
does not provide loans directly to
entities but does so through the
regulated entity, the State of Hawaii’s
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Office of Hawaiian Affairs. The rule
does not create additional requirements
but provides flexibility by expanding
eligibility and availability of loan
proceeds to small entities.
Risks: It is possible that this proposed
change will increase business loan
demand. There is also the possibility
that businesses may act strategically to
qualify for NHLRF loans by adding
Native Hawaiian ownership. This
restructuring may still benefit Native
Hawaiians as more Native Hawaiians
could become business partners with
non-Native Hawaiians. Expansion of the
program to more Native Hawaiian
families is consistent with the policy
goal of the statute which is promoting
economic development among Native
Hawaiians in Hawaii.
Timetable:
Action
Date
NPRM ..................
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Mirtha Beadle,
Senior Policy Advisor, Department of
Health and Human Services,
Administration for Children and
Families, 330 C Street SW, Washington,
DC 20201, Phone: 202 401–6506, Email:
mirtha.beadle@acf.hhs.gov.
RIN: 0970–AC84
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HHS—ACF
71. Paternity Establishment Percentage
Performance Relief
Priority: Other Significant.
Legal Authority: Sec. 1102 of the
Social Security Act
CFR Citation: 45 CFR 305.
Legal Deadline: None.
Abstract: This regulation proposes to
modify the Paternity Establishment
Percentage performance requirements in
child support regulations under 45 CFR
part 305, to provide relief from financial
penalties to states impacted by the
COVID–19 pandemic.
Statement of Need: The COVID–19
pandemic has had a debilitating effect
on state child support programs,
disrupting administrative and judicial
operations and limiting states’ ability to
provide services and maintain
performance. Without regulatory relief,
20 out of the 54 child support programs
(title IV–D under the Act) will be subject
to financial penalties associated with
their failure to achieve performance for
the Paternity Establishment Percentage
(PEP) described in section 409(a)(8) and
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452(g) of the Social Security Act (the
Act) and child support regulations
under 45 CFR part 305. PEP-related
financial penalties, which are imposed
as reductions in the state’s Temporary
Assistance for Needy Families (TANF)
program funding, place an undue
burden on state budgets and threaten
funding that supports the very families
who are most in need during this time
of crisis.
Summary of Legal Basis: This
proposed rule is published under the
authority granted to the Secretary of
Health and Human Services by section
1102 of the Social Security Act (the Act)
(42 U.S.C. 1302). Section 1102 of the
Act authorizes the Secretary to publish
regulations, not inconsistent with the
Act, as may be necessary for the
efficient administration of the functions
with which the Secretary is responsible
under the Act. The proposed relief from
the Paternity Establishment Percentage
performance penalty under this NPRM
is based on statutory authority granted
under section 452(g)(3)(A) of the Act (42
U.S.C. 652(g)(3)(A)).
Alternatives: Because PEP
performance measures and penalties are
required by statute and regulation, relief
can only be provided through regulation
or legislation. The PEP performance
requirement is established under 452(g)
of the Social Security Act and 45 CFR
305.40. Section 452(a)(4)(C)(i) of the Act
requires the Secretary to determine
whether State-reported data used to
determine the performance levels are
complete and reliable. Additionally,
section 409(a)(8)(A) of the Act and 45
CFR 305.61(a)(1) provides for a financial
penalty if there is a failure to achieve
the required level of performance or an
audit determines that the data is
incomplete or unreliable.
Anticipated Cost and Benefits: This
proposed rule, if finalized, will ensure
that penalties are not imposed against a
state’s TANF grant, during a time when
public assistance funds are critically
needed. The financial penalties against
states are estimated at $3.5 million of
penalties for 3 states that did not meet
PEP performance levels in FY 2019 and
FY 2020 and $83 million for 18 states
that did not meet performance levels in
FY 2020 and FY 2021 PEP.
Risks: To be determined.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
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Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Yvette Riddick,
Director, Division of Policy, Office of
Child Support Enforcement, Department
of Health and Human Services,
Administration for Children and
Families, 330 C Street SW, Washington,
DC 20201, Phone: 202 401–4885, Email:
yvette.riddick@acf.hhs.gov.
RIN: 0970–AC86
HHS—ACF
72. ANA Non-Federal Share Emergency
Waivers
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 2991
CFR Citation: 45 CFR 1336.
Legal Deadline: None.
Abstract: This regulation proposes to
streamline the process for
Administration for Native Americans
(ANA) grant program applicants to
request a waiver for non-federal share
for the 20 percent match required by
statute for ANA grants. The regulation
will also propose the ability for current
grantees to request an emergency waiver
for the non-federal share match.
Statement of Need: The Native
American Programs Act of 1974, as
amended, (NAPA) requires projects
awarded funding through sections 803,
804, and 805 provide a 20 percent
match of the total cost of the project,
unless a waiver is obtained through
objective criteria as outlined in ANA’s
regulations. The current regulations
outline the requirements and criteria for
applicants to request a waiver for nonfederal share (NFS) at 45 CFR part
1336.50 at time of application for a new
or continuation award. The COVID–19
pandemic had a detrimental impact on
the economies and financial resources
of ANA’s Native American recipients,
most of whom had to close their borders
to protect their citizens. Many tribal
enterprises were forced to close, and
tourism revenues became non-existent.
Partnerships and vendors were no
longer able to contribute previously
committed resources for NFS. During
this time, many recipients grew
concerned that they would be unable to
fully meet their NFS of their grant
award. ANA explored the possibility of
providing emergency NFS waivers to
ANA grantees. Unfortunately, ANA
learned that it does not currently have
the authority to issue emergency NFS
waivers, as neither emergency waiver
authority nor a process to approve such
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requests exists in ANA’s regulations.
Current regulations require waiver
requests to be submitted at the time of
application or during the noncompetitive continuation process. This
request to update ANA’s regulation
would provide a new provision for
recipients to request an emergency NFS
waiver in the event of a natural or manmade emergency such as a public health
pandemic.
Summary of Legal Basis: The Native
American Programs Act of 1974, as
amended, (NAPA) requires projects
awarded funding through sections 803,
804, and 805 provide a 20 percent
match of the cost of the project, unless
a waiver is obtained through objective
criteria as outlined in ANA’s
regulations. Current regulations outline
the requirements and criteria to request
a waiver at 45 CFR part 1336.50 at time
of application for a new or continuation
award. However, there is no existing
regulations or criteria to provide an
emergency waiver for NFS to recipients
experience a natural or man-made
disaster or public health emergency
such as COVID–19.
Alternatives: The alternative would be
to not offer the emergency waiver.
Anticipated Cost and Benefits: There
are no known costs to the program by
issuing this rule. Benefits—This
proposed rule is responsive to the
President’s Executive Order 13995:
Ensuring an Equitable Pandemic
Response and Recovery and the
Executive Order on Economic Relief
Related to the COVID–19 Pandemic and
also responsive to the needs of Native
American communities. Existing
regulations states that ANA must
determine that approval of an NFS
waiver will not prevent the award of
other grants at levels it believes are
desirable for the purposes of the
program. Approval of this emergency
waiver regulation will also decrease the
potential audit findings of entities not
meeting the required NFS. In addition,
it reduces further harm to recipients that
are impacted by an emergency situation
which caused unforeseen and additional
financial hardships.
Risks: There are no known risks to the
program by issuing this rule.
Timetable:
Action
Date
NPRM ..................
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Mirtha Beadle,
Senior Policy Advisor, Department of
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Health and Human Services,
Administration for Children and
Families, 330 C Street SW, Washington,
DC 20201, Phone: 202 401–6506, Email:
mirtha.beadle@acf.hhs.gov.
RIN: 0970–AC88
HHS—ACF
73. • Foster Care Legal Representation
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Sec. 474(a)(3) of the
Social Security Act; sec. 1102 of the
Social Security Act
CFR Citation: 45 CFR 1356.60(c).
Legal Deadline: None.
Abstract: This regulation proposes to
allow a title IV–E agency to claim
Federal financial participation for the
administrative cost of providing
independent legal representation to a
child who is either a candidate for foster
care or in foster care, and his/her parent
to prepare for and participate in judicial
determinations in foster care and other
related civil legal proceedings.
Statement of Need: Allowing title IV–
E agencies to claim Federal
reimbursement for independent legal
representation in legal proceedings that
are necessary to carry out the
requirements in the agency’s title IV–E
plan, including civil proceedings, may
help prevent the need to remove a child
from the home or, for a child in foster
care, achieve permanence faster.
Research demonstrates that some of the
circumstances bringing families into
contact with the child welfare system
(poverty, educational neglect,
inadequate housing, failure to provide
adequate nutrition, and failure to
safeguard mental health due to domestic
violence) can be addressed before a
child enters foster care by providing
legal representation early in foster care
legal proceedings and in civil legal
matters. When children are removed
from the home, studies show having
access to legal representation for civil
legal issues earlier in a case can improve
the rate of reunification, nearly double
the speed to legal guardianship or
adoption, and result in more permanent
outcomes for children and families.
Summary of Legal Basis: Section
474(a)(3) of the Act authorizes Federal
reimbursement for title IV–E
administrative costs, which are defined
as costs found necessary by the
Secretary for the provision of child
placement services and for the proper
and efficient administration of the State
[title IV–E] plan. Section 1102 of the Act
authorizes the Secretary to publish
regulations, not inconsistent with the
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Act, as may be necessary for the
efficient administration of the functions
with which the Secretary is responsible
under the Act.
Alternatives: If this NPRM is not
published, agencies may continue to
claim FFP for administrative costs of
independent legal representation
provided by attorneys representing
children in title IV–E foster care,
children who are candidates for title IV–
E foster care, and the child’s parents in
all stages of foster care legal proceedings
(Child Welfare Policy Manual (CWPM)
8.1B #30, 31 and 32).
Anticipated Cost and Benefits: This
final rule impacts state and tribal title
IV–E (child welfare) agencies. ACF
estimates that the proposed regulatory
change would cost the federal
government $141 million in FFP per
year within 5 years of implementation.
This proposal does not impose a burden
or cost on the title IV–E agency. The
title IV–E agency has discretion to
provide allowable independent legal
representation to families.
Risks: None.
Timetable:
Action
NPRM ..................
Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kathleen McHugh,
Director, Division of Policy, Children’s
Bureau, ACYF/ACF/HHS, Department
of Health and Human Services,
Administration for Children and
Families, 370 L’Enfant Promenade SW,
Washington, DC 20447, Phone: 202 401–
5789, Fax: 202 205–8221, Email:
kmchugh@acf.hhs.gov.
RIN: 0970–AC89
HHS—ACF
74. • Separate Licensing Standards for
Relative or Kinship Foster Family
Homes
Priority: Other Significant.
Legal Authority: 42 U.S.C. 620 et seq.;
42 U.S.C. 670 et seq.; 42 U.S.C. 1302
CFR Citation: 45 CFR 1355.20.
Legal Deadline: None.
Abstract: This regulation proposes to
allow title IV–E agencies to adopt
separate licensing standards for relative
or kinship foster family homes.
Statement of Need: Currently, the
regulation provides that in order to
claim title IVE, all foster family homes
must meet the same licensing standards,
regardless of whether the foster family
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home is a relative or non-relative
placement. This Notice of Proposed
Rulemaking (NPRM) allows a title IV–E
agency to adopt licensing or approval
standards for all relative foster family
homes that are different from the
licensing standards used for non-related
foster family homes. This will remove a
barrier to licensing relatives, many of
whom are older, more likely to be
single, more likely to be African
American, more likely to live in
poverty, and less well educated.
Summary of Legal Basis: This NPRM
is published under the authority granted
to the Secretary of Health and Human
Services by section 1102 of the Social
Security Act (Act), 42 U.S.C. 1302.
Section 1102 of the Act authorizes the
Secretary to publish regulations, not
inconsistent with the Act, as may be
necessary for the efficient
administration of the functions for
which the Secretary is responsible
pursuant to the Act. Section 472 of the
Act authorizes federal reimbursement
for a FCMP for an otherwise eligible
child when the child is placed in a fully
licensed or approved foster family
home.
Alternatives: There are no satisfactory
alternatives to publishing this NPRM.
This change cannot be made in subregulatory guidance.
Anticipated Cost and Benefits: This
NPRM impacts state and tribal title IV–
E agencies and does not impose a
burden. The title IV–E agency has
discretion to develop separate licensing
standards for relatives and non-relatives
and if they do so, they may claim title
IV–E funding. ACF estimates that the
proposed regulatory change would cost
the Federal Government $3.085 billion
in title IV–E foster care federal financial
participation over 10 years.
Risks: None.
Timetable:
Action
Date
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NPRM ..................
FR Cite
03/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kathleen McHugh,
Director, Division of Policy, Children’s
Bureau, ACYF/ACF/HHS, Department
of Health and Human Services,
Administration for Children and
Families, 370 L’Enfant Promenade SW,
Washington, DC 20447, Phone: 202 401–
5789, Fax: 202 205–8221, Email:
kmchugh@acf.hhs.gov.
RIN: 0970–AC91
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HHS—ADMINISTRATION FOR
COMMUNITY LIVING (ACL)
Proposed Rule Stage
75. • National Institute for Disability,
Independent Living, and Rehabilitation
Research Notice of Proposed
Rulemaking
Priority: Other Significant.
Legal Authority: 29 U.S.C. 29—Labor;
Chapter 16—Vocational Rehabilitation
and Other Rehabilitation Services
Subchapter II—Research and Training;
sec. 762—National Institute on
Disability, Independent Living, and
Rehabilitation Research
CFR Citation: 45 CFR 1330.24.
Legal Deadline: None.
Abstract: The proposed rule will
amend subsection 24 of the National
Institute for Disability, Independent
Living and Rehabilitation Research
(NIDILRR) regulation (45 CFR 1330.24),
which would make revisions to advance
equity in the peer review criteria that
NIDILRR uses to evaluate disability
research applications across all of its
research programs, as well as emphasize
the need for engineering research and
development activities within
NIDILRR’s Rehabilitation Engineering
Research Centers (RERC) program.
Statement of Need: There is a need for
increased representation of people with
disabilities among the research teams of
NIDILRR grantees to help ensure rigor
and relevance of sponsored research.
There is a separate need for increased
emphasis on engineering R&D in
NIDILRR’s Rehabilitation Engineering
Research Centers program.
Summary of Legal Basis: (1) An
update of 45 CFR 1330.24 will
strengthen NIDILRR’s ability to meet
goals described in the Executive Orders
on Advancing Equity. Updating this
regulation will also better address one of
NIDILRR’s core statutory purposes: To
increase opportunities for researchers
who are members of traditionally
underserved populations, including
researchers who are members of
minority groups and researchers who
are individuals with disabilities (29
U.S.C. 760(7)). (2) NIDILRR’s statute
calls for a Rehabilitation Engineering
Research Centers program (29 U.S.C.
764(b)(3)(A)), but related peer review
criteria in 45 CFR 1330.24 do not
currently emphasize the importance of
engineering Research & Development
methods.
Alternatives: None.
Anticipated Cost and Benefits: ACL
anticipates little to no cost associated
with this refinement of existing
regulation. The benefits include the
potential for greater representation of
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people with disabilities and other
underrepresented populations among
NIDILRR-sponsored researchers. The
regulation update also will incite
grantees of the NIDILRR Rehabilitation
Engineering Research Centers program
to include engineering Research &
Development methods in their funded
research projects.
Risks: NIDILRR is addressing
significant risks that (1) The research it
sponsors may not address the needs and
experiences of the full diversity of
people with disabilities, and (2)
NIDILRR Rehabilitation Engineering
Research Centers are not optimally
emphasizing engineering R&D methods.
Timetable:
Action
NPRM ..................
Date
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Richard Nicholls,
Chief of Staff and Executive Secretary,
Department of Health and Human
Services, Administration for
Community Living, 330 C Street SW,
Room 1004B, Washington, DC 20201,
Phone: 202 795–7415, Fax: 202 205–
0399, Email: rick.nicholls@acl.hhs.gov.
RIN: 0985–AA16
BILLING CODE 4150–03–P
DEPARTMENT OF HOMELAND
SECURITY (DHS)
Fall 2021 Statement of Regulatory
Priorities
The Department of Homeland
Security (DHS or Department) was
established in 2003 pursuant to the
Homeland Security Act of 2002, Public
Law 107–296. The DHS mission
statement contains these words: ‘‘With
honor and integrity, we will safeguard
the American people, our homeland,
and our values.’’
DHS was created in the aftermath of
the horrific attacks of 9/11, and its
distinctive mission is defined by that
commitment. The phrase ‘‘homeland
security’’ refers to the security of the
American people, the homeland
(understood in the broadest sense), and
the nation’s defining values. A central
part of the mission of protecting ‘‘our
values’’ includes fidelity to law and the
rule of law, reflected above all in the
Constitution of the United States, and
also in statutes enacted by Congress,
including the Administrative Procedure
Act. That commitment is also associated
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with a commitment to individual
dignity. Among other things, the attacks
of 9/11 were attacks on that value as
well.
The regulatory priorities of DHS are
founded on insistence on the rule of
law—and also on a belief that
individual dignity, symbolized and
made real by the opening words of the
Constitution (‘‘We the People’’), the
separation of powers, and the Bill of
Rights (including the Due Process
Clause), helps to define our mission.
Fulfilling that mission requires the
dedication of more than 240,000
employees in jobs that range from
aviation and border security to
emergency response, from cybersecurity
analyst to chemical facility inspector,
from the economist seeking to identify
the consequences of our actions to the
scientist and policy analyst seeking to
make the nation more resilient against
flooding, drought, extreme heat, and
wildfires. Our duties are wide-ranging,
but our goal is clear: Keep America safe.
Six overarching homeland security
missions make up DHS’s strategic plan:
(1) Counter terrorism and homeland
security threats; (2) secure U.S. borders
and approaches; (3) secure cyberspace
and critical infrastructure; (4) preserve
and uphold the Nation’s prosperity and
economic security; (5) strengthen
preparedness and resilience (including
resilience from risks actually or
potentially aggravated by climate
change); and (6) champion the DHS
workforce and strengthen the
Department. See also 6 U.S.C. 111(b)(1)
(identifying the primary mission of the
Department). In promoting these goals,
we attempt to evaluate our practices by
reference to evidence and data, not by
hunches and guesswork, and to improve
them in real time. We also attempt to
deliver our multiple services in a way
that, at once, protects the American
people and does not impose excessive
or unjustified barriers and burdens on
those who use them.
In achieving those goals, we are
committed to public participation and
to listening carefully to the American
people (and to noncitizens as well). We
are continually strengthening our
partnerships with communities, first
responders, law enforcement, and
Government agencies—at the Federal,
State, local, tribal, and international
levels. We are accelerating the
deployment of science, technology, and
innovation in order to make America
more secure against risks old and new—
and to perform our services better. We
are becoming leaner, smarter, and more
efficient, ensuring that every security
resource is used as effectively as
possible. For a further discussion of our
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mission, see the DHS website at https://
www.dhs.gov/mission.
The regulations we have summarized
below in the Department’s Fall 2021
Regulatory Plan and Agenda support the
Department’s mission. We are
committed to continuing evaluation of
our regulations, consistent with
Executive Order 13563, and Executive
Order 13707, and in a way that
improves them over time. These
regulations will improve the
Department’s ability to accomplish its
mission. In addition, these regulations
respond to and implement legislative
initiatives such as those found in the
Implementing Recommendations of the
9/11 Commission Act of 2007 (9/11
Act), FAA Extension, Safety, and
Security Act of 2016, and the Synthetics
Trafficking and Overdose Prevention
Act of 2018 (STOP Act). We emphasize
here our commitments (1) To fidelity to
law; (2) to treating people with dignity
and respect; (3) to increasing national
resilience against multiple risks and
hazards, including those actually or
potentially associated with climate
change; (4) to modernization of existing
requirements; and (5) to reducing
unjustified barriers and burdens,
including administrative burdens.
DHS strives for organizational
excellence and uses a centralized and
unified approach to managing its
regulatory resources. The Office of the
General Counsel manages the
Department’s regulatory program,
including the agenda and regulatory
plan. In addition, DHS senior leadership
reviews each significant regulatory
project in order to ensure that the
project fosters and supports the
Department’s mission.
The Department is committed to
ensuring that all of its regulatory
initiatives are aligned with its guiding
principles to protect civil rights and
civil liberties, integrate our actions,
listen to those affected by our actions,
build coalitions and partnerships,
eliminate unjustified burdens and
barriers, develop human resources,
innovate, and be accountable to the
American public.
DHS is strongly committed to the
principles described in Executive
Orders 13563 and 12866 (as amended).
Both Executive Orders direct agencies to
assess the costs and benefits of available
regulatory alternatives and, if regulation
is necessary, to select regulatory
approaches that maximize net benefits.
Executive Order 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. Executive Order 13563
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explicitly draws attention to human
dignity and to equity.
Finally, the Department values public
involvement in the development of its
regulatory plan, agenda, and
regulations. It is particularly concerned
with the impact its regulations have on
small businesses and startups,
consistent with its commitment to
promoting economic growth. Consistent
with President Biden’s Executive Order
on Advancing Racial Equity and
Support for Underserved Communities
Through the Federal Government (E.O.
13985). DHS is also concerned to ensure
that its regulations are equitable, and
that they do not have unintended or
adverse effects on (for example) women,
disabled people, people of color, or the
elderly. Its general effort to modernize
regulations, and to remove unjustified
barriers and burdens, is meant in part to
avoid harmful effects on small
businesses, startups, and disadvantaged
groups of multiple sorts. DHS and its
components continue to emphasize the
use of plain language in our regulatory
documents to promote a better
understanding of regulations and to
promote increased public participation
in the Department’s regulations. We
want our regulations to be transparent
and ‘‘navigable,’’ so that people are
aware of how to comply with them (and
in a position to suggest improvements).
The Fall 2021 regulatory plan for DHS
includes regulations from multiple DHS
components, including U.S. Citizenship
and Immigration Services (USCIS), the
U.S. Coast Guard (the Coast Guard), U.S.
Customs and Border Protection (CBP),
Transportation Security Administration
(TSA), the U.S. Immigration and
Customs Enforcement (ICE), the Federal
Emergency Management Agency
(FEMA), and the Cybersecurity and
Infrastructure Security Agency (CISA).
We next describe the regulations that
comprise the DHS fall 2021 regulatory
plan.
Federal Emergency Management
Agency
The Federal Emergency Management
Agency (FEMA) is the government
agency responsible for helping people
before, during, and after disasters.
FEMA supports the people and
communities of our Nation by providing
experience, perspective, and resources
in emergency management. FEMA is
particularly focused on national
resilience in the face of the risks of
flooding, drought, extreme heat, and
wildfire; it is acutely aware that these
risks, and others, are actually or
potentially aggravated by climate
change. FEMA seeks to ensure, to the
extent possible, that changing weather
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conditions do not mean a more
vulnerable nation. FEMA is also focused
on individual equity, and it is aware
that administrative burdens and undue
complexity might produce inequitable
results in practice.
Consistent with President Biden’s
Executive Order on Climate Related
Financial Risk (E.O. 14030), FEMA will
propose a regulation titled National
Flood Insurance Program: Standard
Flood Insurance Policy, Homeowner
Flood Form. The National Flood
Insurance Program (NFIP), established
pursuant to the National Flood
Insurance Act of 1968, is a voluntary
program in which participating
communities adopt and enforce a set of
minimum floodplain management
requirements to reduce future flood
damages. This proposed rule would
revise the Standard Flood Insurance
Policy by adding a new Homeowner
Flood Form and five accompanying
endorsements. The new Homeowner
Flood Form would replace the Dwelling
Form as a source of coverage for one-tofour family residences. Together, the
new Form and endorsements would
more closely align with property and
casualty homeowners’ insurance and
provide increased options and coverage
in a more user-friendly and
comprehensible format.
FEMA will also propose a regulation
titled Individual Assistance Program
Equity to further align with Executive
Order 13895. Climate change results in
more frequent and/or intense extreme
weather events like severe storms,
flooding and wildfires,
disproportionately impacting the most
vulnerable in society. FEMA will
propose to amend its Individual
Assistance (IA) regulations to increase
equity and ease of entry to the IA
Program. To provide a full opportunity
for underserved communities to
participate, FEMA will propose to
amend application of ‘‘safe, sanitary,
and functional’’ for IA repair assistance;
re-evaluate the requirement to apply for
a Small Business Administration loan
prior to receipt of Other Needs
Assistance; add eligibility criteria for its
Serious Needs & Displacement
Assistance; amend its requirements for
Continued Temporary Housing
Assistance; re-evaluate its approach to
insurance proceeds; and amend its
appeals process. FEMA will also
propose revisions to reflect changes to
statutory authority that have not yet
been implemented in regulation, to
include provisions for utility and
security deposit payments, lease and
repair of multi-family rental housing,
childcare assistance, and maximum
assistance limits.
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FEMA will issue a regulation titled
Amendment to the Public Assistance
Program’s Simplified Procedures Large
Project Threshold. It will revise its
regulations governing the Public
Assistance program to update the
monetary threshold at or below which
FEMA will obligate funding based on an
estimate of project costs, and above
which FEMA will obligate funding
based on actual project costs. This rule
will ensure FEMA and recipients can
more efficiently process unobligated
Project Worksheets for COVID–19
declarations, which continue to fund
important pandemic-related work, while
avoiding unnecessary confusion and
administrative burden by not affecting
previous project size determinations.
On October 12, 2021, FEMA issued a
Request for Information to receive the
public’s input on revising the NFIP’s
floodplain management standards for
land management and use regulations to
better align with the current
understanding of flood risk and flood
risk reduction approaches, as directed
by Executive Order 14030. FEMA seeks
input on the floodplain management
standards that communities should
adopt to result in safer, stronger, and
more resilient communities.
Additionally, FEMA seeks input on how
the NFIP can better promote protection
of and minimize any adverse impact to
threatened and endangered species, and
their habitats.
United States Citizenship and
Immigration Services
U.S. Citizenship and Immigration
Services (USCIS) is the government
agency that administers the nation’s
lawful immigration system,
safeguarding its integrity and promise
by efficiently and fairly adjudicating
requests for immigration benefits while
protecting Americans, securing the
homeland, and honoring our values.
USCIS is committed to taking the
necessary steps to reduce barriers to
legal immigration, increase access to
immigration benefits (consistent with
law), and reinvigorate the size and
scope of humanitarian relief. In the
coming year, USCIS intends to pursue
several regulatory actions that support
these goals while balancing our fiscal
stability.
Asylum Reforms. This Administration
is focused on pursuing regulations to
rebuild and streamline the asylum
system, consistent with President
Biden’s Executive Order on Creating a
Comprehensive Regional Framework to
Address the Causes of Migration, to
Manage Migration Throughout North
and Central America, and to Provide
Safe and Orderly Processing of Asylum
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Seekers at the United States Border
(E.O. 14010). On August 20, 2021, DHS/
USCIS and DOJ/Executive Office of
Immigration Review (EOIR) jointly
proposed regulatory amendments that
aim to accelerate the adjudication
process for individuals in expedited
removal proceedings who are seeking
asylum, withholding of removal, or
protection under the Convention
Against Torture. The current system in
place has resulted in unsustainable
backlogs that span many years. USCIS
and EOIR will seek to issue a final rule
that makes concrete and lasting
improvements in the processing of those
cases after considering public input
received on the proposed rule.
(Procedures for Credible Fear Screening
and Consideration of Asylum,
Withholding of Removal, and CAT
Protection Claims by Asylum Officers).
In addition, USCIS will propose
regulations to remove barriers to
affirmative asylum claims, while also
proposing processing timeframes for
initial application for employment
authorization applications filed by
pending asylum applicants that reflect
the operational capabilities of USCIS.
(Rescission of ‘‘Asylum Application,
Interview, & Employment
Authorization’’ Rule and Change to
‘‘Removal of 30-Day Processing
Provision for Asylum Applicant Related
Form I–765 Employment
Authorization’’). USCIS and EOIR will
also take steps to remove or modify
regulatory provisions that have created
unnecessary hurdles in the asylum
system, many of which are currently
enjoined by various courts. (Bars to
Asylum Eligibility and Procedures;
Procedures for Asylum and Withholding
of Removal; Credible Fear and
Reasonable Fear Review). Finally,
USCIS and EOIR will jointly propose
updates to their regulations to clarify
eligibility for asylum and withholding,
and better describe the circumstances in
which a person should be considered a
member of a ‘‘particular social group.’’
(Asylum and Withholding Definitions).
Review of the Public Charge of
Inadmissibility Ground. On August 23,
2021, USCIS published an Advance
Notice of Proposed Rulemaking
(ANPRM) to gather input from
interested and impacted stakeholders on
how USCIS should implement the
public charge ground of inadmissibility.
This action was the first step taken in
response to President Biden’s Executive
Order on Restoring Faith in Our Legal
Immigration Systems and Strengthening
Integration and Inclusion Efforts for
New Americans (E.O. 14012). USCIS
will propose regulations to define the
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term ‘‘public charge’’ and to identify
considerations relevant to the public
charge inadmissibility determination,
while recognizing that we must
continue to be a Nation of opportunity
and of welcome, and that we must
provide due consideration to the
confusion, fear, and negative public
health consequences that may result
from public charge policies.
(Inadmissibility on Public Charge
Grounds).
Deferred Action for Childhood
Arrivals (DACA). On September 28,
2021, USCIS issued a proposed rule that
establishes specified guidelines for
considering requests for deferred action
submitted by certain individuals who
entered the United States many years
ago as children. The proposed rule
invites public comments on a number of
issues relating to DACA, including
issues identified in a recent decision of
the U.S. District Court for the Southern
District of Texas court regarding DHS’s
authority to maintain the DACA policy,
and possible alternatives. In keeping
with President Biden’s Presidential
Memorandum: Preserving and Fortifying
Deferred Action for Childhood Arrivals
(DACA), USCIS will consider public
comments and seek to finalize the
proposed rule in the coming months
(Deferred Action for Childhood
Arrivals).
Improvements to the Overall
Immigration System. After performing
the required biennial fee review, USCIS
will propose adjustments to certain
immigration and naturalization benefit
request fees to ensure that fees recover
full costs borne by the agency. In doing
so, USCIS will adhere to the ideals
described in Executive Orders 14010
and 14012 of removing barriers and
promoting access to the immigration
system; improving and expanding
naturalization processing; and meeting
the administration’s humanitarian
priorities. (U.S. Citizenship and
Immigration Services Fee Schedule).
United States Coast Guard
The Coast Guard is a military, multimission, maritime service of the United
States and the only military
organization within DHS. It is the
principal Federal agency responsible for
maritime safety, security, and
stewardship in U.S. ports and
waterways.
Effective governance in the maritime
domain hinges upon an integrated
approach to safety, security, and
stewardship. The Coast Guard’s policies
and capabilities are integrated and
interdependent, delivering results
through a network of enduring
partnerships with maritime
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stakeholders. Consistent standards of
universal application and enforcement,
which encourage safe, efficient, and
responsible maritime commerce, are
vital to the success of the maritime
industry. The Coast Guard’s ability to
field versatile capabilities and highly
trained personnel is one of the U.S.
Government’s most significant and
important strengths in the maritime
environment.
America is a maritime nation, and our
security, resilience, and economic
prosperity are intrinsically linked to the
oceans. Safety, efficient waterways, and
freedom of transit on the high seas are
essential to our well-being. The Coast
Guard is leaning forward, poised to
meet the demands of the modern
maritime environment. The Coast Guard
creates value for the public through
solid prevention and response efforts.
Activities involving oversight and
regulation, enforcement, maritime
presence, and public and private
partnership foster increased maritime
safety, security, and stewardship.
The statutory responsibilities of the
Coast Guard include ensuring marine
safety and security, preserving maritime
mobility, protecting the marine
environment, enforcing U.S. laws and
international treaties, and performing
search and rescue. The Coast Guard
supports the Department’s overarching
goals of mobilizing and organizing our
Nation to secure the homeland from
terrorist attacks, natural disasters, and
other emergencies. These goals include
protection against the risks associated
with climate change, and the Coast
Guard seeks to obtain scientific
information to assist in that task, while
also acting to promote resilience and
adaptation.
The Coast Guard highlights the
following regulatory actions:
Shipping Safety Fairways Along the
Atlantic Coast. The Coast Guard
published an ANPRM on June 19, 2020.
The Coast Guard is reviewing comments
to help develop a proposed rule that
would establish shipping safety
fairways (fairways) along the Atlantic
Coast of the United States. Fairways are
marked routes for vessel traffic. They
facilitate the direct and unobstructed
transit of ships. The proposed fairways
will be based on studies about vessel
traffic along the Atlantic Coast. The
Coast Guard is taking this action to
ensure that obstruction-free routes are
preserved to and from U.S. ports and
along the Atlantic coast and to reduce
the risk of collisions, allisions and
grounding, as well as alleviate the
chance of increased time and expenses
in transit.
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Electronic Chart and Navigation
Equipment Carriage Requirements. The
Coast Guard will seek comment on the
modification of its chart and
navigational equipment regulations. We
plan to publish an ANPRM that outlines
the Coast Guard’s strategy to revise the
chart and navigational equipment
requirements for all commercial U.S.flagged vessels and foreign-flagged
vessels operating in the waters of the
United States to fulfill the electronic
chart use requirements as required by
statute. Acceptable standards and
capabilities need to be clarified before
paper charts are discontinued and
replaced by digital electronic navigation
charts. The ANPRM should provide us
with information on how widely
electronic charts are used, who is using
them, the appropriate equipment
requirements for different vessel classes,
and where they operate. The public
comments should better enable us to
tailor proposed electronic charts
requirements to vessel class and
location.
MARPOL Annex VI; Prevention of Air
Pollution from Ships. The Coast Guard
is proposing regulations to carry out the
provisions of Annex VI of the MARPOL
Protocol, which is focused on the
prevention of air pollution from ships.
The Act to Prevent Pollution from Ships
has already given direct effect to most
provisions of Annex VI, and the Coast
Guard and the Environmental Protection
Agency have carried out some Annex VI
provisions through previous
rulemakings. This proposed rulemaking
would fill gaps in the existing
framework for carrying out the
provisions of Annex VI. Chapter 4 of
Annex VI contains shipboard energy
efficiency measures that include shortterm measures reducing carbon
emissions linked to climate change and
supports Administration goals outlined
in Executive Order 14008 titled
Tackling the Climate Crisis at Home and
Abroad. This proposed rulemaking
would apply to U.S.-flagged ships. It
would also apply to foreign-flagged
ships operating either in U.S. navigable
waters or in the U.S. Exclusive
Economic Zone.
United States Customs and Border
Protection
Customs and Border Protection (CBP)
is the Federal agency principally
responsible for the security of our
Nation’s borders, both at and between
the ports of entry into the United States.
CBP must accomplish its border security
and enforcement mission without
stifling the flow of legitimate trade and
travel. The primary mission of CBP is its
homeland security mission, that is, to
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prevent terrorists and terrorist weapons
from entering the United States. An
important aspect of this mission
involves improving security at our
borders and ports of entry, but it also
means extending our zone of security
beyond our physical borders.
CBP is also responsible for
administering laws concerning the
importation of goods into the United
States and enforcing the laws
concerning the entry of persons into the
United States. This includes regulating
and facilitating international trade;
collecting import duties; enforcing U.S.
trade, immigration and other laws of the
United States at our borders; inspecting
imports; overseeing the activities of
persons and businesses engaged in
importing; enforcing the laws
concerning smuggling and trafficking in
contraband; apprehending individuals
attempting to enter the United States
illegally; protecting our agriculture and
economic interests from harmful pests
and diseases; servicing all people,
vehicles, and cargo entering the United
States; maintaining export controls; and
protecting U.S. businesses from theft of
their intellectual property.
In carrying out its mission, CBP’s goal
is to facilitate the processing of
legitimate trade and people efficiently
without compromising security.
Consistent with its primary mission of
homeland security, CBP intends to issue
several regulations that are intended to
improve security at our borders and
ports of entry. During the upcoming
year, CBP will also work on various
projects to streamline CBP processing,
reduce duplicative processes, reduce
various burdens on the public, and
automate various paper forms. Below,
CBP provides highlights of certain
planned actions for the coming fiscal
year.
Implementation of the Electronic
System for Travel Authorization (ESTA)
at U.S. Land Borders—Automation of
CBP Form I–94W. CBP intends to amend
existing regulations to implement the
ESTA requirements under the
Implementing Recommendations of the
9/11 Commission Act of 2007 for
noncitizens who intend to enter the
United States under the Visa Waiver
Program (VWP) at land ports of entry.
Currently, noncitizens from VWP
countries must provide certain
biographic information to U.S. CBP
officers at land ports of entry on a paper
form. Under this rule, these VWP
travelers would instead provide this
information to CBP electronically
through ESTA prior to application for
admission to the United States. In
addition to fulfilling a statutory
mandate, this rule will strengthen
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national security through enhanced
traveler vetting, will streamline the
processing of visitors, will reduce
inadmissible traveler arrivals, and will
save time for both travelers and the
government. (Note: There is no
associated Regulatory Plan entry for this
rule because this rule is non-significant
under Executive Order 12866. There is
an entry, however, in the Unified
Agenda.)
Automation of CBP Form I–418 for
Vessels. CBP intends to amend existing
regulations regarding the submission of
Form I–418, Passenger List—Crew List.
Currently, the master or agent of every
commercial vessel arriving in the
United States, with limited exceptions,
must submit a paper Form I–418 to CBP
at the port where immigration
inspection is performed. Most
commercial vessel operators are also
required to submit a paper Form I–418
to CBP at the final U.S. port prior to
departing for a foreign port. Under this
rule, most vessel operators would be
required to electronically submit the
data elements on Form I–418 to CBP
through the National Vessel Movement
Center in lieu of submitting a paper
form. This rule would eliminate the
need to file the paper Form I–418 in
most cases. This rule is included in this
narrative because it reduces
administrative and paperwork burdens
on the regulated public. (Note: There is
no associated Regulatory Plan entry for
this rule because this rule is nonsignificant under Executive Order
12866. There is an entry, however, in
the Unified Agenda.)
Advance Passenger Information
System: Electronic Validation of Travel
Documents. CBP intends to amend
current Advance Passenger Information
System (APIS) regulations to
incorporate additional carrier
requirements that would further enable
CBP to determine whether each
passenger is traveling with valid,
authentic travel documents prior to the
passenger boarding the aircraft. The
proposed regulation would require
commercial air carriers to receive a
second message from CBP that would
state whether CBP matched the travel
documents of each passenger to a valid,
authentic travel document recorded in
CBP’s databases. The proposed
regulation would also require air
carriers to transmit additional data
elements regarding contact information
through APIS for all commercial aircraft
passengers arriving in the United States
to support border operations and
national security. CBP expects that the
collection of these elements would
enable CBP to further support the Center
for Disease Control and Prevention’s
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(CDC’s) mission in monitoring and
tracing the contacts for persons involved
in health incidents (e.g., COVID–19).
This action will result in time savings
to passengers and cost savings to CBP,
carriers, and the public.
In addition to the regulations that CBP
issues to promote DHS’s mission, CBP
issues regulations related to the mission
of the Department of the Treasury.
Under section 403(1) of the Homeland
Security Act of 2002, the former-U.S.
Customs Service, including functions of
the Secretary of the Treasury relating
thereto, transferred to the Secretary of
Homeland Security. As part of the
initial organization of DHS, the Customs
Service inspection and trade functions
were combined with the immigration
and agricultural inspection functions
and the Border Patrol and transferred
into CBP. The Department of the
Treasury retained certain regulatory
authority of the U.S. Customs Service
relating to customs revenue function. In
the coming year, CBP expects to
continue to issue regulatory documents
that will facilitate legitimate trade and
implement trade benefit programs. For a
discussion of CBP regulations regarding
the customs revenue function, see the
regulatory plan of the Department of the
Treasury.
Transportation Security Administration
The Transportation Security
Administration (TSA) protects the
Nation’s transportation systems to
ensure freedom of movement for people
and commerce. TSA applies an
intelligence-driven, risk-based approach
to all aspects of its mission. This
approach results in layers of security to
mitigate risks effectively and efficiently.
TSA seeks to ensure ever-improving
‘‘customer service’’ so as to improve the
experience of the many millions of
travelers whom it serves. In fiscal year
2022, TSA is prioritizing the following
actions that are required to meet
statutory mandates and that are
necessary for national security.
Vetting of Certain Surface
Transportation Employees. TSA will
propose a rule that requires security
threat assessments for security
coordinators and other frontline
employees of certain public
transportation agencies (including rail
mass transit and bus systems), railroads
(freight and passenger), and over-theroad bus owner/operators. The NPRM
will also propose provisions to
implement TSA’s statutory requirement
to recover its cost of vetting user fees.
While many stakeholders conduct
background checks on their employees,
their actions are limited based upon the
data they can access. Through this rule,
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TSA will be able to conduct a more
thorough check against terrorist watchlists of individuals in security-sensitive
positions.
Flight Training Security. In 2004, TSA
published an Interim Final Rule (IFR)
that requires flight schools to notify
TSA when noncitizens, and other
individuals designated by TSA, apply
for flight training or recurrent training.
TSA subsequently issued exemptions
and interpretations in response to
comments on the IFR, questions raised
during operation of the program since
2004, and a notice extending the
comment period on May 18, 2018.
Based on the comments and questions
received, TSA is finalizing the rule with
modifications. TSA is considering
modifications that would change the
frequency of security threat assessments
from a high-frequency event-based
interval to a time-based interval, clarify
the definitions and other provisions of
the rule, and enable industry to use
TSA-provided electronic recordkeeping
systems for all documents required to
demonstrate compliance with the rule.
Indirect Air Carrier Security. Current
regulations for Indirect Air Carriers
(IACs) require annual renewal of the
IAC’s security program and prompt
notification to TSA of any changes to
operations related to information
previously provided to TSA. This rule
will propose a three-year renewal
schedule, rather than annual renewal.
This change will align the security
program renewal requirement with
those applicable to other regulated
entities within the air cargo industry.
These changes will not have a negative
impact on security as TSA will maintain
the requirement to notify the agency of
changes to operations and will continue
its robust inspection and compliance
program. TSA believes this action will
reduce burdens on an industry affected
by the COVID–19 public health crisis
and enhance the industry’s ability to
focus limited human resources on the
core tasks of moving air cargo.
Cybersecurity Requirements for
Certain Surface Owner/Operators. On
July 28, 2021, the President issued the
National Security Memorandum on
Improving Cybersecurity for Critical
Infrastructure Control Systems.
Consistent with that Memorandum and
in response to the ongoing cybersecurity
threat to pipeline systems, TSA issued
security directives to owners and
operators of TSA-designated critical
pipelines that transport hazardous
liquids and natural gas. The security
directives implement urgently needed
protections against cyber intrusions.
The first directive, issued in May 2021,
requires critical owner/operators to (1)
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Report confirmed and potential
cybersecurity incidents to DHS’s
Cybersecurity and Infrastructure
Security Agency (CISA); (2) designate a
Cybersecurity Coordinator to be
available 24 hours a day, seven days a
week; (3) review current cybersecurity
practices; and (4) identify any gaps and
related remediation measures to address
cyber-related risks and report the results
to TSA and CISA within 30 days of
issuance of the security directive. A
second security directive, issued in July
2021, requires these owners and
operators to (1) implement specific
mitigation measures to protect against
ransomware attacks and other known
threats to information technology and
operational technology systems; (2)
develop and implement a cybersecurity
contingency and recovery plan; and (3)
conduct a cybersecurity architecture
design review. TSA is committed to
enhancing and sustaining cybersecurity
in transportation and intends to issue a
rulemaking to codify these and other
requirements for certain surface
transportation owner-operators.
Amending Vetting Requirements for
Employees with Access to a Security
Identification Display Area. The FAA
Extension, Safety, and Security Act of
2016 mandates that TSA consider
modifications to the list of disqualifying
criminal offenses and criteria, develop a
waiver process for approving the
issuance of credentials for unescorted
access, and propose an extension of the
look back period for disqualifying
crimes. Based on these requirements,
and current intelligence pertaining to
the ‘‘insider threat,’’ TSA is developing
a proposed rule. The rule would revise
current vetting requirements to enhance
eligibility and disqualifying criminal
offenses for individuals seeking or
having unescorted access to any
Security Identification Display Area of
an airport.
United States Immigration and Customs
Enforcement
U.S. Immigration and Customs
Enforcement (ICE) is the principal
criminal investigative arm of DHS and
one of the three Department
components charged with the criminal
and civil enforcement of the Nation’s
immigration laws. Its primary mission is
to protect national security, public
safety, and the integrity of our borders
through the criminal and civil
enforcement of Federal law governing
border control, customs, trade, and
immigration. During the coming fiscal
year, ICE will focus rulemaking efforts
on regulations pertaining to adjusting
fees, including the rule mentioned
below.
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Fee Adjustment for U.S. Immigration
and Customs Enforcement Form I–246,
Application for a Stay of Deportation or
Removal. ICE will propose a rule that
would adjust the fee for adjudicating
and handling Form I–246, Application
for a Stay of Deportation or Removal.
The Form I–246 fee was last adjusted in
1989. After a comprehensive fee review,
ICE has determined that the current
Form I–246 fee does not recover the full
costs of processing and adjudicating
Form I–246. The rule will also clarify
the availability of Form I–246 fee
waivers.
Cybersecurity and Infrastructure
Security Agency
The Cybersecurity and Infrastructure
Security Agency (CISA) is responsible
for leading the national effort to develop
cybersecurity and critical infrastructure
security programs, operations, and
associated policy to enhance the
security and resilience of physical and
cyber infrastructure.
Ammonium Nitrate Security Program.
This rule implements a 2007
amendment to the Homeland Security
Act. The amendment requires DHS to
‘‘regulate the sale and transfer of
ammonium nitrate facility . . . to
prevent the misappropriation or use of
ammonium nitrate in an act of
terrorism.’’ CISA published a Notice of
Proposed Rulemaking in 2011. CISA is
planning to issue a Supplemental Notice
of Proposed Rulemaking.
A more detailed description of the
priority regulations that comprise the
DHS regulatory plan follows.
DHS—U.S. CITIZENSHIP AND
IMMIGRATION SERVICES (USCIS)
Proposed Rule Stage
76. Procedures for Asylum and
Withholding of Removal; Credible Fear
and Reasonable Fear Review
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1158; 8
U.S.C. 1225; 8 U.S.C. 1231 and 1231
(note)
CFR Citation: 8 CFR 235; 8 CFR 208;
8 CFR 1208.
Legal Deadline: None.
Abstract: On December 11, 2020, the
Department of Justice and the
Department of Homeland Security
(collectively, ‘‘the Departments’’)
published a final rule titled Procedures
for Asylum and Withholding of
Removal; Credible Fear and Reasonable
Fear Review (RINs 1125–AA94 and
1615–AC42) to amend the regulations
governing credible fear determinations
so that individuals found to have such
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a fear will have their claims for asylum,
withholding of removal under section
241(b)(3) of the Immigration and
Nationality Act (‘‘INA’’ or ‘‘the Act’’)
(‘‘statutory withholding of removal’’), or
protection under the regulations issued
pursuant to the legislation
implementing the Convention Against
Torture and Other Cruel, Inhuman or
Degrading Treatment or Punishment
(‘‘CAT’’), adjudicated by an immigration
judge within the Executive Office for
Immigration Review (‘‘EOIR’’) in
separate proceedings (rather than in
proceedings under section 240 of the
Act), and to specify what standard of
review applies in such proceedings. The
final rule amended the regulations
regarding asylum, statutory withholding
of removal, and withholding and
deferral of removal under the CAT
regulations. The final rule also made
changes to the standards for
adjudication of applications for asylum
and statutory withholding. The
Departments are planning to rescind or
modify the December 2020 rule, in
several rulemaking efforts. The
Departments have proposed to rescind
certain portions of the final rule
(including regulations related to
credible fear screenings) as part of the
rulemaking action described in RIN
1615–AC67.The Departments will also
propose to rescind or modify the
remaining portions of the December
2020 rule under this RIN, 1615–AC42.
Statement of Need: The Departments
are reviewing the regulatory changes
made in the final rule in light of the
issuance of Executive Order 14010 and
Executive Order 14012. This rule is
needed to ensure that the regulations
align with the goals and principles
outlined in Executive Order 14010 and
Executive Order 14012.
Anticipated Cost and Benefits: DHS is
still currently considering the specific
cost and benefit impacts associated with
the proposal to rescind or modify the
December 2020 rule.
Timetable:
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Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
Final Rule; Correction.
Final Rule Effective.
Second NPRM ....
FR Cite
06/15/20
07/15/20
85 FR 36264
12/11/20
01/11/21
85 FR 80274
86 FR 1737
01/11/21
08/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
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URL For Public Comments:
www.regulations.gov.
Agency Contact: Andria Strano, Chief,
Humanitarian Affairs Division,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
Office of Policy and Strategy, 5900
Capital Gateway Drive, Suite 4S190,
Camp Springs, MD 20588–0009, Phone:
240 721–3000.
Related RIN: Related to 1125–AA94,
Related to 1125–AB14, Related to 1615–
AC65.
RIN: 1615–AC42
DHS—USCIS
77. Deferred Action for Childhood
Arrivals
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 6 U.S.C. 101 et seq.;
8 U.S.C. 1101 et seq.
CFR Citation: 8 CFR 106; 8 CFR 236;
8 CFR 274a.
Legal Deadline: None.
Abstract: On June 15, 2012, the DHS
established the DACA policy. The
policy directed USCIS to create a
process to defer removal of certain
noncitizens who years earlier came to
the United States as children, meet
other criteria, and do not present other
circumstances that would warrant
removal. On January 20, 2021, President
Biden directed DHS, to take all
appropriate actions to preserve and
fortify DACA, consistent with
applicable law. On July 16, 2021, the
U.S. District Court for the Southern
District of Texas vacated the June 2012
Memorandum that created the DACA
policy and permanently enjoined DHS
from ‘‘administering the DACA program
and from reimplementing DACA
without compliance with the APA.’’
However, the district court temporarily
stayed its vacatur and injunction with
respect to most individuals granted
deferred action under DACA on or
before July 16, 2021, including with
respect to their renewal requests. The
district court’s vacatur and injunction
were based, in part, on its conclusion
that the June 2012 Memorandum
announced a legislative rule that
required notice-and-comment
rulemaking. The district court further
remanded the DACA policy to DHS for
further consideration. DHS has
announced its intent to appeal the
district court’s decision. Consistent with
the Presidential Memorandum, DHS
intends to engage in notice- andcomment rulemaking to consider all
issues regarding DACA, including those
identified by the district court relating
to the policy’s substantive legality.
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Statement of Need: The Secretary
proposes in this rule to establish
specified guidelines for considering
requests for deferred action submitted
by certain individuals who entered the
United States many years ago as
children. This proposed rule will also
address the availability of employment
authorization for persons who receive
deferred action under the rule, as well
as the issue of lawful presence. The
Secretary will invite public comments
on a number of issues relating to DACA,
including issues identified by the
district court regarding the authority of
DHS to maintain the DACA policy, and
possible alternatives.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
Date
09/28/21
11/29/21
FR Cite
86 FR 53736
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: Andria Strano, Chief,
Humanitarian Affairs Division,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
Office of Policy and Strategy, 5900
Capital Gateway Drive, Suite 4S190,
Camp Springs, MD 20588–0009, Phone:
240 721–3000.
RIN: 1615–AC64
DHS—USCIS
78. Asylum and Withholding
Definitions
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 8 U.S.C. 1101(a)(42);
8 U.S.C. 1158; 8 U.S.C. 1225; 8 U.S.C.
1231 and 1231 (note); E.O. 14010; 86 FR
8267 (Feb. 2, 2021)
CFR Citation: 8 CFR 2; 8 CFR 208; 8
CFR 1208.
Legal Deadline: None.
Abstract: This rule proposes to amend
Department of Homeland Security
(DHS) and Department of Justice (DOJ)
regulations that govern eligibility for
asylum and withholding of removal.
The amendments focus on portions of
the regulations that deal with the
definitions of membership in a
particular social group, the
requirements for failure of State
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protection, and determinations about
whether persecution is on account of a
protected ground. This rule is consistent
with Executive Order 14010 of February
2, 2021, which directs the Departments
to, within 270 days, promulgate joint
regulations, consistent with applicable
law, addressing the circumstances in
which a person should be considered a
member of a particular social group.
Statement of Need: This rule provides
guidance on a number of key
interpretive issues of the refugee
definition used by adjudicators deciding
asylum and withholding of removal
(withholding) claims. The interpretive
issues include whether persecution is
inflicted on account of a protected
ground, the requirements for
establishing the failure of State
protection, and the parameters for
defining membership in a particular
social group. This rule will aid in the
adjudication of claims made by
applicants whose claims fall outside of
the rubric of the protected grounds of
race, religion, nationality, or political
opinion. One example of such claims
which often fall within the particular
social group ground concerns people
who have suffered or fear domestic
violence. This rule is expected to
consolidate issues raised in a proposed
rule in 2000 and to address issues that
have developed since the publication of
the proposed rule. This rule should
provide greater stability and clarity in
this important area of the law. This rule
will also provide guidance to the
following adjudicators: USCIS asylum
officers, Department of Justice Executive
Office for Immigration Review (EOIR)
immigration judges, and members of the
EOIR Board of Immigration Appeals
(BIA).
Furthermore, on February 2, 2021,
President Biden issued Executive Order
14010 that directs DOJ and DHS within
270 days of the date of this order, [to]
promulgate joint regulations, consistent
with applicable law, addressing the
circumstances in which a person should
be considered a member of a ‘particular
social group,’ as that term is used in 8
U.S.C. 1101(a)(42)(A), as derived from
the 1951 Convention relating to the
Status of Refugees and its 1967 Protocol.
Summary of Legal Basis: The purpose
of this rule is to provide guidance on
certain issues that have arisen in the
context of asylum and withholding
adjudications. The 1951 Geneva
Convention relating to the Status of
Refugees contains the internationally
accepted definition of a refugee. United
States immigration law incorporates an
almost identical definition of a refugee
as a person outside his or her country
of origin ‘‘who is unable or unwilling to
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return to, and is unable or unwilling to
avail himself or herself of the protection
of, that country because of persecution
or a well-founded fear of persecution on
account of race, religion, nationality,
membership in a particular social group,
or political opinion.’’ Section 101(a)(42)
of the Immigration and Nationality Act.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
Date
NPRM ..................
FR Cite
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Ronald W. Whitney,
Deputy Chief, Refugee and Asylum Law
Division, Department of Homeland
Security, U.S. Citizenship and
Immigration Services, Office of Chief
Counsel, 20 Massachusetts Avenue NW,
Washington, DC 20529, Phone: 415 293–
1244, Fax: 415 293–1269, Email:
ronald.w.whitney@uscis.dhs.gov.
Related RIN: Related to 1615–AC42,
Related to 1125–AB13, Related to 1125–
AA94.
RIN: 1615–AC65
DHS—USCIS
79. Rescission of ‘‘Asylum Application,
Interview, & Employment
Authorization’’ Rule and Change to
‘‘Removal of 30 Day Processing
Provision for Asylum Applicant
Related Form I–765 Employment
Authorization’’
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 8 U.S.C. 1158(d)(2); 8
U.S.C. 1101 and 1103 ; Pub. L. 103–322;
8 U.S.C. 1105a; 8 U.S.C. 1151, 1153 and
1154; 8 U.S.C. 1182; 8 U.S.C. 1186a; 8
U.S.C. 1255; Pub. L. 113–4; 5 U.S.C. 801
CFR Citation: 8 CFR 208.3; 8 CFR
208.4; 8 CFR 208.7; 8 CFR 208.9; 8 CFR
208.10; 8 CFR 274a.12; 8 CFR 274a.13;
8 CFR 274a.14.
Legal Deadline: None.
Abstract: DHS plans to issue a notice
of proposed rulemaking that would
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rescind or substantively revise two final
rules related to employment
authorization for asylum applicants. On
August 25, 2020, the Department of
Homeland Security (DHS) published a
final rule that modified DHS’s
regulations governing asylum
applications, interviews, and eligibility
for employment authorization based on
a pending asylum application. (85 FR
38532). On August 21, 2020, the
Department of Homeland Security
(DHS) published a final rule that
removed a Department of Homeland
Security (DHS) regulatory provision
stating that U.S. Citizenship and
Immigration Services (USCIS) has 30
days from the date an asylum applicant
files the initial Form I–765, Application
for Employment Authorization, to grant
or deny that initial employment
authorization application. (85 FR
37502).
Statement of Need: The proposed
change is intended to help ensure the
eligibility requirements for employment
authorization for asylum applicants and
processing times established in the DHS
regulations are reasonable.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
NPRM ..................
Date
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Andria Strano, Chief,
Humanitarian Affairs Division,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
Office of Policy and Strategy, 5900
Capital Gateway Drive, Suite 4S190,
Camp Springs, MD 20588–0009, Phone:
240 721–3000.
Related RIN: Related to 1615–AC19,
Related to 1615–AC27.
RIN: 1615–AC66
DHS—USCIS
80. U.S. Citizenship and Immigration
Services Fee Schedule
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 8 U.S.C. 1356(m), (n)
CFR Citation: 8 CFR 103; 8 CFR 106.
Legal Deadline: None.
Abstract: DHS will propose to adjust
the fees charged by U.S. Citizenship and
Immigration Services (USCIS) for
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immigration and naturalization benefit
requests. On August 3, 2020, DHS
adjusted the fees USCIS charges for
immigration and naturalization benefit
requests, imposed new fees, revised
certain fee waiver and exemption
policies, and changed certain
application requirements via the rule
‘‘USCIS Fee Schedule & Changes to
Certain Other Immigration Benefit
Request Requirements.’’ DHS has been
preliminarily enjoined from
implementing that rule by court order.
This rule would rescind and replace the
changes made by the August 3, 2020,
rule and establish new USCIS fees to
recover USCIS operating costs.
Statement of Need: USCIS projects
that its costs of providing immigration
adjudication and naturalization services
will exceed the financial resources
available to it under its existing fee
structure. DHS proposes to adjust the
USCIS fee structure to ensure that
USCIS recovers the costs of meeting its
operational requirements.
The CFO Act requires each agency’s
chief financial officer to ‘‘review, on a
biennial basis, the fees, royalties, rents,
and other charges imposed by the
agency for services and things of value
it provides, and make recommendations
on revising those charges to reflect costs
incurred by it in providing those
services and things of value.’’
Summary of Legal Basis: INA 286(m)
and (n), 8 U.S.C. 1356(m) and (n)
authorize the Attorney General and
Secretary of Homeland Security to
recover the full cost of providing
immigration adjudication and
naturalization services by establishing
and collecting fees deposited into the
Immigration Examinations Fee Account.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
Date
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NPRM ..................
FR Cite
03/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: None.
Agency Contact: Kika M. Scott, Chief
Financial Officer, Department of
Homeland Security, U.S. Citizenship
and Immigration Services, 5900 Capital
Gateway Drive, Suite 4S190, Camp
Springs, MD 20588–0009, Phone: 202
721–3000.
RIN: 1615–AC68
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DHS—USCIS
81. Bars to Asylum Eligibility and
Procedures
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Homeland Security
Act of 2002, Pub. L. 107–296, 116 Stat.
2135, sec. 1102, as amended; 8 U.S.C.
1103(a)(1); 8 U.S.C. 1103(a)(3); 8 U.S.C.
1103(g); 8 U.S.C. 1225(b); 8 U.S.C.
1231(b)(3) and 1231 (note); 8 U.S.C.
1158
CFR Citation: 8 CFR 208; 8 CFR 235;
8 CFR 1003; 8 CFR 1208; 8 CFR 1235.
Legal Deadline: None.
Abstract: In 2020, the Department of
Homeland Security and Department of
Justice (collectively, the Departments)
published final rules amending their
respective regulations governing bars to
asylum eligibility and procedures,
including the Procedures for Asylum
and Bars to Asylum Eligibility, (RINs
1125–AA87 and 1615–AC41), 85 FR
67202 (Oct. 21, 2020), Asylum
Eligibility and Procedural
Modifications, (RINs 1125–AA91 and
1615–AC44), 85 FR 82260 (Dec. 17,
2020) and Security Bars and Processing,
(RINs 1125–AB08 and 1615–AC57), 85
FR 84160, (Dec. 23, 2020) final rules.
The Departments propose to modify or
rescind the regulatory changes
promulgated in these three final rules
consistent with Executive Order 14010
(Feb. 2, 2021).
Statement of Need: The Departments
are reviewing these regulations in light
of the issuance of Executive Order
14010 and Executive Order 14012. This
rule is needed to restore and strengthen
the asylum system and to address
inconsistencies with the goals and
principles outlined in the Executive
Order 14010 and Executive Order
14012.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Andria Strano, Chief,
Humanitarian Affairs Division,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
Office of Policy and Strategy, 5900
Capital Gateway Drive, Suite 4S190,
Camp Springs, MD 20588–0009, Phone:
240 721–3000.
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Related RIN: Related to 1125–AA87,
Split from 1615–AC41, Related to 1125–
AA91, Related to 1615–AC44, Related to
1125–AB08, Related to 1615–AC57.
RIN: 1615–AC69
DHS—USCIS
82. Inadmissibility on Public Charge
Grounds
Priority: Other Significant.
Legal Authority: 6 U.S.C. 101 et seq.;
8 U.S.C. 1101 et seq.
CFR Citation: 8 CFR 212; 8 CFR 245;
. . .
Legal Deadline: None.
Abstract: Section 4 of Executive Order
14012 of February 2, 2021 (86 FR 8277)
directed DHS and other federal agencies
to immediately review agency actions
related to the public charge grounds of
inadmissibility and deportability for
noncitizens at sections 212(a)(4) and
237(a)(5) of the Immigration and
Nationality Act (INA) (8 U.S.C.
1182(a)(4), 1227(a)(5)).
DHS intends to proceed with
rulemaking to define the term public
charge and identify considerations
relevant to the public charge
inadmissibility determination. DHS will
conduct the rulemaking consistent with
section 212(a)(4) of the INA and
consistent with the principles described
in Executive Order 14012. Such
principles include recognizing our
character as a Nation of opportunity and
of welcome and of providing due
consideration to the confusion, fear, and
negative public health consequences
that may result from public charge
policies.
Consistent with section 6 of Executive
Order 12866 (58 FR 51735) and section
2 of Executive Order 13563 (76 FR
3821), and in consideration of the
significant public interest in this
rulemaking proceeding, DHS published
an advance notice of proposed
rulemaking and notice of virtual public
listening sessions on August 23, 2021.
There is a 60-day public comment
period and the listening sessions are
scheduled for September 14 and
October 5, 2021.
Statement of Need: DHS published an
advance notice of proposed rulemaking
seeking broad public feedback on the
public charge ground of inadmissibility
to inform DHS’s development of a future
regulatory proposal. DHS intends to use
this feedback to develop a proposed rule
that will be fully consistent with law;
that will reflect empirical evidence to
the extent relevant and available; that
will be clear, fair, and comprehensible
for officers as well as for noncitizens
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and their families; that will lead to fair
and consistent adjudications and thus
avoid unequal treatment of the similarly
situated; and that will not otherwise
unduly impose barriers on noncitizens
seeking admission to or adjustment of
status in the United States. DHS also
intends to ensure that its regulatory
proposal does not cause undue fear
among immigrant communities or
present other obstacles to immigrants
and their families accessing public
services available to them, particularly
in light of the COVID–19 pandemic and
the resulting long-term public health
and economic impacts in the United
States.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
Date
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
08/23/21
10/22/21
FR Cite
86 FR 47025
03/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
URL For More Information: http://
www.regulations.gov.
URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Mark Phillips,
Residence and Naturalization Division
Chief, Department of Homeland
Security, U.S. Citizenship and
Immigration Services, Office of Policy
and Strategy, 5900 Capital Gateway
Drive, Suite 4S190, Camp Springs, MD
20588–0009, Phone: 240 721–3000.
RIN: 1615–AC74
DHS—USCIS
Final Rule Stage
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83. Procedures for Credible Fear
Screening and Consideration of
Asylum, Withholding of Removal and
Cat Protection Claims by Asylum
Officers
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: INA sec. 103(a)(1);
INA sec. 103(a)(3); 8 U.S.C. 1103(a)(1);
8 U.S.C. 1103(a)(3); INA sec.
235(b)(1)(B); 8 U.S.C. 1225(b)(1)(B); The
Refugee Act of 1980 (‘‘Refugee Act’’)
(Pub. L. 96–212, 94 Stat. 102)
CFR Citation: 8 CFR 208; 8 CFR 235;
8 CFR 1003; 8 CFR 1208; 8 CFR 1235.
Legal Deadline: None.
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Abstract: On August 20, 2021 the
Department of Justice (DOJ) and the
Department of Homeland Security
(DHS) (collectively, the Departments)
published a Notice of Proposed
Rulemaking (NPRM) to amend the
regulations governing the determination
of certain protection claims raised by
individuals subject to expedited
removal and found to have a credible
fear of persecution or torture. Under the
proposed rule, such individuals would
have their claims for asylum,
withholding of removal under section
241(b)(3) of the Immigration and
Nationality Act (INA or the Act)
(statutory withholding of removal), or
protection under the regulations issued
pursuant to the legislation
implementing U.S. obligations under
Article 3 of the Convention Against
Torture and Other Cruel, Inhuman or
Degrading Treatment or Punishment
(CAT) initially adjudicated by an
asylum officer within U.S. Citizenship
and Immigration Services (USCIS). Such
individuals who are denied protection
would be able to seek prompt, de novo
review with an immigration judge (IJ) in
the DOJ Executive Office for
Immigration Review (EOIR), with appeal
available to the Board of Immigration
Appeals (BIA). These changes are
intended to improve the Departments’
ability to consider the asylum claims of
individuals encountered at or near the
border more promptly while ensuring
fundamental fairness.
In conjunction with the above
changes, the Departments are proposing
to return the regulatory framework
governing the credible fear screening
process so as to once more apply the
longstanding ‘‘significant possibility’’
screening standard to all protection
claims, but not apply the mandatory
bars to asylum and withholding of
removal (with limited exception) at this
initial screening stage. The Departments
also propose that, if an asylum officer
makes a positive credible fear
determination, the documentation the
USCIS asylum officer creates from the
individual’s sworn testimony during the
credible fear screening process would
serve as an initial asylum application,
thereby improving efficiency in the
asylum adjudication system. Lastly, the
Departments are proposing to allow,
when detention is unavailable or
impracticable, for the consideration of
parole prior to a positive credible fear
determination of an individual placed
into expedited removal who makes a
fear claim. The Departments are
reviewing the public comments received
and plan to issue a final rule.
Statement of Need: There is wide
agreement that the system for dealing
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with asylum and related protection
claims at the southwest border has long
been overwhelmed and in desperate
need of repair. As the number of such
claims has skyrocketed over the years,
the system has proven unable to keep
pace, resulting in large backlogs and
lengthy adjudication delays. A system
that takes years to reach a result delays
justice and certainty for those who need
protection, and it encourages abuse by
those who will not qualify for protection
and smugglers who exploit the delay for
profit. The aim of this rule is to begin
replacing the current system, within the
confines of the law, with a better and
more efficient one that will adjudicate
protection claims fairly and
expeditiously.
Anticipated Cost and Benefits: DHS
estimated the resource cost needed to
implement and operationalize the rule
along a range of possible future credible
fear volumes. The average annualized
costs could range from $179.5 million to
$995.8 million at a 7 percent discount
rate. At a 7 percent discount factor, the
total ten-year costs could range from
$1.3 billion to $7.0 billion, with a
midrange of $3.2 billion.
There could also be cost-savings
related to Forms I–589 and I–765 filing
volume changes. In addition, some
asylum applicants may realize potential
early labor earnings, which could
constitute a transfer from workers in the
U.S. labor force to certain asylum
applicants, as well as tax impacts.
Qualitative benefits include, but may
not be limited to: (i) Beneficiaries of
new parole standards may not have to
wait lengthy times for a decision on
whether their asylum claims will
receive further consideration; (ii) some
individuals could benefit from de novo
review by an IJ of the asylum officer’s
denial of their asylum; (iii) DOJ–EOIR
may focus efforts on other priority work
and reduce its substantial current
backlog; (iv) as some applicants may be
able to earn income earlier than they
otherwise could currently, burdens to
the support network of the applicant
may be lessened.
Timetable:
Action
NPRM ..................
NPRM Correction
NPRM Comment
Period End.
Final Action .........
Date
08/20/21
10/18/21
10/19/21
FR Cite
86 FR 46906
86 FR 57611
03/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
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international trade and investment
effects, or otherwise be of international
interest.
URL For More Information: http://
www.regulations.gov.
URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Andria Strano, Chief,
Humanitarian Affairs Division,
Department of Homeland Security, U.S.
Citizenship and Immigration Services,
Office of Policy and Strategy, 5900
Capital Gateway Drive, Suite 4S190,
Camp Springs, MD 20588–0009, Phone:
240 721–3000.
Related RIN: Related to 1125–AB20.
RIN: 1615–AC67
information from the public before
drafting a proposed rule should enable
us to issue a proposed rule that better
tailors electronic charts requirements to
vessel class and location.
Alternatives: The Coast Guard will
use the information solicited from the
ANPRM to shape regulatory language
and alternatives.
Anticipated Cost and Benefits: The
Coast Guard will use the ANPRM to
solicit public input to help develop
estimates of the costs and benefits of
any proposed regulation.
Timetable:
Action
Date
ANPRM ...............
DHS—U.S. COAST GUARD (USCG)
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Prerule Stage
84. • Electronic Chart and Navigation
Equipment Carriage Requirements
Priority: Other Significant.
Legal Authority: 46 U.S.C. 3105
CFR Citation: 33 CFR 164 ; 46 CFR 25
and 26 ; 46 CFR 28; 46 CFR 32; 46 CFR
35; 46 CFR 77 and 78; 46 CFR 96 and
97; 46 CFR 108 and 109; 46 CFR 121;
46 CFR 130; 46 CFR 140; 46 CFR 167;
46 CFR 169; 46 CFR 184; 46 CFR 195
and 196.
Legal Deadline: None.
Abstract: The Coast Guard seeks
comments regarding the modification of
the chart and navigational equipment
requirements in titles 33 and 46 of the
Code of Federal Regulations. This
advance notice of proposed rulemaking
(ANPRM) outlines the Coast Guard’s
broad strategy to revise the chart and
navigational equipment requirements
for all commercial U.S.-flagged vessels
and foreign-flagged vessels operating in
the waters of the United States to fulfill
the electronic chart use requirements as
required by statute. This ANPRM is
necessary to obtain additional
information from the public before
issuing a notice of proposed rulemaking.
It will allow us to verify the extent of
the requirements for the rule, such as
how widely electronic charts are used,
who is using them, the appropriate
equipment requirements for different
vessel classes, and where they operate,
allowing us to tailor electronic charts
requirements to vessel class and
location.
Statement of Need: In this ANPRM,
we are seeking information on how
widely electronic charts are used, which
types of vessels are using them, and
where the vessels operate, as well as
views on the appropriate equipment
requirements for different vessel classes.
Issuing this ANPRM to obtain
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04/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Additional Information: Docket
number USCG–2021–0291.
Agency Contact: John Stone, Program
Manager, Department of Homeland
Security, U.S. Coast Guard, Office of
Navigation Systems (CG–NAV), 2703
Martin Luther King Jr. Avenue SE,
STOP 7418, Washington, DC 20593–
7418, Phone: 202 372–1093, Email:
john.m.stone2@uscg.mil.
RIN: 1625–AC74
DHS—USCG
preserved to and from U.S. ports and
along the Atlantic coast. This will
reduce the risk of collision, allision and
grounding, as well as alleviate the
chance of increased time and expenses
in transit.
Summary of Legal Basis: Section
70003 of title 46 United States Code (46
U.S.C. 70003) directs the Secretary of
the department in which the Coast
Guard resides to designate necessary
fairways that provide safe access routes
for vessels proceeding to and from U.S.
ports.
Alternatives: The ANPRM outlined
the Coast Guard’s plans for fairways
along the Atlantic Coast and requested
information and data associated with
the regulatory concepts. The Coast
Guard will use this information and
data to shape regulatory language and
alternatives and assess the associated
impacts in the NPRM.
Anticipated Cost and Benefits: The
fairways are intended to preserve
traditional vessel navigation routes and
are not mandatory. The Coast Guard
anticipates the proposed fairways to
improve navigational safety.
Risks: The Bureau of Ocean Energy
Management (BOEM) is leasing offshore
areas that could affect customary
shipping routes. Expeditious pursuit of
this rulemaking is intended to prevent
conflict between customary shipping
routes and areas that may be leased by
BOEM.
Timetable:
Proposed Rule Stage
Action
85. Shipping Safety Fairways Along the
Atlantic Coast
Priority: Other Significant.
Legal Authority: 46 U.S.C. 70003
CFR Citation: 33 CFR 166.
Legal Deadline: None.
Abstract: The Coast Guard seeks
comments regarding the possible
establishment of shipping safety
fairways (fairways) along the Atlantic
Coast of the United States. Fairways are
marked routes for vessel traffic in which
any obstructions are prohibited. The
proposed fairways are based on two
studies about vessel traffic along the
Atlantic Coast. The Coast Guard is
coordinating this action with the Bureau
of Offshore Energy Management (BOEM)
to minimize the impact on potential
offshore energy leases.
Statement of Need: This rulemaking
would establish shipping safety
fairways along the Atlantic coast of the
United States to facilitate the direct and
unobstructed transits of ships. The
establishment of fairways would ensure
that obstruction-free routes are
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ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
Date
06/19/20
08/18/20
FR Cite
85 FR 37034
06/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Additional Information: Docket
number USCG–2019–0279.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: John Stone, Program
Manager, Department of Homeland
Security, U.S. Coast Guard, Office of
Navigation Systems (CG–NAV), 2703
Martin Luther King Jr. Avenue SE,
STOP 7418, Washington, DC 20593–
7418, Phone: 202 372–1093, Email:
john.m.stone2@uscg.mil.
RIN: 1625–AC57
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DHS—USCG
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86. • Marpol Annex VI; Prevention of
Air Pollution From Ships
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1903
CFR Citation: 33 CFR 151.
Legal Deadline: None.
Abstract: The Coast Guard is
proposing regulations to carry out the
provisions of Annex VI of the MARPOL
Protocol, which is focused on the
prevention of air pollution from ships.
The Act to Prevent Pollution from Ships
has already given direct effect to most
provisions of Annex VI, and the Coast
Guard and the Environmental Protection
Agency have carried out some Annex VI
provisions through previous
rulemakings. This proposed rulemaking
would fill gaps in the existing
framework for carrying out the
provisions of Annex VI. Chapter 4 of
Annex VI contains shipboard energy
efficiency measures that include shortterm measures reducing carbon
emissions linked to climate change and
supports Administration goals outlined
in Executive Order 14008 titled
Tackling the Climate Crisis at Home and
Abroad. This proposed rulemaking
would apply to U.S.-flagged ships. It
would also apply to foreign-flagged
ships operating either in U.S. navigable
waters or in the U.S. Exclusive
Economic Zone.
Statement of Need: The Coast Guard
is proposing regulations to carry out the
provisions of Annex VI of the MARPOL
Protocol, which is focused on the
prevention of air pollution from ships.
The Act to Prevent Pollution from Ships
has already given direct effect to most
provisions of Annex VI, and the Coast
Guard and the Environmental Protection
Agency have carried out some Annex VI
provisions through previous
rulemakings. This proposed rule would
fill gaps in the existing framework for
carrying out the provisions of Annex VI
and explain how the United States has
chosen to carry out certain discretionary
aspects of Annex VI. This proposed rule
would apply to U.S.-flagged ships. And
it would also apply to foreign-flagged
ships operating in U.S. navigable waters
or in the U.S. Exclusive Economic Zone.
Summary of Legal Basis: Section 4 of
the Act to Prevent Pollution from Ships
(Pub. L. 96–478, Oct. 21, 1980, 94 Stat
2297), as reflected in 33 U.S.C. 1903,
directs the Secretary of Homeland
Security to prescribe any necessary or
desired regulations to carry out the
provisions of the MARPOL Protocol.
The ‘‘MARPOL Protocol’’ is defined in
33 U.S.C. 1901 and includes Annex VI
of the International Convention for the
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Prevention of Pollution from Ships,
1973.
Alternatives:
Alternative 1—No Action. USCG
considered taking no action, but 33
U.S.C. 1903 (c)(1) directs the DHS
Secretary to prescribe any regulations
necessary to implement Annex VI. We
have determined that it is necessary for
the Coast Guard to issue regulations to
implement Annex VI. Therefore, if we
take no action, the Coast Guard having
been delegated this rulemaking
authority from the DHS Secretary would
not fulfill its mandate from Congress to
implement Annex VI.
Alternative 2—USCG considered not
pursuing a rulemaking and allowing the
Annex VI International Air Pollution
Prevention (IAPP) certificate provision
(Regulation 6) to be a mechanism to
ensure compliance with Annex VI. We
did not follow this alternative because
not all ships subject to Annex VI would
be required to obtain an IAPP certificate.
Alternative 3—USCG considered
issuing only regulations that were
required to explain how the United
States planned to exercise its discretion
under Annex VI, but we determined that
additional regulations were necessary to
clarify how we would be implementing
Annex VI. The intent of these clarifying
regulations (e.g., how will a vessel that
does not have a GT ITC measurement
know if it will be subject to surveys
under Regulation 5.1) is not to impose
any additional burden—for it is APPS
that requires compliance with Annex
VI, but to make implementation of
Annex VI more effective, efficient, and
transparent.
Anticipated Cost and Benefits: USCG
anticipates the costs for the proposed
rule to come primarily from additional
labor for 5 requirements including
overseeing surveys; developing and
maintaining a fuel-switching procedure;
recording various data during each fuel
switching; developing and managing a
Volatile organic compounds (VOC)
management plan; crew member to
calculate and report the attained Energy
Efficient Design Index (EEDI) of the
vessel, and crew member to develop and
maintain the Ship Energy Efficiency
Management Plan (SEEMP). USCG
estimates that the requirement will total
approximately $2 million over a ten
year period.
USCG expects the proposed rule to
have unquantified benefits from
reduction in fatalities and injuries due
to pollutant in engine emissions, and
also reduced risk of retaliation due to
breaching international agreement.
Timetable:
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Action
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Date
FR Cite
05/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: Frank Strom, Chief,
Systems Engineering Division (CG–
ENG–3), Department of Homeland
Security, U.S. Coast Guard, Office of
Design and Engineering Standards, 2703
Martin Luther King Jr. Avenue SE,
Washington, DC 20593, Phone: 202 372–
1375, Email: frank.a.strom@uscg.mil.
RIN: 1625–AC78
DHS—U.S. CUSTOMS AND BORDER
PROTECTION (USCBP)
Proposed Rule Stage
87. Advance Passenger Information
System: Electronic Validation of Travel
Documents
Priority: Other Significant.
Legal Authority: 49 U.S.C. 44909; 8
U.S.C. 1221
CFR Citation: 19 CFR 122.
Legal Deadline: None.
Abstract: U.S. Customs and Border
Protection (CBP) regulations require
commercial air carriers to electronically
transmit passenger information to CBP’s
Advance Passenger Information System
(APIS) prior to an aircraft’s arrival in or
departure from the United States. CBP
proposes to amend these regulations to
incorporate additional carrier
requirements that will enable CBP to
validate each passenger’s travel
documents prior to the passenger
boarding the aircraft. This proposed rule
would also require air carriers to
transmit additional data elements
through APIS for all commercial aircraft
passengers arriving in the United States
in order to support border operations
and national security. The collection of
additional data elements will support
the efforts of the Centers for Disease
Control, within the Department of
Health and Human Services, to monitor
and contract-trace health incidents.
Statement of Need: Current
regulations require U.S. citizens and
foreign travelers entering and leaving
the United States via air travel to submit
travel documents containing
biographical information, such as a
passenger’s name and date of birth. For
security purposes, CBP compares the
information on passengers’ documents
to various databases and the terrorist
watch list through APIS and
recommends that air carriers deny
boarding to those deemed inadmissible.
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To further improve CBP’s vetting
processes with respect to identifying
and preventing passengers with
fraudulent or improper documents from
traveling or leaving the United States,
CBP proposes to require carriers to
receive from CBP a message that would
state whether CBP matched the travel
documents of each passenger to a valid,
authentic travel document prior to
departure to the United States from a
foreign port or place or departure from
the United States. The proposed rule
also would require carriers to submit
passenger contact information while in
the United States to CBP through APIS.
Submission of such information would
enable CBP to identify and interdict
individuals posing a risk to border,
national, and aviation safety and
security more quickly. Collecting these
additional data elements would also
enable CBP to further assist CDC to
monitor and trace the contacts of those
involved in serious public health
incidents upon CDC request.
Additionally, the proposed rule would
allow carriers to include the aircraft tail
number in their electronic messages to
CBP and make technical changes to
conform with current practice.
Anticipated Cost and Benefits: The
proposed rule would result in
additional opportunity costs of time to
CBP, air carriers, and passengers for
coordination required to resolve a
passenger’s status should there be a
security issue. In addition, CBP has
incurred costs for technological
improvements to its systems. CBP, air
carriers, and passengers would benefit
from reduced passenger processing
times during customs screening.
Unquantified benefits would result from
greater efficiency in passenger
processing pre-flight, improved national
security, and fewer penalties for air
carriers following entry denial of a
passenger.
Timetable:
Action
Date
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03/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Robert Neumann,
Program Manager, Office of Field
Operations, Department of Homeland
Security, U.S. Customs and Border
Protection, 1300 Pennsylvania Avenue
NW, Washington, DC 20229, Phone: 202
412–2788, Email: robert.m.neumann@
cbp.dhs.gov.
RIN: 1651–AB43
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DHS—USCBP
Final Rule Stage
88. Automation of CBP Form I–418 for
Vessels
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 8 U.S.C.
1101 and 1103; 8 U.S.C. 1182; 8 U.S.C.
1221; 8 U.S.C. 1281 and 1282; 19 U.S.C.
66; 19 U.S.C. 1431; 19 U.S.C. 1433; 19
U.S.C. 1434; 19 U.S.C. 1624; 19 U.S.C.
2071 note; 46 U.S.C. 501; 46 U.S.C.
60105
CFR Citation: 8 CFR 251.1; 8 CFR
251.3; 8 CFR 251.5; 8 CFR 258.2; 19 CFR
4.7 and 4.7a; 19 CFR 4.50; 19 CFR 4.81;
19 CFR 4.85; 19 CFR 4.91.
Legal Deadline: None.
Abstract: This rule amends the
Department of Homeland Security’s
regulations regarding the submission of
U.S. Customs and Border Protection
Form I–418, Passenger List—Crew List
(Form I–418). Currently, the master or
agent of every commercial vessel
arriving in the United States, with
limited exceptions, must submit a paper
Form I–418, along with certain
information regarding longshore work,
to CBP at the port where immigration
inspection is performed. Most
commercial vessel operators are also
required to submit a paper Form I–418
to CBP at the final U.S. port prior to
departing for a foreign port. Under this
rule, most vessel operators would be
required to electronically submit the
data elements on Form I–418 to CBP
through the National Vessel Movement
Center in lieu of submitting a paper
form. This rule would eliminate the
need to file the paper Form I–418 in
most cases. This will result in an
opportunity cost savings for vessel
operators as well as a reduction in their
printing and storage costs. CBP no
longer needs this information as it is
receiving it from the Coast Guard.
Statement of Need: Currently, the
master or agent of every commercial
vessel arriving in the United States,
with limited exceptions, must submit
Form I–418, along with certain
information regarding longshore work,
in paper form to CBP at the port where
immigration inspection is performed.
Most commercial vessel operators are
also required to submit a paper Form I–
418 to CBP at the final U.S. port prior
to departing for a foreign place.
Alternative, most vessel operators are
required to electronically submit the
same information to the U.S. Coast
Guard (USCG) prior to arrival into a U.S.
port. Under this rule, vessel operators
will be required to electronically submit
the data elements on Form I–418 to CBP
through an electronic data interchange
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5087
system (EDI) approved by CBP in lieu of
submitting a paper form. This rule will
streamline vessel arrival and departure
processes by providing for the electronic
submission of the information collected
on the Form I–418, eliminating
redundant data submissions,
simplifying vessel inspections, and
automating recordkeeping.
Anticipated Cost and Benefits: This
rule will automate the Form I–418
process for all commercial vessel
operators and eliminate the regulatory
guidelines in place regarding the
submission and retention of paper Form
I–418s. These changes will generally not
introduce new costs to commercial
vessel operators, but they will introduce
some costs to CBP. If vessel operators
request a copy of their stamped and
annotated electronic Form I–418, which
they receive by paper now for CBP
processing, they will incur negligible
costs to do so. CBP will incur
technology and printing costs from the
Form I–418 Automation regulatory
program, including costs to maintain
mobile devices for real-time, electronic
processing, and to print the paper Form
I–418 until the admissibility inspection
process is completely paperless.
However, this rule will provide
considerable benefits and cost savings to
both vessel operators and CBP.
Following this rule’s implementation,
vessel operators will enjoy cost savings
from forgone paper Form I–418
submissions and form printing. CBP
will experience a cost savings from the
rule’s avoided printing, streamlined
mobile post-inspection processing and
electronic recordkeeping. In turn, CBP
may dedicate these cost savings to other
agency mission areas, such as improving
border security or facilitating trade.
Timetable:
Action
Interim Final Rule
Date
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Brian Sale, Branch
Chief, Manifest & Conveyance Security
Division, Cargo & Conveyance, Office of
Field Operation, Department of
Homeland Security, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue NW, Washington, DC 20229,
Phone: 202 325–3338, Email:
brian.a.sale@cbp.dhs.gov; ofomanifestbranch@cbp.dhs.gov.
RIN: 1651–AB18
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DHS—TRANSPORTATION SECURITY
ADMINISTRATION (TSA)
Proposed Rule Stage
89. Vetting of Certain Surface
Transportation Employees
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L.
110–53, secs. 1411, 1414, 1512, 1520,
1522, and 1531
CFR Citation: Not Yet Determined.
Legal Deadline: Other, Statutory,
August 3, 2008, Background and
immigration status check for all public
transportation frontline employees is
due no later than 12 months after date
of enactment.
Sections 1411 and 1520 of Public Law
110–53, Implementing
Recommendations of the 9/11
Commission Act of 2007 (9/11 Act),
(121 Stat. 266, Aug. 3, 2007), require
background checks of frontline public
transportation and railroad employees
not later than one year from the date of
enactment. Requirement will be met
through regulatory action.
Abstract: The 9/11 Act requires
vetting of certain railroad, public
transportation, and over-the-road bus
employees. Through this rulemaking,
the Transportation Security
Administration (TSA) intends to
propose the standards and procedures to
conduct the required vetting. This
regulation is related to 1652–AA55,
Security Training for Surface
Transportation Employees.
Statement of Need: Employee vetting
is an important and effective tool for
averting or mitigating potential attacks
by those with malicious intent who may
target surface transportation and plan or
perpetrate actions that may cause
significant injuries, loss of life, or
economic disruption.
Anticipated Cost and Benefits: TSA is
in the process of determining the costs
and benefits of this rulemaking.
Timetable:
Action
Date
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04/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Victor Parker,
Transportation Security Specialist,
Department of Homeland Security,
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Anticipated Cost and Benefits: TSA is
in the process of determining the costs
and benefits of this rulemaking. Cost
savings are expected to arise from time
saved due to a less frequent security
program renewal cycle.
Timetable:
Transportation Security Administration,
Policy, Plans and Engagement, 6595
Springfield Center Drive, Springfield,
VA 20598–6028, Phone: 571 227–3664,
Email: victor.parker@tsa.dhs.gov.
Alex Moscoso, Chief Economist,
Economic Analysis Branch–
Coordination & Analysis Division,
Department of Homeland Security,
Transportation Security Administration,
Policy, Plans, and Engagement, 6595
Springfield Center Drive, Springfield,
VA 20598–6028, Phone: 571 227–5839,
Email: alex.moscoso@tsa.dhs.gov.
Christine Beyer, Senior Counsel,
Regulations and Security Standards,
Department of Homeland Security,
Transportation Security Administration,
Chief Counsel’s Office, 6595 Springfield
Center Drive, Springfield, VA 20598–
6002, Phone: 571 227–3653, Email:
christine.beyer@tsa.dhs.gov.
Related RIN: Related to 1652–AA55,
Related to 1652–AA56.
RIN: 1652–AA69
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Ronoy Varghese,
Section Chief, Department of Homeland
Security, Transportation Security
Administration, 6595 Springfield Center
Drive, Springfield, VA 20598–6028,
Phone: 571 227–2230, Email:
ronoy.varghese@tsa.dhs.gov.
Related RIN: Related to 1652–AA23.
RIN: 1652–AA72
DHS—TSA
DHS—TSA
90. Indirect Air Carrier Security
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 49 U.S.C. 114; 49
U.S.C. 5103; 49 U.S.C. 40113; 49 U.S.C.
44901 to 44905; 49 U.S.C. 4491 to
44914; 49 U.S.C. 44916 to 44917; 49
U.S.C. 44932; 49 U.S.C. 449354 to
44936; 49 U.S.C. 46105; . . .
CFR Citation: 49 CFR 1548.
Legal Deadline: None.
Abstract: The Transportation Security
Administration (TSA) is reducing the
frequency of renewal applications for
indirect air carriers (IACs). Currently,
these entities must submit an
application to renew their security
program each year. Following a review
of TSA’s regulatory requirements
seeking to reduce the cost of
compliance, TSA determined that the
duration of the security program for
these entities can be increased from one
year to three years without having a
negative impact on transportation
security.
Statement of Need: Consistent with
Executive Order 12866 and OMB
Circular A–4, TSA identified portions of
air cargo regulations that may be
tailored to impose a lesser burden on
society and that may improve
government processes. Under 49 CFR
1548 indirect air carriers are required to
renew their security programs each year.
TSA’s robust inspection and compliance
requirements make the annual renewal
requirement unnecessary.
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Final Rule ............
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05/00/22
FR Cite
74 FR 47705
Final Rule Stage
91. Flight Training Security
Priority: Other Significant.
Legal Authority: 6 U.S.C. 469(b); 49
U.S.C. 114; 49 U.S.C. 44939; 49 U.S.C.
46105
CFR Citation: 49 CFR 1552.
Legal Deadline: Final, Statutory,
February 10, 2004, sec. 612(a) of Vision
100 requires the Transportation Security
Administration (TSA) to issue an
interim final rule within 60 days of
enactment of Vision 100.
Requires the TSA to establish a
process to implement the requirements
of section 612(a) of Vision 100–Century
of Aviation Reauthorization Act (Pub. L.
108–176, 117 Stat. 2490, Dec. 12, 2003),
including the fee provisions, not later
than 60 days after the enactment of the
Act.
Abstract: An Interim Final Rule (IFR)
published and effective on September
20, 2004, created a new part 1552, Flight
Schools, in title 49 of the Code of
Federal Regulations (CFR). This IFR
applies to flight schools and to
individuals who apply for or receive
flight training. Flight schools are
required to notify TSA when
noncitizens, and other individuals
designated by TSA, apply for flight
training or recurrent training. TSA
subsequently issued exemptions and
interpretations in response to comments
on the IFR, questions raised during
operation of the program since 2004,
and a notice extending the comment
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period on May 18, 2018. Based on the
comments and questions received, TSA
is finalizing the rule with modifications,
and considering modifications that
would change the frequency of security
threat assessments from a highfrequency event-based interval to a
time-based interval, clarify the
definitions and other provisions of the
rule, and enable industry to use TSAprovided electronic recordkeeping
systems for all documents required to
demonstrate compliance with the rule.
Statement of Need: In the years since
TSA published the IFR, members of the
aviation industry, the public, and
Federal oversight organizations have
identified areas where the Flight
Training Security Program (formerly the
Alien Flight Student Program) could be
improved. TSA’s internal procedures
and processes for vetting applicants also
have improved and advanced.
Publishing a final rule that addresses
external recommendations and aligns
with modern TSA vetting practices
would streamline the Flight Training
Security Program application, vetting,
and recordkeeping process for all parties
involved.
Anticipated Cost and Benefits: TSA is
considering revising the requirements of
the Flight Training Security Program to
reduce costs and industry burden. One
action TSA is considering is an
electronic recordkeeping platform
where all flight providers would upload
certain information to a TSA-managed
website. Also at industry’s request, TSA
is considering changing the interval for
a security threat assessment of each
noncitizen flight student, eliminating
the requirement for a security threat
assessment for each separate training
event. This change would result in an
annual savings, although there may be
additional start-up and record retention
costs for the agency as a result of these
revisions. The benefits of these actions
would be immediate cost savings to
flight schools and noncitizen students
without compromising the security
profile.
Timetable:
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Action
Date
Interim Final Rule;
Request for
Comments.
Interim Final Rule
Effective.
Interim Final Rule;
Comment Period End.
Notice-Information
Collection; 60Day Renewal.
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09/20/04
FR Cite
69 FR 56324
09/20/04
10/20/04
11/26/04
17:50 Jan 28, 2022
69 FR 68952
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Action
Date
Notice-Information
Collection; 30Day Renewal.
Notice-Information
Collection; 60Day Renewal.
Notice-Information
Collection; 30Day Renewal.
Notice-Alien Flight
Student Program Recurrent
Training Fees.
Notice-Information
Collection; 60Day Renewal.
Notice-Information
Collection; 30Day Renewal.
Notice-Information
Collection; 60Day Renewal.
Notice-Information
Collection; 30Day Renewal.
IFR; Comment
Period Reopened.
IFR; Comment
Period Reopened End.
Notice-Information
Collection; 60Day Renewal.
Notice-Information
Collection; 30Day Renewal.
Final Rule ............
FR Cite
03/30/05
70 FR 16298
06/06/08
73 FR 32346
08/13/08
73 FR 47203
04/13/09
74 FR 16880
09/21/11
76 FR 58531
01/31/12
77 FR 4822
03/10/15
80 FR 12647
06/18/15
80 FR 34927
05/18/18
83 FR 23238
Frm 00089
6002, Phone: 571 227–2465, Email:
david.ross1@tsa.dhs.gov.
Related RIN: Related to 1652–AA61.
RIN: 1652–AA35
DHS—TSA
06/18/18
07/06/18
83 FR 31561
10/31/18
83 FR 54761
09/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Johannes Knudsen,
Program Manager, Alien Flight Student
Program, Department of Homeland
Security, Transportation Security
Administration, Intelligence and
Analysis, 6595 Springfield Center Drive,
Springfield, VA 20598–6010, Phone:
571 227–2188, Email:
johannes.knudsen@tsa.dhs.gov.
Alex Moscoso, Chief Economist,
Economic Analysis Branch—
Coordination & Analysis Division,
Department of Homeland Security,
Transportation Security Administration,
Policy, Plans, and Engagement, 6595
Springfield Center Drive, Springfield,
VA 20598–6028, Phone: 571 227–5839,
Email: alex.moscoso@tsa.dhs.gov.
David Ross, Attorney–Advisor,
Regulations and Security Standards,
Department of Homeland Security,
Transportation Security Administration,
Chief Counsel’s Office, 6595 Springfield
Center Drive, Springfield, VA 20598–
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Long-Term Actions
92. • Surface Transportation
Cybersecurity Measures
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114
CFR Citation: 49 CFR 1570.
Legal Deadline: None.
Abstract: On July 28, 2021, the
President issued the National Security
Memorandum on Improving
Cybersecurity for Critical Infrastructure
Control Systems. Consistent with this
priority of the Administration and in
response to the ongoing cybersecurity
threat to pipeline systems, TSA used its
authority under 49 U.S.C. 114 to issue
security directives to owners and
operators of TSA-designated critical
pipelines that transport hazardous
liquids and natural gas to implement a
number of urgently needed protections
against cyber intrusions. The first
directive, issued in May 2021, requires
critical owner/operators to (1) Report
confirmed and potential cybersecurity
incidents to the Cybersecurity and
Infrastructure Agency (CISA); (2)
designate a Cybersecurity Coordinator to
be available 24 hours a day, seven days
a week; (3) review current cybersecurity
practices; and (4) identify any gaps and
related remediation measures to address
cyber-related risks and report the results
to TSA and CISA within 30 days of
issuance of the SD. A second security
directive issued in July requires these
owners and operators to (1) Implement
specific mitigation measures to protect
against ransomware attacks and other
known threats to information
technology and operational technology
systems; (2) develop and implement a
cybersecurity contingency and recovery
plan; and (3) conduct a cybersecurity
architecture design review. TSA is
committed to enhancing and sustaining
cybersecurity and intends to issue a
rulemaking that will codify certain
requirements with respect to pipeline
and certain other surface modes.
Statement of Need: This rulemaking is
necessary to address the ongoing
cybersecurity threat to U.S.
transportation modes.
Anticipated Cost and Benefits: TSA is
in the process of determining the costs
and benefits of this rulemaking.
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Timetable:
Action
Action
Date
NPRM ..................
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To Be Determined
Prerule Stage
Proposed Rule Stage
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93. Fee Adjustment for U.S.
Immigration and Customs Enforcement
Form I–246, Application for a Stay of
Deportation or Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1231; 8
U.S.C. 1356(m); 8 U.S.C. 1356(n)
CFR Citation: 8 CFR 103.
Legal Deadline: None.
Abstract: The Department of
Homeland Security, U.S. Immigration
and Customs Enforcement (ICE) will
propose to adjust the fee for ICE Form
I–246, Application for a Stay of
Deportation or Removal. ICE has
determined that the current fee does not
fully recover the costs incurred to
perform the full range of activities
associated with determining if a
noncitizen ordered deported or removed
from the United States is eligible to
obtain a stay of deportation or removal.
Statement of Need: ICE has
determined that the current fee for Form
I–246 does not fully recover the costs
incurred to perform the full range of
activities associated with determining if
a foreign national ordered deported or
removed from the United States is
eligible to obtain a stay of deportation
or removal.
Anticipated Cost and Benefits: ICE is
in the process of assessing the impacts
of this rule. The rule would increase the
fee for foreign nationals applying for a
stay of deportation or removal with the
Form I–246. The fee adjustment would
result in an increase in transfers from
foreign nationals to ICE.
Timetable:
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DHS—FEDERAL EMERGENCY
MANAGEMENT AGENCY (FEMA)
DHS—U.S. IMMIGRATION AND
CUSTOMS ENFORCEMENT (USICE)
17:50 Jan 28, 2022
NPRM ..................
FR Cite
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Sharon Hageman,
Acting Deputy Assistant Director,
Department of Homeland Security, U.S.
Immigration and Customs Enforcement,
500 12th Street SW, Mail Stop 5006,
Washington, DC 20536, Phone: 202 732–
6960, Email: ice.regulations@
ice.dhs.gov.
RIN: 1653–AA82
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Scott Gorton,
Executive Director, Surface Policy
Division, Department of Homeland
Security, Transportation Security
Administration, Policy, Plans, and
Engagement, 6595 Springfield Center
Drive, Springfield, VA 20598–6002,
Phone: 571 227–1251, Email: tsasurface@tsa.dhs.gov.
RIN: 1652–AA74
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Date
94. • RFI National Flood Insurance
Program’s Floodplain Management
Standards for Land Management & Use,
& an Assessment of the Program’s
Impact on Threatened and Endangered
Species & Their Habitats
Priority: Other Significant.
Legal Authority: 42 U.S.C. 4001 et seq.
CFR Citation: 44 CFR 59.1; 44 CFR
60.3(d)(3); 44 CFR 64.3(a)(1).
Legal Deadline: None.
Abstract: The Federal Emergency
Management Agency (FEMA) is issuing
this Request for Information to receive
the public’s input on two topics. First,
FEMA seeks the public’s input on
revising the National Flood Insurance
Program’s (NFIP) floodplain
management standards for land
management and use regulations to
better align with the current
understanding of flood risk and flood
risk reduction approaches. Specifically,
FEMA is seeking input from the public
on the floodplain management
standards that communities should
adopt to result in safer, stronger, and
more resilient communities.
Additionally, FEMA seeks input on how
the NFIP can better promote protection
of and minimize any adverse impact to
threatened and endangered species, and
their habitats.
Statement of Need: FEMA is issuing
this Request for Information to seek
information from the public on the
agency’s current floodplain management
standards to ensure the agency receives
public input as part of the agency’s
regular review of programs, regulations,
and policies, and to inform any action
to revise the NFIP minimum floodplain
management standards. FEMA also
plans to re-evaluate the implementation
of the NFIP under the Endangered
Species Act at the national level to
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complete a revised Biological
Evaluation re-examining how NFIP
actions influence land development
decisions; the potential for such actions
to have adverse effects on threatened
and endangered species and critical
habitats; and to identify program
changes that would prevent jeopardy to
threatened and endangered species,
and/or destruction or adverse
modification of designated critical
habitats, as well as to promote the
survival and recovery of threatened and
endangered species. As a result, FEMA
also requests input from the public on
what measures the NFIP can take to
further protect and minimize any
adverse impacts to threatened and
endangered species and their habitat.
Anticipated Cost and Benefits: DHS is
currently considering the specific cost
and benefit impacts of the proposed
provisions.
Timetable:
Action
Request for Information.
Announcement of
Public Meetings.
Announcement of
Additional Public Meeting; Extension of Comment Period.
Request for Information Comment Period
End.
Date
FR Cite
10/12/21
86 FR 56713
10/28/21
86 FR 59745
11/22/21
86 FR 66329
01/27/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Additional Information: Docket ID
FEMA–2021–0024.
URL For More Information: http://
www.regulations.gov.
URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Rachel Sears, Federal
Insurance and Mitigation
Administration, Department of
Homeland Security, Federal Emergency
Management Agency, 400 C Street SW,
Washington, DC 20472, Phone: 202 646–
2977, Email: fema-regulations@
fema.dhs.gov.
RIN: 1660–AB11
DHS—FEMA
Proposed Rule Stage
95. National Flood Insurance Program:
Standard Flood Insurance Policy,
Homeowner Flood Form
Priority: Other Significant. Major
under 5 U.S.C. 801.
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Legal Authority: 42 U.S.C. 4001 et seq.
CFR Citation: 44 CFR 61.
Legal Deadline: None.
Abstract: The National Flood
Insurance Program (NFIP), established
pursuant to the National Flood
Insurance Act of 1968, is a voluntary
program in which participating
communities adopt and enforce a set of
minimum floodplain management
requirements to reduce future flood
damages. This proposed rule would
revise the Standard Flood Insurance
Policy by adding a new Homeowner
Flood Form and five accompanying
endorsements. The new Homeowner
Flood Form would replace the Dwelling
Form as a source of coverage for one-tofour family residences. Together, the
new Form and endorsements would
more closely align with property and
casualty homeowners’ insurance and
provide increased options and coverage
in a more user-friendly and
comprehensible format.
Statement of Need: The National
Flood Insurance Act requires FEMA to
provide by regulation the general terms
and conditions of insurability
applicable to properties eligible for
flood insurance coverage. 42 U.S.C.
4013(a). To comply with this
requirement, FEMA adopts the Standard
Flood Insurance Policy (SFIP) in
regulation, which sets out the terms and
conditions of insurance. See 44 CFR
part 61, Appendix A. FEMA must use
the SFIP for all flood insurance policies
sold through the NFIP. See 44 CFR
61.13.
The SFIP is a single-peril (flood)
policy that pays for direct physical
damage to insured property. There are
currently three forms of the SFIP: The
Dwelling Form, the General Property
Form, and the Residential
Condominium Building Association
Policy (RCBAP) Form. The Dwelling
Form insures a one-to-four family
residential building or a single-family
dwelling unit in a condominium
building. See 44 CFR part 61, Appendix
A(1). Policies under the Dwelling Form
offer coverage for building property, up
to $250,000, and personal property up
to $100,000. The General Property Form
ensures a five-or-more family residential
building or a non-residential building.
See 44 CFR part 61, Appendix A(2). The
General Property Form offers coverage
for building and contents up to
$500,000 each. The RCBAP Form
insures residential condominium
association buildings and offers
building coverage up to $250,000
multiplied by the number of units and
contents coverage up to $100,000 per
building. See 44 CFR part 61, appendix
A(3). RCBAP contents coverage insures
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property owned by the insured
condominium association. Individual
unit owners must purchase their own
Dwelling Form policy in order to insure
their own contents.
FEMA last substantively revised the
SFIP in 2000. See 65 FR 60758 (Oct. 12,
2000). In 2020, FEMA published a final
rule that made non-substantive
clarifying and plain language
improvements to the SFIP. See 85 FR
43946 (July 20, 2020). However, many
policyholders, agents, and adjusters
continue to find the SFIP difficult to
read and interpret compared to other,
more modern, property and casualty
insurance products found in the private
market. Accordingly, FEMA proposes to
adopt a new Homeowner Flood Form.
The new Homeowner Flood Form,
which FEMA proposes to add to its
regulations at 44 CFR 61 appendix A(4),
would protect property owners in a oneto-four family residence. Upon
adoption, the Homeowner Flood Form
would replace the Dwelling Form as a
source of coverage for this class of
residential properties. FEMA would
continue to use the Dwelling Form to
insure landlords, renters, and owners of
mobile homes, travel trailers, and
condominium units. Compared to the
current Dwelling Form, the new
Homeowner Flood Form would clarify
coverage and more clearly highlight
conditions, limitations, and exclusions
in coverage as well as add and modify
coverages and coverage options. FEMA
also proposes adding to its regulations
five endorsements to accompany the
new Form: Increased Cost of
Compliance Coverage, Actual Cash
Value Loss Settlement, Temporary
Housing Expense, Basement Coverage,
and Builder’s Risk. These endorsements,
which FEMA proposes to codify at 44
CFR 61 appendices A(101)–(105),
respectively, would give policyholders
the option of amending the Homeowner
Flood Form to modify coverage with a
commensurate adjustment to premiums
charged. Together, the Homeowner
Flood Form and accompanying
endorsements would increase options
and coverage for owners of one-to-four
family residences.
FEMA intends that this new Form
will be more user-friendly and
comprehensible. As a result, the new
Homeowner Flood Form and its
accompanying endorsements would
provide a more personalized,
customizable product than the NFIP has
offered during its 50 years. In addition
to aligning with property and casualty
homeowners’ insurance, the result
would increase consumer choice and
simplify coverage.
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Anticipated Cost and Benefits: FEMA
estimates that this rulemaking would
result in an increase in transfer
payments from policyholders to FEMA
and insurance providers in the form of
flood insurance premiums, and from
FEMA to policyholders in the form of
claims payments. Additionally, this
rulemaking would result in benefits to
policyholders, insurance providers, and
FEMA, mostly through cost savings due
to increased clarity and expanded
coverage options. It would also help the
NFIP better signal risk through
premiums, reduce the need for Federal
assistance, and increase resilience by
enhancing mitigation efforts. Lastly, one
increase in costs for FEMA will be for
expenditures on implementation and
familiarization of the rule.
Timetable:
Action
NPRM ..................
Date
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Christine Merk, Lead
Management and Program Analyst,
Department of Homeland Security,
Federal Emergency Management
Agency, Insurance Analytics and Policy
Branch, 400 C Street SW, Washington,
DC 20472, Phone: 202 735–6324, Email:
christine.merk@fema.dhs.gov.
RIN: 1660–AB06
DHS—FEMA
Final Rule Stage
96. • Amendment to the Public
Assistance Program’s Simplified
Procedures Large Project Threshold
Priority: Other Significant.
Legal Authority: 42 U.S.C. 5189
CFR Citation: 44 CFR 206.203(c)(1);
44 CFR 206.203(c)(2).
Legal Deadline: Final, Statutory,
February 26, 2014, Every 3 years, the
President, acting through the
Administrator, shall review the
threshold for eligibility under section
422 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act.
Abstract: The Federal Emergency
Management Agency (FEMA) is revising
its regulations governing the Public
Assistance program to update the
monetary threshold at or below which
FEMA will obligate funding based on an
estimate of project costs, and above
which FEMA will obligate funding
based on actual project costs. This rule
will ensure FEMA and recipients can
more efficiently process unobligated
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
Project Worksheets for COVID–19
declarations, which continue to fund
important pandemic-related work, while
avoiding unnecessary confusion and
administrative burden by not affecting
previous project size determinations.
Statement of Need: FEMA’s Public
Assistance (PA) program provides grants
to State, local, Tribal, and Territorial
governments, as well as eligible private
nonprofit (PNP) organizations, for debris
removal, emergency protective
measures, and the repair, replacement,
or restoration of disaster-damaged
facilities after a Presidentially-declared
major disaster. FEMA categorizes each
grant award as either a small or large
project, which is determined by a
monetary threshold set each year by
FEMA pursuant to statute. (See section
422 of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act,
codified at 42 U.S.C. 5189). FEMA
obligates money for a small project
based on an estimate of the project
costs, and FEMA obligates money for a
large project based on actual project
costs as the project progresses and cost
documentation is provided to FEMA.
This expedites FEMA’s processing of PA
grant funding by eliminating much of
the administrative burden that FEMA
experiences when awarding projects at
or above the threshold (i.e., large
projects). Ultimately, this reduces
FEMA’s cost of administering PA
funding and allows FEMA to expedite
its provision of Federal disaster
assistance.
In 2013, the Sandy Recovery
Improvement Act amended section
422(b) of the Stafford Act and required
FEMA to complete an analysis to
determine whether an increase in the
large project threshold was appropriate.
Following this analysis, in 2014 FEMA
updated the maximum threshold from
$68,500 to $120,000 and continued to
adjust the threshold annually to reflect
changes in the Consumer Price Index, as
required under section 422(b)(2).
Section 422(b)(3) requires FEMA to
review the threshold every three years.
FEMA conducted an analysis in 2017
and recommended no change to the
threshold at that time. As a result, the
maximum threshold for Fiscal Year (FY)
2021 is currently set at $132,800.
Since FEMA’s analysis in 2017, the
U.S. has seen increased disaster activity
either due to, or amplified or aggravated
by, the climate crisis. For example, in
2017, Hurricanes Harvey, Irma, and
Maria caused a combined total of $293.6
billion in damages. Damages from
wildfires in that year and the next
totaled approximately $61 billion. In
2020, FEMA responded to 22 one
billion-dollar events the highest in its
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history which included a record number
of tropical storms in the Atlantic and
the Nation’s most active wildfire year
recorded. The estimated damages from
these 22 events totaled approximately
$95 billion. In addition to increased
natural disasters, in 2020 FEMA also
issued an unprecedented 57 major
disaster declarations in response to
COVID–19, including for every State, 5
territories, the Seminole Tribe of
Florida, and the District of Columbia. In
FY 2020 declarations, FEMA’s funding
under the PA program is over $32
billion. Although costs for COVID–19
accounted for 94 percent of this
funding, FEMA expects climate change
to make natural disasters more frequent
and more destructive, requiring greater
spending on recovery in the future.
As a result, in 2020, FEMA conducted
another analysis to ensure that FEMA is
maximizing the benefits of simplified
procedures in light of its more recent
disaster spending. Based on this
analysis, FEMA determined that it
should increase the threshold to
$1,000,000, with continued annual
adjustment for inflation based on the
Consumer Price Index.
Anticipated Cost and Benefits: FEMA
estimates that this rulemaking would
result in transfers from FEMA to PA
recipients and familiarization costs for
PA applicants. Additionally, this rule
would reduce the administrative burden
and improve program efficiency for PA
recipients, subrecipients, and FEMA,
resulting in cost savings to FEMA and
PA recipients/subrecipients.
Timetable:
Action
Date
Final Rule ............
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: Federal,
Local, State, Tribal.
Agency Contact: Valerie Boulet,
Program Administration Section, Public
Assistance Division, Department of
Homeland Security, Federal Emergency
Management Agency, 500 C Street SW,
Washington, DC 20472–3100, Phone:
202 538–3860, Email: valerie.boulet@
fema.dhs.gov.
RIN: 1660–AB10
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DHS—FEMA
Long-Term Actions
97. Individual Assistance Program
Equity
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 5155; 42
U.S.C. 5174; 42 U.S.C. 5189a
CFR Citation: 44 CFR 206.101; 44 CFR
206.110 to 206.115; 44 CFR 206.117 to
206.119; 44 CFR 206.191.
Legal Deadline: None.
Abstract: As climate change results in
more frequent and/or intense extreme
weather events like severe storms,
flooding and wildfires,
disproportionately impacting the most
vulnerable in society and in furtherance
of E.O. 13895, the Federal Emergency
Management Agency (FEMA) proposes
to amend its Individual Assistance (IA)
regulations to increase equity and ease
of entry to the IA Program. To provide
a full opportunity for underserved
communities to participate, FEMA
proposes to amend application of ‘safe,
sanitary, and functional’ for IA repair
assistance; re-evaluate the requirement
to apply for a Small Business
Administration loan prior to receipt of
Other Needs Assistance; add eligibility
criteria for its Serious Needs &
Displacement Assistance; amend its
requirements for Continued Temporary
Housing Assistance; re-evaluate its
approach to insurance proceeds; and
amend its appeals process. FEMA also
proposes revisions to reflect changes to
statutory authority that have not yet
been implemented in regulation, to
include provisions for utility and
security deposit payments, lease and
repair of multi-family rental housing,
childcare assistance, and maximum
assistance limits.
Statement of Need: FEMA’s
Individuals and Households Program
(IHP) regulations have not had a major
review and update since section 206 of
the Disaster Mitigation Act of 2000
replaced the Individual and Family
Grant Assistance Program with the
current IHP. Some minor changes to
Repair Assistance were completed in
2013, but Congress has passed multiple
other laws that have superseded
portions of the regulations and created
other programs or forms of assistance
with no supporting regulations. FEMA
proposes an update to the IHP
regulations now to bring them up to
date and address other lessons learned
through the course of implementing the
IHP in disasters much larger than any
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previously addressed at the time the
regulations were first developed.
Timetable:
Action
Date
NPRM ..................
FR Cite
11/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
Agency Contact: Kristina McAlister,
Supervisory Emergency Management
Specialist (Recovery), Department of
Homeland Security, Federal Emergency
Management Agency, Individual
Assistance Division Recovery
Directorate, 500 C Street SW,
Washington, DC 20472, Phone: 202 604–
8007, Email: kristina.mcalister@
fema.dhs.gov.
RIN: 1660–AB07
DHS—CYBERSECURITY AND
INFRASTRUCTURE SECURITY
AGENCY (CISA)
Proposed Rule Stage
facilities register with the Department of
Homeland Security and be vetted
against the Terrorist Screening Database.
The statute further requires that
information about transactions of
ammonium nitrate be recorded and
kept. Given the widespread use of
ammonium nitrate in many sectors of
the economy, including industrial,
agricultural, and consumer uses, the
Department is exploring ways to reduce
the threat of terrorism posed by
ammonium nitrate while remaining
sensitive to the impacts on the supply
chain and legitimate users.
Summary of Legal Basis: This
regulation is statutorily mandated by 6
U.S.C. 488 et seq.
Anticipated Cost and Benefits: In the
2011 NPRM, CISA estimated cost of this
proposed rule would range from $300
million to $1,041 million over 10 years
at a 7 percent discount rate. In the
intervening years, CISA has adjusted its
approach to this rulemaking and has
made significant changes to the way we
estimate the costs associated with this
SNPRM. At this time CISA is still
developing the cost estimates for and
substantive contents of this SNPRM.
Timetable:
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98. Ammonium Nitrate Security
Program
Action
Priority: Other Significant. Major
under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under PL 104–
4.
Legal Authority: 6 U.S.C. 488 et seq.
CFR Citation: 6 CFR 31.
Legal Deadline: NPRM, Statutory,
May 26, 2008, Publication of Notice of
Proposed Rulemaking. Final, Statutory,
December 26, 2008, Publication of Final
Rule.
Abstract: The Cybersecurity and
Infrastructure Security Agency (CISA) is
proposing a rulemaking to implement
the December 2007 amendment to the
Homeland Security Act titled ‘‘Secure
Handling of Ammonium Nitrate.’’ This
amendment requires the Department of
Homeland Security to ‘‘regulate the sale
and transfer of ammonium nitrate by an
ammonium nitrate facility . . . to
prevent the misappropriation or use of
ammonium nitrate in an act of
terrorism.’’ CISA previously issued a
Notice of Proposed Rulemaking (NPRM)
on August 3, 2011. CISA is planning to
issue a Supplemental Notice of
Proposed Rulemaking (SNPRM).
Statement of Need: A Federal
regulation governing the sale and
transfer of ammonium nitrate is
statutorily mandated. The statute
requires that purchasers of ammonium
nitrate and owners of ammonium nitrate
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Date
ANPRM ...............
ANPRM Correction.
ANPRM Comment
Period End.
NPRM ..................
Notice of Public
Meetings.
Notice of Public
Meetings.
NPRM Comment
Period End.
Notice of Availability.
Notice of Availability Comment
Period End.
Supplemental
NPRM.
10/29/08
11/05/08
FR Cite
73 FR 64280
73 FR 65783
12/29/08
08/03/11
10/07/11
76 FR 46908
76 FR 62311
11/14/11
76 FR 70366
12/01/11
06/03/19
84 FR 25495
09/03/19
03/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
Local, State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Ryan Donaghy,
Deputy Branch Chief for Chemical
Security Policy, Rulemaking, and
Engagement, Department of Homeland
Security, Cybersecurity and
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Infrastructure Security Agency, 245
Murray Lane SW, Mail Stop 0610,
Arlington, VA 20528, Phone: 571 532–
4127, Email: ryan.donaghy@
cisa.dhs.gov.
Related RIN: Previously reported as
1601–AA52.
RIN: 1670–AA00
BILLING CODE 9110–9B–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
Statement of Regulatory Priorities for
Fiscal Year 2022
Introduction
The Regulatory Plan for the
Department of Housing and Urban
Development (HUD) for Fiscal Year (FY)
2022 highlights the most significant
regulations and policy initiatives that
HUD seeks to complete during the
upcoming fiscal year. As the Federal
agency that serves as the nation’s
housing agency, HUD is committed to
addressing the housing needs of all
Americans by creating strong,
sustainable, inclusive communities, and
quality affordable homes for all. As a
result, HUD plays a significant role in
the lives of families and in communities
throughout America.
HUD is currently working to
strengthen the housing market to bolster
the economy and protect consumers;
meet the need for quality affordable
rental homes; utilize housing as a
platform for improving quality of life;
build inclusive and sustainable
communities free from discrimination
and transform the way HUD does
business. Under the leadership of
Secretary Marcia L. Fudge, HUD is
dedicated to implementing the
Administration’s priorities by setting
forth initiatives related to recovery from
the COVID–19 pandemic, providing
economic relief to those HUD serves,
advancing racial equity and civil rights,
and tackling the climate emergency.
Since the beginning of the
Administration, HUD has taken a
number of actions to advance equity in
its programs and secure equal access to
housing opportunity for all. For
example, on February 11, 2021, HUD
issued a memorandum directing its
Office of Fair Housing and Equal
Opportunity and organizations that
enter into agreements with the
Department to carry out fair housing
laws and activities to fully enforce the
Fair Housing Act to prohibit
discrimination based on sexual
orientation and gender identity; on
April 26, 2021, HUD issued a plan of
action the Department will take to
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strengthen Nation-to-Nation relations
and improve HUD-wide Tribal
consultation; on June 10, 2021, HUD
published an interim final rule to
restore certain definitions and
certifications to its regulations
implementing the Fair Housing Act’s
requirement to affirmatively further fair
housing (AFFH) (86 FR 30779); and on
June 25, 2021, HUD published a
proposed rule to reinstate HUD’s
discriminatory effects standard (86 FR
33590).
The rules highlighted in HUD’s
regulatory plan for FY 2022 reflect
HUD’s efforts to continue its work in
meeting the needs of underserved
communities and providing for equal
access to housing opportunities. In
addition, it reflects HUD’s efforts to
strengthen the housing market and
protect consumers, and to aid in
recovery from the COVID–19 pandemic.
Additionally, HUD notes that the FY
2022 Semiannual Regulatory Agenda
includes additional rules that advance
the Administration’s priorities,
including, rules to advance equity by
ensuring non-discrimination based on
disability in HUD programs, and a rule
to help address the climate emergency
by improving the resilience of HUDassisted or financed projects to the effect
of climate change.
Affirmatively Furthering Fair Housing
Executive Order 13985, ‘‘Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government,’’ (86 FR 7009,
January 20, 2021) requires each agency
to consider whether new policies,
regulations, or guidance documents may
be necessary to advance equity in
agency actions and programs. Further,
on January 26, 2021 (86 FR 7487),
President Biden issued a ‘‘Memorandum
on Redressing Our Nation’s and the
Federal Government’s History of
Discriminatory Housing Practices and
Policies,’’ which explained that the
Federal Government will work with
communities to, among other things,
end housing discrimination, lift barriers
that restrict housing and neighborhood
choice, promote diverse and inclusive
communities, and to secure equal access
to housing opportunity for all.
As noted above, on June 10, 2021,
HUD published an interim final rule to
restore certain definitions and
certifications to its regulations
implementing the Fair Housing Act’s
requirement. HUD will build on that
rule and issue an AFFH proposed rule
that seeks to ensure that HUD and its
grantees are sufficiently effective in
fulfilling the purposes and policies of
the Fair Housing Act. HUD’s proposed
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rule will provide HUD and its program
participants with a more effective Fair
Housing Planning Process as a means to
meet their duty to affirmatively further
the Fair Housing Act. Currently, HUD
funding recipients must certify
compliance with their duty to AFFH on
an annual basis and HUD itself has a
continuous statutory obligation to
ensure that the Fair Housing Act’s
AFFH obligations are followed.
For decades, courts have held that the
AFFH obligation imposes a duty on
HUD and its grantees to affirmatively
further the purposes of the Fair Housing
Act. These courts have held that for
funding recipients to meet their AFFH
obligations they must, at a minimum,
make decisions informed by preexisting
racial and socioeconomic residential
segregation. The courts have further
held that, informed by such
information, funding recipients must
strive to dismantle historic patterns of
racial segregation; preserve integrated
housing that already exists; and
otherwise take meaningful steps to
further the Fair Housing Act’s purposes
beyond merely refraining from taking
discriminatory actions and banning
others from such discrimination.
Through this proposed rule, HUD plans
to implement the AFFH mandate and
work towards a more equitable future
for all by developing a Fair Housing
Planning Process that reduces burdens
for program participants and achieves
material, positive change that
affirmatively furthers fair housing.
Specifically, HUD is focused on
advancing equity and providing access
to opportunity for underserved
populations in a manner that is more
effective in achieving measurable
improvements while avoiding
unnecessary burden.
Aggregate Costs and Benefits
Executive Order 12866, as amended,
requires the agency to provide its best
estimate of the combined aggregate costs
and benefits of all regulations included
in the agency’s Regulatory Plan that will
be pursued in FY 2022. HUD expects
that the neither the total economic costs
nor the total efficiency gains will exceed
$100 million. HUD grantees are already
familiar with the AFFH compliance
process as instituted by the 2015 rule
and the 2021 interim final rule. Having
learned from prior rulemakings, HUD
believes that the rule will create the
right balance of analysis so that grantees
will have the available data necessary to
help them in completing any analytical
requirements without adding the same
level of costs associated with the 2015
rulemaking.
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Statement of Need
The rule is needed to conform HUD
regulations with statutory standards and
judicial interpretations of those
standards, and to ensure consistency in
fair housing certifications across HUD
programs. This proposed rule would
consider HUD’s AFFH rule published
on July 16, 2015 (80 FR 42272) (2015
AFFH rule) but improve upon its
framework and impose less regulatory
burden.
Alternatives: Alternatives to
promulgating this rule involve finalizing
the interim rule, ‘‘Restoring
Affirmatively Furthering Fair Housing
Definitions and Certifications,’’ without
taking further action or repromulgating
the 2015 AFFH rule without considering
changes that could reduce regulatory
burden and enable a more meaningful
fair housing planning process. If HUD
were to finalize the interim rule without
taking further action, there would be
inconsistency in fair housing
certifications across different
jurisdictions, as the interim rule does
not require that jurisdictions submit fair
housing plans in any particular form,
such as an Analysis of Impediments, or
an Assessment of Fair Housing, as was
previously required. If HUD were to
repromulgate the 2015 AFFH rule
without considering changes, HUD
would miss an opportunity to improve
upon that rule and reduce the
significant regulatory burdens resulting
from that rule. HUD believes neither of
those options are better than providing
for a new certification process that will
undergo new public comment.
Risks: Previous iterations of the AFFH
rule have resulted in an amount of
burden on grantees that made
implementation challenging. HUD must
balance the use of data and the depth of
analysis that is required of differing
sized grantees to ensure that grantees
can implement the affirmatively
furthering fair housing mandate while
continuing to fulfill their programmatic
requirements. In promulgating this rule,
HUD will attempt to secure support
from as many stakeholders as possible
to ensure maximum compliance with
the duty to AFFH.
Timetable:
Action
Proposed Rule ....
Date
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Governmental
jurisdictions.
Government Levels Affected: Yes.
Federalism Affected: No.
Energy Affected: No.
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International Impacts: No.
Increased Forty-Year Term for Loan
Modifications
Executive Order 14002, ‘‘Economic
Relief Related to the COVID–19
Pandemic’’ (Jan. 22, 2021), directs
federal agencies to ‘‘promptly identify
actions they can take within existing
authorities to address the current
economic crisis resulting from the
[COVID 19] pandemic.’’ In response to
this Executive Order and in support of
the goal of achieving broad economic
recovery following the COVID–19
pandemic, HUD has established
expanded COVID–19 Loss Mitigation
Options to address the impacts many
Americans are experiencing in
recovering financially from the longlasting effects of the pandemic. HUD
continues to evaluate both the effects of
the pandemic on its portfolio as well as
the economic indicators of the broader
recovery.
This proposed rule would amend
HUD’s current regulation to allow for
mortgagees to recast the total unpaid
loan and other eligible costs for a new
term not exceeding 480 months. HUD
anticipates that this would allow
mortgagees greater ability to assist
defaulted borrowers, including
borrowers affected by the COVID–19
pandemic, with avoiding foreclosure.
HUD’s current regulations allow
mortgagees to modify a Federal Housing
Administration (FHA) insured mortgage
by recasting the total unpaid loan and
other eligible costs for a term limited to
360 months to cure a borrower’s default.
Mortgagees are required to consider
utilizing deeds in lieu of foreclosure,
pre-foreclosure sales, partial claims,
assumptions, special forbearance, and
recasting of mortgages.1 One of these
options allows mortgagees to modify a
mortgage for the purpose of changing
the amortization provisions and
recasting the total unpaid loan and other
eligible costs for a term not exceeding
360 months from the date of the
modification.2
Allowing mortgagees to provide a 40year loan modification would support
HUD’s mission of fostering
homeownership by assisting more
borrowers with retaining their homes
after a default episode while mitigating
losses to FHA’s Mutual Mortgage
Insurance (MMI) Fund. For many
borrowers who have become delinquent,
a lowered monthly payment is key to
their ability to bring the mortgage
current, prevent re-default, and
ultimately retain their home and build
1 24
2 24
CFR 203.501.
CFR 203.616
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wealth through homeownership. The
difference between the monthly
payment provided under a 40-year loan
modification and a 30-year loan
modification may be significant for a
borrower and their ability to afford the
modified payment.
Aggregate Costs and Benefits
Executive Order 12866, as amended,
requires the agency to provide its best
estimate of the combined aggregate costs
and benefits of all regulations included
in the agency’s Regulatory Plan that will
be pursued in FY 2021. HUD expects
that neither the total economic costs nor
the total efficiency gains will exceed
$100 million. This proposed rule would
increase available loss mitigation
options for borrowers and enable more
borrowers to avoid foreclosure and
remain in their homes. HUD also
anticipates that this would have a
positive effect on the FHA Mutual
Mortgage Insurance Fund by lowering
defaults.
Statement of Need
Borrowers impacted by the COVID–19
pandemic, including those who may redefault in the future after having
received a loss mitigation option under
HUD’s COVID–19 policies, may need a
40-year loan modification to provide a
monthly payment that they can afford.
It is vital that these borrowers receive
any loss mitigation options at HUD’s
disposal and for which they are eligible
to avoid foreclosure whenever possible
and to mitigate the impact of the
COVID–19 pandemic.
Additionally, given the large number
of FHA-insured mortgages that have
been originated or refinanced in the past
few years in a historically low interest
rate environment, simply extending out
the term of a mortgage in default for
another 30 years at a similar interest rate
would not provide a substantial
reduction to a borrower’s monthly
mortgage payment. Therefore, providing
this option for relief for all borrowers
and originators is prudent for all FHAinsured mortgages.
Alternatives
HUD has considered other loss
mitigation options which would allow
borrowers to avoid foreclosure in
response to the COVID–19 pandemic.
HUD has made many of these options
available through mortgagee letter. HUD
does not view these options as
alternatives, as different circumstances
may call for different forms of loss
mitigation. Additionally, HUD finds that
this new option should not be limited
only in response to the COVID–19
pandemic, but should be available in all
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circumstances where it could help
individuals keep their homes.
Risks
Although the impact of introducing a
40-year loan modification option for
borrowers on the MMI Fund will
needed to be modeled, HUD anticipates
a favorable impact through reduced
utilization of other, more costly loss
mitigation options and foreclosure
prevention.
Additionally, HUD anticipates that
the effect on FHA-insured mortgagors
will be minor. HUD recognizes that a
40-year mortgage would cost the
borrower in the form of greater interest
paid over time and slower equity
building. However, HUD notes that the
average life of an FHA-insured mortgage
is approximately seven years, and HUD
anticipates that a borrower would
similarly refinance a 40-year mortgage.
Any additional interest and slowed
equity build that a borrower might pay
with a 40-year modified loan compared
to a 30-year modified loan, especially
when looked at over the life of an
average FHA-insured mortgage, would
not impose a significant burden to
borrowers and would be outweighed by
the benefits to a borrower of being able
to retain their home.
Timetable:
Action
Proposed rule ......
Date
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism Affected: No.
Energy Affected: No.
International Impacts: No.
HUD—OFFICE OF HOUSING (OH)
Proposed Rule Stage
99. Increased 40-Year Term for Loan
Modifications (FR–6263)
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 12 U.S.C. 1707, 1709,
1710, 1715b, 1715z–16, 1715u, and
1715z–21; 15 U.S.C. 1639c; 42 U.S.C.
3535(d)
CFR Citation: 24 CFR 203.
Legal Deadline: None.
Abstract: This would amend the
current regulation at 24 CFR 203.616 to
permit the modification of an FHAinsured mortgage for a maximum term
not to exceed 480 months, or 40 years.
The current regulation allows a
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mortgagee to modify a loan to cure a
default by recasting the total unpaid
amount due and other eligible costs for
a term not exceeding 360 months, or 30
years. Increasing the term length of a
modified loan would provide borrowers
with a deeper reduction to their
monthly mortgage payments as the
outstanding principal would be spread
over a longer time frame. This change
would provide more FHA borrowers
with the ability to retain their homes
after default, including borrowers who
have exhausted their partial claim
allocation, as well as provide more
affordable housing payments. This
change would also align FHA with
modifications available to borrowers
with mortgages backed by Fannie Mae
or Freddie Mac, which currently
provide a 40-year loan modification
option.
Statement of Need: HUD anticipates
that this would allow mortgagees greater
ability to assist defaulted borrowers,
including mortgagees affected by the
COVID–19 pandemic, with avoiding
foreclosure. It is vital that borrowers
receive any loss mitigation options at
HUD’s disposal and for which they are
eligible to avoid foreclosure whenever
possible and to mitigate the impact of a
loss of job or other financial strains such
as those resulting from the COVID–19
pandemic.
Additionally, given the large number
of FHA-insured mortgages that have
been originated or refinanced in the past
few years in a historically low interest
rate environment, simply extending out
the term of a mortgage in default for
another 30 years at a similar interest rate
would not provide a substantial
reduction to a borrower’s monthly
mortgage payment. Therefore, providing
this option for relief for all borrowers
and originators is prudent for all FHAinsured mortgages.
Summary of Legal Basis: Executive
Order 14002, Economic Relief Related to
the COVID–19 Pandemic (Jan. 22, 2021),
directs federal agencies to promptly
identify actions they can take within
existing authorities to address the
current economic crisis resulting from
the [COVID 19] pandemic. In response
to this Executive Order and in support
of the goal of achieving broad economic
recovery following the COVID–19
pandemic, HUD has established
expanded COVID–19 Loss Mitigation
Options to address the impacts many
Americans are experiencing in
recovering financially from the longlasting effects of the pandemic.
Alternatives: HUD has considered
other loss mitigation options which
would allow borrowers to avoid
foreclosure in response to the COVID–
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Jkt 256001
19 pandemic. HUD has made many of
these options available through
mortgagee letter. HUD does not view
these options as alternatives, as different
circumstances may call for different
forms of loss mitigation. Additionally,
HUD finds that this new option should
not be limited only in response to the
COVID–19 pandemic, but should be
available in all circumstances where it
could help individuals keep their
homes.
Anticipated Cost and Benefits:
Executive Order 12866, as amended,
requires the agency to provide its best
estimate of the combined aggregate costs
and benefits of all regulations included
in the agency’s Regulatory Plan that will
be pursued in FY 2021. HUD expects
that neither the total economic costs nor
the total efficiency gains will exceed
$100 million. This proposed rule would
increase available loss mitigation
options for borrowers and enable more
borrowers to avoid foreclosure and
remain in their homes. HUD also
anticipates that this would have a
positive effect on the FHA Mutual
Mortgage Insurance Fund by lowering
defaults.
Risks: Although the impact of
introducing a 40-year loan modification
option for borrowers on the MMI Fund
will needed to be modeled, HUD
anticipates a favorable impact through
reduced utilization of other, more costly
loss mitigation options and foreclosure
prevention.
Additionally, HUD anticipates that
the effect on FHA-insured mortgagors
will be minor. HUD recognizes that a
40-year mortgage would cost the
borrower in the form of great interest
paid over time and slower equity
building. However, HUD notes that the
average life of an FHA-insured mortgage
is approximately seven years, and HUD
anticipates that a borrower would
similarly refinance a 40-year mortgage.
Any additional interest and slowed
equity build that a borrower might pay
with a 40-year modified loan compared
to a 30-year modified loan, especially
when looked at over the life of an
average FHA-insured mortgage, would
not impose a significant burden to
borrowers and would be outweighed by
the benefits to a borrower of being able
to retain their home.
Timetable:
Action
Date
NPRM ..................
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
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Agency Contact: Elissa Saunders,
Acting Director, Office of Single Family
Asset Management, Department of
Housing and Urban Development, Office
of Housing, 451 Seventh Street SW,
Washington, DC 20410, Phone: 202 708–
2121.
RIN: 2502–AJ59
HUD—OFFICE OF FAIR HOUSING AND
EQUAL OPPORTUNITY (FHEO)
Proposed Rule Stage
100. Affirmatively Furthering Fair
Housing (FR–6250)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 3608(e)(5);
42 U.S.C. 5304; 42 U.S.C. 12705(b); 42
U.S.C. 1437c–1; 42 U.S.C. 3535(d); 42
U.S.C. 3600 to 3620
CFR Citation: 24 CFR 5, 91, 92, 570,
574, 576, and 903.
Legal Deadline: None.
Abstract: Through this proposed rule,
HUD seeks to provide HUD and its
program participants with a more
effective means to affirmatively further
the purposes and policies of the Fair
Housing Act. The current procedures for
affirmatively furthering fair housing
carried out by program participants are
not sufficiently effective to fulfill the
purposes and policies of the Fair
Housing Act. HUD will be seeking
public comment on a new proposed rule
that is focused on advancing equity and
providing access to opportunity for
underserved populations in a manner
that is more effective in achieving
measurable improvements while
avoiding unnecessary burden.
Statement of Need: The rule is needed
to conform HUD regulations with
statutory standards and judicial
interpretations of those standards, and
to ensure consistency in fair housing
certifications across HUD programs.
This proposed rule would consider
HUD’s AFFH rule published on July 16,
2015 (80 FR 42272) (2015 AFFH rule)
but improve upon its framework and
impose less regulatory burden.
Summary of Legal Basis: Executive
Order 13985, Advancing Racial Equity
and Support for Underserved
Communities Through the Federal
Government, (86 FR 7009, January 20,
2021) requires each agency to consider
whether new policies, regulations, or
guidance documents may be necessary
to advance equity in agency actions and
programs. Further, on January 26, 2021
(86 FR 7487), President Biden issued a
Memorandum on Redressing Our
Nation’s and the Federal Government’s
History of Discriminatory Housing
Practices and Policies, which explained
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that the Federal Government will work
with communities to, among other
things, end housing discrimination, lift
barriers that restrict housing and
neighborhood choice, promote diverse
and inclusive communities, and secure
equal access to housing opportunity for
all.
Alternatives: Alternatives to
promulgating this rule involve finalizing
the interim rule, Restoring Affirmatively
Furthering Fair Housing Definitions and
Certifications, without taking further
action or repromulgating the 2015 AFFH
rule without considering changes that
could reduce regulatory burden and
enable a more meaningful fair housing
planning process. If HUD were to
finalize the interim rule without taking
further action, there would be
inconsistency in fair housing
certifications across different
jurisdictions, as the interim rule does
not require that jurisdictions submit fair
housing plans in any particular form,
such as an Analysis of Impediments or
an Assessment of Fair Housing, as was
previously required. If HUD were to
repromulgate the 2015 AFFH rule
without considering changes, HUD
would miss an opportunity to improve
upon that rule and reduce the
significant regulatory burdens resulting
from that rule. HUD believes neither of
those options are better than providing
for a new certification process that will
undergo new public comment.
Anticipated Cost and Benefits:
Executive Order 12866, as amended,
requires the agency to provide its best
estimate of the combined aggregate costs
and benefits of all regulations included
in the agency’s Regulatory Plan that will
be pursued in FY 2022. HUD expects
that the neither the total economic costs
nor the total efficiency gains will exceed
$100 million. HUD grantees are already
familiar with the AFFH compliance
process as instituted by the 2015 rule
and the 2021 interim final rule. Having
learned from prior rulemakings, HUD
believes that the rule will create the
right balance of analysis so that grantees
will have the available data necessary to
help them in completing any analytical
requirements without adding the same
level of costs associated with the 2015
rulemaking.
Risks: Previous iterations of the AFFH
rule have resulted in an amount of
burden on grantees that made
implementation challenging. HUD must
balance the use of data and the depth of
analysis that is required of differing
sized grantees to ensure that grantees
can implement the affirmatively
furthering fair housing mandate while
continuing to fulfill their programmatic
requirements. In promulgating this rule,
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HUD will attempt to secure support
from as many stakeholders as possible
to ensure maximum compliance with
the duty to AFFH.
Timetable:
Action
Date
NPRM ..................
FR Cite
12/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State.
Agency Contact: Demetria McCain,
Principal Deputy Assistant Secretary for
Fair Housing and Equal Opportunity,
Department of Housing and Urban
Development, Office of Fair Housing
and Equal Opportunity, 451 Seventh
Street, Washington, DC 20410, Phone:
202 402–5188.
RIN: 2529–AB05
BILLING CODE 4210–67–P
UNITED STATES DEPARTMENT OF
THE INTERIOR
Fall 2021 Regulatory Plan
Introduction
The U.S. Department of the Interior
(Department) is the principal steward of
our Nation’s public lands and resources,
including many of our cultural
treasures. The Department serves as
trustee to Native Americans, Alaska
Natives, and Federally-Recognized
Tribes and is responsible for our
ongoing relationships with the island
territories under U.S. jurisdiction and
the freely associated states. Among the
Department’s many responsibilities is
managing more than 500 million surface
acres of Federal land, which constitutes
approximately 20 percent of the
Nation’s land area, as well as
approximately 700 million subsurface
acres of Federal mineral estate, and
more than 2.5 billion acres of
submerged lands on the Outer
Continental Shelf (OCS).
In addition, the Department protects
and recovers endangered species;
protects natural, historic, and cultural
resources; provides scientific and other
information about those resources; and
manages water projects that are an
essential lifeline and economic engine
for many communities.
Hundreds of millions of people visit
Department-managed lands each year to
take advantage of a wide range of
recreational pursuits—including
camping, hiking, hunting, fishing, and
various other forms of outdoor
recreation—and to learn about our
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Nation’s history. Each of these activities
supports local communities and their
economies. The Department also
provides access to Federal lands and
offshore areas for the development of
energy, minerals, and other natural
resources that generate billions of
dollars in revenue.
In short, the Department of the
Interior plays a central role in how the
United States stewards its public lands,
ensures environmental protections,
pursues environmental justice, honors
the nation-to-nation relationship with
tribes and the special relationships with
other indigenous people and the insular
areas.
Regulatory and Deregulatory Priorities
To help advance the Secretary of the
Interior’s (Secretary) commitment to
honoring the Nation’s trust
responsibilities and to conserve and
manage the Nation’s natural resources
and cultural heritage, the Department’s
regulatory and deregulatory priorities in
the coming fiscal year (FY) will focus
on:
• Tackling the Climate Crisis,
Strengthening Climate Resiliency, and
Facilitating the Transition to Renewable
Energy;
• Upholding Trust Responsibilities to
Federally-Recognized American Indian
and Alaska Native Tribes Restoring
Tribal Lands, and Protecting Natural
and Cultural Resources Advancing
Equity and Supporting Underserved
Communities;
• Investing in Healthy Lands, Waters
and Local Economies and Strengthening
Conservation, and Protecting
Endangered Species and their Habitat
Tackling the Climate Crisis,
Strengthening Climate Resiliency, and
Facilitating the Transition to Renewable
Energy
In one of his first official actions after
taking the oath of office on January 20,
2021, President Biden signed Executive
Order (E.O.) 13990, entitled ‘‘Protecting
Public Health and the Environment and
Restoring Science to Tackle the Climate
Crisis.’’ This Executive order
established the Biden-Harris
administration’s policy to ‘‘improve
public health and protect our
environment, to ensure access to clean
air and water, to reduce greenhouse gas
emissions and to bolster resilience of
the impacts of climate change.’’ An
accompanying document, entitled ‘‘Fact
Sheet: List of Agency Actions for
Review,’’ directed several Federal
agencies, including the Department, to
review various regulations in
accordance with E.O. 13990, and that
review will continue for FY 2022.
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To help implement the commitment
to tackling the climate crisis, Secretary
Haaland signed her first Secretary’s
Order (SO), SO 3398, entitled
‘‘Revocation of Secretary’s Orders
Inconsistent with Protecting Public
Health and the Environment and
Restoring Science to Tackle the Climate
Crisis.’’ SO 3398 implements the review
of Departmental actions mandated by
Executive Order 13990. Foundational to
this process is the commitment to
science and transparency and a pledge
‘‘to conserve and restore our land,
water, and wildlife; to reduce
greenhouse gas emissions; to create jobs
through a growing clean energy
economy; and to bolster resilience to the
impacts of climate change.’’ SO 3398
revoked 12 SOs that were issued
between March 29, 2017, and December
22, 2020, and directed the Department
to conduct reviews and take appropriate
actions on certain regulations. The SO
further directed Bureaus and Offices to
review all policies and guidance
documents that may warrant further
action to be consistent with Executive
Order 13990.
Recognizing the ongoing threat that
climate change poses to our Nation and
to the world, on January 27, 2021,
President Biden also issued Executive
Order 14008 entitled, ‘‘Tackling the
Climate Crisis at Home and Abroad.’’
Executive Order 14008 directed Federal
agencies to take a government-wide
approach to the climate crisis and
established a National Climate Task
Force to facilitate the organization and
deployment of such an approach.
To implement the directives in
Executive Order 14008, on April 16,
2021, Secretary Haaland issued SO
3399, which directs a ‘‘DepartmentWide Approach to the Climate Crisis
and Restoring Transparency and
Integrity to the Decision-Making
Process.’’ SO 3399 established a
Departmental Climate Task Force
charged with developing a strategy to
reduce climate pollution; improving and
increasing adaptation and resilience to
the impacts of climate change;
addressing current and historic
environmental injustice; protecting
public health; and conserving
Department-managed lands.
In accordance with Executive Orders
13990 and 14008, a number of bureaus
in the Department are pursuing
regulatory actions to implement these
administration priorities. The Bureau of
Land Management (BLM), for example,
is proposing rules to ensure the
responsible development of oil and gas
on public lands, including ‘‘Waste
Prevention, Production Subject to
Royalties, and Resource Conservation 43
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CFR parts 3160 and 3170’’ (1004–AE79),
known as the Waste Prevention Rule,
and ‘‘Revision of Existing Regulations
Pertaining to Fossil Fuel Leases and
Leasing Process 43 CFR parts 3100 and
3400’’ (1004–AE80), known as the Fossil
Fuel Rule. The Waste Prevention Rule
would reduce methane emissions in the
oil and gas sector and mitigate impacts
of climate change. The Fossil Fuel Rule
would update BLM’s process for leasing
to ensure the protection and proper
stewardship of the public lands,
including potential climate and other
impacts associated with fossil fuel
activities. Also, to comply with
Executive Order 14008, BLM plans to
complete a comprehensive review and
reconsideration of Federal fossil fuel
leasing practices considering BLM’s
broad stewardship responsibilities over
the public lands, including potential
climate and other impacts associated
with fossil fuel activities on public
lands.
Similarly, the Bureau of Ocean Energy
Management (BOEM) is also
undertaking a comprehensive review
and reconsideration of offshore Federal
oil and gas permitting and leasing
practices, including potential climate
and other impacts associated with
offshore oil and gas activities. The
BOEM will evaluate the sources and
impacts of climate change on the OCS,
working in consultation with the
Secretary of Agriculture, the Secretary
of Commerce, through the National
Oceanic and Atmospheric
Administration, and the Secretary of
Energy. Given the Secretary’s Outer
Continental Shelf Lands Act (OCSLA)
mandate to conserve the natural
resources on the OCS, this initiative will
evaluate the causes and effects of
climate change and determine what
appropriate measures BOEM should
take to further control emissions of
greenhouse gasses, including whether to
adjust royalties associated with coal, oil,
and gas resources extracted from public
lands and offshore waters, develop
regulations, or to take other action to
account for corresponding climate costs.
One of the explicit directions in
Executive Order 14008 provides that the
Secretary, in consultation with the
heads of other relevant agencies, will
review siting and permitting processes
on public lands and in offshore waters
to identify steps that can be taken,
consistent with applicable law, to
increase renewable energy production.
The Department is committed to fully
facilitating the development of
renewable energy on public lands and
waters, as well as supporting tribal and
territorial efforts to develop renewable
energy, including deploying 30
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gigawatts (GW) of offshore wind by 2030
and 25GW of onshore renewable energy
by 2025. This mandate is to be
undertaken while also ensuring
appropriate protection of public lands,
waters, and biodiversity and creating
good jobs.
As part of these efforts in FY 2022,
BOEM will propose a rule entitled,
‘‘Renewable Energy Modernization
Rule’’ (1010–AE04), that will
substantially update the existing
renewable energy regulations to
facilitate responsible development of
renewable energy resources more
rapidly on the OCS and promote U.S.
energy independence. This rule would
also significantly reduce costs to
developers for expanding renewable
energy development in an
environmentally sound manner.
Similarly, BLM plans to update its
regulations for onshore rights-of-way,
leasing, and operations related to all
activities associated with renewable
energy and transmission lines (1004–
AE78). This proposed rule would
improve permitting activities and
processes to facilitate increased
renewable energy production on public
lands.
Upholding Trust Responsibilities to
Federally-Recognized American Indian
and Alaska Native Tribes Restoring
Tribal Lands, and Protecting Natural
and Cultural Resources
Among the Department’s most
important responsibilities is its
commitment to honor the nation-tonation relationship between the Federal
Government and Tribes. Secretary
Haaland is strongly committed to
strengthening how the Department
carries out its trust responsibilities and
to increasing economic development
opportunities for Tribes and other
historically underserved communities.
As part of these efforts, on April 27,
2021, Secretary Haaland signed SO 3400
entitled, ‘‘Delegation of Authority for
Non-Gaming Off-Reservation Fee-toTrust Acquisitions.’’ SO 3400 is
intended to ensure that off-reservation
fee-to-trust applications are effectively
and efficiently processed. As Secretary
Haaland noted upon signing the SO, ‘‘At
Interior, we have an obligation to work
with Tribes to protect their lands and
ensure that each Tribe has a homeland
where its citizens can live together and
lead safe and fulfilling lives . . . Our
actions today will help us meet that
obligation and will help empower
Tribes to determine how their lands are
used—from conservation to economic
development projects.’’
To advance the Department’s trust
responsibilities, the Bureau of Indian
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Affairs (BIA) is currently identifying
opportunities to promote Tribal
economic growth and development. For
example, BIA is working to remove
barriers to the development of
renewable energy and other resources in
Indian country. During FY 2021, BIA
finalized a rule that removed several
required items from Tribal Energy
Resource Agreement (TERA)
applications and offered a new
economic development option for Tribal
Energy Development Organizations
(TEDOs) (1076–AF65) (86 FR 40147,
July 27, 2021).
In consultation with Tribes, BIA has
been engaged in efforts to update and
improve its regulations governing how it
manages land held in trust or in
restricted status for Tribes and
individual Indians. This year, BIA
published a final rule that modernizes
the way the BIA Land Title and Records
Office (LTRO) maintains title to Indian
trust land and streamlines the process
for probating estates that contain trust
property to reduce delays (1076–AF56)
(86 FR 45631, August 16, 2021). The
bureau has also launched a broader
review to determine whether any
regulatory reforms are needed to
facilitate restoration of Tribal lands and
safeguard natural and cultural
resources. The BIA has preliminarily
identified as a candidate for revision the
regulations governing leases of Indian
land for agricultural purposes, which
are found at 25 CFR part 162 (1076–
AF66).
The BIA is also committed to
improving regulations meant to protect
sacred and cultural resources. The BIA
is working with the National Park
Service (NPS) to consult with Tribes on
updates to regulations implementing the
Native American Graves and
Repatriation Act (NAGPRA), 43 CFR 10
(1024–AE19). These regulations would
provide a systematic process for the
disposition and repatriation of Native
American human remains, funerary
objects, sacred objects, and objects of
cultural patrimony. The updates are
intended to simplify and improve the
regulatory process for repatriation,
rectify provisions in the current
regulations that inhibit and effectively
prevent respectful repatriation, and
remove the burden on Indian Tribes and
Native Hawaiian organizations to
initiate the process and add a
requirement for museums and Federal
agencies to complete the process.
Advancing Equity and Supporting
Underserved Communities
The Biden-Harris administration and
Secretary Haaland recognize and
support the goals of advancing equity
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and addressing the needs of
underserved communities. In January
2021, the President signed Executive
Order 13985 entitled, ‘‘Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government.’’ This Executive
order directs all Federal agencies to
pursue a comprehensive approach to
advancing equity for all, including
people of color and others who have
been historically underserved,
marginalized, and adversely affected by
persistent poverty and inequality. In FY
2022, the Department will undertake a
number of regulatory actions that will
assist people who reside in underserved
communities.
The BLM (1004–AE60), FWS (1018–
BD78), and NPS (1024–AE75), are
proposing right-of-way (ROW) rules that
would improve efficiencies in the
communications programs, including
plans and agreements for electric
transmission, distribution facilities and
broadband facilities. These rules are
intended to increase services, such as
broadband connectivity, with resulting
benefits to underserved communities
and visitors to Departmental lands and
promote good governance.
Investing in Healthy Lands, Waters and
Local Economies and Strengthening
Conservation, and Protecting
Endangered Species and Their Habitat
The Department’s FY 2022 regulatory
agenda will continue to advance the
goals of investing in healthy lands,
waters, and local economies across the
country. These regulatory efforts, which
are consistent with the Biden-Harris
administration’s ‘‘America the
Beautiful’’ Initiative, include expanding
opportunities for outdoor recreation,
including hunting and fishing, for all
Americans; enhancing conservation
stewardship; and improving the
management of species and their
habitat.
For example, the U.S. Fish and
Wildlife Service (FWS) opened, for the
first time, seven national wildlife
refuges (NWRs), totaling 2.1 million
acres of public lands, that were
previously closed to hunting and sport
fishing. Hunters and anglers are among
the most ardent conservationists. The
FWS opened or expanded hunting and
sport fishing at 81 other NWRs and
added pertinent station-specific
regulations for other NWRs that pertain
to migratory game bird hunting, upland
game hunting, big game hunting, and
sport fishing for the 2021–2022 season.
The FWS also opened hunting or sport
fishing on one unit of the National Fish
Hatchery System (NFH), adding
pertinent station-specific regulations for
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migratory game bird hunting, upland
game hunting, big game hunting, and
sport fishing at this NFH for the 2021–
2022 season. Finally, FWS made
regulatory changes to existing stationspecific regulations to reduce the
regulatory burden on the public,
increase access for hunters and anglers
on FWS lands and waters, and comply
with a Presidential mandate for plain
language standards. By responsibly
expanding these opportunities, the
Department is enhancing the lives of
millions of Americans, promoting
conservation stewardship, and
stimulating the national economy (86
FR 48822, August 31, 2021).
The NPS is also pursuing several
regulatory actions under the
Department’s direction and in
accordance with these goals. These
regulatory actions would authorize
recreational activities, such as off-road
vehicle use, snowmobiling, the use of
motorized and non-motorized vessels,
personal watercraft, and bicycling,
within appropriate, designated areas of
certain National Park System units.
These regulations would benefit local
economies as well as promote healthy
lands and waters.
The Biden-Harris administration and
Secretary Haaland are strongly
committed to strengthening
conservation and improving
conservation partnerships. Through this
regulatory plan, the Department affirms
the importance of the Endangered
Species Act (ESA) in providing a broad
and flexible framework to facilitate
conservation with a variety of
stakeholders. The Department, through
FWS, is committed to working with
diverse Federal, Tribal, state, and
industry partners to not only protect
and recover America’s imperiled
wildlife but to ensure the ESA is
helping meet 21st century challenges.
In FY 2022, FWS will continue its
reviews of several ESA rules that were
finalized prior to January 20, 2021, to
continue improving the implementation
of the ESA so that it is clearly and
consistently applied, helps recover
listed species, and provides the
maximum degree of certainty possible to
all parties. For example, FWS and the
National Marine Fisheries Service
(NMFS) are reviewing the final rule that
became effective on January 15, 2021,
entitled, ‘‘Regulations for Listing
Endangered and Threatened Species
and Designating Critical Habitat,’’ that
established a regulatory definition of
‘‘habitat.’’ FWS is also reviewing the
final rule entitled, ‘‘Endangered and
Threatened Wildlife and Plants;
Regulations for Designating Critical
Habitat,’’ that became effective on
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January 19, 2021. That rule set forth a
process for excluding areas of critical
habitat under section 4(b)(2) of the ESA,
which mandates our consideration of
the impacts of designating critical
habitat and permits exclusions of
particular areas following a
discretionary exclusion analysis.
Finally, FWS and NMFS are reviewing
the final rule entitled, ‘‘Endangered and
Threatened Wildlife and Plants;
Regulations for Interagency
Cooperation’’ to determine whether and
how the rule should be revised or
rescinded.
Bureaus and Offices Within the
Department of the Interior
The following is an overview of some
of the major regulatory and deregulatory
priorities of the Department’s Bureaus
and Offices.
Bureau of Indian Affairs
The BIA enhances the quality of life,
promotes economic opportunity, and
protects and improves the trust assets of
approximately 1.9 million American
Indians, Indian Tribes, and Alaska
Natives. The BIA maintains a
government- to-government relationship
with the 574 Federally-Recognized
Indian Tribes. The BIA also administers
and manages 55 million acres of surface
land and 57 million acres of subsurface
minerals held in trust by the United
States for American Indians and Indian
Tribes.
Regulatory and Deregulatory Actions
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In FY 2021, BIA finalized a rule that
removed several required items from
TERA applications and offers a new
economic development option for
TEDOs (86 FR 40147, July 27, 2021).
The BIA also published a final rule
that modernizes the manner in which
the BIA LTRO maintains title to Indian
trust land and streamlines the process
for adjudicating probates of estates
containing trust property to reduce
delays (86 FR 45631, August 16, 2021).
The BIA intends to prioritize the
following rulemakings in FY 2022:
Tribal Transportation Program:
Allowable Lengths of Access Roads
(1076–AF48)
This rule would change the allowable
length of access roads in the National
Tribal Transportation Facilities
Inventory, as determined by 25 CFR
170.447, to increase the 15-mile limits
on the length of access roads and create
parity among all Tribes, regardless of
land base or remoteness of location.
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Trust Fund Accounts for Tribes and
Individual Indians—Supervised
Accounts (1076–AF57)
This rule would update the
qualifications required for Indian Affairs
personnel who conduct reviews of
supervised individual Indian Money
(IIM) accounts to ensure that personnel
have appropriate accounting skills and
make other changes to reflect the
transition of duties from social services
providers to IIM account specialists in
the newly established Bureau of Trust
Funds Administration (BTFA).
Leasing of Osage Reservation Lands for
Oil and Gas Mining (1076–AF59)
The regulations in 25 CFR part 226
would be revised because they are
outdated; do not reflect current oil and
gas operations within the Osage Mineral
Estate or the industry at large; and are
inconsistent with Departmental
regulations governing oil and gas
exploration and development
throughout the rest of Indian country.
The last substantive revision to the
regulations in 25 CFR part 226 occurred
in 1974, with many provisions
remaining unchanged since well before
then.
105(l) Leases Under the Indian SelfDetermination and Education
Assistance Act (ISDEAA) (1076–AF60)
The current regulations governing
105(l) leases at 25 CFR 900, subpart H,
allow Tribes to be compensated for a
broad range of expenses ranging from
rent to depreciation and ‘‘other
reasonable expenses.’’ The revisions
would establish sideboards on what
costs the Department will pay Tribes for
105(l) leases including, for examples,
more specific direction on the timing
and scope of future 105(l) leases.
Self-Governance PROGRESS Act
Regulations (1076–AF62)
This rule would implement the
requirements of the PROGRESS Act
requiring updates to BIA’s regulations
governing Tribal Self-Governance. The
PROGRESS Act amends subchapter I of
the Indian Self-Determination and
Education Assistance Act (ISDEAA), 25
U.S.C. 5301 et seq., which addresses
Indian Self-Determination, and
subchapter IV of the ISDEAA which
addresses the Department’s Tribal SelfGovernance Program. The PROGRESS
Act calls for a negotiated rulemaking
committee to be established under 5
U.S.C. 565, with membership consisting
only of representatives of Federal and
Tribal governments, with the Office of
Self-Governance serving as the lead
agency for the Department. The
PROGRESS Act also authorizes the
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Secretary to adapt negotiated
rulemaking procedures to the unique
context of self-governance and the
government-to-government relationship
between the United States and Indian
Tribes.
Indian Business Incubators Program
(1076–AF63)
This rule would establish the
structure for the Office of Indian Energy
and Economic Development (IEED) to
implement the Native American
Business Incubators Program, which
was established by statute in October
2020. The rule will establish how IEED
will provide competitive grants to
eligible applicants to establish and
operate business incubators that serve
Tribal reservation communities. The
business incubators will provide
tailored business incubation services to
Native businesses and Native
entrepreneurs to overcome the unique
obstacles they confront in offering
products and services to reservation
communities.
Agricultural Leasing of Indian Land
(1076–AF66)
This rule would update provisions
addressing leasing of trust or restricted
land (Indian land) for agricultural
purposes to reflect updates that have
been made to business and residential
leasing provisions and address outdated
provisions.
Federal Recognition of Tribes Under
Alaska IRA (1076–AF51)
This rule will establish criteria and
procedures for groups seeking
recognition as Tribes under the Alaska
Indian Reorganization Act (Alaska IRA),
which is separate and distinct from the
Indian Reorganization Act of 1934,
which has its own set of regulations for
seeking recognition as Tribes. The
Alaska IRA provides that groups of
Indians in Alaska having a common
bond of occupation, or association, or
residence within a well-defined
neighborhood, community, or rural
district may organize to adopt
constitutions and bylaws and receive
charters of incorporation and Federal
loans. This rule will also establish what
documents are required to apply. To
date, there has been no regulatory
process or criteria established for
seeking recognition under the Alaska
IRA.
Elections of Osage Minerals Council
(1076–AF58)
Current BIA regulations address how
BIA conducts elections of offices of the
Osage Tribe, including provisions
addressing nominating conventions and
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petitions, election notices, opening and
closing of polls, ballots, and contesting
elections. This rule will remove
outdated and unnecessary provisions. .
Statutory changes and the Osage Nation
Constitution have significantly pared
down the role of BIA in the Tribe’s
elections. The only remaining portion
that will be included in this rule states
that BIA will provide, at the Osage
Nation’s request, a list of voters and
their headright interests to the Osage
Minerals Council Election Board.
Bureau of Indian Education
The Bureau of Indian Education (BIE)
mission is to provide students at BIEfunded schools with a culturally
relevant, high-quality education that
prepares students with the knowledge,
skills, and behaviors needed to flourish
in the opportunities of tomorrow,
become healthy and successful
individuals, and lead their communities
and sovereign nations to a thriving
future that preserves their unique
cultural identities. The BIE is the
preeminent provider of culturally
relevant educational services and
supports provided by highly effective
educators to students at BIE-funded
schools to foster lifelong learning.
Regulatory and Deregulatory Actions
As BIE continues its work to fulfill its
mission while keeping students and
school staff safe and healthy, BIE
finalized a new regulation in FY 2021
that will allow individual BIE-operated
schools to retain the funding received
through leasing their lands and facilities
to third-parties, and direct that funding
back into the school (86 FR 34943, July
1, 2021). The new regulation will also
allow individual BIE-operated schools
to retain fundraising proceeds and use
those proceeds for the benefit of the
school.
Appeals From Administrative Actions
(1076–AF64)
This rule would clarify the processes
for appeals of actions taken by officials
in the Office of the Assistant Secretary
Indian Affairs, BIA, BIE, and BTFA
(collectively, Indian Affairs).
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Bureau of Land Management
The BLM manages more than 245
million acres of public land, known as
the National System of Public Lands,
primarily located in 12 Western states,
including Alaska. The BLM also
administers 700 million acres of subsurface mineral estate throughout the
Nation. The agency’s mission is to
sustain the health, diversity, and
productivity of America’s public lands
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for the use and enjoyment of present
and future generations.
Regulatory and Deregulatory Actions
The BLM has identified the following
priority rulemaking actions for FY 2022:
Livestock Grazing (1004–AE82)
This proposed rule would revise
BLM’s grazing regulations to improve
resource management and increase
efficiency by streamlining and clarifying
grazing processes and improving
coordination among Federal, State, and
local government entities. The proposed
rule would revise the regulations at 43
CFR parts 4100, 1600, and 1500. These
revisions and additions would help to
provide the public and land managers
with accurate and reliable information
regarding grazing administration on
public lands.
Update of the Communications Uses
Program, Right-of-Way Cost Recovery
Fee Schedules, and Section 512 of
FLPMA for Rights-of-Way (1004–AE60)
The BLM is proposing amendments to
its existing ROW regulations to
streamline and improve efficiencies in
the communications uses program,
update the cost recovery fee schedules
for ROW work activities, and include
provisions governing the development
and approval of operating plans and
agreements for ROWs for electric
transmission and distribution facilities.
Communications uses, such as
broadband, are a subset of ROW
activities authorized under the Federal
Land Policy and Management Act of
1976 (FLPMA), as amended. Cost
recovery fees apply to most ROW
activities authorized under either
FLPMA or the Mineral Leasing Act of
1920, as amended. This proposed rule
would also implement vegetation
management requirements included in
the Consolidated Appropriations Act,
2018 (codified at 43 U.S.C. 1772) to
address fire risk from and to power-line
ROWs on public lands and national
forests. The regulatory amendments
would also codify legislated agency
requirements regarding review and
approval of utilities maintenance plans,
liability limitations, and definitions of
hazard trees and emergency conditions.
Bonding (1004–AE68)
This proposed rule would update the
bonding procedures for ROWs on BLMmanaged public land. The proposed rule
would revise the bonding portion of the
BLM’s ROW regulations to make them
clearer and easier to understand, which
would facilitate efficient bond
calculations.
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Rights-of-Way, Leasing and Operations
For Renewable Energy and
Transmission Lines 43 CFR Parts 2800,
2880, 3200 (1004–AE78)
This proposed rule would revise
BLM’s regulations for ROWs, leasing,
and operations related to all activities
associated with renewable energy and
transmission lines. The Energy Act of
2020 and E.O. 14008 prioritize the
Department’s need to improve
permitting activities and processes to
facilitate increased renewable energy
production on public lands.
Waste Prevention, Production Subject to
Royalties, and Resource Conservation 43
CFR Parts 3160 and 3170 (1004–AE79)
This proposed rule would update
BLM’s regulations governing the waste
of natural gas through venting, flaring,
and leaks on onshore Federal and
Indian oil and gas leases. The proposed
rule would address the priorities
associated with Executive Order 14008.
In addition, in accordance with
Executive Order 13990, this proposed
rule would reduce methane emissions
in the oil and gas sector and mitigate
impacts of climate change.
Revision of Existing Regulations
Pertaining to Fossil Fuel Leases and
Leasing Process 43 CFR Parts 3100 and
3400 (1004–AE80)
This proposed rule would revise
BLM’s fossil fuel regulations to update
the fees, rents, royalties, and bonding
requirements related to oil and gas
leasing, development, and production.
The proposed rule would also update
BLM’s process for leasing to ensure the
protection and proper stewardship of
the public lands, including potential
climate and other impacts associated
with fossil fuel activities.
Revision of Existing Regulations
Retaining to Leasing and Operations of
Geothermal 43 CFR Part 3200 (1004–
AE84)
This proposed rule would update and
codify BLM’s Geothermal Resource
Orders into regulation, including
common geothermal standard practices,
and inspection requirements and
procedures.
Protection, Management, and Control of
Wild Horses and Burros 43 CFR Part
4700 (1004–AE83)
This proposed rule would address
wild horse and burro management
challenges by adding regulatory tools
that better reflect BLM’s current
statutory authorities. For example, the
existing regulations do not address
certain management authorities that
Congress has provided since 1986 to
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control wild horse and burro
populations, such as the BLM’s
authority to sell excess wild horses and
burros. Updating the regulations would
also facilitate management strategies
and priorities that were not utilized
when the regulations were originally
promulgated, such as the application of
fertility control vaccines, managing for
nonreproducing herds, and feeding and
caring for unsold and unadopted
animals at off-range corrals and
pastures. The proposed rule would also
clarify ambiguities and management
limitations in the existing regulations.
Bureau of Ocean Energy Management
The mission of BOEM is to manage
development of U.S. OCS energy and
mineral resources in an environmentally
and economically responsible way. The
BOEM is responsible for stewardship of
U.S. OCS energy and mineral resources,
as well as protecting the environment
that the development of those resources
may impact. The resources we manage
belong to the American people and
future generations of Americans; wise
use of and fair return for these resources
are foremost in our management efforts.
In accordance with its statutory
mandate under OCSLA, BOEM is
committed to implementing its dual
mission of promoting the expeditious
and orderly development of the Nation’s
energy resources while simultaneously
protecting the marine, human, and
coastal environment of the OCS State
submerged lands and the coastal
communities. Consistent with the policy
outlined by the administration in E.O.
14008, BOEM is reevaluating all of its
programs related to the offshore
development of energy and mineral
resources offshore. The BOEM is
working with the Department as a whole
to review options for expanding
renewable energy production while
evaluating alternatives to better protect
the lands, waters, and biodiversity of
species located within the U.S.
exclusive economic zone.
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Regulatory and Deregulatory Actions
In FY 2022, the BOEM plans to
prioritize the following rulemaking
actions:
Renewable Energy Modernization Rule
(1010–AE04)
The BOEM’s most important
regulatory initiative is focused on
expanding offshore wind energy’s role
in strengthening U.S. energy security
and independence, create jobs, provide
benefits to local communities, and
further develop the U.S. economy. The
BOEM’s renewable energy program has
matured over the past 10 years, a time
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in which BOEM has conducted
numerous auctions and issued and
managed multiple commercial leases.
Based on this experience, BOEM has
identified multiple opportunities to
update its regulations to better facilitate
the development of renewable energy
resources and to promote U.S. energy
independence.
The BOEM is proposing a rule that
would update the existing renewable
energy regulations to help facilitate the
timely and responsible development of
renewable energy resources on the OCS
and promote U.S. energy independence.
This proposed rule contains reforms
identified by BOEM and recommended
by industry, including proposals for
incremental funding of
decommissioning accounts; more
flexible geophysical and geotechnical
survey submission requirements;
streamlined approval of meteorological
buoys; revised project verification
procedures; and greater clarity regarding
safety requirements. This rule advances
the administration’s energy policies in a
safe and environmentally sound manner
that provides a fair return to the
American taxpayer while, at the same
time, significantly reducing industry
development.
Air Quality Rule (1010–AE09)
In accordance with the
administration’s renewed commitment
to ensure the robust protection for the
lands, waters, and biodiversity of the
United States, BOEM is reevaluating the
entirety of its air quality regulatory
program and will propose further
enhancements. The BOEM and the
Department are proposing a new
offshore air quality rule to tighten
pollution standards for offshore
operations and require improved
pollution control technology. The
proposed rule would amend regulations
for air quality measurement, evaluation,
and control for offshore oil and gas
operations. The goal of this new
proposed rule would be to improve the
ambient air quality of the coastal States
and their corresponding State
submerged lands by addressing a
number of issues that were not
addressed by BOEM’s prior final air
quality rule. The BOEM expects to
revisit a number of the topics that were
originally reviewed in 2016.
Bureau of Safety and Environmental
Enforcement
The Bureau of Safety and
Environmental Enforcement’s (BSEE)
mission is to promote safety, protect the
environment, and conserve resources
offshore through vigorous regulatory
oversight and enforcement. The BSEE is
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the lead Federal agency charged with
improving safety and ensuring
environmental protection related to
conventional and renewable energy
activities on the U.S. OCS.
Regulatory and Deregulatory Actions
The BSEE has identified the following
rulemaking priorities for FY 2022:
Oil-Spill Response Requirements for
Facilities Located Seaward of the Coast
Line Proposed Rule (1014–AA44)
The Oil Spill Response Requirements
regulations in 30 CFR part 254 were last
updated over 20 years ago (62 FR 13996,
Mar. 25, 1997). This proposed rule
would update the existing regulations in
order to incorporate the latest
advancements in spill response and
preparedness policies and technologies,
as well as lessons learned and
recommendations from reports related
to the Deepwater Horizon explosion and
subsequent oil spill.
Revisions to Subpart J—Pipelines and
Pipeline Rights-of-Way Proposed Rule
(1014–AA45)
This proposed rule would revise
specific provisions of the current
Pipelines and Pipeline ROW regulations
under 30 CFR 250 subpart J in order to
bring those regulations up to date with
current technology and state-of-the-art
safety equipment and procedures,
primarily through the incorporation of
industry standards.
Outer Continental Shelf Lands Act;
Operating in High-Pressure and/or HighTemperature (HPHT) Environments
(1014–AA49)
Currently, BSEE has no regulations
specific to high pressure and/or high
temperature (HPHT) projects, requiring
BSEE to issue multiple guidance
documents clarifying the specific HPHT
information prospective operators
should submit to BSEE to support the
Bureau’s programmatic reviews and
approvals of such projects. This
proposed rule would formally codify
BSEE’s existing process for reviewing
and approving projects in HPHT
environments.
Oil and Gas and Sulfur Operations in
the Outer Continental Shelf-Blowout
Preventer Systems and Well Control
Revisions (1014–AA52)
The BSEE is revising existing
regulations for well control and blowout
preventer systems.
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Bureau of Ocean Energy Management,
and Bureau of Safety and Environmental
Enforcement Renewable Energy Split
Final Rule (1082–AA03)
The BOEM currently has authority
over all renewable energy activities on
the OCS under regulations at 30 CFR
part 585. The BOEM and BSEE are in
the process of amending the
Department’s Manual chapters to
transfer the safety, environmental
enforcement, and compliance functions
relevant to renewable energy activities
from BOEM to BSEE. Consistent with
that effort, BSEE and BOEM would
amend their respective regulations to
reflect the split of functions between the
two Bureaus.
Office of the Chief Information Officer
The Office of the Chief Information
Officer (OCIO) provides leadership to
the Department and its Bureaus in all
areas of information management and
technology. To successfully serve the
Department’s multiple missions, the
OCIO applies modern Information
Technology tools, approaches, systems,
and products. Effective and innovative
use of technology and information
resources enables transparency and
accessibility of information and services
to the public.
For FY 2022, OCIO is working on
these priority rules:
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Network Security System of Records
(1090–AB14)
This rule would revise the
Department’s Privacy Act regulations at
43 CFR 2.254 to claim Privacy Act
exemptions for certain records in the
DOI–49, Network Security, system of
records from one or more provisions of
the Privacy Act pursuant to 5 U.S.C
552a(j) and (k), because of criminal,
civil, and administrative law
enforcement requirements.
Insider Threat Program System of
Records (1090–AB15)
This rule would revise the
Department’s Privacy Act regulations at
43 CFR 2.254 to claim Privacy Act
exemptions for certain records in the
DOI–50, Insider Threat Program, system
of records from one or more provisions
of the Privacy Act pursuant to 5 U.S.C.
552a(j) and (k), because of criminal,
civil, and administrative law
enforcement requirements.
Personnel Security Files System of
Records (1090–AB16)
This rule would revise the
Department’s Privacy Act regulations at
43 CFR 2.254 to claim Privacy Act
exemptions for certain records in the
DOI–45, Personnel Security Files,
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system of records from one or more
provisions of the Privacy Act pursuant
to 5 U.S.C. 552a(k), because of criminal,
civil, and administrative law
enforcement requirements.
Social Security Number Fraud
Prevention Act of 2017 Implementation
(1090–AB24)
This direct final rule will amend 43
CFR part 2 to add subpart M to
implement the Social Security Number
Fraud Prevention Act of 2017, which
directs Federal agencies to issue
regulations that prohibit the inclusion of
an individual’s Social Security number
(SSN) on any document sent through
the mail unless the Secretary deems it
necessary. The regulations also include
requirements for protecting documents
with SSNs sent through postal mail.
Office of Environmental Policy and
Compliance
The Office of Environmental Policy
and Compliance (OEPC) serves as a
leader in conservation stewardship and
the sustainable development and use of
Department-managed resources for the
benefit of the public. The office fosters
partnerships to enhance resource use
and protection, as well as to expand
public access to safe and clean lands
under the Department’s jurisdiction.
The office also strives to continually
streamline environmental policies and
procedures to increase management
effectiveness and efficiency, reduce
duplicative practices, and realize cost
savings.
For FY 2022, OEPC will publish in
the Federal Register:
Implementation of the National
Environmental Policy Act (NEPA) of
1969 (1090–AB18)
This rule would develop regulations
to streamline OEPC’s NEPA process and
comply with E.O. 13990 and SO 3399.
Office of Grants Management
The Office of Grants Management is
responsible for providing executive
leadership, oversight, and policy for the
financial assistance across the
Department.
Financial Assistance Interior Regulation
(1090–AB23)
This rule will align the Department’s
regulations with new regulatory
citations and requirements adopted by
the Office of Management and Budget
(OMB). On August 13, 2020, OMB
published a revision to sections of Title
2 of the Code of Federal Regulations,
Guidance for Grants and Agreements.
The revision was an administrative
simplification and did not make any
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substantive changes to 2 CFR part 200
policies and procedures. This rule will
codify these changes in the
Department’s financial assistance
regulations located in 2 CFR part 1402.
(86 FR 57529, October 18, 2021).
Office of Hearings and Appeals
The Office of Hearings and Appeals
(OHA) exercises the delegated authority
of the Secretary to conduct hearings and
decide appeals from decisions of the
Bureaus and Offices of the Department.
The OHA provides an impartial forum
for parties who are affected by the
decisions of the Department’s Bureaus
and Offices to obtain independent
review of those decisions. The OHA also
handles the probating of Indian trust
estates, ensuring that individual Indian
interests in allotted lands, their
proceeds, and other trust assets are
conveyed to the decedents’ rightful
heirs and beneficiaries.
Updates to American Indian Probate
Regulations (1094–AA55)
This final rule will make regulatory
changes relating to efficiency and
streamlining of probate processes,
ensuring that the Department meets its
trust obligations, and helping achieve
the American Indian Probate Reform
Act/statutory goal of reducing
fractionalization of trust property
interests.
Practices Before the Department of
Interior (1094–AA56)
This direct final rule will amend
existing regulations to keep up to date
office addresses for hearings and
appeals purposes, to allow for the OHA
Director to issue interim orders in
emergency circumstances, and to allow
for the OHA Director to issue standing
orders that will improve OHA’s service
to the public and the parties by
modernizing its processes.
Office of Natural Resources Revenue
The Office of Natural Resources
Revenue (ONRR) continues to collect,
account for, and disburse revenues from
Federal offshore energy and mineral
leases and from onshore mineral leases
on Federal and Indian lands. The ONRR
operates nationwide and is primarily
responsible for the timely and accurate
collection, distribution, and accounting
of revenues associated with mineral and
energy production.
ONRR 2020 Valuation Reform and Civil
Penalty Rule: Final Withdrawal Rule
(1012–AA27)
The ONRR is withdrawing the ONRR
2020 Valuation Reform and Civil
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Penalty Rule (86 FR 54045, September
30, 2021).
Amendments to ONRR’s Mail Addresses
Listed in Tiltle30 CFR, Chapter XII
(1012–AA28)
This rule will amend mailing
addresses listed in parts of Title 30 CFR,
Chapter XII due to ONRR’s main
building renovation, which changed the
organizations mailing addresses.
Civil Monetary Penalty Rates Inflation
Adjustments for Calendar Year 2022
(1012–AA31)
This rule will adjust the maximum
civil monetary penalty rates for inflation
and announces the rates applicable to
calendar year 2022.
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Office of Small and Disadvantaged
Business Utilization
The Office of Small and
Disadvantaged Business Utilization
advises the Secretary on small business
issues and collaborates with leadership
to maximize small business
opportunities. The office implements
policies, procedures, and training
programs for the Department to
emphasize its commitment to
contracting with small businesses. The
mission also includes outreach to small
and disadvantaged business
communities, including Indian
economic enterprises, small
disadvantaged, women-owned, veteranowned, service-disabled veteran owned,
small businesses located in historically
underutilized business zones areas, and
the Ability One Program.
Department of the Interior Acquisition
Regulations, Buy Indian Act Acquisition
Regulations (1090–AB21)
This rule would revise regulations
implementing the Buy Indian Act,
which provides the Department with
authority to set aside procurement
contracts for Indian-owned and
controlled businesses. These revisions
would eliminate barriers to Indian
Economic Enterprises from competing
on certain construction contracts,
expand Indian Economic Enterprises’
ability to subcontract construction work
consistent with other socio-economic
set-aside programs, and give greater
preference to Indian Economic
Enterprises when a deviation from the
Buy Indian Act is necessary, among
other updates (86 FR 59338, October 27,
2021).
Office of Surface Mining Reclamation
and Enforcement
The Office of Surface Mining
Reclamation and Enforcement (OSMRE)
was created by the Surface Mining
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Control and Reclamation Act of 1977
(SMCRA). The OSMRE works with
States and Tribes to ensure that citizens
and the environment are protected
during coal mining and that the land is
restored to beneficial use when mining
is finished. The OSMRE and its partners
are also responsible for reclaiming and
restoring lands and water degraded by
mining operations before 1977. The
OSMRE focuses on overseeing the state
programs and developing new tools to
help the states and tribes get the job
done.
The OSMRE also works with colleges
and universities and other State and
Federal agencies to further the science
of reclaiming mined lands and
protecting the environment, including
initiatives to promote planting more
trees and establishing much-needed
wildlife habitat.
Regulatory and Deregulatory Actions
The OSMRE does not currently expect
to finalize any significant regulatory
actions during FY 2022. The OSMRE
does anticipate publishing:
Ten Day Notices (1029–AC81)
This rule would reexamine OSMRE’s
regulations on the ten-day notices rule
that went into effect on December 24,
2020.
Emergency Preparedness for
Impoundments (1029–AC82)
This rule would incorporate certain
aspects of the Federal Guidelines for
Dam Safety (FGDS) into OSMRE’s
existing regulations. These regulations
relate to emergency preparedness for
impoundments and propose to
incorporate the FGDS Emergency Action
Plans (EAP) and After-Action Reports
(AAR). The proposed rule may result in
revisions to OSMRE’s regulations at 30
CFR 701.5, 780.25, 784.16, 816.49,
817.49, 816.84, and 817.84. Also,
OSMRE may add new provisions to the
regulations to explain the EAP and AAR
requirements and align the classification
of impoundments with industry and
other Government agency standards.
U.S. Fish and Wildlife Service
The mission of FWS is to work with
others to conserve, protect, and enhance
fish, wildlife, and plants and their
habitats for the continuing benefit of the
American people. The FWS also
provides opportunities for Americans to
enjoy the outdoors and our shared
natural heritage. The FWS also
promotes and encourages the pursuit of
recreational activities such as hunting
and fishing and wildlife observation.
The FWS manages a network of 567
NWRs, with at least one refuge in each
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U.S. State and territory, and with more
than 100 refuges close to major urban
centers. The Refuge System plays an
essential role in providing outdoor
recreation opportunities to the
American public. In 2019, more than 59
million visitors went to refuges to hunt,
fish, observe or photograph wildlife, or
participate in environmental education
or interpretation.
The FWS fulfills its responsibilities
through a diverse array of programs that:
• Protect and recover endangered and
threatened species;
• Monitor and manage migratory
birds;
• Restore nationally significant
fisheries;
• Enforce Federal wildlife laws and
regulate international trade;
• Conserve and restore wildlife
habitat such as wetlands;
• Manage and distribute over a billion
dollars each year to States, territories,
and Tribes for fish and wildlife
conservation;
• Help foreign governments conserve
wildlife through international
conservation efforts; and
• Fulfill our Federal Tribal trust
responsibility.
Regulatory and Deregulatory Actions
The FWS has identified the following
priority rulemaking actions for FY 2022:
Regulations Under the Endangered
Species Act (ESA):
The FWS will promulgate multiple
regulatory actions under the ESA to
prevent the extinction of and facilitate
the recovery of both domestic and
foreign animal and plant species.
Accordingly, FWS will add species to,
remove species from, and reclassify
species on the Lists of Endangered and
Threatened Wildlife and Plants and
designate critical habitat for certain
listed species, in accordance with the
National Listing Workplan. The
Workplan enables FWS to prioritize
workloads based on the needs of
candidate and petitioned species, while
providing greater clarity and
predictability about the timing of listing
determinations to State wildlife
agencies, nonprofit organizations, and
other stakeholders and partners. The
Workplan represents the conservation
priorities of FWS based on its review of
scientific information. The goal is to
encourage proactive conservation so
that Federal protections are not needed
in the first place. The FWS also plans
to promulgate several species-specific
rules to protect threatened species
under section 4(d) of the ESA.
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The Unified Agenda includes
rulemaking actions pertaining to these
issues:
Endangered and Threatened Wildlife
and Plants; Revised Designation of
Critical Habitat for the Northern Spotted
Owl (1018–BF01)
This rule revised the designated
critical habitat for the northern spotted
owl (Strix occidentalis caurina) under
the ESA. After a review of the best
available scientific and commercial
information, FWS withdrew the January
15, 2021, final rule that would have
excluded approximately 3.4 million
acres of designated critical habitat for
the northern spotted owl. Instead, FWS
revised the species’ designated critical
habitat by excluding approximately
204,294 acres (82,675 hectares) in
Benton, Clackamas, Coos, Curry,
Douglas, Jackson, Josephine, Klamath,
Lane, Lincoln, Multnomah, Polk,
Tillamook, Washington, and Yamhill
Counties, Oregon, under section 4(b)(2)
of the Act (86 FR 62606, November 10,
2021).
Endangered and Threatened Wildlife
and Plants; Listing Determination and
Critical Habitat Designation for the
Monarch Butterfly (1018–BE30)
This rule would list the monarch
butterfly under the ESA in FY 2024, if
listing is still warranted at that time.
FWS would also propose to designate
critical habitat for the species, if
prudent and determinable.
Endangered and Threatened Wildlife
and Plants; Revision of the Regulations
for Listing Endangered and Threatened
Species and Designation of Critical
Habitat (1018–BE69)
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The FWS and the National Marine
Fisheries Service propose to rescind the
final rule titled ‘‘Regulations for Listing
Endangered and Threatened Species
and Designating Critical Habitat’’ that
was published on December 16, 2020,
and became effective on January 15,
2021. The proposed rescission, if
finalized, would remove the regulatory
definition of ‘‘habitat’’ established by
that rule.
Endangered and Threatened Wildlife
and Plan; Revision of the Regulations
for Designating Critical Habitat (1018–
BD84)
The FWS proposes to rescind the final
rule titled ‘‘Endangered and Threatened
Wildlife and Plants; Regulations for
Designating Critical Habitat’’ that
published on December 18, 2020, and
became effective January 19, 2021. The
proposed rescission, if finalized, would
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remove the regulations established by
that rule.
Endangered and Threatened Wildlife
and Plants; Regulations for Listing
Endangered and Threatened Species
and Designating Critical Habitat (1018–
BF95)
This joint Departments of Commerce
and the Interior (the Departments) rule
would review the previous rulemaking
action with the title ‘‘Endangered and
Threatened Wildlife and Plants;
Regulations for Listing Species and
Designating Critical Habitat,’’ (84 FR
45020; August 27, 2019), in which we
revised the regulations for adding and
removing species from the Lists of
Endangered and Threatened Wildlife
and Plants and clarified procedures for
designation of critical habitat. The
Departments’ review will determine
whether and how that rule should be
revised.
Endangered and Threatened Wildlife
and Plants; Revisiting the Interagency
Cooperation Final Rule (1018–BF96)
This joint rule by the Departments of
Commerce and the Interior would
review Endangered and Threatened
Wildlife and Plants; Regulations for
Interagency Cooperation (84 FR 44976;
August 27, 2019) to determine whether
and how the rule should be revised or
rescinded.
Endangered and Threatened Wildlife
and Plants; Compensatory Mitigation
Mechanisms Under the Endangered
Species Act (1018–BF63):
This rulemaking action would address
section 329 of the National Defense
Authorization Act for Fiscal Year 2021,
Objectives, Performance Standards, and
Criteria for Use of Wildlife Conservation
Banking Programs. This law requires
FWS to publish an advance notice of
proposed rulemaking (ANPRM) by
January 1, 2022. The purpose of the
ANPRM is to inform FWS’s
development of regulations related to
wildlife conservation banking to ensure
opportunities for Department of Defense
participation in wildlife conservation
banking programs pursuant to section
2694c of title 10, United States Code.
Regulations Governing Take of
Migratory Birds (1018–BD76):
On January 7, 2021, the FWS
published a final rule defining the scope
of the Migratory Bird Treaty Act
(MBTA) as it applies to conduct
resulting in the injury or death of
migratory birds protected by the MBTA.
We are now revoking that rule. The
effect of this rule is a return to
implementing the MBTA as prohibiting
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incidental take and applying
enforcement discretion, consistent with
judicial precedent.
Protection of Migratory Birds;
Definitions and Authorizations (1018–
BF71)
This rule would amend FWS
regulations by providing definitions to
terms used in the MBTA. This proposed
rule would clarify that the MBTA’s
prohibitions on taking and killing
migratory birds includes foreseeable,
direct taking and killing that is
incidental to other activities. The rule
would also propose to establish
authorizations for compliance with
MBTA prohibitions.
Eagle Permits; Incidental Take (1018–
BE70)
This rule would provide potential
approaches for further expediting and
simplifying the permit process
authorizing incidental take of eagles.
The new process would improve and
make more efficient the permitting
process for incidental take of eagles in
a manner that is compatible with the
preservation of bald and golden eagles.
Possession of Eagle Specimens for
Religious Purposes (1018–BB88)
This rule would propose extending
legal access to bald and golden eagle
parts and feathers for religious use to
persons other than enrolled members of
federally recognized Tribes.
2021–2022 Station-Specific Hunting and
Sport Fishing Regulations (1018–BF09)
The FWS opens, for the first time,
seven National Wildlife Refuges (NWRs)
that are currently closed to hunting and
sport fishing. In addition, the Service
opens or expands hunting and sport
fishing at 81 other NWRs and adds
pertinent station-specific regulations for
other NWRs that pertain to migratory
game bird hunting, upland game
hunting, big game hunting, and sport
fishing for the 2021–2022 season. The
Service also opens hunting or sport
fishing on one unit of the National Fish
Hatchery System (NFH). We add
pertinent station-specific regulations
that pertain to migratory game bird
hunting, upland game hunting, big game
hunting, and sport fishing at this NFH
for the 2021–2022 season. Finally, we
make regulatory changes to existing
station-specific regulations in order to
reduce the regulatory burden on the
public, increase access for hunters and
anglers on Service lands and waters,
and comply with a Presidential mandate
for plain language standards (86 FR
48822, August 31, 2021).
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Revision of Regulations Implementing
the Convention on International Trade
in Endangered Species of Wild Fauna
and Flora (CITES); Updates Following
the Eighteenth Meeting of the
Conference of the Parties (CoP18) to
CITES (1018–BF14)
The FWS is taking direct final action
to revise regulations that implement the
Convention on International Trade in
Endangered Species of Wild Fauna and
Flora (CITES or Treaty) by incorporating
certain non-controversial provisions
adopted at the sixteenth through
eighteenth meetings of the Conference
of the Parties (CoP16–CoP18) to CITES
and clarifying and updating certain
other provisions. These changes will
bring U.S. regulations in line with
certain revisions adopted at the three
most recent meetings of the CoP, which
took place in March 2013 (CoP16),
September–October 2016 (CoP17), and
August 2019 (CoP18). The revised
regulations will help FWS more
effectively promote species
conservation, help us continue to fulfill
our responsibilities under the Treaty,
and help those affected by CITES to
understand how to conduct lawful
international trade.
National Park Service
The National Park Service (NPS)
preserves the natural and cultural
resources and values within 423 units of
the National Park System encompassing
more than 85 million acres of lands and
waters for the enjoyment, education,
and inspiration of this and future
generations. The NPS also cooperates
with partners to extend the benefits of
resource conservation and outdoor
recreation throughout the United States
and the world.
Regulatory and Deregulatory Actions
The following are the NPS’s
rulemaking priorities during FY 2022
year:
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Native American Graves Protection and
Repatriation Act Regulations (1024–
AE19)
This rule would revise the NAGPRA
implementing regulations. The rule
would eliminate ambiguities, correct
inaccuracies, simplify excessively
burdensome and complicated
requirements, clarify timelines, and
remove offensive terminology in the
existing regulations that have inhibited
the respectful repatriation of most
Native American human remains. This
rule would simplify and improve the
regulatory process for repatriation and
thereby advance the goals of racial
justice, equity, and inclusion.
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Colonial National Historical Park;
Vessels and Commercial PassengerCarrying Motor Vehicles (1024–AE39)
This final rule will amend the special
regulations for Colonial National
Historical Park. This rule will remove a
regulation that prevents the
Superintendent from designating sites
within the park for launching and
landing private vessels. The rule will
also remove outdated permit and fee
requirements for commercial passengercarrying vehicles.
Visitor Experience Improvements
Authority Contracts (1024–AE47)
This proposed rule would implement
the Visitor Experience Improvements
Authority (VEIA) given to NPS by
Congress in title VII of the National Park
Service Centennial Act. This authority
allows the NPS to award and administer
commercial services contracts for the
operation and expansion of commercial
visitor facilities and visitor services
programs in units of the National Park
System. The VEIA supplements but
does not replace the existing authority
granted to the NPS in the Concessions
Management Improvement Act of 1988
to enter into concession contracts.
Whiskeytown National Recreation Area;
Bicycling (1024–AE52)
This rule would allow bicycles on
approximately 75 miles of trails
throughout Whiskeytown National
Recreation Area; 17 miles of trail will be
newly constructed. Bicycling is an
established use at the recreation area
that has never been properly authorized
under NPS bicycle regulations.
Pictured Rocks National Lakeshore;
Snowmobiles (1024–AE53)
This final rule will clarify where
snowmobiles may be used within the
boundaries of the Lakeshore by
replacing general language allowing
snowmobiles on unplowed roads and
the shoulders of plowed roads with a
comprehensive list of designated
snowmobile routes.
Gulf Islands National Seashore; Personal
Watercraft (1024–AE55)
This final rule will amend special
regulations for Gulf Island National
Seashore that govern the use of personal
watercraft (PWC) within the National
Seashore in Mississippi and Florida.
NPS regulations only allow for the
operation of PWCs in park areas were
authorized by special regulation.
Commercial Visitor Services;
Concession Contracts (1024–AE57)
This final rule will revise regulations
that govern the solicitation, award, and
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administration of concessions contracts
to provide commercial visitor services at
National Park System units under the
Concessions Management Improvement
Act of 1998. This rule would reduce
administrative burdens and expand
sustainable, high quality, and
contemporary concessioner-provided
visitor services in national parks.
Curation of Federally-Owned and
Administered Archeological Collections
(1024–AE58)
This final rule will amend the
regulations for the curation of federallyowned and administered archeological
collections to establish definitions,
standards, and procedures to dispose of
particular material remains that are
determined to be of insufficient
archaeological interest. This rule will
promote more efficient and effective
curation of these archeological
collections.
Ozark National Scenic Riverways;
Motorized Vessels (1024–AE62)
This rule would amend special
regulations for Ozark National Scenic
Riverways. The rule would modify
regulations governing the use of
motorized vessels within the Riverways
to help accommodate a variety of
desired river conditions and
recreational uses, promote high quality
visitor experiences, promote visitor
safety, and minimize conflicts among
different user groups. The rule would
implement a management action that
represents a compromise between user
groups and was the result of a long
planning process with robust
community engagement.
Mount Rainier National Park; Fishing
(1024–AE66)
This rule would revise special
regulations for Mount Rainier National
Park to remove all fishing closures and
restrictions from 36 CFR 7.5. Instead,
the NPS would manage fishing though
administrative orders in the
Superintendent’s Compendium. This
action would help implement a 2018
Fish Management Plan that aims to
conserve native fish populations and
restore aquatic ecosystems by reducing
or eliminating nonnative fish.
Bureau of Reclamation
The Bureau of Reclamation’s
Reclamation mission is to manage,
develop, and protect water and related
resources in an environmentally and
economically sound manner in the
interest of the American public. To
accomplish this mission, Reclamation
employs management, engineering, and
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science to achieve effective and
environmentally sensitive solutions.
Reclamation’s projects provide:
Irrigation water service; municipal and
industrial water supply; hydroelectric
power generation; water quality
improvement; groundwater
management; fish and wildlife
enhancement; outdoor recreation; flood
control; navigation; river regulation and
control; system optimization; and
related uses. In addition, Reclamation
continues to provide increased security
at its facilities.
Regulatory and Deregulatory Actions
Reclamation’s rulemaking priorities
for FY 2022 include the following:
Public Conduct on Bureau of
Reclamation Facilities, Lands and
Waterbodies (1006–AA58)
This proposed update to an existing
rule would revise existing definitions
for the use of aircraft, the possession of
firearms, camping, swimming, and
winter recreation for the wide range of
circumstances found across Reclamation
and would clarify the permitting of
memorials and correct inconsistencies
found within this part.
Departmental
For FY 2022, the Department intends
to publish in the Federal Register:
Paleontological Resources Preservation.
(1093–AA25)
This rule addresses the management,
collection, and curation of
paleontological resources on or from
Federal lands administered by the
Department using scientific principles
and expertise, including collection in
accordance with permits; curation in an
approved repository; and maintenance
of confidentiality of specific locality
data.
BILLING CODE 4334–63–P
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DEPARTMENT OF JUSTICE (DOJ)—
FALL 2021
Statement of Regulatory Priorities
The mission of the Department of
Justice is to uphold the rule of law, to
protect the public against foreign and
domestic threats, to provide Federal
leadership in preventing and controlling
crime, and to ensure equal justice under
the law for all. In carrying out this
mission, the Department is guided by
the core values of integrity, fairness, and
commitment to promoting the impartial
administration of justice—including for
those in historically underserved,
vulnerable, or marginalized
communities. Consistent with its
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mission and values, the Department is
prioritizing activities that strengthen
enforcement of civil rights laws, defend
against domestic and international
terrorism, combat gun violence, and
reform criminal justice systems. Because
the Department of Justice is primarily a
law enforcement agency, not a
regulatory agency, it carries out its
principal investigative, prosecutorial,
and other enforcement activities
through means other than the regulatory
process.
The regulatory priorities of the
Department include initiatives in the
areas of immigration, criminal justice
reform, and gun violence reduction.
Those initiatives, as well as regulatory
initiatives by several other components
carrying out key law enforcement
priorities, are summarized below.
Bureau of Alcohol, Tobacco, Firearms
and Explosives (ATF)
ATF issues regulations to enforce the
Federal laws relating to the
manufacture, importation, sale, and
other commerce in firearms and
explosives. ATF’s mission and
regulations are designed to, among other
objectives: (1) Curb illegal traffic in, and
criminal use of, firearms and explosives;
and (2) assist State, local, and other
Federal law enforcement agencies in
reducing violent crime. ATF will
continue, as a priority during fiscal year
2021, to seek modifications to its
regulations governing commerce in
firearms and explosives in furtherance
of these important goals.
ATF plans to finalize regulations
regarding definitions of firearm, firearm
frame or receiver, gunsmith, complete
weapon, complete muffler or silencer
device, privately made firearm, and
readily, and finalize regulations on
marking and recordkeeping that are
necessary to implement these new or
amended definitions (RIN 1140–AA54).
The intent of this rulemaking is to
consider technological developments
and modern terminology in the firearms
industry, and to enhance public safety
by helping to stem the proliferation of
unmarked, privately made firearms that
have increasingly been recovered at
crime scenes. Further, ATF plans to
finalize regulations to implement
certain provisions of Public Law 105–
277, Omnibus Consolidated and
Emergency Supplemental
Appropriations Act, 1999 (RIN 1140–
AA10), and to set forth factors
considered when evaluating firearms
with an attached stabilizing brace to
determine whether they are considered
firearms under the National Firearms
Act and/or the Gun Control Act (RIN
1140–AA55). This second rule would
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make clear that all weapons that fall
under the National Firearms Act,
however they are made, are subject to its
heightened regulations—including
registration and background check
requirements. ATF also has begun a
rulemaking process that amends 27 CFR
part 447 to update the terminology in
ATF’s import control regulations based
on similar terminology amendments
made by the Department of State on the
U.S. Munitions List in the International
Traffic in Arms Regulations, and the
Department of Commerce on the
Commerce Control List in the Export
Administration Regulations (RIN 1140–
AA49).
Bureau of Prisons (BOP)
BOP issues regulations to enforce the
Federal laws relating to its mission: To
protect public safety by ensuring that
federal offenders serve their sentences
of imprisonment in facilities that are
safe, humane, cost-efficient, and
appropriately secure, and to provide
reentry programming to ensure their
successful return to the community.
Over the past year, the Bureau has
successfully implemented its Incident
Action Plan, developed in response to
2020 pandemic conditions to facilitate
continuity of operations, supplies,
inmate movement, visitation, staff
training, and official staff travel. As
pandemic conditions continue to
evolve, BOP plans to continue to
employ and improve its Incident Action
Plan, currently comprised of BOP’s
approved Pandemic Influenza Plan; its
Incident Command System (ICS)
framework; and guidance and directives
from the World Health Organization
(WHO), the Centers for Disease Control
and Prevention (CDC), the Office of
Personnel Management (OPM), DOJ, and
the Office of the Vice President.
In the near future, BOP plans to
finalize procedures for eligible inmates
to earn FSA Time Credits, as authorized
by the First Step Act of 2018 (FSA),
Public Law 115–391, 132 Stat. 5194
(2018). The FSA provides that eligible
inmates earn FSA Time Credits towards
prerelease custody or early transfer to
supervised release for successfully
completing approved Evidence-Based
Recidivism Reduction (EBRR) Programs
or Productive Activities (PAs) assigned
to each inmate based on the inmate’s
risk and needs assessment.
BOP will also finalize regulations
implementing additional legislative
changes enacted in the FSA to broaden
the Good Conduct Time Credit system,
revise inmate disciplinary regulations,
and provide effective literacy
programming which serves both general
and specialized inmate needs.
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Civil Rights Division (CRT)
CRT works to uphold the civil and
constitutional rights of all Americans,
particularly some of the most vulnerable
members of our society. Consistent with
this mission, CRT plans to engage in
three separate rulemakings under the
Americans with Disabilities Act (ADA).
First, CRT plans to amend its current
regulations under section 504 of the
Rehabilitation Act of 1973, which
prohibits discrimination based on
disability in programs and activities
conducted by an Executive agency, to
bring them up to date. Second, the
Department plans to publish a new
ANPRM seeking public input on
possible revisions to its ADA
regulations to ensure the accessibility of
equipment and furniture in public
entities and public accommodations
programs and services. Third, the
Department of Justice intends to
propose requirements for the
construction and alteration of
pedestrian facilities covered by subtitle
A of title II of the ADA that are
consistent with the Access Board’s
minimum ‘‘Accessibility Guidelines for
Pedestrian Facilities in the Public Rightof-Way.’’ These requirements would
ensure that sidewalks and other
pedestrian facilities in the public rightof-way are accessible to and usable by
individuals with disabilities.
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Drug Enforcement Administration
(DEA)
DEA is the primary agency
responsible for coordinating the drug
law enforcement activities of the United
States and assists in the implementation
of the President’s National Drug Control
Strategy. DEA implements and enforces
titles II and III of the Comprehensive
Drug Abuse Prevention and Control Act
of 1970 and the Controlled Substances
Import and Export Act (21 U.S.C. 801–
971), as amended, collectively referred
to as the Controlled Substances Act
(CSA). DEA’s mission is to enforce the
CSA and its regulations and bring to the
criminal and civil justice system those
organizations and individuals involved
in the growing, manufacture, or
distribution of controlled substances
and listed chemicals appearing in or
destined for illicit traffic in the United
States. The CSA and its implementing
regulations are designed to prevent,
detect, and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
providing for the legitimate medical,
scientific, research, and industrial needs
of the United States.
Pursuant to its statutory authority,
DEA intends to propose a regulation
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that allows practitioners, subject to
certain limitations, to supply up to a
three-day supply of buprenorphine or
other medications for maintenance and
detoxification treatment of opioid use
disorder, as instructed by Congress in
Public Law 116–215 (RIN–1117–AB73).
The intent of this rulemaking is to
ensure patients with opioid use disorder
have access to needed medications
while longer-term treatment is being
coordinated. DEA also anticipates
finalizing a rulemaking action clarifying
the procedures a registrant must follow
in the event a suspicious order for
controlled substances is received (RIN
1117–AB47).
Executive Office for Immigration
Review (EOIR)
EOIR’s primary mission is to
adjudicate immigration cases by fairly,
expeditiously, and uniformly
interpreting and administering the
Nation’s immigration laws. Under
delegated authority from the Attorney
General, EOIR conducts immigration
court proceedings, appellate reviews,
and administrative hearings.
Immigration judges in EOIR’s Office of
the Chief Immigration Judge adjudicate
cases to determine whether noncitizens
should be ordered removed from the
United States or should be granted some
form of protection or relief from
removal. The Board of Immigration
Appeals (BIA) has jurisdiction over
appeals from the decisions of
immigration judges, as well as other
matters. Accordingly, the Department of
Justice has a significant role in the
administration of the Nation’s
immigration laws. The Attorney General
also is responsible for civil litigation
and criminal prosecutions relating to
the immigration laws.
Consistent with Executive Order
14010, EOIR is developing numerous
regulations related to the asylum
system. Specifically, EOIR is working
with the Department of Homeland
Security (DHS) to finalize a recently
proposed rule to amend the procedures
for the processing of asylum claims in
expedited removal proceedings (RIN
1125–AB20). In addition, EOIR and DHS
intend to propose a rule to address the
circumstances in which an individual
would be considered a member of a
‘‘particular social group’’ (RIN 1125–
AB13). Similarly, EOIR and DHS intend
to propose a rule to rescind bars to
asylum implemented by three prior
rules: RIN 1125–AA87 related to an
applicant’s criminal activity, RIN 1125–
AA91 related to an applicant’s transit
through third countries, and RIN 1125–
AB08 related to public health concerns.
Moreover, EOIR intends to issue a rule
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to rescind or revise previous regulatory
amendments regarding the time allowed
for filing applications for asylum and
withholding of removal by individuals
in proceedings before EOIR (RIN 1125–
AB15). EOIR is developing a proposed
rule that would require immigration
judges to conduct a hearing in which
the applicant may provide testimony on
his or her application for asylum and
withholding of removal before the judge
could deny the application (RIN 1125–
AB22).
Finally, EOIR is also working to revise
and update the regulations relating to
immigration proceedings to increase
efficiencies and productivity, while also
safeguarding due process. EOIR is in the
process of publishing a final rule
regarding its new EOIR Case and
Appeals System, which provides for
greatly expanded electronic filing and
calendaring for cases before EOIR’s
immigration courts and the BIA (RIN
1125–AA81). In addition, EOIR is
drafting a proposed rule that would
codify administrative closure
procedures before the immigration
courts and the BIA and make other
revisions to ensure that BIA
adjudications appropriately balance due
process and efficiency considerations
(RIN 1125–AB18). Further, EOIR is
planning to finalize a rule that would
establish procedures for practitioners to
provide individual document assistance
without triggering the full obligations
required of practitioners engaging in full
representation of a noncitizen in EOIR
proceedings (RIN 1125–AA83)
Federal Bureau of Investigation (FBI)
The Federal Bureau of Investigation is
responsible for protecting and defending
the United States against terrorist and
foreign intelligence threats, upholding
and enforcing the criminal laws of the
United States, and providing leadership
and criminal justice services to Federal,
State, municipal, and international
agencies and partners. Only in limited
contexts does the FBI rely on
rulemaking. For example, the FBI is
currently drafting a rule that establishes
the criteria for use by a designated
entity in deciding fitness as described
under the Child Protection
Improvements Act (CPIA), 34 U.S.C.
40102, Public Law 115–141, div. S. title
I, section 101(a)(1), Mar. 23, 2018, 132
Stat. 1123.
The CPIA requires that the Attorney
General shall, by rule, establish the
criteria for use by designated entities in
making a determination of fitness
described in subsection (b)(4) of the Act
concerning whether the provider has
been convicted of, or is under pending
indictment for, a crime that bears upon
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the provider’s fitness to have
responsibility for the safety and
wellbeing of children, the elderly, or
individuals with disabilities and shall
convey that determination to the
qualified entity. Such criteria shall be
based on the criteria established
pursuant to section 108(a)(3)(G)(i) of the
Prosecutorial Remedies and Other Tools
to end the Exploitation of Children
Today Act of 2003 (34 U.S.C. 40102
note) and section 658H of the Child Care
and Development Block Grant Act of
1990 (42 U.S.C. 9858f).
Office of Justice Programs (OJP)
OJP provides innovative leadership to
Federal, State, local, and tribal justice
systems by disseminating state-of-the-art
knowledge and practices and providing
financial assistance for the
implementation of crime fighting
strategies.
OJP published a notice of proposed
rulemaking for the Office of Juvenile
Justice and Delinquency Prevention
(OJJDP) Formula Grant Program on
August 8, 2016, and in early 2017
published a final rule addressing some
of those provisions. For other provisions
included in the proposed rule, OJJDP
received many comments that require
additional time for OJJDP to consider.
OJP published an additional final rule
removing certain provisions of the
regulations that are no longer legally
supported, and to make technical
corrections, in June 2021. OJJDP now
plans to publish a second notice of
proposed rulemaking addressing
amendments to the Juvenile Justice and
Delinquency Prevention Act included in
the Juvenile Justice Reform Act signed
into law on December 21, 2018, and the
remaining changes that OJJDP intends to
make to the formula grant program
regulation.
DOJ—CIVIL RIGHTS DIVISION (CRT)
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Prerule Stage
101. • Nondiscrimination on the Basis
of Disability by State and Local
Governments and Places of Public
Accommodation; Equipment and
Furniture
Priority: Other Significant.
Legal Authority: 42 U.S.C. 12101 et
seq.
CFR Citation: 28 CFR 35; 28 CFR 36.
Legal Deadline: None.
Abstract: The ADA requires State and
local governments and public
accommodations to provide programs,
activities, and services in a manner that
is accessible to people with disabilities,
including non-fixed equipment and
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furniture that is used in the delivery of
programs, activities, and services. The
ADA also requires that covered entities
communicate effectively with people
with disabilities and provide
appropriate auxiliary aids and services.
While some types of fixed equipment
and furniture are explicitly covered by
the 2010 Standards for Accessible
Design, there are no specific provisions
in the ADA regulations that include
standards for the accessibility of
equipment and furniture that are not
fixed. See, e.g., 28 CFR 36.406(b) (the
1991 and 2010 Standards apply to fixed
or built-in elements of buildings and
structures). Because the 2010 ADA
Standards include accessibility
requirements for some types of fixed
equipment (e.g., ATMs, washing
machines, dryers, tables, benches, and
vending machines), the Department
plans to look to these standards for
guidance, where applicable, when it
proposes accessibility standards for
equipment and furniture that is not
fixed.
The Department plans to publish an
ANPRM seeking public input on
possible revisions to its ADA
regulations to ensure the accessibility of
equipment and furniture in public
entities’ and public accommodations’
programs and services.
Statement of Need: The Department’s
Americans with Disabilities Act (ADA)
regulations contain the ADA Standards
for Accessible Design (the ADA
Standards) which provide accessibility
standards for some types of fixed or
built-in equipment and furniture.
However, there are no specific
provisions in the ADA Standards or the
ADA regulations governing the
accessibility of equipment and furniture
that are not fixed or built in. Changes
in technology have resulted in the
development and improved availability
of accessible equipment and furniture
that benefit individuals with disabilities,
and accessible equipment and furniture
is often critical to an entity’s ability to
provide an individual with a disability
equal access to its services. This rule is
necessary to ensure that inaccessible
equipment and furniture do not prevent
people with disabilities from accessing
State and local governments and public
accommodations’ programs and
services.
Summary of Legal Basis: The
summary of the legal basis for this
regulation is set forth in the above
abstract.
Alternatives: There are no appropriate
alternatives to issuing this ANPRM. The
Architectural and Transportation
Barriers Compliance Board (Access
Board) may issue minimum standards
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on equipment and furniture, but these
standards only become binding when
the Department adopts the Access
Board’s standards through a rulemaking.
Alternatively, the Department may
create its own technical standards and
implement them through a rulemaking.
Anticipated Cost and Benefits: The
Department anticipates costs to covered
entities, including State and local
governments and places of public
accommodation. Entities may need to
acquire new equipment or furniture or
retrofit existing equipment and furniture
to meet technical standards that the
Department includes in its regulations.
Risks: Failure to implement technical
standards to ensure that people with
disabilities have access to equipment
and furniture in public entities’ and
public accommodations’ programs and
services will make some of these
programs and services inaccessible to
people with disabilities.
Timetable:
Action
ANPRM ...............
Date
FR Cite
09/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
Agency Contact: Rebecca Bond, Chief,
Disability Rights Section, Department of
Justice, Civil Rights Division, 4
Constitution Square, 150 M Street NE,
Washington, DC 20002, Phone: 202 305–
2952.
RIN: 1190–AA76
DOJ—CRT
Proposed Rule Stage
102. Implementation of the ADA
AMendments Act of 2008: Federally
Conducted (Section 504 of the
Rehabilitation Act of 1973)
Priority: Other Significant.
Legal Authority: Pub. L. 110–325; 29
U.S.C. 794 (sec. 504 of the Rehab. Act
of 1973); E.O. 12250 (45 FR 72855)
CFR Citation: 28 CFR 39.
Legal Deadline: None.
Abstract: Section 504 of the
Rehabilitation Act of 1973, as amended
(29 U.S.C. 794), prohibits discrimination
on the basis of disability in programs
and activities conducted by an
Executive agency. The Department
plans to revise its 504 Federally
conducted regulation at 28 CFR part 39
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
to incorporate amendments to the
statute, including the changes in the
meaning and interpretation of the
applicable definition of disability
required by the ADA Amendments Act
of 2008, Public Law 110–325, 122 Stat.
3553 (Sep. 25, 2008); incorporate
requirements and defenses stemming
from judicial decisions; and make other
non-substantive clarifying edits,
including updating outdated
terminology and references.
Statement of Need: This rule is
necessary to bring the Department’s
prior section 504 Federally conducted
regulation, which has not been updated
in three decades, into compliance with
judicial decisions establishing rights
and defenses under section 504, as well
as statutory amendments to the
Rehabilitation Act, including the new
definition of disability provided by the
ADA Amendments Act of 2008, which
became effective on January 1, 2009.
Additionally, following the passage of
the Americans with Disabilities Act
(ADA), amendments to the
Rehabilitation Act sought to ensure that
the same precepts and values embedded
in the ADA were also reflected in the
Rehabilitation Act. To ensure the
intended parity between the two laws,
it also necessary to update the Federally
conducted regulation to align it with the
relevant provisions of Title II of the
ADA. An updated Federally conducted
regulation would consolidate the
existing Section 504 requirements in
one place for easy reference.
Summary of Legal Basis: The
summary of the legal basis of authority
for this regulation is set forth above in
the abstract.
Alternatives: There are no appropriate
alternatives to issuing this NPRM since
it implements requirements and
defenses arising from the statute and
judicial decisions.
Anticipated Cost and Benefits:
Because the NPRM would incorporate
existing legal requirements and defenses
in the Department’s section 504
Federally conducted regulation, the
Department does not anticipate any
costs from this rule.
Risks: Failure to update the
Department’s section 504 Federally
conducted regulation to conform to legal
requirements and defenses provided
under statute and judicial decisions will
interfere with the Department’s ability
to meet its non-discrimination
requirements under section 504.
Timetable:
Action
Date
NPRM ..................
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Action
Date
NPRM Comment
Period End.
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Additional Information: Transferred
from RIN 1190–AA60.
Agency Contact: Rebecca Bond, Chief,
Disability Rights Section, Department of
Justice, Civil Rights Division, 4
Constitution Square, 150 M Street NE,
Washington, DC 20002, Phone: 202 305–
2952.
RIN: 1190–AA73
DOJ—CRT
103. • Nondiscrimination on the Basis
of Disability by State and Local
Governments; Public Right-of-Way
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 12134(a);
42 U.S.C. 12134(c)
CFR Citation: 28 CFR 35.
Legal Deadline: None.
Abstract: The Department of Justice
anticipates issuing a Notice of Proposed
Rulemaking that would establish
accessibility requirements to ensure that
sidewalks and other pedestrian facilities
in the public right-of-way are accessible
to and usable by individuals with
disabilities.
The Americans with Disabilities Act
(ADA) directs the Architectural and
Transportation Barriers Compliance
Board (Access Board) to issue minimum
guidelines to ensure that buildings,
facilities, rail passenger cars, and
vehicles are accessible, in terms of
architecture and design, transportation,
and communication, to individuals with
disabilities. The Access Board intends
to issue minimum accessibility
guidelines for pedestrian facilities in the
public right-of-way, called the
Accessibility Guidelines for Pedestrian
Facilities in the Public Right-of-Way.
The ADA directs the Department of
Justice to promulgate regulations
implementing subtitle A of title II of the
ADA. The ADA further directs that the
Department of Justice’s regulations
include standards that are consistent
with the minimum ADA guidelines
issued by the Access Board.
Accordingly, the Department of Justice
intends to propose requirements for the
construction and alteration of
pedestrian facilities covered by subtitle
A of Title II of the ADA that are
consistent with the Access Board’s
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minimum Accessibility Guidelines for
Pedestrian Facilities in the Public Rightof-Way.
Statement of Need: This rule is
necessary to ensure that pedestrian
facilities in the public right-of-way are
accessible to and usable by individuals
with disabilities. The Access Board
intends to issue minimum accessibility
guidelines for pedestrian facilities in the
public right-of-way, and the ADA
requires the Department of Justice to
include standards in its regulations
implementing subtitle A of title II of the
ADA that are consistent with the
minimum ADA guidelines issued by the
Access Board. Accordingly, the
Department of Justice intends to
propose requirements for the
construction and alteration of
pedestrian facilities covered by subtitle
A of title II of the ADA that are
consistent with the Access Board’s
minimum Accessibility Guidelines for
Pedestrian Facilities in the Public Rightof-Way. These requirements would
ensure that people with disabilities have
access to sidewalks, curb ramps,
pedestrian street crossings, and other
pedestrian facilities in the public rightof-way.
Summary of Legal Basis: The
summary of the legal basis for this
regulation is set forth in the above
abstract.
Alternatives: There are no appropriate
alternatives to issuing this NPRM
because the ADA requires the
Department of Justice to include
standards in its regulations
implementing subtitle A of title II of the
ADA that are consistent with the
minimum ADA guidelines issued by the
Access Board. The Access Board’s
accessibility guidelines will only
become binding when the Department
of Justice adopts them as legally
enforceable requirements through
rulemaking.
Anticipated Cost and Benefits: The
Department anticipates costs to state
and local governments given that this
rule would require that the construction
and alteration of pedestrian facilities in
the public right-of-way comply with the
Department’s accessibility requirements
under subtitle A of title II of the ADA.
Risks: Failure to adopt requirements
for the construction and alteration of
pedestrian facilities covered by subtitle
A of title II of the ADA that are
consistent with the Access Board’s
minimum Accessibility Guidelines for
Pedestrian Facilities in the Public Rightof-Way would mean that such Access
Board guidelines would remain
nonbinding and unenforceable. It would
also mean that the Department would
not be complying with its obligation to
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ensure that the standards in its
regulations are consistent with the
minimum ADA guidelines issued by the
Access Board.
Timetable:
Action
Date
NPRM ..................
FR Cite
09/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Governmental
Jurisdictions.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
Agency Contact: Rebecca Bond, Chief,
Disability Rights Section, Department of
Justice, Civil Rights Division, 4
Constitution Square, 150 M Street NE,
Washington, DC 20002, Phone: 202 305–
2952.
RIN: 1190–AA77
DOJ—BUREAU OF ALCOHOL,
TOBACCO, FIREARMS, AND
EXPLOSIVES (ATF)
Final Rule Stage
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104. Definition of ‘‘Frame or Receiver’’
and Identification of Firearms
Priority: Other Significant.
Legal Authority: 18 U.S.C. 921 to 931;
22 U.S.C. 2778; 26 U.S.C. 5812; 26
U.S.C. 5822; 26 U.S.C. 7801 and 7805
CFR Citation: 27 CFR 447; 27 CFR
478; 27 CFR 479.
Legal Deadline: None.
Abstract: The Department of Justice
proposes amending Bureau of Alcohol,
Tobacco, Firearms, and Explosives
regulations to provide new regulatory
definitions of firearm frame or receiver
and frame or receiver because they are
outdated. The Department also proposes
amending ATF’s definitions of firearm
and gunsmith to clarify the meaning of
those terms, and to add new regulatory
terms such as complete weapon,
complete muffler or silencer device,
privately made firearm, and readily for
purposes of clarity given advancements
in firearms technology. Further, the
Department proposes amendments to
ATF’s regulations on marking and
recordkeeping that are necessary to
implement these new or amended
definitions.
Statement of Need: This rule is
intended to clarify the definition of
firearm and to provide a more
comprehensive definition of frame or
receiver so that those definitions more
accurately reflect firearm configurations
not explicitly captured under the
existing definitions in 27 CFR 478.11
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and 479.11. Further, this NPRM
proposes new terms and definitions to
take into account technological
developments and modern terminology
in the firearms industry, as well as
amendments to the marking and
recordkeeping requirements that would
be necessary to implement these
definitions.
Summary of Legal Basis: The Attorney
General has express authority pursuant
to 18 U.S.C. 926 to prescribe rules and
regulations necessary to carry out the
provisions of chapter 44, title 18, United
States Code. The detailed legal analysis
supporting the amendments in this rule
are expressed in the abstract for the rule
itself.
Alternatives: There are no feasible
alternatives to the proposed rule that
would allow ATF to maximize benefits.
Anticipated Cost and Benefits: The
rule will not be economically
significant; however, it is a significant
regulatory action under section 3(f)(4) of
Executive Order 12866 because this rule
raises novel legal or policy issues
arising out of legal mandates. ATF
estimates that the costs for this
proposed rule is minimal. The total 10year undiscounted cost of this proposed
rule is estimated to be $1.3 million. The
total 10-year discounted cost of the rule
is $1.0 million and $1.2 million at 7
percent and 3 percent respectively. The
annualized cost of this proposed rule
would be $147,048 and $135,750, also at
7 percent and 3 percent, respectively.
This rule provides for updated
definitions to account for technological
advances, ensures traceability regardless
of age of firearm, and makes consistent
marking requirements
Risks: Without this rule, public safety
will continue to be threatened by the
lack of traceability of firearms.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
05/21/21
08/19/21
FR Cite
86 FR 27720
06/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Vivian Chu,
Department of Justice, Bureau of
Alcohol, Tobacco, Firearms, and
Explosives, 99 New York Avenue NE,
Washington, DC 20226, Phone: 202 648–
7070.
RIN: 1140–AA54
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DOJ—ATF
105. Factoring Criteria for Firearms
With an Attached Stabilizing Brace
Priority: Other Significant.
Legal Authority: 18 U.S.C 921 to 931;
26 U.S.C 5812; 26 U.S.C 5822; 26 U.S.C.
7801; 26 U.S.C. 7805
CFR Citation: 27 CFR 478; 27 CFR
479.
Legal Deadline: None.
Abstract: The Department of Justice is
planning to propose to amend the
regulations of the Bureau of Alcohol,
Tobacco, Firearms, and Explosives to set
forth factors considered when
evaluating firearms with an attached
stabilizing brace to determine whether
they are considered firearms under the
National Firearms Act and/or the Gun
Control Act.
Statement of Need: This rule is
intended to clarify when a rifle is
intended to be fired from the shoulder
and to set forth factors that ATF
considers when evaluating firearms
with an attached purported stabilizing
brace to determine whether these are
rifles under the GCA or NFA, and
therefore whether they are firearms
subject to the NFA. It amends the
definition of rifle in 27 CFR 478.11 and
479.11, respectively, by adding a
sentence at the end of each definition.
The new sentence would clarify that the
term rifle includes any weapon with a
rifled barrel and equipped with an
attached stabilizing brace that has
objective design features and
characteristics that indicate that the
firearm is designed to be fired from the
shoulder, as indicated on ATF
Worksheet 4999.
Summary of Legal Basis: The Attorney
General has express authority pursuant
to 18 U.S.C. 926 to prescribe rules and
regulations necessary to carry out the
provisions of chapter 44, title 18, United
States Code. The detailed legal analysis
supporting the amendments in this rule
are expressed in the abstract for the rule
itself.
Alternatives: There are no feasible
alternatives to the proposed rule that
would allow ATF to maximize benefits.
Anticipated Cost and Benefits: The
rule is a significant regulatory action
that is economically significant under
section 3(f) of Executive Order 12866,
because the rule will have an annual
effect on the economy of $100 million
or more. The annualized cost of this
proposed rule would be $114.7 million
and $125.7 million, at 3 percent and 7
percent, respectively. This proposed
rule would affect attempts by
manufacturers and individuals to
circumvent the requirements of the NFA
and would affect the criminal use of
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weapons with a purported stabilizing
brace.
Risks: Without this rule, public safety
will continue to be threatened by the
criminal use of such firearms, which are
easily concealable from the public and
first responders.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
06/10/21
09/08/21
FR Cite
86 FR 30826
08/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
Agency Contact: Denise Brown,
Regulations Writer, Department of
Justice, Bureau of Alcohol, Tobacco,
Firearms, and Explosives, 99 New York
Avenue NE, Washington, DC 20226,
Phone: 202 648–7070.
RIN: 1140–AA55
DOJ—EXECUTIVE OFFICE FOR
IMMIGRATION REVIEW (EOIR)
Proposed Rule Stage
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106. Bars to Asylum Eligibility and
Procedures
Priority: Other Significant.
Legal Authority: Homeland Security
Act of 2002, Pub. L. 107–296, 116 Stat.
2135, sec. 1102, as amended; 8 U.S.C.
1103(a)(1), (a)(3), (g); 8 U.S.C. 1225(b); 8
U.S.C. 1231(b)(3) and 1231 note; 8
U.S.C. 1158; E. O. 14010, 86 FR 8267
(Feb. 2, 2021)
CFR Citation: 8 CFR 208; 8 CFR 235;
8 CFR 1208; 8 CFR 1235; 8 CFR 1003.
Legal Deadline: None.
Abstract: In 2020, the Department of
Homeland Security and Department of
Justice (collectively, the Departments)
published final rules amending their
respective regulations governing bars to
asylum eligibility and procedures,
including the Procedures for Asylum
and Bars to Asylum Eligibility, (RINs
1125–AA87 and 1116–AC41), 85 FR
67202 (Oct. 21, 2020), Asylum
Eligibility and Procedural
Modifications, (RINs 1125–AA91 and
1615–AC44), 85 FR 82260 (Dec. 17,
2020), and Security Bars and Processing,
(RINs 1125–AB08 and 1615–AC57), 85
FR 84160 (Dec. 23, 2020), final rules.
The Departments propose to modify or
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rescind the regulatory changes
promulgated in these three final rules,
consistent with Executive Order 14010
(Feb. 2, 2021).
Statement of Need: The Departments
are reviewing these regulations in light
of the issuance of Executive Order
14010 and Executive Order 14012. This
rule is needed to restore and strengthen
the asylum system and to address
inconsistencies with the goals and
principles outlined in the Executive
Order 14010 and Executive Order
14012.
Summary of Legal Basis: The Attorney
General has general authority under 8
U.S.C. 1103(g) to establish regulations
related to the immigration and
naturalization of noncitizens. More
specifically, under 8 U.S.C.
1158(b)(2)(C) and (d)(5)(B), the Attorney
General has authority to provide by
regulation additional conditions and
limitations consistent with the INA for
asylum eligibility. Thus, this proposed
rule utilizes such authority to propose
revisions to the regulations related to
processing procedures for asylum and
withholding of removal claims.
Alternatives: Unless the Departments
rely on the pending litigation to enjoin
Asylum and Bars to Asylum Eligibility,
85 FR 67202, and Asylum Eligibility
and Procedural Modifications, 85 FR
82260, there are no other alternatives to
revise those two rules. As for Security
Bars and Processing, 85 FR 84160 (Dec.
23, 2020), because it relies on the
framework for applying bars to asylum
during credible fear processing that was
established in an enjoined rule titled
Procedures for Asylum and Withholding
of Removal; Credible Fear and
Reasonable Fear Review, 85 FR 80274,
the only alternative is to wait for the
outcome of that litigation before making
changes to the regulation. Relying on
litigation to address these rules could be
extremely time-burdensome and may
introduce confusion as to effectiveness
of the regulations. Thus, the
Departments consider this alternative to
be a burdensome and inadvisable course
of action and therefore not feasible.
Anticipated Cost and Benefits: DOJ
and DHS are currently considering the
specific cost and benefit impacts of the
proposed provisions.
Risks: Without this rulemaking,
regulations related to Procedures for
Asylum and Bars to Asylum Eligibility,
85 FR 67202, and Asylum Eligibility
and Procedural Modifications, 85 FR
82260, will remain enjoined pending
litigation. This is inadvisable, as
litigation typically takes much time to
resolve. Moreover, the implementation
of Security Bars and Processing, 85 FR
80274, will not be viable (as described
PO 00000
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in the Alternatives section). Thus, the
Department strongly prefers proactively
addressing the regulations through this
proposed rule.
Timetable:
Action
NPRM ..................
Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
URL For More Information: http://
www.regulations.gov.
URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Lauren Alder Reid,
Assistant Director, Office of Policy,
Executive Office for Immigration
Review, Department of Justice,
Executive Office for Immigration
Review, 5107 Leesburg Pike, Suite 1800,
Falls Church, VA 22041, Phone: 703
305–0289, Email: pao.eoir@usdoj.gov.
Related RIN: Related to 1615–AC69,
Related to 1125–AB08.
RIN: 1125–AB12
DOJ—EOIR
107. Asylum and Withholding
Definitions
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 8 U.S.C. 1101(a)(42);
8 U.S.C. 1158; 8 U.S.C. 1225; 8 U.S.C.
1231 and 1231 note; Executive Order
14010, 86 FR 8267 (Feb. 2, 2021)
CFR Citation: 8 CFR 2; 8 CFR 208; 8
CFR 1208.
Legal Deadline: None.
Abstract: This rule proposes to amend
Department of Homeland Security
(DHS) and Department of Justice (DOJ)
regulations that govern eligibility for
asylum and withholding of removal.
The amendments focus on portions of
the regulations that deal with the
definitions of membership in a
particular social group, the
requirements for failure of State
protection, and determinations about
whether persecution is on account of a
protected ground.
This rule is consistent with Executive
Order 14010 of February 2, 2021, which
directs the Departments to, within 270
days, promulgate joint regulations,
consistent with applicable law,
addressing the circumstances in which
a person should be considered a
member of a particular social group.
Statement of Need: This rule provides
guidance on a number of key
interpretive issues of the refugee
definition used by adjudicators deciding
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asylum and withholding of removal
(withholding) claims. The interpretive
issues include whether persecution is
inflicted on account of a protected
ground, the requirements for
establishing the failure of State
protection, and the parameters for
defining membership in a particular
social group. This rule will aid in the
adjudication of claims made by
applicants whose claims fall outside of
the rubric of the protected grounds of
race, religion, nationality, or political
opinion. One example of such claims
which often fall within the particular
social group ground concerns people
who have suffered or fear domestic
violence. This rule is expected to
consolidate issues raised in a proposed
rule in 2000 and to address issues that
have developed since the publication of
the proposed rule. This rule should
provide greater stability and clarity in
this important area of the law. This rule
will also provide guidance to the
following adjudicators: USCIS asylum
officers, Department of Justice Executive
Office for Immigration Review (EOIR)
immigration judges, and members of the
EOIR Board of Immigration Appeals
(BIA).
Furthermore, on February 2, 2021,
President Biden issued Executive Order
14010 that directs DOJ and DHS within
270 days of the date of this order, [to]
promulgate joint regulations, consistent
with applicable law, addressing the
circumstances in which a person should
be considered a member of a ‘‘particular
social group,’’ as that term is used in 8
U.S.C. 1101(a)(42)(A), as derived from
the 1951 Convention relating to the
Status of Refugees and its 1967 Protocol.
Summary of Legal Basis: The purpose
of this rule is to provide guidance on
certain issues that have arisen in the
context of asylum and withholding
adjudications. The 1951 Geneva
Convention relating to the Status of
Refugees contains the internationally
accepted definition of a refugee. United
States immigration law incorporates an
almost identical definition of a refugee
as a person outside his or her country
of origin ‘‘who is unable or unwilling to
return to, and is unable or unwilling to
avail himself or herself of the protection
of, that country because of persecution
or a well-founded fear of persecution on
account of race, religion, nationality,
membership in a particular social group,
or political opinion.’’ Section 101(a)(42)
of the Immigration and Nationality Act.
Alternatives: Because this rulemaking
is mandated by executive order to be
completed within a short timeframe,
there are no feasible alternatives at this
time.
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Anticipated Cost and Benefits: DOJ
and DHS are currently considering the
specific cost and benefit impacts of the
proposed provisions.
Risks: Without this rulemaking, the
circumstances by which a person is
considered a member of a particular
social group will continue to be subject
to judicial and agency interpretation,
which may differ by circuit and changes
in administration.
Timetable:
Action
Date
NPRM ..................
FR Cite
11/00/21
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Federalism: Undetermined.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
URL For More Information: http://
www.regulations.gov.
URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Lauren Alder Reid,
Assistant Director, Office of Policy,
Executive Office for Immigration
Review, Department of Justice,
Executive Office for Immigration
Review, 5107 Leesburg Pike, Suite 1800,
Falls Church, VA 22041, Phone: 703
305–0289, Email: pao.eoir@usdoj.gov.
Related RIN: Related to 1125–AA94,
Related to 1615–AC65, Related to 1615–
AC42.
RIN: 1125–AB13
DOJ—EOIR
108. Procedures for Asylum and
Withholding of Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103(g); 8
U.S.C. 1229a(c)(4)(B); 8 U.S.C.
1158(d)(5)(B)
CFR Citation: 8 CFR 1003.10; 8 CFR
1208; 8 CFR 1235; 8 CFR 1240.
Legal Deadline: None.
Abstract: On December 16, 2020, by
the rule titled Procedures for Asylum
and Withholding of Removal (RIN
1125–AA93) the Department of Justice
(Department) amended the regulations
governing asylum and withholding of
removal, including changes to what
must be included with an application
for it to be considered complete and the
consequences of filing an incomplete
application, and changes related to the
180-day asylum adjudications clock. To
revise the regulations related to
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Fmt 4701
Sfmt 4702
5113
adjudicatory procedures for asylum and
withholding of removal, the Department
is planning to rescind or modify the
regulatory revisions made by that rule
under this RIN.
Statement of Need: This proposed
rule will revise the regulations related to
adjudicatory procedures for asylum and
withholding of removal. On December
16, 2020, the Department of Justice
(Department) amended the regulations
governing asylum and withholding of
removal, including changes to what
must be included with an application
for it to be considered complete and the
consequences of filing an incomplete
application, and changes related to the
180-day asylum adjudications clock.
Procedures for Asylum and Withholding
of Removal, 85 FR 81698 (RIN 1125–
AA93). In light of Executive Orders
14010 and 14012, 86 FR 8267 (Feb. 2,
2021) and 86 FR 8277 (Feb. 2, 2021), the
Department reconsidered its position on
those matters and now issues this
proposed rule to revise the regulations
accordingly.
Summary of Legal Basis: The Attorney
General has general authority under 8
U.S.C. 1103(g) to establish regulations
related to the immigration and
naturalization of noncitizens. More
specifically, under 8 U.S.C.
1158(d)(5)(B), the Attorney General has
authority to provide by regulation
additional conditions and limitations
consistent with the INA for the
consideration of asylum applications.
Thus, this proposed rule utilizes such
authority to propose revisions to the
regulations related to adjudicatory
procedures for asylum and withholding
of removal pursuant, in part, to 8 U.S.C.
1229a(c)(4)(B).
Alternatives: Unless the Department
relies on litigation to permanently
enjoin the December 2020 rule, 85 FR
81698 (Dec. 16, 2020), there are no other
alternatives to revise the regulations.
Relying on litigation could be extremely
time-burdensome and may introduce
confusion as to effectiveness of the
regulations. Thus, the Department
considers this alternative to be an
inadequate and inadvisable course of
action.
Anticipated Cost and Benefits: The
Department believes this proposed rule
will not be economically significant.
The Department believes the costs to the
public will be negligible, if any, given
that costs will revert to those
established prior to the December 2020
rule. This proposed rule imposes no
new additional costs to the Department
or to respondents: Respondents have
always been required to submit
complete asylum applications in order
to have them adjudicated, and
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immigration judges have always
maintained the authority to set
deadlines. In addition, this proposed
rule proposes no new fees. The
Department believes that this proposed
rule would impose only minimal, if any,
direct costs on the public. Any new
minimal cost would be limited to the
cost of the public familiarizing itself
with proposed rule, although, as
previously stated, the proposed rule
reinstates most of the regulatory
language to that which was in effect
before the December 2020 rule. Further,
an immigration judge’s ability to set
filing deadlines is already established
by regulation, and filing deadlines for
both applications and supporting
documents are already well-established
aspects of immigration court
proceedings guided by regulations and
the OCIJ Practice Manual. Thus, the
Department expects little in the
proposed rule to require extensive
familiarization.
Risks: Without this rulemaking, the
regulations will remain enjoined
pending litigation (as described in the
Alternatives section). This is
inadvisable, as litigation typically takes
an inordinate time to resolve. The
Department highly prefers proactively
addressing the regulations through this
proposed rule.
Timetable:
Action
Date
NPRM ..................
FR Cite
11/00/21
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Additional Information: Related to
EOIR Docket No. 19–0010.
URL For More Information: http://
www.regulations.gov.
URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Lauren Alder Reid,
Assistant Director, Office of Policy,
Executive Office for Immigration
Review, Department of Justice,
Executive Office for Immigration
Review, 5107 Leesburg Pike, Suite 1800,
Falls Church, VA 22041, Phone: 703
305–0289, Email: pao.eoir@usdoj.gov.
Related RIN: Related to 1125–AA93.
RIN: 1125–AB15
DOJ—EOIR
109. Appellate Procedures and
Decisional Finality in Immigration
Proceedings; Administrative Closure
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 6 U.S.C.
521; 8 U.S.C. 1101; 8 U.S.C. 1103; 8
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U.S.C. 1154–1155; 8 U.S.C. 1158; 8
U.S.C. 1182; 8 U.S.C. 1226; 8 U.S.C.
1229; 8 U.S.C. 1229a; 8 U.S.C. 1229b; 8
U.S.C. 1229c; 8 U.S.C. 1231; 8 U.S.C.
1254a; 8 U.S.C. 1255; 8 U.S.C. 1324d; 8
U.S.C. 1330; 8 U.S.C. 1361–1362; 28
U.S.C. 509–510; 28 U.S.C. 1746; sec. 2
Reorg. Plan No. 2 of 1950, 3 CFR 1949–
1953, Comp. p. 1002; sec. 203 of Pub.
L. 105–100, 111 Stat. 2196–200; secs.
1506 and 1510 of Pub. L. 106–386, 114
Stat. 1527–29, 1531–32; sec. 1505 of
Pub. L. 106–554, 114 Stat. 2763A–326 to
–328
CFR Citation: 8 CFR 1003.1; 8 CFR
1003.2; 8 CFR 1003.3; 8 CFR 1003.10.
Legal Deadline: None.
Abstract: On December 16, 2020, by a
rule titled Appellate Procedures and
Decisional Finality in Immigration
Proceedings; Administrative Closure
(RIN 1125–AA96) the Department of
Justice (Department) amended its
regulations regarding appellate
procedures to ensure that immigration
proceeding appeals are adjudicated in
an efficient manner and to eliminate
unnecessary remands by the Board of
Immigration Appeals. The Department
also amended its regulations to promote
the final disposition of cases at both the
immigration court and appellate levels.
The Department is planning to modify
or rescind those regulations under this
RIN.
Statement of Need: On December 16,
2020, the Department of Justice
(Department) amended the regulations
related to processing of appeals and
administrative closure. Appellate
Procedures and Decisional Finality in
Immigration Proceedings;
Administrative Closure, 85 FR 81588
(RIN 1125–AA96). In light of Executive
Orders 14010 and 14012, 86 FR 8267
(Feb. 2, 2021) and 86 FR 8277 (Feb. 2,
2021), the Department reconsidered its
position on those matters and now
issues this proposed rule to revise the
regulations accordingly and make other
related amendments. This proposed rule
clarifies immigration judge and Board of
Immigration Appeals (BIA) authority,
including providing general
administrative closure authority and the
ability to sua sponte reopen and
reconsider cases. The proposed rule also
revises BIA standards involving
adjudication timelines, briefing
schedules, self-certification, remands,
background checks, administrative
notice, and voluntary departure. Lastly,
the proposed rule removes the EOIR
Director’s authority to issue decisions in
certain cases, removes the ability of
immigration judges to certify cases for
quality assurance, and revises
procedures for the forwarding of the
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record on appeal, as well as other minor
revisions.
Summary of Legal Basis: The Attorney
General has general authority under 8
U.S.C. 1103(g) to establish regulations
related to the immigration and
naturalization of noncitizens. Thus, this
proposed rule utilizes such authority to
propose revisions to the regulations
regarding immigration appeals
processing and administrative closure.
Alternatives: Unless the Department
relies on litigation to permanently
enjoin the December 2020 rule, 85 FR
81588 (Dec. 16, 2020), there are no other
alternatives to revise the regulations.
Relying on litigation could be extremely
time-burdensome and may introduce
confusion as to effectiveness of the
regulations. Thus, the Department
considers this alternative to be an
inadequate and inadvisable course of
action.
Anticipated Cost and Benefits: The
Department is largely reinstating the
briefing schedules that the December
2020 rule revised. As stated in the
December 2020 rule, 85 FR at 81650, the
basic briefing procedures have remained
across rules; thus, the Department
believes the costs to the public will be
negligible, if any, given that costs will
revert back to those established for
decades prior to the December 2020
rule. The proposed rule imposes no new
additional costs, as much of the
proposed rule involves internal case
processing. For those provisions that
constitute more than simple internal
case processing measures, such as the
amendments to the BIA’s administrative
closure authority, they likewise would
not impose significant costs to the
public. Indeed, such measures would
generally reduce costs, as they facilitate
and reintroduce various mechanisms for
fair, efficient case processing.
Risks: Without this rulemaking, the
regulations will remain enjoined
pending litigation (as described in the
Alternatives section). This is
inadvisable, as litigation typically takes
an inordinate time to resolve. The
Department highly prefers proactively
addressing the regulations through this
proposed rule.
Timetable:
Action
NPRM ..................
Date
FR Cite
11/00/21
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Additional Information: Related to
EOIR Docket No. 19–0022.
URL For More Information: http://
www.regulations.gov.
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URL For Public Comments: http://
www.regulations.gov.
Agency Contact: Lauren Alder Reid,
Assistant Director, Office of Policy,
Executive Office for Immigration
Review, Department of Justice,
Executive Office for Immigration
Review, 5107 Leesburg Pike, Suite 1800,
Falls Church, VA 22041, Phone: 703
305–0289, Email: pao.eoir@usdoj.gov.
Related RIN: Related to 1125–AA96.
RIN: 1125–AB18
Appearance as an Attorney or
Representative with EOIR.
Risks: Without this rulemaking,
noncitizens may be at risk of being
defrauded by unqualified individuals
offering assistance with immigration
documents. Additionally, without
assistance from a practitioner,
noncitizens may be at risk of failing to
obtain benefits for which they are
otherwise eligible.
Timetable:
Action
DOJ—EOIR
Final Rule Stage
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110. Professional Conduct for
Practitioners—Rules and Procedures,
and Representation and Appearances
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8
U.S.C. 1326
CFR Citation: 8 CFR 1003.
Legal Deadline: None.
Abstract: This rule amends
Department of Justice regulations
addressing the assistance of individuals
with the writing or filing of documents
in proceedings before the Executive
Office for Immigration Review. The rule
also proposes to make minor technical
revisions and to amend outdated
references to the former Immigration
and Naturalization Service.
Statement of Need: This rule would
establish procedures for practitioners to
provide individual document assistance
without triggering the full obligations
required of practitioners engaging in full
representation of a noncitizen in EOIR
proceedings.
Summary of Legal Basis: The Attorney
General has general authority under 8
U.S.C. 1103(g) to establish regulations
related to the immigration and
naturalization of noncitizens. Thus, this
proposed rule utilizes such authority to
propose revisions to the regulations
regarding the procedures for
practitioners to assist noncitizens in
removal proceedings.
Alternatives: There are no feasible
alternatives that will make the necessary
changes to the representation
requirement.
Anticipated Cost and Benefits: EOIR
expects the costs resulting from this rule
to be de minimis, as it does not impose
new or additional costs on EOIR,
practitioners, or noncitizens.
Additionally, the number of
practitioners impacted by this rule
would be insignificant because most
practitioners do not solely provide
preparation of a filing and are already
required to file a Notice of Entry of
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Date
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
Final Action .........
FR Cite
03/27/19
04/26/19
84 FR 11446
09/30/20
10/30/20
85 FR 61640
11/00/21
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Lauren Alder Reid,
Assistant Director, Office of Policy,
Executive Office for Immigration
Review, Department of Justice,
Executive Office for Immigration
Review, 5107 Leesburg Pike, Suite 1800,
Falls Church, VA 22041, Phone: 703
305–0289, Email: pao.eoir@usdoj.gov.
RIN: 1125–AA83
DOJ—EOIR
111. Procedures for Credible Fear
Screening and Consideration of
Asylum, Withholding of Removal and
CAT Protection Claims by Asylum
Officers
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 8 U.S.C. 1103(g); 8
U.S.C. 1158(b)(2)(C); 8 U.S.C.
1158(d)(5)(B); 8 U.S.C. 1225; 8 U.S.C.
1231(b)(3)
CFR Citation: 8 CFR 208; 8 CFR 235;
8 CFR 1003; 8 CFR 1208; 8 CFR 1235.
Legal Deadline: None.
Abstract: The Department of Justice
and the Department of Homeland
Security (DHS) propose to amend the
regulations so that individuals found to
have a credible fear can have their
claims for asylum, withholding of
removal under section 241(b)(3) of the
Immigration and Nationality Act
(statutory withholding of removal), or
protection under the regulations issued
pursuant to the legislation
implementing the Convention Against
Torture and Other Cruel, Inhuman or
Degrading Treatment or Punishment,
initially adjudicated by an asylum
officer within DHS with administrative
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review of the decision by the Executive
Office for Immigration Review.
Statement of Need: There is wide
agreement that the system for dealing
with asylum and related protection
claims at the southwest border has long
been overwhelmed and in desperate
need of repair. As the number of such
claims has skyrocketed over the years,
the system has proven unable to keep
pace, resulting in large backlogs and
lengthy adjudication delays. A system
that takes years to reach a result delays
justice and certainty for those who need
protection, and it encourages abuse by
those who will not qualify for protection
and smugglers who exploit the delay for
profit. The aim of this rule is to begin
replacing the current system, within the
confines of the law, with a better and
more efficient one that will adjudicate
protection claims fairly and
expeditiously.
Summary of Legal Basis: The Attorney
General has general authority under 8
U.S.C. 1103(g) to establish regulations
related to the immigration and
naturalization of noncitizens. More
specifically, under 8 U.S.C.
1158(b)(2)(C) and (d)(5)(B), the Attorney
General has authority to provide by
regulation additional conditions and
limitations consistent with the INA for
the consideration of asylum
applications. Thus, this proposed rule
utilizes such authority to propose
revisions to the regulations related to
processing procedures for asylum and
withholding of removal claims pursuant
to 8 U.S.C. 1225 and 1231.
Alternatives: There are no feasible
alternatives that make similarly
impactful changes to the system without
a more widespread overhaul of the
entire system in one rulemaking.
Anticipated Cost and Benefits: DHS
estimated the resource cost needed to
implement and operationalize the rule
along a range of possible future credible
fear volumes. The average annualized
costs could range from $179.5 million to
$995.8 million at a 7 percent discount
rate. At a 7 percent discount factor, the
total ten-year costs could range from
$1.3 billion to $7.0 billion, with a
midrange of $3.2 billion.
There could also be cost-savings
related to Forms I–589 and I–765 filing
volume changes. In addition, some
asylum applicants may realize potential
early labor earnings, which could
constitute a transfer from workers in the
U.S. labor force to certain asylum
applicants, as well as tax impacts.
Qualitative benefits include, but may
not be limited to: (i) Beneficiaries of
new parole standards may not have to
wait lengthy times for a decision on
whether their asylum claims will
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receive further consideration; (ii) some
individuals could benefit from de novo
review by an IJ of the asylum officer’s
denial of their asylum; (iii) DOJ–EOIR
may focus efforts on other priority work
and reduce its substantial current
backlog; (iv) as some applicants may be
able to earn income earlier than they
otherwise could currently, burdens to
the support network of the applicant
may be lessened.
Risks: Without this rulemaking, the
current system will remain status quo.
The backlogs and delays will continue
to grow, and potential for abuse will
remain. Most importantly, noncitizens
in need of protection will continue to
experience delays in the adjudication of
their claims.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
08/20/21
10/19/21
FR Cite
86 FR 46906
03/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Additional Information: Joint rule
with DHS 1616–AC67.
URL For More Information: http://
regulations.gov.
URL For Public Comments: http://
regulations.gov.
Agency Contact: Lauren Alder Reid,
Assistant Director, Office of Policy,
Executive Office for Immigration
Review, Department of Justice,
Executive Office for Immigration
Review, 5107 Leesburg Pike, Suite 1800,
Falls Church, VA 22041, Phone: 703
305–0289, Email: pao.eoir@usdoj.gov.
RIN: 1125–AB20
BILLING CODE 4410–BP–P
U.S. DEPARTMENT OF LABOR
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Fall 2021 Statement of Regulatory
Priorities
Introduction
The Department’s Fall 2021
Regulatory Agenda continues to
advance the Department’s mission to
foster, promote, and develop the welfare
of wage earners, job seekers, and
retirees; improve working conditions;
advance opportunities for profitable
employment; and assure work-related
benefits and rights. These rules will
strengthen protections for some of the
Nation’s most vulnerable workers,
empower and support opportunities for
advancement, secure our safety nets and
advance equity and economic security.
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In just the first months of the Biden
Administration, the Department of
Labor has begun historic rulemakings on
issues central to workers in the United
States and their families, including
worker safety, protections from
discrimination, fair wages, and
retirement security and health care.
These include the following
rulemakings:
• We issued an Emergency
Temporary Standard to help protect
millions of frontline healthcare workers
from exposure and spread of COVID–19,
a virus that has already claimed the
lives of over 750,000 people in the U.S.
We also issued an Emergency
Temporary Standard on Vaccination
and Testing to protect more than 84
million additional workers from the
consequences of COVID–19 exposure on
the job. These science-based standards
outline workplace safety protocols and
will help save thousands of lives and
prevents hundreds of thousands of
hospitalizations.
• We finalized Interim Final Rules
with the U.S. Department of Health and
Human Services, the U.S. Department of
Treasury, and the Office of Personnel
Management to implement the No
Surprises Act and protect people from
unexpected medical expenses. Surprise
billing can cause economic devastation
for patients. This rule puts patients first
by providing safeguards to keep families
from financial ruin when they need
medical care.
• We have also expeditiously
withdrawn or rescinded rules as
necessary to protect and strengthen
workers’ economic security, including
withdrawing the Independent
Contractor Rule and rescinding the Joint
Employer Rule.
The 2021 Regulatory Plan highlights
the Labor Department’s most
noteworthy and significant rulemaking
efforts, with each addressing the top
priorities of its regulatory agencies:
Employee Benefits Security
Administration (EBSA), Employment
and Training Administration (ETA),
Mine Safety and Health Administration
(MSHA), Office of Federal Contract
Compliance Programs (OFCCP),
Occupational Safety and Health
Administration (OSHA), Office of
Workers’ Compensation Programs
(OWCP), and Wage and Hour Division
(WHD). These regulatory priorities
exemplify the Secretary’s agenda to
empower all workers morning, noon,
and night, including:
• Investing in and valuing the
nation’s care economy;
• Building a safe, modern, inclusive
workforce; and
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• Supporting a lifetime of worker
empowerment.
Under Secretary Walsh’s leadership,
the Department is committed to
ensuring that equity, a strong
foundation of evidence, and extensive
stakeholder outreach are integral to all
of our regulatory efforts. Our Regulatory
Agenda additionally reflects our
ongoing commitment to the Biden
Administration’s prioritization of
economic relief, raising wages, and
addressing the threat of climate change,
while embedding equity across the
department’s agencies, policies, and
programs.
Investing In and Valuing the Nation’s
Care Economy
The Department’s regulatory priorities
reflect the Secretary’s focus on care
infrastructure to ensure workers have
the opportunity and support to thrive in
their jobs. That means ensuring workers
can care for their families without
risking their jobs, stay home when
they’re sick or when they need to care
for a sick family member, and have
access to the resources they need to
manage their mental health.
• EBSA’s rulemaking implementing
the Mental Health Parity and Addiction
Equity Act (MHPAEA) will strengthen
health enforcement by clarifying plan
and issuer obligations, promote
compliance and address amendments to
the Act from the Consolidated
Appropriations Act of 2021.
In addition, OSHA will supplement
its outreach and enforcement with
rulemaking that protects employees in
the care economy. Enhancing our care
infrastructure starts with making sure
our frontline care providers are safe on
the job.
• OSHA will propose an Infectious
Diseases rulemaking to protect
employees in healthcare and other high
risk environments from exposure to and
transmission of persistent and new
infectious diseases, ranging from
ancient scourges such as tuberculosis to
newer threats such as Severe Acute
Respiratory Syndrome (SARS), the 2019
Novel Coronavirus (COVID–19), and
other diseases.
• OSHA will initiate small business
consultations as its first step in
developing a Workplace Violence
rulemaking, to provide protections for
healthcare and other care economy
workers, who are the most frequent
victims of violence on the job.
Building a Safe, Modern, Inclusive
Workforce
The Department’s regulatory priorities
reflect the Secretary’s focus on ensuring
people can have a good job and
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opportunity for advancement. That
means people can have a job that is safe,
a job that pays a fair wage, a job that
does not discriminate and that has
opportunities for advancement. And
that means a job where workers have a
seat at the table and have a say in their
work.
The Department’s health and safety
regulatory proposals are aimed at
eliminating preventable workplace
injuries, illnesses and fatalities.
Workplace safety also protects workers’
economic security, ensuring that illness
and injury do not force families into
poverty. Our efforts will prevent
workers from having to choose between
their lives and their livelihood.
• OSHA will propose a rulemaking
on heat illness prevention. Increased
temperatures are posing a serious threat
to workers laboring outdoors and in
non-climate controlled indoor settings.
Exposure to excessive heat is not only
a hazard in itself, causing heat illness
and even death; it is also an indirect
hazard linked to the loss of cognitive
skills which can also lead to workplace
injuries and worker deaths. OSHA will
develop a standard to protect workers
from these heat hazards in the
workplace, helping to save lives while
we confront the growing threat of
climate change.
• MSHA will propose a new silica
standard to effectively assess health
concerns with a goal of ensuring that all
miners are safe at their work places.
• MSHA will promulgate a rule
establishing that mine operators must
develop and implement a written safety
program for surface mobile equipment
used at surface mines and surface areas
of underground mines, in order to
provide safe environments for miners.
The Department’s regulatory agenda
prioritizes workers’ economic security;
ensures they receive a fair day’s pay for
a fair day’s work, and do not face
discrimination in hiring, employment,
or benefits on the basis of race, gender,
religion, disability, national origin,
veteran’s status, sexual orientation, or
gender identity. ETA, OFCCP and WHD
will focus on regulatory changes that
will have significant impact on workers
of color, immigrant workers, and
workers with disabilities.
• OFCCP is proposing to rescind
certain provisions related to the
religious exemption for federal
contractors and subcontractors, ensuring
that the religious exemption contained
in Executive Order 11246 is applied
consistently with nondiscrimination
principles of Title VII of the Civil Rights
Act of 1964, as amended.
• OFCCP will issue a proposal to
modify the procedures for resolving
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potential employment discrimination,
which is creating hurdles to effective
enforcement.
• WHD issued regulations to
implement President Biden’s executive
order requiring federal contractors to
pay a $15 minimum wage to hundreds
of thousands of workers who are
working on federal contracts. This will
eliminate subminimum wages paid to
some tipped workers and workers with
disabilities, improve the economic
security of families and make progress
toward reversing decades of income
inequality.
• WHD is proposing to update and
modernize the regulations
implementing the Davis Bacon and
Related Acts to provide greater clarity
and ensure workers are truly paid local
prevailing wages on federal construction
contracts.
• WHD will propose updates to the
overtime regulations to ensure that
middle class jobs pay middle class
wages, extending important overtime
pay protections to millions of workers
and raising their pay.
• WHD engaged in rulemaking to
ensure the economic security of tipped
workers.
• ETA will ensure fair wages and
strengthen protections for foreign and
U.S. workers under the H–1B/H–2A visa
programs through regulatory changes.
The Department is committed to
ensuring workers have opportunities for
employment and training and
advancement in their jobs.
• ETA will ensure job-seekers can
more easily get the support they need by
proposing changes to the Wagner-Peyser
Employment Service regulations.
• ETA is focused on ensuring highquality apprenticeship programs, and as
part of this, has proposed rescinding
Industry Recognized Apprenticeship
Programs (IRAP) rules and suspending
further application review efforts for
new IRAP Standard Recognition Entities
in order to renew focus on Registered
Apprenticeship.
The Department is committed to
ensuring workers have a seat at the table
and furthering this Administration’s
support for unions and workers who are
organizing unions, which are critical to
achieving economic fairness and racial
and gender justice.
Supporting a Lifetime of Worker
Empowerment
We are focused on making sure
people do not have to worry that the
loss of a job or need for medical care
will destroy their financial well-being.
People should be able to save for
retirement, access health care, and have
the support they need to get through a
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5117
personal or family crisis or when they
become injured or ill on the job.
• EBSA will support the
administration’s agenda to address the
threat of climate change by
implementing two executive orders that
increase transparency in climate-related
financial investment options. To carry
out Executive Order 13990 ‘‘Protecting
Public Health and the Environment and
Restoring Science to Tackle the Climate
Crisis,’’ and Executive Order 14030,
‘‘Climate-Related Financial Risks,’’
EBSA is proposing to remove provisions
of the current regulation that
inappropriately discourage
consideration of environmental, social,
and governance issues by fiduciaries in
making investment and proxy voting
decisions, and provide further clarity
that would help safeguard the interests
of participants and beneficiaries in the
plan benefits.
DOL—OFFICE OF FEDERAL
CONTRACT COMPLIANCE
PROGRAMS (OFCCP)
Proposed Rule Stage
112. Proposal To Rescind Implementing
Legal Requirements Regarding the
Equal Opportunity Clause’s Religious
Exemption
Priority: Other Significant.
Legal Authority: E.O. 11246
CFR Citation: 41 CFR 60–1.
Legal Deadline: None.
Abstract: The Office of Federal
Contract Compliance Programs is
proposing to rescind the December 8,
2020, final rule, ‘‘Implementing Legal
Requirements Regarding the Equal
Opportunity Clause’s Religious
Exemption’’ (85 FR 79324), which
would include the removal of certain
definitions at 41 CFR 60–1.3 related to
the religious exemption and 41 CFR 60–
1.5(e) and (f). The rescission would
ensure that the religious exemption
contained in section 204(c) of Executive
Order 11246 is consistent with
nondiscrimination principles of Title
VII of the Civil Rights Act of 1964, as
amended. The notice of proposed
rescission was published on November
9, 2021.
Statement of Need: The Office of
Federal Contract Compliance Programs
issued a proposal to rescind the
regulations established in the final rule
titled Implementing Legal Requirements
Regarding the Equal Opportunity
Clause’s Religious Exemption and
returning to the agency’s traditional
approach, which applies Title VII
principles and applicable case law and
thus will promote clarity and
consistency in the application of the
religious exemption.
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Summary of Legal Basis: Executive
Order 11246 (as amended).
Alternatives: OFCCP considered the
alternative of engaging in affirmative
rulemaking to replace the 2020 rule
rather than rescinding it.
Anticipated Cost and Benefits: The
Department prepared estimates of the
anticipated costs and discussed benefits
associated with the proposed rule.
Risks: To be determined.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
Final Rule Effective.
Notification of
Proposed Rescission.
Notification of
Proposed Rescission Comment Period
End.
FR Cite
08/15/19
09/16/19
84 FR 41677
12/09/20
01/08/21
85 FR 79324
11/09/21
86 FR 62115
12/09/21
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected:
Undetermined.
URL For Public Comments: https://
www.regulations.gov/document/OFCCP2021-0001-0001.
Agency Contact: Tina Williams,
Director, Division of Policy and Program
Development, Department of Labor,
Office of Federal Contract Compliance
Programs, 200 Constitution Avenue NW,
Room C–3325, Washington, DC 20210,
Phone: 202 693–0104, Email:
williams.tina.t@dol.gov.
RIN: 1250–AA09
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113. Modification of Procedures To
Resolve Potential Employment
Discrimination
Date
NPRM ..................
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Tina Williams,
Director, Division of Policy and Program
Development, Department of Labor,
Office of Federal Contract Compliance
Programs, 200 Constitution Avenue NW,
Room C–3325, Washington, DC 20210,
Phone: 202 693–0104, Email:
williams.tina.t@dol.gov.
RIN: 1250–AA14
Proposed Rule Stage
Priority: Other Significant.
Legal Authority: E.O. 11246; 29 U.S.C.
793; 38 U.S.C. 4216
CFR Citation: 41 CFR 60–1, 60–2, 60–
4, 60–20, 60–30; 41 CFR 60–40, 60–50,
60–300, 60–741.
Legal Deadline: None.
Abstract: This proposal would modify
certain provisions set forth in the
November 10, 2020 final rule,
Nondiscrimination Obligations of
Federal Contractors and Subcontractors:
Procedures To Resolve Potential
Employment Discrimination (85 FR
71553) and make other related changes
to the pre-enforcement notice and
conciliation process. The proposal will
17:50 Jan 28, 2022
Action
DOL—WAGE AND HOUR DIVISION
(WHD)
DOL—OFCCP
VerDate Sep<11>2014
promote effective enforcement through
OFCCP’s regulatory procedures.
Statement of Need: The Office of
Federal Contract Compliance Programs
intends to issue a Proposed Rule to
modify regulations that delineate
procedures and standards the agency
follows when issuing pre-enforcement
notices and securing compliance
through conciliation. This proposal
would support OFCCP in fulfilling its
mission to ensure equal employment
opportunity.
Summary of Legal Basis: Executive
Order 11246 (as amended), section 503
of the Rehabilitation Act (as amended),
and the Vietnam Era Veterans’
Readjustment Assistance Act (as
amended).
Alternatives: To be determined.
Anticipated Cost and Benefits: The
Department will prepare estimates of
the anticipated costs and discuss
benefits associated with the proposed
rule.
Risks: To be determined.
Timetable:
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114. Defining and Delimiting the
Exemptions for Executive,
Administrative, Professional, Outside
Sales and Computer Employees
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 29 U.S.C. 201 et seq.;
29 U.S.C. 213
CFR Citation: 29 CFR 541.
Legal Deadline: None.
Abstract: WHD is reviewing the
regulations at 29 CFR 541, which
implement the exemption of bona fide
executive, administrative, and
professional employees from the Fair
Labor Standards Act’s minimum wage
and overtime requirements.
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Statement of Need: One of the
primary goals of this rulemaking would
be to update the salary level
requirement of the section 13(a)(1)
exemption. A salary level test has been
part of the regulations since 1938 and it
has been long recognized that the best
single test of the employer’s good faith
in attributing to the employee’s services
is the amount he pays for them. In prior
rulemakings, the Department explained
its commitment to update the standard
salary level and Highly Compensated
Employees (HCE) total compensation
levels more frequently. Regular updates
promote greater stability, avoid
disruptive salary level increases that can
result from lengthy gaps between
updates and provide appropriate wage
protection.
Summary of Legal Basis: Section
13(a)(1) of the FLSA, codified at 29
U.S.C. 213(a)(1), exempts any employee
employed in a bona fide executive,
administrative, or professional capacity
or in the capacity of outside salesman
(as such terms are defined and
delimited from time to time by
regulations of the Secretary, subject to
the provisions of the [Administrative
Procedure Act.]) The FLSA does not
define the terms executive,
administrative, professional, or outside
salesman. However, pursuant to
Congress’ grant of rulemaking authority,
the Department issued regulations at 29
CFR part 541, defining the scope of the
section 13(a)(1) exemptions. Congress
explicitly delegated to the Secretary of
Labor the power to define and delimit
the specific terms of the exemptions
through notice-and-comment
rulemaking.
Alternatives: Alternatives will be
developed in considering proposed
revisions to the current regulations. The
public will be invited to provide
comments on the proposed revisions
and possible alternatives.
Anticipated Cost and Benefits: The
Department will prepare estimates of
the anticipated costs and benefits
associated with the proposed rule.
Risks: This action does not affect
public health, safety, or the
environment.
Timetable:
Action
NPRM ..................
Date
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal,
Local, State, Tribal.
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Federalism: Undetermined.
Agency Contact: Amy DeBisschop,
Director of the Division of Regulations,
Legislation, and Interpretation,
Department of Labor, Wage and Hour
Division, 200 Constitution Avenue NW,
FP Building, Room S–3502,
Washington, DC 20210, Phone: 202 693–
0406.
RIN: 1235–AA39
DOL—WHD
Alternatives: Alternatives will be
developed in considering proposed
revisions to the current regulations. The
public will be invited to provide
comments on the proposed revisions
and possible alternatives.
Anticipated Cost and Benefits: The
Department will prepare estimates of
the anticipated costs and benefits
associated with the proposed rule.
Risks: This action does not affect
public health, safety, or the
environment.
Timetable:
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115. Modernizing the Davis-Bacon and
Related Acts Regulations
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 40 U.S.C. 3141 et
seq.; 40 U.S.C. 3145
CFR Citation: 29 CFR 1; 29 CFR 3; 29
CFR 5; 29 CFR 6; 29 CFR 7.
Legal Deadline: None.
Abstract: The Davis-Bacon Act (DBA)
was enacted in 1931 and amended in
1935 and 1964. The DBA requires the
payment of locally prevailing wages and
fringe benefits to laborers and
mechanics as determined by the
Department of Labor. The DBA applies
to direct Federal contracts and District
of Columbia contracts in excess of
$2,000 for the construction, alteration,
or repair of public buildings or public
works. Congress has included DBA
prevailing wage requirements in
numerous statutes (referred to as
Related Acts) under which Federal
agencies assist construction projects
through grants, loans, guarantees,
insurance, and other methods. Covered
contractors and subcontractors must pay
their laborers and mechanics employed
under the contract no less than the
locally prevailing wage rates and fringe
benefits as required by the applicable
wage determination. The Department
proposes to update and modernize the
regulations implementing the DavisBacon and Related Acts to provide
greater clarity and enhance their
usefulness in the modern economy.
Statement of Need: The Department
proposes to update and modernize the
regulations implementing the DavisBacon and Related Acts to provide
greater clarity and enhance their
usefulness in the modern economy.
Summary of Legal Basis: These
regulations are authorized by Title 40,
sections 3141–3148. Minimum wages
are defined as those determined by the
Secretary to be (a) prevailing; (b) in the
locality of the project; (c) for similar
craft and skills; (d) on comparable
construction work. See section 3142.
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Action
Date
NPRM ..................
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal,
Local, State, Tribal.
Federalism: Undetermined.
Agency Contact: Amy DeBisschop,
Director of the Division of Regulations,
Legislation, and Interpretation,
Department of Labor, Wage and Hour
Division, 200 Constitution Avenue NW,
FP Building, Room S–3502,
Washington, DC 20210, Phone: 202 693–
0406.
RIN: 1235–AA40
DOL—WHD
Final Rule Stage
116. Tip Regulations Under the Fair
Labor Standards Act (FLSA)
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: Fair Labor Standards
Act; 29 U.S.C. 201 et seq.; 29 U.S.C.
203(m); Pub. L. 115–141
CFR Citation: 29 CFR 531; 29 CFR 10;
29 CFR 516; 29 CFR 578; 29 CFR 579;
29 CFR 580.
Legal Deadline: None.
Abstract: In the Consolidated
Appropriations Act of 2018 (‘‘CAA’’),
Congress amended section 3(m) of the
Fair Labor Standards Act (‘‘FLSA’’) to
prohibit employers from keeping tips
received by their employees, regardless
of whether the employers take a tip
credit under section 3(m). Congress also
amended section 16(e) of the FLSA to
allow the Department to impose civil
money penalties (‘‘CMPs’’) when
employers unlawfully keep employees’
tips. On December 30, 2020, the Wage
and Hour Division (‘‘WHD’’) published
Tip Regulations Under the Fair Labor
Standards Act (the ‘‘2020 Tip final
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5119
rule’’) in the Federal Register to address
these amendments and to codify
guidance regarding the FLSA tip credit’s
application to employees who perform
tipped and non-tipped duties. The
effective date of the 2020 Tip final rule
was March 1, 2021, but the Department
extended that date until April 30, 2021,
in accordance with the Presidential
directive as expressed in the
memorandum of January 20, 2021, from
the Assistant to the President and Chief
of Staff. The Department further delayed
three portions of the 2020 Tip final rule
until December 31, 2021: Two portions
addressing the assessment of CMPs and
the portion addressing the application
of the FLSA tip credit to tipped
employees who perform tipped and
non-tipped duties. The Department
proposed to withdraw these three
portions of the 2020 Tip final rule and
proposed new language addressing
these three issues. On September 24,
2021, a Department final rule (CMP final
rule) was published in the Federal
Register, which among other things,
adopted language upholding the
Department’s statutorily-granted
discretion with regard to section
3(m)(2)(B) CMPs, and aligned the
Department’s regulations with the
FLSA’s statutory text. On June 23, 2021,
the Department published an NPRM
(Dual Jobs NPRM) in the Federal
Register, 86 FR 32818, proposing to
withdraw and repropose the portion of
the 2020 Tip final rule addressing when
a tipped employee performs both tipped
and non-tipped duties under the FLSA.
The comment period closed on August
23, 2021. The Department published a
final rule on October 29, 2021 to finalize
its proposal to withdraw one portion of
the Tip Regulations Under the FLSA
(2020 Tip final rule) and finalize its
proposed revisions related to the
determination of when a tipped
employee is employed in dual jobs.
Specifically, the Department amended
its regulations to clarify that an
employer may only take a tip credit
when its tipped employees perform
work that is part of the employee’s
tipped occupation.
Statement of Need: Upon review of
the portion of the 2020 Tip final rule
addressing when a tipped employee
performs both tipped and non-tipped
duties under the FLSA, the Department
was concerned that the lack of clear
guidelines in the rule regarding when a
tipped employee who is performing
non-tipped duties is still engaged in a
tipped occupation, such that an
employer can continue to take a tip
credit for the time the tipped employee
spends on such non-tipped work failed
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to achieve its goal of providing certainty
for employers and created the potential
for the misuse of the FLSA tip credit.
Among other things, the 2020 Tip final
rule would have permitted an employer
to take a tip credit for time that an
employee in a tipped occupation spends
performing related, non-tipped duties
contemporaneously with tipped duties,
or for a reasonable time immediately
before or after performing the tipped
duties. The Department believes that
because the 2020 Tip final rule did not
define these key terms, the 2020 Tip
final rule will invite rather than limit
litigation in this area, and thus may not
support one of the rule’s stated
justifications for departing from
established guidance. The Dual Jobs
final rule clarifies that an employer may
only take a tip credit when its tipped
employees perform work that is part of
the employee’s tipped occupation.
Summary of Legal Basis: The Fair
Labor Standards Act (FLSA or Act)
generally requires covered employers to
pay employees at least the federal
minimum wage, which is currently
$7.25 per hour. See 29 U.S.C. 206(a)(1).
Section 3(m) of the FLSA allows an
employer that meets certain
requirements to take a credit toward its
minimum wage obligations of a limited
amount, currently up to $5.12 per hour,
of the tips received by employees
(known as a tip credit). See 29 U.S.C.
203(m)(2)(A). Section 3(t) of the FLSA
defines a tipped employee for whom an
employer may take a tip credit under
section 3(m) as any employee engaged
in an occupation in which he
customarily and regularly receives more
than $30 a month in tips. See 29 U.S.C.
203(t). The FLSA regulations addressing
tipped employment are codified at 29
CFR 531.50 through 531.60. See also 29
CFR 10.28 (establishing a tip credit for
federal contractor employees covered by
Executive Order 13658 who are tipped
employees under section 3(t) of the
FLSA).
Alternatives: The Department issued
this final rule upon a reasoned
determination that its benefits justify its
costs; and that it is tailored to impose
the least burden on society, consistent
with obtaining the regulatory objectives;
and that, in choosing among alternative
regulatory approaches, the agency has
selected those approaches that
maximize net benefits. Executive Order
13563 recognizes that some costs and
benefits are difficult to quantify and
provides that, when appropriate and
permitted by law, agencies may
consider and discuss qualitatively
values that are difficult or impossible to
quantify, including equity, human
dignity, fairness, and distributive
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impacts. The analysis in the final rule
outlines the impacts that the
Department anticipates may result from
this rule.
Anticipated Cost and Benefits: The
Department believes that the revisions
to its regulations regarding when a
tipped employee is employed in dual
jobs provides increased clarity to
employers and workers and ensures
workers are paid the wages they are
owed. In the Dual Jobs final rule, the
Department estimated that these
changes would lead to costs for Year 1
that will consist of rule familiarization
costs, adjustment costs, and
management costs, and would be
$224,882,399 ($23,827,236 +
$23,827,236 + $177,227,926). For the
following years, the Department
estimates that costs will only consist of
management costs and would be
$177,227,926. Additionally, the
Department estimated average
annualized costs of this rule over 10
years. Over 10 years, it will have an
average annual cost of $183.6 million
calculated at a 7 percent discount rate
($151.1 million calculated at a 3 percent
discount rate). All costs are in 2019
dollars.
Risks: This action does not affect
public health, safety, or the
environment.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period Extended.
NPRM Comment
Period Extended End.
NPRM; and Withdrawal of
NPRM dated
12/05/2017 (82
FR 57395).
NPRM Comment
Period End.
NPRM Comment
Period Extension.
NPRM Comment
Period Extension End.
Final Rule (2020
Tip final rule).
Proposed Delay
of Final Rule
Effective Date
(to 4/30/21).
Proposed Delay
of Final Rule
Effective Date
Comment Period End.
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12/05/17
12/15/17
FR Cite
82 FR 57395
82 FR 59562
02/05/18
10/08/19
84 FR 53956
12/09/19
12/11/19
12/30/20
85 FR 86756
02/05/21
86 FR 8325
Fmt 4701
Sfmt 4702
Final Rule Delay
of Effective
Date (to 4/30/
21).
Final Rule Delay
of Effective
Date Effective.
NPRM; Partial
Withdrawal
(CMP NPRM).
NPRM; Partial
Withdrawal
(CMP NPRM)
Comment Period End.
NPRM; Proposed
Delay of Effective Date (to 12/
31/2021).
NPRM; Proposed
Delay of Effective Date Comment Period
End (to 12/31/
21).
Final Rule; Delay
of Effective
Date (to 12/31/
21).
Final Rule; Partial
Withdrawal
(CMP Final
Rule).
Final Rule; Partial
Withdrawal
(CMP Final
Rule) Effective.
NPRM; Partial
Withdrawal
(Dual Jobs
NPRM).
NPRM; Partial
Withdrawal
(Dual Jobs
NPRM) Comment Period
End.
Final Rule; Partial
Withdrawal
(Dual Jobs
Final Rule).
Final Rule; Partial
Withdrawal
(Dual Jobs
Final Rule) Effective.
Date
02/26/21
FR Cite
86 FR 11632
04/30/21
03/25/21
86 FR 15817
05/24/21
03/25/21
86 FR 15811
04/14/21
04/29/21
86 FR 22597
09/24/21
86 FR 52973
11/23/21
06/23/21
86 FR 32818
08/23/21
10/29/21
86 FR 60114
12/28/21
84 FR 67681
12/11/19
02/17/21
Action
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Amy DeBisschop,
Director of the Division of Regulations,
Legislation, and Interpretation,
Department of Labor, Wage and Hour
Division, 200 Constitution Avenue NW,
FP Building, Room S–3502,
Washington, DC 20210, Phone: 202 693–
0406.
RIN: 1235–AA21
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DOL—WHD
117. E.O. 14026, Increasing the
Minimum Wage for Federal Contractors
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Unfunded Mandates: This action may
affect the private sector under Public
Law 104–4.
Legal Authority: E.O. 14026
CFR Citation: 29 CFR 23; 29 CFR 10.
Legal Deadline: None.
Abstract: On April 27, 2021, President
Joseph Biden issued E.O. 14026,
Increasing the Minimum Wage for
Federal Contractors to promote
economy and efficiency in procurement
by increasing the hourly minimum wage
rate paid by parties that contract with
the Federal Government to $15.00 for
those employees working on or in
connection with a Federal Government
contract. These regulations will
implement the Executive Order.
Statement of Need: President Biden
issued Executive Order 14026 pursuant
to his authority under the Constitution
and the laws of the United States,
expressly including the Federal
Property and Administrative Services
Act (Procurement Act), 40 U.S.C. 101 et
seq. 86 FR 22835. The Executive order
directs the Secretary to issue regulations
by November 24, 2021, consistent with
applicable law, to implement the order’s
requirements.
Summary of Legal Basis: The
Procurement Act authorizes the
President to prescribe policies and
directives that the President considers
necessary to carry out the statutory
purposes of ensuring economical and
efficient government procurement and
administration of government property.
40 U.S.C. 101, 121(a). Executive Order
14026 delegates to the Secretary the
authority to issue regulations to
implement the requirements of this
order. 86 FR 22836. The Secretary has
delegated his authority to promulgate
these regulations to the Administrator of
the WHD and to the Deputy
Administrator of the WHD if the
Administrator position is vacant.
Secretary’s Order 01–2014 (Dec. 19,
2014), 79 FR 77527 (published Dec. 24,
2014); Secretary’s Order 01–2017 (Jan.
12, 2017), 82 FR 6653 (published Jan.
19, 2017).
Alternatives: The Department noted
that due to the prescriptive nature of
Executive Order 14026, the Department
does not have the discretion to
implement alternatives that would
violate the text of the Executive order,
such as the adoption of a higher or
lower minimum wage rate, or continued
exemption of recreational businesses.
However, the Department considered
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several alternatives to discretionary
proposals set forth in this final rule. In
the final rule, the Department proposed
to define the term United States, when
used in a geographic sense, to mean the
50 States, the District of Columbia,
Puerto Rico, the Virgin Islands, Outer
Continental Shelf lands as defined in
the Outer Continental Shelf Lands Act,
American Samoa, Guam, the
Commonwealth of the Northern Mariana
Islands, Wake Island, and Johnston
Island.
The Department considered defining
the term United States to exclude
contracts performed in the territories
listed above, consistent with the
discretionary decision made in the
Department’s prior rulemaking
implementing Executive Order 13658.
Such an alternative would result in
fewer contracts covered by Executive
Order 14026 and fewer workers entitled
to an initial $15 hourly minimum wage
for work performed on or in connection
with such contracts. This alternative
was rejected because the Department
has further examined the issue since its
prior rulemaking in 2014 and
consequently determined that the
Federal Government’s procurement
interests in economy and efficiency
would be promoted by extending the
Executive Order 14026 minimum wage
to workers performing on or in
connection with covered contracts.
A second alternative the Department
considered in the final rule was raising
(or eliminating) the 20 percent threshold
for an exclusion for FLSA-covered
workers performing in connection with
covered contracts. If the Department
were to omit this exclusion, more
workers would be covered by the rule,
and contractors would be required to
pay more workers the applicable
minimum wage rate (initially $15 per
hour) for time spent performing in
connection with covered contracts. This
would result in greater income transfers
to workers. Conversely, if the
Department were to raise the 20 percent
threshold, fewer workers would be
covered by the rule, resulting in a
smaller income transfer to workers.
The Department rejected this
regulatory alternative because having an
exclusion for FLSA-covered workers
performing in connection with covered
contracts based on a 20 percent of hours
worked in a week standard is a
reasonable interpretation.
Anticipated Cost and Benefits: In the
final rule, the Department estimated the
number of employees who would, as a
result of the Executive order and the
proposed rule, see an increase in their
hourly wage, i.e., affected employees.
The Department estimates there will be
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327,300 affected employees in the first
year of implementation (Table 1 of final
rule). During the first 10 years the rule
is in effect, average annualized direct
employer costs are estimated to be $2.4
million (Table 1 of final rule) assuming
a 7 percent real discount rate (hereafter,
unless otherwise specified, average
annualized values will be presented
using a 7 percent real discount rate).
This estimated annualized cost includes
$1.9 million for regulatory
familiarization and $538,500 for
implementation costs. Other potential
costs are discussed qualitatively.
The direct transfer payments
associated with this rule are transfers of
income from employers to employees in
the form of higher wage rates. Estimated
average annualized transfer payments
are $1.75 billion per year over 10 years.
The Department expects that
increasing the minimum wage of
Federal contract workers will generate
several important benefits. However,
due to data limitations, these benefits
are not monetized. As noted in the
Executive order, the NPRM will
promote economy and efficiency.
Specifically, the proposed rule
discusses benefits from improved
government services, increased morale
and productivity, reduced turnover,
reduced absenteeism, and reduced
poverty and income inequality for
Federal contract workers.
Risks: This action does not affect
public health, safety, or the
environment.
Timetable:
Action
NPRM ..................
NPRM Comment
Period Extension.
NPRM Comment
Period Extension End.
Final Rule ............
Final Rule Effective Date.
Final Rule Applicability Date.
Date
07/23/21
08/04/21
FR Cite
86 FR 38816
86 FR 41907
08/27/21
11/24/21
01/30/22
86 FR 67126
01/30/22
Regulatory Flexibility Analysis
Required: No.
Government Levels Affected: None.
Agency Contact: Amy DeBisschop,
Director of the Division of Regulations,
Legislation, and Interpretation,
Department of Labor, Wage and Hour
Division, 200 Constitution Avenue NW,
FP Building, Room S–3502,
Washington, DC 20210, Phone: 202 693–
0406.
RIN: 1235–AA41
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DOL—EMPLOYMENT AND TRAINING
ADMINISTRATION (ETA)
Proposed Rule Stage
118. Wagner–Peyser Act Staffing
Priority: Other Significant.
Legal Authority: Wagner–Peyser Act
CFR Citation: 20 CFR 651; 20 CFR
652; 20 CFR 653; 20 CFR 658.
Legal Deadline: None.
Abstract: The Department proposes to
revise the Wagner-Peyser Act
regulations regarding Employment
Services (ES) staffing to require that
states use state merit staff to provide ES
services, including Migrant and
Seasonal Farmworker (MSFW) services,
and to improve service delivery for
migrant and seasonal farmworkers
(MSFW).
Statement of Need: The Department
has identified areas of the regulation
that should be changed to create a
uniform standard of ES services
provision for all States.
Summary of Legal Basis: The
Department is undertaking this
rulemaking pursuant to its authority
under the Wagner-Peyser Act.
Alternatives: Two alternatives will be
considered, and the public will have the
opportunity to comment on these
alternatives after publication of the
NPRM.
Anticipated Cost and Benefits: The
proposed rule is expected to have onetime rule familiarization costs of $4,205
in 2020 dollars, as well as unknown
transition costs. The proposed rule is
also expected to have annual transfer
payments of $9.6 million for three of the
five States that currently have non-State
merit staff providing some labor
exchange services. In the NPRM, the
Department will solicit comments from
stakeholders and the public on the
unknown transition costs, plus transfer
payments that would be incurred by the
two additional States with some nonState merit staff providing labor
exchange services.
Risks: This action does not affect the
public health, safety, or the
environment.
Timetable:
Action
Date
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NPRM ..................
FR Cite
01/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: State.
Agency Contact: Kimberly Vitelli,
Administrator, Office of Workforce
Investment, Department of Labor,
Employment and Training
Administration, 200 Constitution
Avenue NW, FP Building, Room C–
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4526, Washington, DC 20210, Phone:
202 693–3980, Email: vitelli.kimberly@
dol.gov.
RIN: 1205–AC02
DOL—ETA
119. Apprenticeship Programs, Labor
Standards for Registration, Amendment
of Regulations
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: The National
Apprenticeship Act, as amended (50
Stat. 664) 29 U.S.C. 50
CFR Citation: 29 CFR 29.
Legal Deadline: None.
Abstract: On February 17, 2021, the
President signed an Executive Order: (1)
Revoking Executive Order 13801 (issued
on June 15, 2017); and (2) directing
federal departments and agencies to
consider taking steps promptly to
rescind any orders, rules, regulations,
guidelines or policies implementing
Executive Order 13801. The Department
is considering amending its
apprenticeship regulations to rescind
subpart B of title 29 CFR part 29, Labor
Standards for the Registration of
Apprenticeship Programs, including the
status of those Standards Recognition
Entities and Industry Recognized
Apprenticeship Programs (IRAPs) that
previously received recognition under
the provisions of 29 CFR part 29,
subpart B, and to make additional
conforming edits in subpart A as
appropriate.
Statement of Need: Executive Order
14016 (86 FR 11089), issued by the
President on February 17, 2021, directed
Federal agencies to promptly consider
taking steps to rescind any orders, rules,
regulations, guidelines, or policies
implementing E.O. 13801. In response
to E.O. 14016, the Department has
reviewed the IRAP system and has
determined that, because the IRAP
system has fewer quality training and
worker protection standards than the
Registered Apprenticeship system and
results in a duplicative system of
apprenticeship, it will issue a proposed
regulation to rescind subpart B of title
29 CFR part 29, Labor Standards for the
Registration of Apprenticeship
Programs.
Summary of Legal Basis: The National
Apprenticeship Act of 1937 (NAA), 29
U.S.C. 50, authorizes the Secretary of
Labor (Secretary) to: (1) Formulate and
promote the use of labor standards
necessary to safeguard the welfare of
apprentices and to encourage their
inclusion in apprenticeship contracts;
(2) bring together employers and labor
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for the formulation of programs of
apprenticeship; and (3) cooperate with
State agencies engaged in the
formulation and promotion of standards
of apprenticeship.
Alternatives: Alternatives were
proposed in the NPRM that is open for
public comment.
Anticipated Cost and Benefits: The
Department’s preliminary estimates is
anticipated cost savings of $8.9 million
over the first 10 years of the proposed
rule (2022–2031). Details for costs and
benefits will be prepared.
Risks: This action does not affect the
public health, safety, or the
environment.
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
Date
11/15/21
01/14/22
FR Cite
86 FR 62966
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: John V. Ladd,
Administrator, Office of
Apprenticeship, Department of Labor,
Employment and Training
Administration, 200 Constitution
Avenue NW, FP Building, Room C–
5311, Washington, DC 20210, Phone:
202 693–2796, Fax: 202 693–3799,
Email: ladd.john@dol.gov.
RIN: 1205–AC06
DOL—EMPLOYEE BENEFITS
SECURITY ADMINISTRATION (EBSA)
Proposed Rule Stage
120. Prudence and Loyalty in Selecting
Plan Investments and Exercising
Shareholder Rights
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 29 U.S.C. 1104; 29
U.S.C. 1135
CFR Citation: 29 CFR 2550.
Legal Deadline: None.
Abstract: This rulemaking
implements Executive Order 13990 of
January 20, 2021, titled Protecting
Public Health and the Environment and
Restoring Science to Tackle the Climate
Crisis, and Executive Order 14030 of
May 20, 2021, titled Climate-Related
Financial Risks. Among other things,
these Executive Orders direct Federal
agencies to review existing regulations
promulgated, issued, or adopted
between January 20, 2017, and January
20, 2021, that are or may be inconsistent
with, or present obstacles to, the
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policies set forth in section 1 of the
orders 86 FR 7037 (January 25, 2021); 86
FR 27967 (May 25, 2021). Such policies
include the promotion and protection of
public health and the environment and
ensuring that agency activities are
guided by the best science and protected
by processes that ensure the integrity of
Federal decision-making, and to
advance consistent, clear, intelligible,
comparable, and accurate disclosure of
climate-related financial risk, including
both physical and transition risks.
Section 2 of E.O. 13990 provides that for
any such regulatory actions identified
by the agencies, the heads of agencies
shall, as appropriate and consistent with
applicable law, consider suspending,
revising, or rescinding the agency
actions. Section 4 of E.O. 14030 directs
the Secretary of Labor to consider
publishing, by September 2021, for
notice and comment a proposed rule to
suspend, revise, or rescind ‘‘Financial
Factors in Selecting Plan Investments,’’
85 FR 72846 (November 13, 2020), and
‘‘Fiduciary Duties Regarding Proxy
Voting and Shareholder Rights,’’ 85 FR
81658 (December 16, 2020). The
Department of Labor’s Employee
Benefits Security Administration
therefore will undertake a review of
regulations under title I of the Employee
Retirement Income Security Act in
accordance with these orders, including
‘‘Financial Factors in Selecting Plan
Investments,’’ 85 FR 72846 (November
13, 2020), and ‘‘Fiduciary Duties
Regarding Proxy Voting and
Shareholder Rights,’’ 85 FR 81658
(December 16, 2020).
Statement of Need: The Department of
Labor’s Employee Benefits Security
Administration undertook a review of
the ‘‘Financial Factors in Selecting Plan
Investments’’ and the ‘‘Fiduciary Duties
Regarding Proxy Voting and
Shareholder Rights,’’ final rules in
accordance with Executive Order 13990
and Executive Order 14030. Those final
rules were intended to provide clarity
and certainty regarding the scope and
application of ERISA fiduciary duties to
plan investment decisions and to the
exercise of shareholder rights, including
proxy voting. Stakeholder reactions to
the 2020 rules, however, suggest that the
rules may have caused more confusion
than clarity. Many interested
stakeholders have expressed concerns
that the terms and tone of the rules and
related preambles have increased
uncertainty about the extent to which
plan fiduciaries may take into account
environmental, social, or governance
(ESG) considerations, including climaterelated financial risk, in their
investment and proxy voting decisions,
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and that the final rules have and will
continue to have chilling effects
contrary to the financial interests of
ERISA plans and their participants and
beneficiaries. The NPRM is needed to
address these concerns and negative
impacts.
Summary of Legal Basis: The
Department is proposing the
amendments pursuant to ERISA
sections 404 (29 U.S.C. 1104) and 505
(29 U.S.C. 1135), and Executive Order
14030 (86 FR 27967 (May 25, 2021)) and
Executive Order 13990 (86 FR 7037
(January 25, 2021)).
Alternatives: The Department
considered various alternatives,
including leaving the current
regulations in place without change,
rescinding the Financial Factors in
Selecting Plan Investments and
Fiduciary Duties Regarding Proxy
Voting and Shareholder Rights final
rules, and revising the current
regulation by, in effect, reverting it to its
form before the 2020 final rules.
Anticipated Cost and Benefits:
Anticipated Benefits—The primary
benefit of the proposal is clarification of
legal standards, which should empower
fiduciaries to take proper account of
ESG factors when making investment
decisions and exercising proxy voting
rights on behalf of plan participants.
The Department has heard from
stakeholders that the current regulation,
and investor confusion about it, has
already had a chilling effect on
appropriate integration of ESG factors in
investment decisions, and could deter
plan fiduciaries from taking into
account ESG factors even when they are
material to a risk-return analysis.
Stakeholders also indicated that
confusion surrounding the current
regulation could discourage proxy
voting and other exercises of
shareholder rights even when doing so
is in the plan’s best interest. A
significant benefit of this proposal
would be to ensure that plans do not
inappropriately avoid considering
material ESG factors when selecting
investments or exercising shareholder
rights, as they might otherwise be
inclined to do under the current
regulation. Acting on material ESG
factors in these contexts, and in a
manner consistent with the proposal,
will redound, in the first instance, to
employee benefit plans covered by
ERISA and their participants and
beneficiaries, and secondarily and
indirectly, to society more broadly but
without any sacrifices by the
participants and beneficiaries in ERISA
plans. Further, by ensuring that plan
fiduciaries would not sacrifice
investment returns or take on additional
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5123
investment risk to promote unrelated
goals, this proposal would lead to
increased investment returns over the
long run. The proposal would also make
certain that ERISA regulation would not
chill or otherwise discourage proxy
voting by plans governed by the
economic interests of the plan and its
participants. This would promote
management accountability to
shareholders, including the affected
shareholder plans. These benefits, while
difficult to quantify, are anticipated to
outweigh the costs.
Anticipated Costs—By reversing
aspects of the current regulation, this
proposal would facilitate certain
activities among plan fiduciaries in their
investment decisions, including
potential changes in asset management
strategies and proxy voting behavior,
that these plan fiduciaries otherwise
likely would not take under the current
regulation. The precise impact of this
proposal on such behavior is uncertain.
Therefore, a precise quantification of all
costs similarly is not possible. To the
extent that the proposal changes
investment-related behavior among
ERISA plans, its benefits are expected to
outweigh the costs. Overall, the costs of
the proposal are expected to be
relatively small, in part because the
Department assumes most plan
fiduciaries are complying with the pre2020 interpretive bulletins to the extent
relevant to costs (specifically
Interpretive Bulletin 2016–1 and 2015–
1), and it is expected that the proposal
would track that guidance to a very
large extent. Known incremental costs
of the proposal would be minimal on a
per-plan basis.
Risks: The risk of not pursuing this
rulemaking is that, if the current
regulation is not amended, it could have
a) a negative impact on plans’ financial
performance as they avoid materially
sound ESG investments or integration of
material ESG considerations in
investment analysis, b) a negative
impact on plans’ financial performance
as they shy away from economically
relevant considerations in proxy voting
and from exercising shareholder rights
on material issues, and c) broader
negative economic/societal impacts
(e.g., negative impacts on climate
change and on corporate managers’
accountability to the shareholders who
own the companies they serve).
Timetable:
Action
NPRM ..................
NPRM Comment
Period End.
E:\FR\FM\31JAP2.SGM
31JAP2
Date
10/14/21
12/13/21
FR Cite
86 FR 57272
5124
Action
Analyze Comments.
Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
Date
FR Cite
Timetable:
Action
03/00/22
Date
NPRM ..................
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: Jeffrey J. Turner,
Deputy Director, Office of Regulations
and Interpretations, Department of
Labor, Employee Benefits Security
Administration, 200 Constitution
Avenue NW, FP Building, Room N–
5655, Washington, DC 20210, Phone:
202 693–8500.
RIN: 1210–AC03
khammond on DSKJM1Z7X2PROD with PROPOSALS2
DOL—EBSA
121. • Mental Health Parity and
Addiction Equity Act and the
Consolidated Appropriations Act, 2021
Priority: Other Significant.
Legal Authority: Pub. L. 116–260,
Division BB, Title II; Pub. L. 110–343,
secs. 511–512
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule would propose
amendments to the final rules
implementing the Mental Health Parity
and Addiction Equity Act (MHPAEA).
The amendments would clarify plans’
and issuers’ obligations under the law,
promote compliance with MHPAEA,
and update requirements to take into
account experience with MHPAEA in
the years since the rules were finalized
as well as amendments to the law
recently enacted as part of the
Consolidated Appropriations Act, 2021.
Statement of Need: There have been
a number of legislative enactments
related to MHPAEA since issuance of
the 2014 final rules, including the 21st
Century Cures Act, the Support Act, and
the Consolidated Appropriations Act,
2021. This rule would propose
amendments to the final rules and
incorporate examples and modifications
to account for this legislation and
previously issued guidance and to take
into account experience with MHPAEA
in the years since the rules were
finalized.
Summary of Legal Basis: The
Department of Labor regulations would
be adopted pursuant to the authority
contained in 29 U.S.C. 1002, 1135, 1182,
1185d, 1191a, 1191b, and 1191c;
Secretary of Labor’s Order 1–2011, 77
FR 1088 (Jan. 9, 2012).
Alternatives: Not yet determined.
Anticipated Cost and Benefits: Not yet
determined.
Risks: Not yet determined.
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FR Cite
07/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: Amber Rivers,
Director, Office of Health Plan
Standards and Compliance Assistance,
Department of Labor, Employee Benefits
Security Administration, 200
Constitution Avenue NW, Washington,
DC 20210, Phone: 202 693–8335, Email:
rivers.amber@dol.gov.
RIN: 1210–AC11
DOL—EBSA
Final Rule Stage
122. Requirements Related to Surprise
Billing, Part 1
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 116–260,
Division BB, Title I and Title II
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory, July
1, 2021, Statutory Deadline for
Rulemaking.
Abstract: This interim final rule with
comment would implement certain
protections against surprise medical
bills under the No Surprises Act,
including requirements on group health
plans, issuers offering group or
individual health insurance coverage,
providers, facilities, and providers of air
ambulance services.
Statement of Need: Surprise bills can
cause significant financial hardship and
cause individuals to forgo care. The No
Surprises Act provides federal
protections against surprise billing and
limits out-of-network cost sharing under
many of the circumstances in which
surprise medical bills arise most
frequently. These interim final rules
fulfill a rulemaking requirement under
the No Surprises Act and protect
individuals from surprise medical bills
for emergency services, air ambulance
services furnished by nonparticipating
providers, and non-emergency services
furnished by nonparticipating providers
at participating facilities in certain
circumstances.
Summary of Legal Basis: The
Department of Labor regulations are
adopted pursuant to the authority
contained in 29 U.S.C. 1002, 1135, 1182,
1185d, 1191a, 1191b, and 1191c;
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Secretary of Labor’s Order 1–2011, 77
FR 1088 (Jan. 9, 2012).
Alternatives: In developing the
interim final rules, the Departments
considered various alternative
approaches, including whether costsharing should be based on the
recognized amount in circumstances
where the billed charge is lower,
whether plans and issuer should take
into account the number of claims paid
at the contracted rate when calculating
the qualifying payment amount, and
many others.
Anticipated Cost and Benefits: The
provisions in these interim final rules
will ensure that participants,
beneficiaries, and enrollees with health
coverage are protected from surprise
medical bills. Individuals with health
coverage will gain peace of mind,
experience a reduction in out-of-pocket
expenses, be able to meet their
deductible and out-of-pocket maximum
limits sooner, and may experience
increased access to care. Plans, issuers,
health care providers, facilities, and
providers of air ambulance services will
incur costs to comply with the
requirements in these interim final
rules.
Risks: The risk of not pursuing this
rulemaking is that the Department
would fail to meet its statutory
obligations to issue regulations, group
health plans would lack guidance
needed to comply with the statutory
requirements, and individuals would
continue to be burdened by surprise
medical bills.
Timetable:
Action
Interim Final Rule
Interim Final Rule
Comment Period End.
Interim Final Rule
Effective (Applicability Date 1/
1/2022).
Analyze Comments.
Date
07/13/21
09/07/21
FR Cite
86 FR 36872
09/13/21
11/00/21
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal,
State.
Federalism: This action may have
federalism implications as defined in
E.O. 13132.
Agency Contact: Amber Rivers,
Director, Office of Health Plan
Standards and Compliance Assistance,
Department of Labor, Employee Benefits
Security Administration, 200
Constitution Avenue NW, Washington,
E:\FR\FM\31JAP2.SGM
31JAP2
Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
DC 20210, Phone: 202 693–8335, Email:
rivers.amber@dol.gov.
RIN: 1210–AB99
DOL—EBSA
khammond on DSKJM1Z7X2PROD with PROPOSALS2
123. Requirements Related to Surprise
Billing, Part 2
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 116–260,
Division I BB, Title I and Title II
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory,
October 1, 2021, Statutory Deadline for
Rulemaking.
Abstract: This interim final rule with
comment would implement additional
protections against surprise medical
bills under the No Surprises Act,
including provisions related to the
independent dispute resolution
processes.
Statement of Need: Surprise bills can
cause significant financial hardship and
cause individuals to forgo care. The No
Surprises Act provides federal
protections against surprise billing and
limits out-of-network cost sharing under
many of the circumstances in which
surprise medical bills arise most
frequently. These interim final rules
implement provisions of the No
Surprises Act related to the independent
dispute resolution process for settling
payment disputes and protect
individuals from surprise medical bills
for emergency services, air ambulance
services furnished by nonparticipating
providers, and non-emergency services
furnished by nonparticipating providers
at participating facilities in certain
circumstances.
Summary of Legal Basis: The
Department of Labor regulations are
adopted pursuant to the authority
contained in 29 U.S.C. 1002, 1135, 1182,
1185d, 1191a, 1191b, and 1191c;
Secretary of Labor’s Order 1–2011, 77
FR 1088 (Jan. 9, 2012).
Alternatives: In developing the
interim final rules, the Departments
considered various alternative
approaches, including how to select a
certified independent dispute resolution
(IDR) entity if the parties fail to do so.
The Department considered alternative
approaches, including whether the
Department should consider the specific
fee of the certified IDR entity, or look to
other factors, such as how often the
certified IDR entity chooses the amount
closest to the qualifying payment
amount.
Anticipated Cost and Benefits: These
interim final rules will ensure that
consumers are protected from out-of-
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network medical costs by creating a
process for plans and issuers and
nonparticipating providers and facilities
to resolve disputes on out-of-network
rates. The Departments expect a
significant reduction in the incidence of
surprise billing, resulting in significant
savings for consumers. There may be a
potential transfer from providers,
including air ambulance providers and
facilities, to the participant, beneficiary,
or enrollee if the out-of-network rate
collected is lower than what would have
been collected had the provider or
facility balance billed the participant,
beneficiary, or enrollee. Overall, these
interim final rules provide a mechanism
to effectively resolve disputes between
issuers and providers, while protecting
patients.
Risks: The risk of not pursuing this
rulemaking is that group health plans
would lack guidance needed to comply
with the statutory requirements, plans
and health care providers would not be
able to resolve payment disputes, and
individuals would continue to be
burdened by surprise medical bills.
Timetable:
Action
Date
Interim Final Rule
Interim Final Rule
Effective.
Interim Final Rule
Comment Period End.
10/07/21
10/07/21
FR Cite
86 FR 55980
12/06/21
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: Federal,
State.
Agency Contact: Amber Rivers,
Director, Office of Health Plan
Standards and Compliance Assistance,
Department of Labor, Employee Benefits
Security Administration, 200
Constitution Avenue NW, Washington,
DC 20210, Phone: 202 693–8335, Email:
rivers.amber@dol.gov.
RIN: 1210–AC00
DOL—MINE SAFETY AND HEALTH
ADMINISTRATION (MSHA)
Proposed Rule Stage
124. Respirable Crystalline Silica
Priority: Other Significant.
Legal Authority: 30 U.S.C. 811; 30
U.S.C. 813(h); 30 U.S.C. 957
CFR Citation: 30 CFR 56; 30 CFR 57;
30 CFR 60; 30 CFR 70; 30 CFR 71; 30
CFR 72; 30 CFR 75; 30 CFR 90.
Legal Deadline: None.
Abstract: Many miners are exposed to
respirable crystalline silica (RCS) in
respirable dust. These miners can
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develop lung diseases such as chronic
obstructive pulmonary disease, and
various forms of pneumoconiosis, such
as silicosis, progressive massive fibrosis,
and rapidly progressive
pneumoconiosis. These diseases are
irreversible and may ultimately be fatal.
MSHA’s existing standards limit miners’
exposures to RCS. MSHA will publish a
proposed rule to address the existing
permissible exposure limit of RCS for all
miners and to update the existing
respiratory protection standards under
30 CFR 56, 57, and 72.
Statement of Need: Many miners are
exposed to respirable crystalline silica
(RCS) in respirable dust, which can
result in the onset of diseases such as
silicosis and rapidly progressive
pneumoconiosis. These lung diseases
are irreversible and may ultimately be
fatal. MSHA is examining the existing
limit on miners’ exposures to RCS to
safeguard the health of America’s
miners. Based on MSHA’s experience
with existing standards and regulations,
as well as OSHA’s RCS standards and
NIOSH research, MSHA will develop a
rule applicable to metal, nonmetal, and
coal operations.
Summary of Legal Basis: Sections
101(a), 103(h), and 508 of the Federal
Mine Safety and Health Act of 1977
(Mine Act), as amended (30 U.S.C.
811(a), 813(h), and 957).
Alternatives: MSHA will examine one
or two different levels of miners’ RCS
exposure limit and assess the
technological and economic feasibility
of such option(s).
Anticipated Cost and Benefits: To be
determined.
Risks: Miners face impairment risk of
health and functional capacity due to
RCS exposures. MSHA will examine the
existing RCS standard and determine
ways to reduce the health risks associate
with RCS exposure.
Timetable:
Action
Request for Information (RFI).
RFI Comment Period End.
NPRM ..................
Date
08/29/19
FR Cite
84 FR 45452
10/28/19
05/00/22
Regulatory Flexibility Analysis
Required: Undetermined.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Local,
State.
Agency Contact: Jessica Senk,
Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 201 12th Street S, Suite
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
401, Arlington, VA 22202, Phone: 202
693–9440.
RIN: 1219–AB36
DOL—MSHA
khammond on DSKJM1Z7X2PROD with PROPOSALS2
125. Safety Program for Surface Mobile
Equipment
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: 30 U.S.C. 811; 30
U.S.C. 813(h); 30 U.S.C. 957
CFR Citation: 30 CFR 56; 30 CFR 57;
30 CFR 77.
Legal Deadline: None.
Abstract: MSHA would require mine
operators to establish a written safety
program for mobile equipment and
powered haulage equipment (except belt
conveyors) used at surface mines and
surface areas of underground mines.
Under this proposal, mine operators
would be required to assess hazards and
risks and identify actions to reduce
accidents related to surface mobile
equipment. The operators would have
flexibility to develop and implement a
safety program that would work best for
their mining conditions and operations.
This proposed rule is to reduce fatal and
nonfatal injuries involving surface
mobile equipment used at mines and to
improve miner safety and health.
Statement of Need: Although mine
accidents are declining, accidents
involving mobile and powered haulage
equipment are still a leading cause of
fatalities in mining. To reduce fatal and
nonfatal injuries involving surface
mobile equipment used at mines, MSHA
is proposing a regulation that would
require mine operators employing six or
more miners to develop a written safety
program for mobile and powered
haulage equipment (excluding belt
conveyors) at surface mines and surface
areas of underground mines. The
written safety program would include
actions mine operators would take to
identify hazards and risks to reduce
accidents, injuries, and fatalities related
to surface mobile equipment.
Summary of Legal Basis: Sections
101(a), 103(h), and 508 of the Federal
Mine Safety and Health Act of 1977
(Mine Act), as amended (30 U.S.C.
811(a), 813(h), and 957).
Alternatives: MSHA considered
requiring all mines, regardless of size, to
develop and implement a written safety
program for surface mobile equipment.
Based on the Agency’s experience,
MSHA concluded that a mine operator
with five or fewer miners would
generally have a limited inventory of
surface mobile equipment. These
operators would also have less complex
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mining operations, with fewer mobile
equipment hazards that would
necessitate a written safety program.
Thus, these mine operators are not
required to have a written safety
program, although MSHA would
encourage operators with five or fewer
miners to have safety programs. MSHA
will consider comments and suggestions
received on alternatives or best practices
that all mines might use to develop
safety programs (whether written or not)
for surface mobile equipment.
Anticipated Cost and Benefits: The
proposed rule would not be
economically significant, and it would
have some net benefits.
Risks: Miners operating mobile and
powered haulage equipment or working
nearby face risks of workplace injuries,
illnesses, or deaths. The proposed rule
would allow a flexible approach to
reducing hazards and risks specific to
each mine so that mine operators would
be able to develop and implement safety
programs that work for their operation,
mining conditions, and miners.
Timetable:
Action
Date
Request for Information (RFI).
Notice of Public
Stakeholder
Meetings.
Stakeholder Meeting—Birmingham, AL.
Stakeholder Meeting—Dallas, TX.
Stakeholder Meeting (Webinar)—
Arlington, VA.
Stakeholder Meeting—Reno, NV.
Stakeholder Meeting—Beckley,
WV.
Stakeholder Meeting—Albany,
NY.
Stakeholder Meeting—Arlington,
VA.
RFI Comment Period End.
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
FR Cite
06/26/18
83 FR 29716
07/25/18
83 FR 35157
08/07/18
08/09/18
08/16/18
08/21/18
09/11/18
09/20/18
09/25/18
12/24/18
09/09/21
11/08/21
86 FR 50496
10/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Jessica Senk,
Director, Office of Standards,
Regulations, and Variances, Department
of Labor, Mine Safety and Health
Administration, 201 12th Street S, Suite
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401, Arlington, VA 22202, Phone: 202
693–9440.
RIN: 1219–AB91
DOL—OCCUPATIONAL SAFETY AND
HEALTH ADMINISTRATION (OSHA)
Prerule Stage
126. Prevention of Workplace Violence
in Health Care and Social Assistance
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 29 U.S.C. 655(b); 5
U.S.C. 609
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Request for Information
(RFI) (published on December 7, 2016
81 FR 88147)) provides OSHA’s history
with the issue of workplace violence in
health care and social assistance,
including a discussion of the Guidelines
that were initially published in 1996, a
2014 update to the Guidelines, the
agency’s use of 5(a)(1) in enforcement
cases in health care. The RFI solicited
information primarily from health care
employers, workers and other subject
matter experts on impacts of violence,
prevention strategies, and other
information that will be useful to the
agency. OSHA was petitioned for a
standard preventing workplace violence
in health care by a broad coalition of
labor unions, and in a separate petition
by the National Nurses United. On
January 10, 2017, OSHA granted the
petitions. OSHA is preparing for
SBREFA.
Statement of Need: Workplace
violence is a widespread problem, and
there is growing recognition that
workers in healthcare and social service
occupations face unique risks and
challenges. In 2018, the rate of serious
workplace violence incidents (those
requiring days off for an injured worker
to recuperate) was more than five times
greater in these occupations than in
private industry on average, with both
the number and share of incidents rising
faster in these professions than among
other workers.
Healthcare and social services
account for nearly as many serious
violent injuries as all other industries
combined. Workplace violence comes at
a high cost. It harms workers often both
physically and emotionally and makes it
more difficult for them to do their jobs.
Workers in some medical and social
service settings are more at risk than
others. According to the Bureau of Labor
Statistics, in 2018 workers at psychiatric
and substance abuse hospitals
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Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Regulatory Plan
experienced the highest rate of violent
injuries that resulted in days away from
work, at approximately 125 injuries per
10,000 full-time employees (FTEs). This
is about 6 times the rate for workers at
nursing and residential care facilities
(21.1/10,000). But even workers
involved in ambulatory care, while less
likely than other healthcare workers to
experience violent injuries, were 1.5
times as likely as workers outside of
healthcare to do so.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to set mandatory occupational safety
and health standards to assure safe and
healthful working conditions for
working men and women (29 U.S.C.
651).
Alternatives: One alternative to
proposed rulemaking would be to take
no regulatory action. As OSHA develops
more information, it will also make
decisions relating to the scope of the
standard and the requirements it may
impose.
Anticipated Cost and Benefits: The
estimates of costs and benefits are still
under development.
Risks: Analysis of risks is still under
development.
Timetable:
Action
Date
Request for Information (RFI).
RFI Comment Period End.
Initiate SBREFA ..
12/07/16
FR Cite
81 FR 88147
04/06/17
12/00/21
khammond on DSKJM1Z7X2PROD with PROPOSALS2
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions,
Organizations.
Government Levels Affected: Local,
State.
Agency Contact: Andrew Levinson,
Deputy Director, Directorate of
Standards and Guidance, Department of
Labor, Occupational Safety and Health
Administration, 200 Constitution
Avenue NW, FP Building, Room N–
3718, Washington, DC 20210, Phone:
202 693–1950, Email: levinson.andrew@
dol.gov.
RIN: 1218–AD08
DOL—OSHA
127. Heat Illness Prevention in Outdoor
and Indoor Work Settings
Priority: Other Significant.
Legal Authority: Not Yet Determined
CFR Citation: None.
Legal Deadline: None.
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Abstract: Heat is the leading weatherrelated killer, and it is becoming more
dangerous as 18 of the last 19 years were
the hottest on record. Excessive heat can
cause heat stroke and even death if not
treated properly. It also exacerbates
existing health problems like asthma,
kidney failure, and heart disease.
Workers in agriculture and construction
are at highest risk, but the problem
affects all workers exposed to heat,
including indoor workers without
climate-controlled environments.
Essential jobs where employees are
exposed to high levels of heat are
disproportionately held by Black and
Brown workers.
Heat stress killed 815 US workers and
seriously injured more than 70,000
workers from 1992 through 2017,
according to the Bureau of Labor
Statistics. However, this is likely a vast
underestimate, given that injuries and
illnesses are under reported in the US,
especially in the sectors employing
vulnerable and often undocumented
workers. Further, heat is not always
recognized as a cause of heat-induced
injuries or deaths and can easily be
misclassified, because man of the
symptoms overlap with other more
common diagnoses.
To date, California, Washington,
Minnesota, and the US military have
issued heat protections. OSHA currently
relies on the general duty clause (OSH
Act Section 5(a))(1)) to protect workers
from this hazard. Notably, from 2013
through 2017, California used its heat
standard to conduct 50 times more
inspections resulting in a heat-related
violation than OSHA did nationwide
under its general duty clause. It is likely
to become even more difficult to protect
workers from heat stress under the
general duty clause in light of the 2019
Occupational Safety and Health Review
Commission’s decision in Secretary of
Labor v. A.H. Sturgill Roofing, Inc.
OSHA was petitioned by Public
Citizen for a heat stress standard in
2011. The Agency denied this petition
in 2012, but was once again petitioned
by Public Citizen, on behalf of
approximately 130 organizations, for a
heat stress standard in 2018 and 2019.
Most recently in 2021, Public Citizen
petitioned OSHA to issue an emergency
temporary standard on heat stress.
OSHA is still considering these
petitions and has neither granted nor
denied to date. In 2019 and 2021, some
members of the Senate also urged OSHA
to initiate rulemaking to address heat
stress.
Given the potentially broad scope of
regulatory efforts to protect workers
from heat hazards, as well as a number
of technical issues and considerations
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with regulating this hazard (e.g., heat
stress thresholds, heat acclimatization
planning, exposure monitoring, medical
monitoring), a Request for Information
would allow the agency to begin a
dialogue and engage with stakeholders
to explore the potential for rulemaking
on this topic.
Statement of Need: Heat stress killed
more than 900 US workers, and caused
serious heat illness in almost 100 times
as many, from 1992 through 2019,
according to the Bureau of Labor
Statistics. However, this is likely a vast
underestimate, given that injuries and
illnesses are underreported in the US,
especially in the sectors employing
vulnerable and often undocumented
workers. Further, heat is not always
recognized as a cause of heat-induced
illnesses or deaths, which are often
misclassified, because many of the
symptoms overlap with other more
common diagnoses. Moreover, climate
change is increasing the heat hazard
throughout the nation: 2020 was either
the hottest or the second hottest year on
record, with 2021 on track to be even
hotter. Although official figures are not
yet available, we already know that in
many states heat related deaths are
higher are far higher than normal this
year.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to set mandatory occupational safety
and health standards to assure safe and
healthful working conditions for
working men and women (29 U.S.C.
651).
Alternatives: One alternative to
proposed rulemaking would be to take
no regulatory action. As OSHA develops
more information, it will also make
decisions relating to the scope of the
standard and the requirements it may
impose.
Anticipated Cost and Benefits: The
estimates of costs and benefits are still
under development.
Risks: Analysis of risks is still under
development.
Timetable:
Action
ANPRM ...............
ANPRM Comment
Period End.
Date
10/27/21
12/27/21
FR Cite
86 FR 59309
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected:
Undetermined.
Agency Contact: Andrew Levinson,
Deputy Director, Directorate of
Standards and Guidance, Department of
Labor, Occupational Safety and Health
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Administration, 200 Constitution
Avenue NW, FP Building, Room N–
3718, Washington, DC 20210, Phone:
202 693–1950, Email: levinson.andrew@
dol.gov.
RIN: 1218–AD39
DOL—OSHA
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Proposed Rule Stage
128. Infectious Diseases
Priority: Economically Significant.
Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 5 U.S.C. 533; 29
U.S.C. 657 and 658; 29 U.S.C. 660; 29
U.S.C. 666; 29 U.S.C. 669; 29 U.S.C. 673
CFR Citation: 29 CFR 1910.
Legal Deadline: None.
Abstract: Employees in health care
and other high-risk environments face
long-standing infectious disease hazards
such as tuberculosis (TB), varicella
disease (chickenpox, shingles), and
measles, as well as new and emerging
infectious disease threats, such as
Severe Acute Respiratory Syndrome
(SARS), the 2019 Novel Coronavirus
(COVID–19), and pandemic influenza.
Health care workers and workers in
related occupations, or who are exposed
in other high-risk environments, are at
increased risk of contracting TB, SARS,
Methicillin-Resistant Staphylococcus
Aureus (MRSA), COVID–19, and other
infectious diseases that can be
transmitted through a variety of
exposure routes. OSHA is examining
regulatory alternatives for control
measures to protect employees from
infectious disease exposures to
pathogens that can cause significant
disease. Workplaces where such control
measures might be necessary include:
Health care, emergency response,
correctional facilities, homeless shelters,
drug treatment programs, and other
occupational settings where employees
can be at increased risk of exposure to
potentially infectious people. A
standard could also apply to
laboratories, which handle materials
that may be a source of pathogens, and
to pathologists, coroners’ offices,
medical examiners, and mortuaries.
Statement of Need: Employees in
health care and other high-risk
environments face long-standing
infectious disease hazards such as
tuberculosis (TB), varicella disease
(chickenpox, shingles), and measles, as
well as new and emerging infectious
disease threats, such as Severe Acute
Respiratory Syndrome (SARS), the 2019
Novel Coronavirus (COVID–19), and
pandemic influenza. Health care
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workers and workers in related
occupations, or who are exposed in
other high-risk environments, are at
increased risk of contracting TB, SARS,
Methicillin-Resistant Staphylococcus
Aureus (MRSA), COVID–19, and other
infectious diseases that can be
transmitted through a variety of
exposure routes.
Summary of Legal Basis: The
Occupational Safety and Health Act of
1970 authorizes the Secretary of Labor
to set mandatory occupational safety
and health standards to assure safe and
healthful working conditions for
working men and women (29 U.S.C.
651).
Alternatives: One alternative is to take
no regulatory action. OSHA is
examining regulatory alternatives for
control measures to protect employees
from infectious disease exposures to
pathogens that can cause significant
disease. In addition to health care,
workplaces where SERs suggested such
control measures might be necessary
include: Emergency response,
correctional facilities, homeless shelters,
drug treatment programs, and other
occupational settings where employees
can be at increased risk of exposure to
potentially infectious people.
A standard could also apply to
laboratories, which handle materials
that may be a source of pathogens, and
to pathologists, coroners’ offices,
medical examiners, and mortuaries.
OSHA offered several alternatives to the
SBREFA panel when presenting the
proposed Infectious Disease (ID) rule.
OSHA considered a specification
oriented rule rather than a performance
oriented rule, but has preliminarily
determined that this type of rule would
provide less flexibility and would likely
fail to anticipate all of the potential
hazards and necessary controls for every
type and every size of facility and
would under-protect workers. OSHA
also considered changing the scope of
the rule by restricting the ID rule to
workers who have occupational
exposure during the provision of direct
patient care in institutional settings but
based on the evidence thus far analyzed,
workers performing other covered tasks
in both institutional and noninstitutional settings also face a risk of
infection because of their occupational
exposure.
Anticipated Cost and Benefits: The
estimates of costs and benefits are still
under development.
Risks: Analysis of risks is still under
development.
Timetable:
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Fmt 4701
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Action
Request for Information (RFI).
RFI Comment Period End.
Analyze Comments.
Stakeholder Meetings.
Initiate SBREFA ..
Complete
SBREFA.
NPRM ..................
Date
05/06/10
FR Cite
75 FR 24835
08/04/10
12/30/10
07/05/11
76 FR 39041
06/04/14
12/22/14
04/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses,
Governmental Jurisdictions.
Government Levels Affected: Local,
State.
Federalism: Undetermined.
Agency Contact: Andrew Levinson,
Deputy Director, Directorate of
Standards and Guidance, Department of
Labor, Occupational Safety and Health
Administration, 200 Constitution
Avenue NW, FP Building, Room N–
3718, Washington, DC 20210, Phone:
202 693–1950, Email: levinson.andrew@
dol.gov.
RIN: 1218–AC46
BILLING CODE 4510–HL–P
DEPARTMENT OF TRANSPORTATION
(DOT)
Introduction: Department Overview
DOT has statutory responsibility for
ensuring the United States has the safest
and most efficient transportation system
in the world. To accomplish this goal,
DOT regulates safety in the aviation,
motor carrier, railroad, motor vehicle,
commercial space, transit, and pipeline
transportation areas. The Department
also regulates aviation consumer and
economic issues and provides financial
assistance and writes the necessary
implementing rules for programs
involving highways, airports, mass
transit, the maritime industry, railroads,
motor transportation and vehicle safety.
DOT also has responsibility for
developing policies that implement a
wide range of regulations that govern
Departmental programs such as
acquisition and grants management,
access for people with disabilities,
environmental protection, energy
conservation, information technology,
occupational safety and health, property
asset management, seismic safety,
security, emergency response, and the
use of aircraft and vehicles. In addition,
DOT writes regulations to carry out a
variety of statutes ranging from the Air
Carrier Access Act and the Americans
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with Disabilities Act to Title VI of the
Civil Rights Act. The Department carries
out its responsibilities through the
Office of the Secretary (OST) and the
following operating administrations
(OAs): Federal Aviation Administration
(FAA); Federal Highway Administration
(FHWA); Federal Motor Carrier Safety
Administration (FMCSA); Federal
Railroad Administration (FRA); Federal
Transit Administration (FTA); Maritime
Administration (MARAD); National
Highway Traffic Safety Administration
(NHTSA); Pipeline and Hazardous
Materials Safety Administration
(PHMSA); and Great Lakes St. Lawrence
Seaway Development Corporation
(GLS).
The Department’s Regulatory
Philosophy and Initiatives
The U.S. Department of
Transportation (Department or DOT)
issues regulations to ensure the United
States transportation system is the safest
in the world, and addresses other urgent
challenges facing the Nation, including
the coronavirus disease 2019 (COVID–
19) pandemic, job creation, equity, and
climate change. These issues are
addressed, in part, by encouraging
innovation, thereby ensuring that the
Department’s regulations keep pace
with the latest developments and reflect
its top priorities.
The Department’s actions are also
governed by several recent executive
orders issued by the President, which
direct agencies to utilize all available
regulatory tools to address pressing
national challenges. On January 20,
2021, the President signed Executive
Order 13992, Revocation of Certain
Executive Orders Concerning Federal
Regulation. This Executive Order directs
Federal agencies to promptly take steps
to rescind any orders, rules, regulations,
guidelines, or policies that would
hamper the agencies’ flexibility to use
robust regulatory action to address
national priorities. On January 20, the
President also issued Executive Order
13990, Protecting Public Health and the
Environment and Restoring Science To
Tackle the Climate Crisis. This
Executive Order directs Federal
agencies to review all regulatory actions
issued in the previous Administration
and revise or rescind any of those
actions that do not adequately respond
to climate change, protect the
environment, advance environmental
justice, or improve public health.
Section 2(a)(ii) of Executive Order
13990 specifically requires the
Department of Transportation to review
‘‘The Safer Affordable Fuel-Efficient
(SAFE) Vehicles Rule Part One: One
National Program,’’ 84 FR 51310
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(September 27, 2019) (SAFE I Rule) and
‘‘The Safer Affordable Fuel-Efficient
(SAFE) Vehicles Rule for Model Years
2021–2026 Passenger Cars and Light
Trucks,’’ 85 FR 24174 (April 30, 2020)
(SAFE II Rule). The Secretary of
Transportation directed NHTSA to
review these fuel economy rules.
On July 9, 2021, the President signed
Executive Order 14036, Promoting
Competition in the American Economy.
Among other things, this Executive
Order requires the Department to
enhance consumer access to airline
flight information and ensure that
consumers are not exposed or subject to
advertising, marketing, pricing, and
charging of ancillary fees that may
constitute an unfair or deceptive
practice or an unfair method of
competition. This Executive Order also
requires the Department to: (1) Publish
a notice of proposed rulemaking
(NPRM) requiring airlines to refund
baggage fees when a passenger’s luggage
is substantially delayed and other
ancillary fees when passengers pay for
a service that is not provided; and (2)
consider initiating a rulemaking to
ensure that consumers have ancillary
fee information, including ‘‘baggage
fees,’’ ‘‘change fees,’’ and ‘‘cancellation
fees,’’ at the time of ticket purchase.
On August 5, 2021, the President
signed Executive Order 14037,
Strengthening American Leadership in
Clean Cars and Trucks. This Executive
Order requires that the Department
consider beginning work on a
rulemaking to establish new fuel
economy standards for passenger cars
and light-duty trucks beginning with
model year 2027 and extending through
and including at least model year 2030.
This Executive Order also requires the
Department to consider beginning work
on a rulemaking to establish new fuel
efficiency standards for heavy-duty
pickup trucks and vans beginning with
model year 2028 and extending through
and including at least model year 2030.
Finally, this Executive Order requires
the Department to consider beginning
work on a rulemaking to establish new
fuel efficiency standards for mediumand heavy-duty engines and vehicles to
begin as soon as model year 2030.
In response to Executive Order 13992,
in April 2021, the Department issued a
final rule revising the regulations
governing its regulatory process to
ensure that it has the maximum
flexibility necessary to quickly respond
to the urgent challenges facing our
Nation. Following implementation of
the final rule, in June 2021, the
Secretary of Transportation signed a
Departmental Order strengthening the
Department’s internal rulemaking
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procedures and revitalizing the
partnership between Operating
Administrations and the Office of the
Secretary in promulgating regulations to
better achieve the Department’s goals
and priorities. As part of this critical
overhaul, a Regulatory Leadership
Group was established, led by the
Deputy Secretary of Transportation,
which provides vital legal and policy
guidance on the Department’s regulatory
agenda.
In response to Executive Order 13990,
in May 2021, the Department issued an
NPRM proposing to repeal the SAFE I
Rule and associated guidance
documents. In August 2021, the
Department issued a Supplemental
Notice of Proposed Rulemaking inviting
comments on the appropriate path
forward regarding civil penalties
imposed on violations of DOT’s vehicle
emissions rules. Finally, in September
2021, the Department issued an NPRM
proposing more stringent vehicle
emission limits than those set by the
SAFE II Rule.
In response to Executive Orders 14036
and 14037, the Department is
considering the following rulemakings:
(1) Refunding Fees for Delayed Checked
Bags and Ancillary Services That Are
Not Provided; (2) Airline Ticket
Refunds; (3) Amendments to
Department’s Procedures in Regulating
Unfair and Deceptive Practices; and (4)
fuel economy standards for passenger
cars, light-duty trucks, heavy-duty
pickup trucks, and vans.
The Department’s regulatory activities
also remain directed toward protecting
safety for all persons. Safety is a
pressing national concern and our
highest priority; the Department
remains focused on managing safety
risks and ensuring that the United States
has the safest and most efficient
transportation system in the world. This
focus is as urgent as ever; after decades
of declines in the number of fatalities on
our roads, the United States has been
seeing a recent increase in fatalities
among pedestrians, bicyclists, and
vehicle occupants that must be reversed.
Similarly, we must address disparities
in how the burden of these safety risks
fall on different communities.
The Department’s Regulatory Priorities
The regulatory plan laid out below
reflects a careful balance that
emphasizes the Department’s priorities
in responding to the urgent challenges
facing our nation.
Safety. Safety is our North Star. The
DOT Regulatory Plan reflects this
commitment to safety through a
balanced regulatory approach grounded
in reducing transportation-related
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fatalities and injuries. Our goals are to
manage safety risks, reverse recent
trends negatively affecting safety, and
build on the successes that have already
been achieved to make our
transportation system safer than it has
ever been. Innovations should reduce
deaths and serious injuries on our
Nation’s transportation network, while
committing to the highest standards of
safety across technologies. For example,
the Department is working on two
rulemakings to require or standardize
equipment performance for automatic
emergency braking on heavy trucks and
newly manufactured light vehicles.
Responding to the COVID–19
Pandemic. The Department is providing
rapid response and emergency review of
legal and operational challenges
presented by COVID–19 and its
associated burdens within the
transportation network. Since the
beginning of this Administration, our
efforts have focused on ensuring
compliance with the mask requirements
issued by the Centers for Disease
Control and Prevention and the
Transportation Security Administration.
These requirements help reduce the
spread of the COVID–19 disease within
the transportation sector and among the
traveling public. DOT is also addressing
regulatory compliance made
impracticable by the COVID–19 public
health emergency due to facility
closures, personnel shortages, and other
restrictions.
Economic Growth. The safe and
efficient movement of goods and
passengers requires us not just to
maintain, but to improve our national
transportation infrastructure. But that
cannot happen without changes to the
way we plan, fund, and approve
projects. Accordingly, our Regulatory
Plan incorporates regulatory actions that
increase competition and consumer
protection, as well as streamline the
approval process and facilitate more
efficient investment in infrastructure,
which is necessary to maintain global
leadership and foster economic growth.
Climate Change. Climate change is
one of the most urgent challenges facing
our nation. The Department has engaged
in multiple regulatory activities to
address this challenge. As discussed
earlier, the Department is actively
engaged in updating its regulations with
the goal of reducing emissions. The
Department is also engaged in
rulemakings to measure and reduce
emissions from transportation projects
and improve safety related to movement
of natural gas.
Equity. Ensuring that the
transportation system equitably benefits
underserved communities is a top
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priority. As discussed earlier, the
Department is urgently working to
address the threat of climate change,
which is a burden often
disproportionately borne by
underserved communities. This work is
guided by the Departmental and
interagency work being done pursuant
to Executive Order 13985, Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government. The Department is
also working on a rulemaking that
would make it easier for members of
underserved communities to apply to
and be a part of the Disadvantaged
Business Enterprise (DBE) and Airport
Concession DBE Program. In addition,
the Department is working on multiple
rulemakings to ensure access to
transportation for people with
disabilities. For example, the
Department is working on a rulemaking
to ensure that people with disabilities
can access lavatories on single-aisle
aircraft, and it has commenced a
rulemaking to ensure that disabled
persons have equitable access to transit
facilities.
All OAs are prioritizing their
regulatory actions in accordance with
Executive Orders 13985, 13990, and
13992 to make sure they are providing
the highest level of safety while
responding to the urgent challenges
facing our Nation. Since each OA has its
own area of focus, we summarize the
regulatory priorities of each below.
More information about each of the
rules discussed below can be found in
the DOT Unified Agenda.
Office of the Secretary of
Transportation
OST oversees the regulatory processes
for the Department. OST implements
the Department’s regulatory policies and
procedures and is responsible for
ensuring the involvement of senior
officials in regulatory decision making.
Through the Office of the General
Counsel, OST is also responsible for
ensuring that the Department complies
with the Administrative Procedure Act,
Executive Orders 12866 and 13563,
DOT’s Regulatory Policies and
Procedures, and other legal and policy
requirements affecting the Department’s
rulemaking activities. In addition, OST
has the lead role in matters concerning
aviation consumer and economic rules,
Title VI of the Civil Rights Act, the
Americans with Disabilities Act, and
rules that affect multiple elements of the
Department.
OST provides guidance and training
regarding compliance with regulatory
requirements and processes for
personnel throughout the Department.
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OST also plays an instrumental role in
the Department’s efforts to improve our
economic analyses; risk assessments;
regulatory flexibility analyses; other
related analyses; retrospective reviews
of rules; and data quality, including
peer reviews. The Office of the General
Counsel (OGC) is the lead office that
works with the Office of Management
and Budget’s (OMB) Office of
Information and Regulatory Affairs
(OIRA) to comply with Executive Order
12866 for significant rules, coordinates
the Department’s response to OMB’s
intergovernmental review of other
agencies’ significant rulemaking
documents, and other relevant
Administration rulemaking directives.
OGC also works closely with
representatives of other agencies, the
White House, and congressional staff to
provide information on how various
proposals would affect the ability of the
Department to perform its safety,
infrastructure, and other missions.
In July 2021, the President issued
Executive Order 14036, which directed
the Department to take actions that
would promote competition and deliver
benefits to America’s consumers,
including potentially initiating a
rulemaking to ensure that air consumers
have ancillary fee information,
including ‘‘baggage fees,’’ ‘‘change fees,’’
and ‘‘cancellation fees,’’ at the time of
ticket purchase. Among a number of
steps to further the Administration’s
goals in this area, the Department has
initiated a rulemaking to enhance
consumers’ ability to determine the true
cost of travel, titled ‘‘Enhancing
Transparency of Airline Ancillary
Service Fees.’’ In addition, OST will
further enhance its airline passenger
protections through the rulemaking
initiatives required by Executive Order
14036.
Advancing equity in air transportation
for individuals with disabilities is also
a priority for the Administration. To
further this goal, the Department is
developing a rulemaking to improve the
accessibility of lavatories on single-aisle
aircraft. In this rulemaking, the
Department is considering options to
significantly improve the ability of
passengers with disabilities to travel
with freedom and dignity by being able
to access the lavatory.
Federal Aviation Administration
FAA is charged with safely and
efficiently operating and maintaining
the most complex aviation system in the
world. To enhance aviation safety, FAA
is finalizing a rulemaking that would
require certain airport certificate holders
to develop, implement, maintain, and
adhere to a safety management system.
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FAA is also developing a proposal to
reduce risks caused by latent defects in
critical systems on transport category
airplanes.
The FAA will continue to advance
rulemakings to ensure that the United
States has the safest aviation, most
efficient, and modern aviation system in
the word, including proposing a
rulemaking that would require certain
aircraft, engine, and propeller
manufacturers; certificate holders
conducting common carriage
operations; certain maintenance
providers; and persons conducting
certain, specific types of air tour
operations to implement a Safety
Management System. FAA will also
manage rulemakings to further advance
the integration of unmanned aircraft
systems and commercial space
operations into the national airspace
system. In addition, the FAA will
propose requirements for the
certification of certain airplanes to
enforce compliance with the emissions
standards adopted by the Environmental
Protection Agency under the Clean Air
Act.
Federal Highway Administration
FHWA carries out the Federal
highway program in partnership with
State and local agencies to meet the
Nation’s transportation needs. FHWA’s
mission is to improve the quality and
performance of our Nation’s highway
system and its intermodal connectors.
Consistent with this mission, FHWA
is scheduled to update the Manual on
Uniform Traffic Control Devices for
Streets and Highways (MUTCD),
conforming technical provisions of the
2009 edition to reflect advances in
technologies and operational practices
that are not currently allowed in the
MUTCD. This update will incorporate
the latest human factors research to
make road signage more accessible,
thereby ensuring that both pedestrians
and vehicles comply with that signage
and reduce the risk of an accident. The
Agency will also pursue a new
regulation requiring safety integration
across all Federal-aid programs and any
necessary mitigation on Federal-aid
projects. In addition, FHWA will work
on a rulemaking to establish a method
for the measurement and reporting of
greenhouse gas emissions associated
with transportation.
Federal Motor Carrier Safety
Administration
The mission of FMCSA is to reduce
crashes, injuries, and fatalities involving
commercial trucks and buses. A strong
regulatory program is a cornerstone of
FMCSA’s compliance and enforcement
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efforts to advance this safety mission. In
addition to Agency-directed regulations,
FMCSA develops regulations mandated
by Congress, through legislation such as
the Moving Ahead for Progress in the
21st Century (MAP–21) and the Fixing
America’s Surface Transportation
(FAST) Acts. FMCSA regulations
establish minimum safety standards for
motor carriers, commercial drivers,
commercial motor vehicles, and State
agencies receiving certain motor carrier
safety grants and issuing commercial
drivers’ licenses.
FMCSA will continue to coordinate
efforts on the development of
autonomous vehicle technologies and
review existing regulations to identify
changes that might be needed to ensure
that DOT regulations ensure safety and
keep pace with innovations.
Additionally, in support of the National
Highway Traffic Safety Administration’s
(NHTSA) automatic emergency braking
(AEB) rulemaking for heavy trucks,
FMCSA will seek information and
comment concerning the maintenance
and operation of AEB by motor carriers.
National Highway Traffic Safety
Administration
The mission of NHTSA is to save
lives, prevent injuries, and reduce
economic costs due to roadway crashes.
The statutory responsibilities of NHTSA
relating to motor vehicles include
reducing the number, and mitigating the
effects, of motor vehicle crashes and
related fatalities and injuries; providing
safety-relevant information to aid
prospective purchasers of vehicles,
child restraints, and tires; and
improving light-, medium-, and heavyduty vehicle fuel efficiency
requirements. NHTSA pursues policies
that enable safety, climate and energy
policy and conservation, equity, and
mobility. NHTSA develops safety
standards and regulations driven by
data and research, including those
mandated by Congress under the MAP–
21 Act, the FAST Act, and the Energy
Independence and Security Act, among
others. NHTSA’s regulatory priorities
for Fiscal Year 2022 focus on issues
related to safety, climate, equity, and
vulnerable road users.
To enhance the safety of vulnerable
road users and vehicle occupants,
NHTSA plans to issue a proposal to
require automatic emergency braking
(AEB) on light vehicles, including
Pedestrian AEB. For heavy trucks,
NHTSA also plans to propose to require
AEB. For climate and equity, NHTSA
plans to complete a rulemaking to
address corporate average fuel economy
(CAFE) preemption, pursuant to
Executive Order 13990. Improving fuel
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economy for light, medium and heavyduty vehicles can have significant
public health impacts, especially for
overburdened communities. NHTSA
also plans to issue a final rule for Model
Year 2024–2026 CAFE standards for
passenger cars and light trucks. More
information about these rules can be
found in the DOT Unified Agenda.
Federal Railroad Administration
FRA exercises regulatory authority
over all areas of railroad safety and,
where feasible, incorporates flexible
performance standards. The current
FRA regulatory program continues to
reflect a number of pending proceedings
to satisfy mandates resulting from the
Rail Safety Improvement Act of 2008
(RSIA08), the Passenger Rail Investment
and Improvement Act of 2008 (PRIIA),
and the FAST Act. These actions
support a safe, high-performing
passenger rail network, address the safe
and effective movement of energy
products, and encourage innovation and
the adoption of new technology in the
rail industry to improve safety and
efficiencies. FRA’s regulatory priority
for Fiscal Year 2022 is to propose
regulations addressing the issue of the
requirements for safe minimum train
crew size depending on the type of
operation.
Federal Transit Administration
The mission of FTA is to improve
public transportation for America’s
communities. To further that end, FTA
provides financial and technical
assistance to local public transit
systems, including buses, subways, light
rail, commuter rail, trolleys, and ferries,
oversees safety measures, and helps
develop next-generation technology
research. FTA’s regulatory activities
implement the laws that apply to
recipients’ uses of Federal funding and
the terms and conditions of FTA grant
awards.
In furtherance of its mission and
consistent with statutory changes, in
Fiscal Year 2022, FTA will update its
Buy America regulation to incorporate
changes to the waiver process made by
MAP–21 and the FAST Act and to make
other conforming updates and
amendments. FTA will also modify its
Bus Testing regulation to improve
testing procedures and to respond to
technological advancements in vehicle
testing. Finally, the Agency is
considering a rulemaking that would
address transit roadway worker
protections and operator assaults.
Maritime Administration
MARAD administers Federal laws and
programs to improve and strengthen the
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maritime transportation system to meet
the economic, environmental, and
security needs of the Nation. To that
end, MARAD’s efforts are focused upon
ensuring a strong American presence in
the domestic and international trades
and to expanding maritime
opportunities for American businesses
and workers.
MARAD’s regulatory objectives and
priorities reflect the Agency’s
responsibility for ensuring the
availability of water transportation
services for American shippers and
consumers and, in times of war or
national emergency, for the U.S. armed
forces.
For Fiscal Year 2022, MARAD will
continue its work increasing the
efficiency of program operations by
updating and clarifying implementing
rules and program administrative
procedures.
Pipeline and Hazardous Materials
Safety Administration
PHMSA has responsibility for
rulemaking focused on hazardous
materials transportation and pipeline
safety. In addition, PHMSA administers
programs under the Federal Water
Pollution Control Act, as amended by
the Oil Pollution Act of 1990.
In Fiscal Year 2022, PHMSA will
focus on the Gas Pipeline Leak
Detection and Repair rulemaking, which
would amend the Pipeline Safety
Regulations to enhance requirements for
detecting and repairing leaks on new
and existing natural gas distribution, gas
transmission, and gas gathering
pipelines. PHMSA anticipates that the
amendments proposed in this
rulemaking would reduce methane
emissions arising from avoidance/
remediation of leaks and incidents from
natural gas pipelines and address
environmental justice concerns by
improving the safety of natural gas
pipelines near environmental justice
communities and mitigating the risks for
those communities arising from climate
change.
PHMSA will also focus on the
Improving the Safety of Transporting
Liquefied Natural Gas rulemaking. This
rulemaking action would amend the
Hazardous Materials Regulations
governing transportation of liquefied
natural gas (LNG) in rail tank cars. This
rulemaking action would incorporate
the results of ongoing research efforts
and collaboration with other
Department of Transportation Operating
Administrations and external technical
experts; respond to a directive in
Executive Order 13990 for PHMSA to
review recent actions that could be
obstacles to Administration policies
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promoting public health and safety, the
environment, and climate change
mitigation; and provide an opportunity
for stakeholders and the public to
contribute their perspectives on rail
transportation of LNG.
DOT—OFFICE OF THE SECRETARY
(OST)
Proposed Rule Stage
129. +Processing Buy America and Buy
American Waivers Based on
Nonavailability
Priority: Other Significant.
Legal Authority: 23 U.S.C. 313; 49
U.S.C. 5323(j); 49 U.S.C. 24405(a); 49
U.S.C. 50101; Consolidated
Appropriations Act of 2018, div. L, title
IV, sec. 410; 41 U.S.C. 8301 to 8305;
E.O. 13788, Buy American and Hire
American (April 18, 2017)
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule will establish the
applicable regulatory standard for
waivers from the Buy America
requirement on the basis that a product
or item is not manufactured in the
United States meeting the applicable
Buy America requirement. This
standard will require the use of items
and products with the maximum known
amount of domestic content. The rule
will also establish the required
information, which is expected to be
consistent across the Department, the
applicants must provide in applying for
such waivers.
Statement of Need: Pursuant to
Executive Order 13788, Buy American
and Hire American, which establishes
as a policy of the executive branch to
‘‘maximize, consistent with law . . . the
use of goods, products, and materials
produced in the United States,’’ DOT
will be requiring that applicants for
non-availability waivers select products
that maximize domestic content. In
addition, this rule will streamline the
Buy America non-availability waiver
process, and improve coordination
across the Department of
Transportation.
Summary of Legal Basis: 23 U.S.C.
313; 49 U.S.C. 5323(j); 49 U.S.C.
24405(a); 49 U.S.C. 50101; Consolidated
Appropriations Act, 2018, div. L, tit. IV
section 410; 41 U.S.C. 8301–8305;
Executive Order 13788, Buy American
and Hire American (Apr. 18, 2017).
Alternatives: TBD.
Anticipated Cost and Benefits: TBD.
Risks: TBD.
Timetable:
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Action
NPRM ..................
Date
FR Cite
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Federalism: Undetermined.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Michael A. Smith,
Attorney Advisor, Department of
Transportation, Office of the Secretary,
1200 New Jersey Avenue SE,
Washington, DC 20590, Phone: 202 366–
4000, Email: michael.a.smith@dot.gov.
RIN: 2105–AE79
DOT—OST
130. +Accessible Lavatories on SingleAisle Aircraft: Part II
Priority: Other Significant. Major
under 5 U.S.C. 801.
Legal Authority: Air Carrier Access
Act, 49 U.S.C. 41705
CFR Citation: 14 CFR 382.
Legal Deadline: None.
Abstract: This rulemaking proposes
that airlines make lavatories on new
single-aisle aircraft large enough,
equivalent to that currently found on
twin-aisle aircraft, to permit a passenger
with a disability (with the help of an
assistant, if necessary) to approach,
enter, and maneuver within the aircraft
lavatory as necessary to use all lavatory
facilities and leave by means of the
aircraft’s on-board wheelchair.
Statement of Need: This rulemaking
proposes to improve accessibility of
lavatories on single-aisle aircraft.
Summary of Legal Basis: 49 U.S.C.
41705; 14 CFR part 382.
Alternatives: N/A.
Anticipated Cost and Benefits: TBD.
Risks: N/A.
Timetable:
Action
NPRM ..................
Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Blane A. Workie,
Assistant General Counsel, Department
of Transportation, Office of the
Secretary, 1200 New Jersey Avenue SE,
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Washington, DC 20590. Phone: 202 366–
9342, Fax: 202 366–7153, Email:
blane.workie@ost.dot.gov.
Related RIN: Split from 2105–AE32,
Related to 2105–AE88.
RIN: 2105–AE89
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DOT—OST
131. • +Enhancing Transparency of
Airline Ancillary Service Fees
Priority: Other Significant.
Legal Authority: 49 U.S.C. 41712
CFR Citation: 14 CFR 399.
Legal Deadline: None.
The Department of Transportation is
proposing to amend its aviation
consumer protection regulations to
ensure that consumers have ancillary
fee information, including ‘‘baggage
fees,’’ ‘‘change fees,’’ and ‘‘cancellation
fees’’ at the time of ticket purchase. This
rulemaking would also examine
whether fees for certain ancillary
services should be disclosed at the first
point in a search process where a fare
is listed. This rulemaking implements
section 5, paragraph (m)(i)(F) of
Executive Order 14.
Abstract: This rulemaking would
amend DOT’s aviation consumer
protection regulations to ensure that
consumers have ancillary fee
information, including ‘‘baggage fees,’’
‘‘change fees,’’ and ‘‘cancellation fees’’
at the time of ticket purchase. This
rulemaking would also examine
whether fees for certain ancillary
services should be disclosed at the first
point in a search process where a fare
is listed. This rulemaking implements
section 5, paragraph (m)(i)(F) of
Executive Order 14036 on Promoting
Competition in the American Economy,
which directs the Department to better
protect consumers and improve
competition.
Statement of Need: This rulemaking
proposes that consumers have ancillary
fee information, including ‘‘baggage
fees,’’ ‘‘change fees,’’ and ‘‘cancellation
fees,’’ at the time of ticket purchase.
Summary of Legal Basis: 49 U.S.C.
41712; 14 CFR part 399, Executive
Order 14036.
Alternatives: N/A.
Anticipated Cost and Benefits: TBD.
Risks: N/A.
Timetable:
Action
Date
NPRM ..................
FR Cite
06/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
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URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Blane A. Workie,
Assistant General Counsel, Department
of Transportation, Office of the
Secretary, 1200 New Jersey Avenue SE,
Washington, DC 20590, Phone: 202 366–
9342, Fax: 202 366–7153, Email:
blane.workie@ost.dot.gov.
RIN: 2105–AF10
DOT—FEDERAL AVIATION
ADMINISTRATION (FAA)
Final Rule Stage
132. +Registration and Marking
Requirements for Small Unmanned
Aircraft
Priority: Other Significant.
Legal Authority: 49 U.S.C. 106(f), 49
U.S.C. 41703, 44101 to 44106, 44110 to
44113, and 44701
CFR Citation: 14 CFR 1; 14 CFR 375;
14 CFR 45; 14 CFR 47; 14 CFR 48; 14
CFR 91.
Legal Deadline: None.
Abstract: This rulemaking would
provide an alternative, streamlined and
simple, web-based aircraft registration
process for the registration of small
unmanned aircraft, including small
unmanned aircraft operated exclusively
for limited recreational operations, to
facilitate compliance with the statutory
requirement that all aircraft register
prior to operation. It would also provide
a simpler method for marking small
unmanned aircraft that is more
appropriate for these aircraft. This
action responds to public comments
received regarding the proposed
registration process in the Operation
and Certification of Small Unmanned
Aircraft notice of proposed rulemaking,
the request for information regarding
unmanned aircraft system registration,
and the recommendations from the
Unmanned Aircraft System Registration
Task Force.
Statement of Need: This interim final
rule (IFR) provides an alternative
process that small unmanned aircraft
owners may use to comply with the
statutory requirements for aircraft
operations. As provided in the
clarification of these statutory
requirements and request for further
information issued October 19, 2015, 49
U.S.C. 44102 requires aircraft to be
registered prior to operation. See 80 FR
63912 (October 22, 2015). Currently, the
only registration and aircraft
identification process available to
comply with the statutory aircraft
registration requirement for all aircraft
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5133
owners, including small unmanned
aircraft, is the paper-based system set
forth in 14 CFR parts 45 and 47. As the
Secretary and the Administrator noted
in the clarification issued October 19,
2015 and further analyzed in the
regulatory evaluation accompanying
this rulemaking, the Department and the
FAA have determined that this process
is too onerous for small unmanned
aircraft owners and the FAA. Thus, after
considering public comments and the
recommendations from the Unmanned
Aircraft System (UAS) Registration Task
Force, the Department and the FAA
have developed an alternative process,
provided by this IFR (14 CFR part 48),
for registration and marking available
only to small unmanned aircraft owners.
Small unmanned aircraft owners may
use this process to comply with the
statutory requirement to register their
aircraft prior to operating in the
National Airspace System (NAS).
Summary of Legal Basis: The FAA’s
authority to issue rules on aviation
safety is found in Title 49 of the United
States Code. Subtitle I, Section 106
describes the authority of the FAA
Administrator. Subtitle VII, Aviation
Programs, describes in more detail the
scope of the agency’s authority. This
rulemaking is promulgated under the
authority described in 49 U.S.C. 106(f),
which establishes the authority of the
Administrator to promulgate regulations
and rules; and 49 U.S.C. 44701(a)(5),
which requires the Administrator to
promote safe flight of civil aircraft in air
commerce by prescribing regulations
and setting minimum standards for
other practices, methods, and
procedures necessary for safety in air
commerce and national security. This
rule is also promulgated pursuant to 49
U.S.C. 44101–44106 and 44110–44113
which require aircraft to be registered as
a condition of operation and establish
the requirements for registration and
registration processes. Additionally, this
rulemaking is promulgated pursuant to
the Secretary’s authority in 49 U.S.C.
41703 to permit the operation of foreign
civil aircraft in the United States.
Alternatives: Currently, the only
registration and aircraft identification
process available to comply with the
statutory aircraft registration
requirement for all aircraft owners,
including small unmanned aircraft, is
the paper-based system set forth in 14
CFR parts 45 and 47. As the Secretary
and the Administrator noted in the
clarification issued October 19, 2015
and further analyzed in the regulatory
evaluation accompanying this
rulemaking, the Department and the
FAA have determined that this process
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is too onerous for small unmanned
aircraft owners and the FAA.
Anticipated Cost and Benefits: In
order to implement the new
streamlined, web-based system
described in this interim final rule (IFR),
the FAA will incur costs to develop,
implement, and maintain the system.
Small UAS owners will require time to
register and mark their aircraft, and that
time has a cost. The total of government
and registrant resource cost for small
unmanned aircraft registration and
marking under this new system is $56
million ($46 million present value at 7
percent) through 2020. In evaluating the
impact of this interim final rule, we
compare the costs and benefits of the
IFR to a baseline consistent with
existing practices: For modelers, the
exercise of discretion by FAA (not
requiring registration) and continued
broad public outreach and educational
campaign, and for non-modelers,
registration via part 47 in the paperbased system. Given the time to register
aircraft under the paper-based system
and the projected number of sUAS
aircraft, the FAA estimates the cost to
the government and non-modelers
would be about $383 million. The
resulting cost savings to society from
this IFR equals the cost of this baseline
policy ($383 million) minus the cost of
this IFR ($56 million), or about $327
million ($259 million in present value at
a 7 percent discount rate). These cost
savings are the net quantified benefits of
this IFR.
Risks: Many of the owners of these
new sUAS may have no prior aviation
experience and have little or no
understanding of the NAS, let alone
knowledge of the safe operating
requirements and additional
authorizations required to conduct
certain operations. Aircraft registration
provides an immediate and direct
opportunity for the agency to engage
and educate these new users prior to
operating their unmanned aircraft and
to hold them accountable for
noncompliance with safe operating
requirements, thereby mitigating the
risk associated with the influx of
operations. In light of the increasing
reports and incidents of unsafe
incidents, rapid proliferation of both
commercial and model aircraft
operators, and the resulting increased
risk, the Department has determined it
is contrary to the public interest to
proceed with further notice and
comment rulemaking regarding aircraft
registration for small unmanned aircraft.
To minimize risk to other users of the
NAS and people and property on the
ground, it is critical that the Department
be able to link the expected number of
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new unmanned aircraft to their owners
and educate these new owners prior to
commencing operations.
Timetable:
Action
Date
Interim Final Rule
Interim Final Rule
Effective.
OMB approval of
information collection.
Interim Final Rule
Comment Period End.
Final Rule ............
FR Cite
12/16/15
12/21/15
80 FR 78593
12/21/15
80 FR 79255
01/15/16
03/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory
action will be likely to have
international trade and investment
effects, or otherwise be of international
interest.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Bonnie Lefko,
Department of Transportation, Federal
Aviation Administration, 6500 S
MacArthur Boulevard, Registry Building
26, Room 118, Oklahoma City, OK
73169, Phone: 405 954–7461, Email:
bonnie.lefko@faa.gov.
RIN: 2120–AK82
DOT—FEDERAL HIGHWAY
ADMINISTRATION (FHWA)
Proposed Rule Stage
133. +Greenhouse Gas Emissions
Measure
Priority: Other Significant. Major
status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 23 U.S.C. 150
CFR Citation: 23 CFR 490.
Legal Deadline: None.
Abstract: This rulemaking would
establish a method for the measurement
and reporting of greenhouse gas (GHG)
emissions associated with on-road
transportation under title 23 of the
United States Code (U.S.C.). It is
proposed as an addition to existing
FHWA regulations that establish a set of
performance measures for State
departments of transportation (State
DOTs) and metropolitan planning
organizations (MPOs) to use pursuant to
23 U.S.C. 150(c) or other authorities.
Statement of Need: The proposed
national performance management
measure responds to the climate crisis.
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Establishing a method for measuring
and reporting greenhouse gas (GHG)
emissions associated with
transportation under title 23, United
States Code, is necessary because the
environmental sustainability, including
the carbon footprint, of the
transportation system is an important
attribute of the system that States can
use to assess the performance of the
Interstate and non-Interstate National
Highway System (NHS). Consistent
measurement and reporting of GHG
emissions from on-road mobile source
emissions under the proposed rule
would assist all levels of government
and the public in making more informed
choices about GHG emissions trends.
Summary of Legal Basis: FHWA has
the legal authority to establish the
proposed GHG emissions measure
under 23 U.S.C. 150(c)(3), which calls
for performance measures that the States
can use to assess performance of the
Interstate and non-Interstate NHS for
purposes of carrying out the National
Highway Performance Program (NHPP)
under 23 U.S.C. 119. Specifically,
FHWA interprets the performance of the
Interstate System and the NHS under 23
U.S.C. 150(c)(3)(A)(ii)(IV)–(V) to include
environmental performance, consistent
with the national goals established
under 23 U.S.C. 150(b). Other statutory
provisions also support the proposed
measure, including 23 U.S.C. 119
(NHPP) and 23 U.S.C. 101(b)(3)(G)
(transportation policy), 134(a)(1)
(transportation planning policy),
134(c)(1) (metropolitan planning), and
135(d)(1) and (d)(2) (statewide planning
process and a performance-based
approach).
Alternatives: FHWA is developing a
proposed rule and will consider all
available alternatives in the
development of its proposal.
Anticipated Cost and Benefits: FHWA
is preparing a regulatory analysis of the
costs and benefits associated with the
proposed rule. In the analysis, FHWA
anticipates quantifying estimates where
possible and qualitatively discussing
costs and benefits that cannot be
quantified.
Risks: FHWA is developing a
proposed rule and will consider
potential risks in the development of its
proposal.
Timetable:
Action
NPRM ..................
Date
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
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Government Levels Affected: Local,
State.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Michael Culp,
Department of Transportation, Federal
Highway Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590, Phone: 202 366–9229, Email:
michael.culp@dot.gov.
RIN: 2125–AF99
DOT—FHWA
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Final Rule Stage
134. +Manual on Uniform Traffic
Control Devices for Streets and
Highways
Priority: Other Significant.
Legal Authority: 23 U.S.C. 101(a), 104,
109(d), 114(a), 217, 315, and 402(a)
CFR Citation: 23 CFR 655.
Legal Deadline: None.
Abstract: This rulemaking would
update the Manual on Uniform Traffic
Control Devices for Streets and
Highways (MUTCD) incorporated by
reference at 23 CFR part 655. The new
edition would update the technical
provisions of the 2009 edition to reflect
advances in technologies and
operational practices that are not
currently allowed in the MUTCD.
Statement of Need: Updates to the
Manual on Uniform Traffic Control
Devices for Streets and Highways
(MUTCD) are needed to update the
technical provisions to reflect advances
in technologies and operational
practices, incorporate recent trends and
innovations, and set the stage for
automated driving systems as those
continue to take shape. The proposed
changes to the MUTCD would promote
uniformity and incorporate technology
advances in the traffic control device
application. They ultimately would
improve and encourage the safe and
efficient utilization of roads that are
open to public travel.
Summary of Legal Basis: FHWA
proposed this rule under 23 U.S.C.
109(d), 315, and 402(a), which give the
Secretary of Transportation the
authority to promulgate uniform
provisions to promote the safe and
efficient utilization of the highways.
The Secretary has delegated this
authority to FHWA under 49 CFR 1.85.
Alternatives: FHWA continues to
consider all available alternatives in this
rulemaking as the Agency considers
public comments received on the Notice
of Proposed Amendments (NPA) to
inform a final rule.
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Anticipated Cost and Benefits: FHWA
estimated the costs and potential
benefits of the proposed changes to the
MUTCD in an economic analysis.
FHWA analyzed the expected
compliance costs associated with 132
proposed substantive revisions. As
summarized in the NPA, FHWA found
that 8 of those substantive revisions
have quantifiable economic impacts.
FHWA quantified the total estimated
cost of 3 substantive revisions for which
costs can be quantified as $541,978
when discounted at 7 percent and
$589,667 when discounted at 3 percent,
measured in 2018 dollars. FHWA lacked
information to estimate the cost of 5
substantive revisions but expects they
will have net benefits based on per-unit
or per-mile costs and benefits of the
proposed revisions. FHWA will update
the economic analysis to reflect the final
rule, to be designated as the 11th edition
of the MUTCD.
Risks: FHWA is continuing to
consider potential risks as the Agency
considers public comments received on
the NPA to inform a final rule.
Timetable:
Action
Date
NPRM ..................
Publication Date
for Extension of
Comment Period.
NPRM Comment
Period End.
Final Rule ............
12/14/20
02/02/21
FR Cite
85 FR 80898
05/14/21
09/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal,
Local, State, Tribal.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Kevin Sylvester,
Department of Transportation, Federal
Highway Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590, Phone: 202 366–2161, Email:
kevin.sylvester@dot.gov.
RIN: 2125–AF85
30166; 49 U.S.C. 322; delegation of
authority at 49 CFR 1.95
CFR Citation: 49 CFR 571.
Legal Deadline: None.
Abstract: This notice will seek
comments on a proposal to require and/
or standardize equipment performance
for automatic emergency braking on
heavy trucks. The agency previously
published a notice (80 FR 62487) on
October 16, 2015, granting a petition for
rulemaking submitted by the Truck
Safety Coalition, the Center for Auto
Safety, Advocates for Highway and Auto
Safety, and Road Safe America (dated
February 19, 2015), to establish a safety
standard to require automatic forward
collision avoidance and mitigation
(FCAM) systems on certain heavy
vehicles. For several years, NHTSA has
researched forward collision avoidance
and mitigation technology on heavy
vehicles, including forward collision
warning and automatic emergency
braking systems. This rulemaking
proposes test procedures for measuring
performance of these systems.
Statement of Need: This proposed
rule would establish a safety standard to
require and/or standardize performance
of automatic forward collision
avoidance and mitigation systems on
heavy vehicles. NHTSA believes there is
potential for AEB to improve safety by
reducing the likelihood of rear-end
crashes involving heavy vehicles and
the severity of crashes. NHTSA is
commencing the rulemaking process to
potentially require new heavy vehicles
to be equipped with automatic
emergency braking systems, or to
standardize AEB performance when the
systems are optionally installed on
vehicles.
Summary of Legal Basis: 49 U.S.C.
322, 30111, 30115, 30117 and 30166;
delegation of authority at 49 CFR 1.95.
Alternatives: NHTSA will present
regulatory alternatives in the NPRM.
Anticipated Cost and Benefits:
NHTSA will present preliminary costs
and benefits in the NPRM.
Risks: The agency believes there are
no substantial risks to this rulemaking.
Timetable:
Action
NPRM ..................
DOT—NATIONAL HIGHWAY TRAFFIC
SAFETY ADMINISTRATION (NHTSA)
Proposed Rule Stage
135. +Heavy Vehicle Automatic
Emergency Braking
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 30111; 49
U.S.C. 30115; 49 U.S.C. 30117; 49 U.S.C.
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Date
FR Cite
04/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: David Hines,
Director, Office of Crash Avoidance
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Standards, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590, Phone: 202–366–2720, Email:
david.hines@dot.gov.
RIN: 2127–AM36
Agency Contact: David Hines,
Director, Office of Crash Avoidance
Standards, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590, Phone: 202–366–2720, Email:
david.hines@dot.gov.
RIN: 2127–AM37
DOT—NHTSA
136. +Light Vehicle Automatic
Emergency Braking (AEB) With
Pedestrian AEB
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 30111; 49
U.S.C. 30115; 49 U.S.C. 30117; 49 U.S.C.
30166; 49 U.S.C. 322; delegation of
authority at 49 CFR 1.95
CFR Citation: 49 CFR 571.
Legal Deadline: None.
Abstract: This notice will seek
comment on a proposal to require and/
or standardize performance for Light
Vehicle Automatic Emergency Braking
(AEB), including Pedestrian AEB
(PAEB), on all newly manufactured light
vehicles. A vehicle with AEB detects
crash imminent situations in which the
vehicle is moving forward towards
another vehicle and/or a pedestrian, and
automatically applies the brakes to
prevent the crash from occurring, or to
mitigate the severity of the crash. This
rulemaking would set performance
requirements and would specify a test
procedure under which compliance
with those requirements would be
measured.
Statement of Need: This proposed
rule would reduce rear end vehicle-tovehicle crashes and could reduce motor
vehicle impacts with pedestrians that
often result in death and injury.
Summary of Legal Basis: 49 U.S.C.
322, 30111, 30115, 30117, 30166;
delegation of authority at 49 CFR 1.95.
Alternatives: NHTSA will present
regulatory alternatives in the NPRM.
Anticipated Cost and Benefits:
NHTSA will present preliminary costs
and benefits in the NPRM.
Risks: The agency believes there are
no substantial risks to this rulemaking.
Timetable:
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Action
Date
NPRM ..................
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
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DOT—NHTSA
Final Rule Stage
137. +Corporate Average Fuel Economy
(CAFE) Preemption
Priority: Other Significant.
Legal Authority: delegation of
authority at 49 CFR 1.95
CFR Citation: 49 CFR 533.
Legal Deadline: None.
Abstract: This action would repeal of
The Safer Affordable Fuel-Efficient
(SAFE) Vehicles Rule Part One: One
National Program, 84 FR 51310 (Sept.
27, 2019) (‘‘SAFE I Rule’’).
Statement of Need: This action is
directed under Executive Order 13990.
Summary of Legal Basis: This
rulemaking would respond to
requirements of the Energy
Independence and Security Act of 2007
(EISA), Title 1, Subtitle A, Section 102,
as it amends 49 U.S.C. 32902, which
was signed into law December 19, 2007.
The statute requires that corporate
average fuel economy standards be
prescribed separately for passenger
automobiles and non-passenger
automobiles. The law requires the
standards be set at least 18 months prior
to the start of the model year.
Alternatives: NHTSA considered
alternatives in its May 2021 NPRM.
NHTSA will update the regulatory
alternatives in the final rule as
appropriate.
Anticipated Cost and Benefits:
NHTSA estimated costs and benefits in
its May 2021 NPRM. NHTSA will
update the costs and benefits in the final
rule as appropriate.
Risks: The agency believes there are
no substantial risks to this rulemaking.
Timetable:
Action
FR Cite
04/00/22
URL For Public Comments:
www.regulations.gov.
Agency Contact: Kerry Kolodziej,
Trial Attorney, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Ave. SE, Washington, DC 20590,
Phone: 202 366–2161, Email:
kerry.kolodziej@dot.gov.
RIN: 2127–AM33
Date
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
05/12/21
06/11/21
FR Cite
86 FR 25980
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
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138. +Passenger Car and Light Truck
Corporate Average Fuel Economy
Standards
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: Delegation of
authority at 49 CFR 1.95
CFR Citation: 49 CFR 533.
Legal Deadline: None.
Abstract: This rulemaking would
reconsider Corporate Average Fuel
Economy (CAFE) standards for
passenger cars and light trucks that were
established in the agency’s April 30,
2020 final rule. This rulemaking would
respond to requirements of the Energy
Independence and Security Act of 2007
(EISA), title 1, subtitle A, section 102, as
it amends 49 U.S.C. 32902. The statute
requires that corporate average fuel
economy standards be prescribed
separately for passenger automobiles
and non-passenger automobiles. For
model years 2021 to 2030, the average
fuel economy required to be attained by
each fleet of passenger and nonpassenger automobiles shall be the
maximum feasible for each model year.
The law requires the standards be set at
least 18 months prior to the start of the
model year.
Statement of Need: This action is
directed under Executive Order 13990.
Summary of Legal Basis: This
rulemaking would respond to
requirements of the Energy
Independence and Security Act of 2007
(EISA), Title 1, Subtitle A, Section 102,
as it amends 49 U.S.C. 32902, which
was signed into law December 19, 2007.
The statute requires that corporate
average fuel economy standards be
prescribed separately for passenger
automobiles and non-passenger
automobiles. The law requires the
standards be set at least 18 months prior
to the start of the model year.
Alternatives: NHTSA considered
alternatives in its September 2021
NPRM. NHTSA will update the
regulatory alternatives in the final rule
as appropriate.
Anticipated Cost and Benefits:
NHTSA estimated costs and benefits in
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its September 2021 NPRM. NHTSA will
update the costs and benefits in the final
rule as appropriate.
Risks: The agency believes there are
no substantial risks to this rulemaking.
Timetable:
Action
Date
NPRM ..................
NPRM Comment
Period End.
Final Action .........
09/03/21
10/26/21
FR Cite
86 FR 49602
03/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Gregory Powell,
Program Analyst, Department of
Transportation, National Highway
Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC
20590, Phone: 202 366–5206, Email:
gregory.powell@dot.gov.
RIN: 2127–AM34
DOT—FEDERAL RAILROAD
ADMINISTRATION (FRA)
Anticipated Cost and Benefits: FRA is
currently expecting the economic
impact of this rule is expected to be less
than $100 million; however, FRA has
not yet quantified the costs or benefits
associated with this proposed
rulemaking.
Risks: The NPRM is based off a risk
assessment that individual railroads
will have to perform. The risks should
be negatively impacted.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local,
State.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Amanda Maizel,
Attorney Adviser, Department of
Transportation, Federal Railroad
Administration, 1200 New Jersey
Avenue SE, Washington, DC 20590,
Phone: 202 493–8014, Email:
amanda.maizel@dot.gov.
RIN: 2130–AC88
Proposed Rule Stage
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139. +Train Crew Staffing
Priority: Other Significant.
Legal Authority: 49 CFR 1.89(a); 49
U.S.C. 20103
CFR Citation: 49 CFR 218.
Legal Deadline: None.
Abstract: This rulemaking would
address the potential safety impact of
one-person train operations, including
appropriate measures to mitigate an
accident’s impact and severity, and the
patchwork of State laws concerning
minimum crew staffing requirements.
This rulemaking would address the
issue of minimum requirements for the
size of different train crew staffs,
depending on the type of operations.
Statement of Need: To address the
potential safety impact of one-person
train operations, including appropriate
measures to mitigate an accident’s
impact and severity, and the patchwork
of State laws concerning minimum crew
staffing requirements, FRA is drafting an
NPRM that would address the issue of
minimum requirements for the size of
different train crew staffs, depending on
the type of operation.
Summary of Legal Basis: 49 U.S.C.
20103; 49 CFR 1.89(a).
Alternatives: FRA will analyze
regulatory alternatives in the NPRM.
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DOT—PIPELINE AND HAZARDOUS
MATERIALS SAFETY
ADMINISTRATION (PHMSA)
Long-Term Actions
140. +Pipeline Safety: Class Location
Requirements
Priority: Economically Significant.
Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 60101 et
seq.
CFR Citation: 49 CFR 192.
Legal Deadline: None.
Abstract: This rulemaking action
would address class location
requirements for natural gas
transmission pipelines, specifically as
they pertain to actions operators are
required to take following class location
changes due to population growth near
the pipeline. Operators have suggested
that performing integrity management
measures on pipelines where class
locations have changed due to
population increases would be an
equally safe but less costly alternative to
the current requirements of either
reducing pressure, pressure testing, or
replacing pipe.
Statement of Need: Section 5 of the
Pipeline Safety Act of 2011 required the
Secretary of Transportation to evaluate
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5137
and issue a report on whether integrity
management (IM) requirements should
be expanded beyond high-consequence
areas and whether such expansion
would mitigate the need for class
location requirements. PHMSA issued a
report to Congress on its evaluation of
this issue in April 2016, noting it would
further evaluate the feasibility and
appropriateness of alternatives to
address pipe replacement requirements
when class locations change due to
population growth. PHMSA issued an
advance notice of proposed rulemaking
on July 31, 2018, to obtain public
comment on whether allowing IM
measures on pipelines where class
locations have changed due to
population increases would be an
equally safe but less costly alternative to
the current class location change
requirements. PHMSA is proposing
revisions to the Federal Pipeline Safety
Regulations to amend the requirements
for pipelines that experience a change in
class location. This proposed rule
addresses a part of a congressional
mandate from the Pipeline Safety Act of
2011 and responds to public input
received as part of the rulemaking
process. The amendments in this
proposed rule would add an alternative
set of requirements operators could use,
based on implementing integrity
management principles and pipe
eligibility criteria, to manage certain
pipeline segments where the class
location has changed from a Class 1
location to a Class 3 location. PHMSA
intends for this alternative to provide
equivalent public safety in a more costeffective manner to the current natural
gas pipeline safety rules, which require
operators to either reduce the pressure
of the pipeline, pressure test the
pipeline segment to higher standards, or
replace the pipeline segment.
Summary of Legal Basis: Congress
established the current framework for
regulating the safety of natural gas
pipelines in the Natural Gas Pipeline
Safety Act of 1968 (NGPSA). The
NGPSA provided the Secretary of
Transportation the authority to
prescribe minimum Federal safety
standards for natural gas pipeline
facilities. That authority, as amended in
subsequent reauthorizations, is
currently codified in the Pipeline Safety
Laws (49 U.S.C. 60101 et seq.).
Alternatives: PHMSA is evaluating
and considering additional regulatory
alternatives to these proposed
requirements, including a ‘‘no action’’
alternative.
Anticipated Cost and Benefits:
Estimated annual cost savings are $149
million.
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Risks: The alternative conditions
PHMSA is proposing to allow operators
to manage class location changes
through IM will provide an equivalent
level of safety as the existing class
location change regulations.
Timetable:
Action
Date
ANPRM ...............
ANPRM Comment
Period End.
NPRM ..................
NPRM Comment
Period End.
Final Rule ............
FR Cite
07/31/18
10/01/18
83 FR 36861
10/14/20
12/14/20
85 FR 65142
03/00/23
Regulatory Flexibility Analysis
Required: Undetermined.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
URL For Public Comments:
www.regulations.gov.
Agency Contact: Cameron H.
Satterthwaite, Transportation
Regulations Specialist, Department of
Transportation, Pipeline and Hazardous
Materials Safety Administration, 1200
New Jersey Avenue SE, Washington, DC
20590, Phone: 202–366–8553, Email:
cameron.satterthwaite@dot.gov.
RIN: 2137–AF29
BILLING CODE 4910–9X–P
DEPARTMENT OF THE TREASURY
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Statement of Regulatory Priorities
The primary mission of the
Department of the Treasury is to
maintain a strong economy and create
economic and job opportunities by
promoting the conditions that enable
economic growth and stability at home
and abroad, strengthen national security
by combatting threats and protecting the
integrity of the financial system, and
manage the U.S. Government’s finances
and resources effectively.
Consistent with this mission,
regulations of the Department and its
constituent bureaus are promulgated to
interpret and implement the laws as
enacted by Congress and signed by the
President. It is the policy of the
Department to comply with applicable
requirements to issue a Notice of
Proposed Rulemaking and carefully
consider public comments before
adopting a final rule. Also, the
Department invites interested parties to
submit views on rulemaking projects
while a proposed rule is being
developed.
To the extent permitted by law, it is
the policy of the Department to adhere
to the regulatory philosophy and
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principles set forth in Executive Orders
12866, 13563, and 13609 and to develop
regulations that maximize aggregate net
benefits to society while minimizing the
economic and paperwork burdens
imposed on persons and businesses
subject to those regulations.
Alcohol and Tobacco Tax and Trade
Bureau
The Alcohol and Tobacco Tax and
Trade Bureau (TTB) issues regulations
to implement and enforce Federal laws
relating to alcohol, tobacco, firearms,
and ammunition excise taxes and
certain non-tax laws relating to alcohol.
TTB’s mission and regulations are
designed to:
(1) Collect the taxes on alcohol,
tobacco products, firearms, and
ammunition;
(2) Protect the consumer by ensuring
the integrity of alcohol products;
(3) Ensure only qualified businesses
enter the alcohol and tobacco industries;
and
(4) Prevent unfair and unlawful
market activity for alcohol and tobacco
products.
In FY 2022, TTB will continue its
multi-year Regulations Modernization
effort by prioritizing projects that reduce
regulatory burdens, streamline and
simplify requirements, and improve
service to regulated businesses.
Specifically, TTB plans to publish
deregulatory rules that will reduce the
amount of information industry
members must submit to TTB in
connection with permit and similar
applications to engage in regulated
businesses, and reduce the types of
operational activities that require prior
approval. TTB expects these proposals
to ultimately reduce the amount of
operational information industry
members must submit to TTB and
provide for the piloting of a combined
tax return and simplified operations
report, reducing the overall number of
reports industry members must submit.
These measures are expected to reduce
burden on industry member and
provide them greater flexibility, and
make starting new businesses easier and
faster for new industry members.
TTB will also prioritize rulemaking to
amend its regulations to reflect statutory
changes pursuant to the Taxpayer
Certainty and Disaster Tax Act of 2020,
which made permanent most of the
Craft Beverage Modernization and Tax
Reform provisions of the Tax Cuts and
Jobs Act of 2017. These legislative
changes include reduced tax rates for
beer and distilled spirits and tax credits
for wine, among other provisions that
had previously been provided on a
temporary basis, as well as new
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provisions on the types of activities that
qualify for reduced tax rates for distilled
spirits and on permissible transfers of
bottled distilled spirits in bond.
Additionally, as a result of this
legislation, and as addressed in a June
2021 Report to Congress on
Administration of Craft Beverage
Modernization Act Refund Claims for
Imported Alcohol, TTB will also
prioritize rulemaking to implement and
administer refund claims for imported
alcohol.
Additional priority projects include
rulemaking to authorize new container
sizes (standards of fill) for wine and
responding to industry member
petitions to authorize new wine treating
materials and processes, new grape
varietal names for use on labels of wine,
and new American Viticultural Areas
(AVAs).
This fiscal year TTB plans to
prioritize the following measures:
• Streamlining and Modernizing the
Permit Application Process (RINs: 1513–
AC46, 1513–AC47, and 1513–AC48,
Modernization of Permit and
Registration Application Requirements
for Distilled Spirits Plants, Permit
Applications for Wineries, and
Qualification Requirements for Brewers,
respectively.
In FY 2017, TTB engaged in a review
of its regulations to identify any
regulatory requirements that could
potentially be eliminated, modified, or
streamlined to reduce burdens on
industry related to application and
qualification requirements. Since that
time, TTB has removed a number of
requirements, particularly with regard
to the information that is required to be
submitted on TTB permit-related forms.
In FY 2022, TTB intends to propose
amending its regulations to further
streamline the qualification and
application requirements for new and
existing businesses, including distilled
spirits plants, wineries, and breweries.
• Streamlining of Tax Return and
Report Requirements (RIN: 1513–AC68).
In FY 2022, TTB intends to propose
for notice and comment regulatory
amendments to substantially streamline
current requirements pertaining to tax
returns and operational reports and
reducing the amount of information and
the number of reports submitted. This
measure will also include updates to
return and report requirements to
improve overall tax oversight and
enforcement.
• Modernizing the Alcohol Beverage
Labeling and Advertising Requirements
(RIN: 1513–AC66, Modernization of the
Labeling and Advertising Regulations
for Distilled Spirits and Malt Beverage,
and RIN: 1513–AC67, Modernization of
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Wine Labeling and Advertising
Regulations).
The Federal Alcohol Administration
Act requires that alcohol beverages
introduced in interstate commerce have
a label approved under regulations
prescribed by the Secretary of the
Treasury. TTB conducted an analysis of
its alcohol beverage labeling regulations
to identify any that might be outmoded,
ineffective, insufficient, or excessively
burdensome, and to modify, streamline,
expand, or repeal them in accordance
with that analysis. These regulations
were also reviewed to assess their
applicability to the modern alcohol
beverage marketplace. As a result of this
review, in FY 2019, TTB proposed
revisions to the regulations concerning
the labeling requirements for wine,
distilled spirits, and malt beverages.
TTB anticipated that these regulatory
changes would assist industry in
voluntary compliance, decrease
industry burden, and result in the
regulated industries being able to bring
products to market without undue
delay. TTB received over 1,100
comments in response to the notice,
which included suggestions for further
revisions. In FY 2020, TTB published in
the Federal Register (85 FR 18704) a
final rule amending its regulations to
make permanent certain of the proposed
liberalizing and clarifying changes, and
to provide certainty with regard to
certain other proposals that commenters
generally opposed and that TTB did not
intend to adopt. In FY 2022, TTB
intends to address remaining aspects of
this rulemaking initiative, including
incorporating a proposed reorganization
of the regulatory provisions intended to
make the regulations easier to read and
understand, for which industry
members expressed support.
• Implementation of the Craft
Beverage Modernization Act (RIN: 1513–
AC87, Implementing the Craft Beverage
Modernization Act Permanent
Provisions, and RIN: 1513–AC89,
Administering the Craft Beverage
Modernization Act Refund Claims for
Imported Alcohol).
TTB is amending its regulations for
beer, wine, and distilled spirits,
including those related to
administration of import claims, to
implement changes made to the Internal
Revenue Code by the Taxpayer
Certainty and Disaster Act of 2020,
which made permanent most of the
Craft Beverage Modernization and Tax
Reform (CBMA) provisions of the Tax
Cuts and Jobs Act of 2017. The CBMA
provisions reduced excise taxes on all
beverage alcohol producers, large and
small, foreign and domestic. In 2020,
these tax cuts were made permanent.
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The 2020 provisions also transferred
responsibility for administering certain
CBMA provisions for imported alcohol
from U.S. Customs and Border
Protection (CBP) to the Treasury
Department after December 31, 2022.
Importers will be required to pay the
full tax rate at entry and submit refund
claims to Treasury. Treasury intends for
TTB to administer these claims.
• Authorizing the Use of Additional
Wine Treating Materials and Soliciting
Comments on Proposed Changes to the
Limits on the Use of Wine Treating
Materials to Reflect ‘‘Good
Manufacturing Practice’’ (RIN: 1513–
AB61 and 1513–AC75).
In FY 2017, TTB proposed to amend
its regulations pertaining to the
production of wine to authorize
additional treatments that may be
applied to wine and to juice from which
wine is made. These proposed
amendments were made in response to
requests from wine industry members to
authorize certain wine treating materials
and processes not currently authorized
by TTB regulations. Although TTB may
administratively approve such
treatments, such administrative
approval does not guarantee acceptance
in foreign markets of any wine so
treated. Under certain international
agreements, wine made with wine
treating materials is not subject to
certain restrictions if the authorization
to use the treating materials is
implemented through public notice;
thus, rulemaking facilitates the
acceptance of exported wine made using
those treatments in foreign markets. In
FY 2018, TTB reopened the comment
period for the notice in response to
industry member requests and, after
consideration of the comments, TTB
intends in FY 2022 to issue a final rule
on those proposals. In FY 2022, TTB
also intends to propose for public
comment additional changes to the
regulations governing wine treating
materials, in response to a petition to
more broadly amend the regulations to
allow more wine treating materials to be
used within the limitations of ‘‘good
manufacturing practice’’ rather than
within specified numerical limits.
• Addition of New Standards of Fill
for Wine (RIN: 1513–AC86)
TTB plans to publish a proposal to
amend the regulations governing wine
containers to add additional authorized
standards of fill in response to requests
it has received for such standards, and
to be consistent with a Side Letter
included as part of a U.S.–Japan Trade
Agreement that addresses issues related
to market access and, specifically, to
alcohol beverage standards of fill. TTB
will also propose a technical
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5139
amendment to add equivalent standard
United States measures to the wine
labeling regulations for recently
approved wine standards of fill and for
the additional sizes proposed in this
notice.
• Addition of Singani to the
Standards of Identity for Distilled
Spirits (RIN: 1513–AC61).
On August 25, 2021, TTB published a
proposal (86 FR 47429) to amend the
regulations that set forth the standards
of identity for distilled spirits to include
Singani as a type of brandy that is a
distinctive product of Bolivia. This
proposal follows a joint petition
submitted by the Plurinational State of
Bolivia and Singani 63, Inc., and
subsequent discussions with the Office
of the United States Trade
Representative. TTB solicited comments
on this proposal, including comments
on its proposal to authorize a minimum
bottling proof of 35 percent alcohol by
volume (or 70° proof) for Singani. TTB
expects to publish a final rule in FY22.
• Proposal to Amend the Regulations
to Add New Grape Variety Names for
American Wines (RIN: 1513–AC24).
In FY 2017, TTB proposed to amend
its wine labeling regulations by adding
a number of new names to the list of
grape variety names approved for use in
designating American wines. The
proposed deregulatory amendments
would allow wine bottlers to use these
additional approved grape variety
names on wine labels and in wine
advertisements in the U.S. and
international markets. In 2018, TTB
reopened the comment period for the
notice in response to requests. TTB was
unable to complete this project in FY
2020 because of redirected efforts to
address COVID–19 guidance, and TTB
now intends to issue a final rule in FY
2022.
Office of the Comptroller of the
Currency
The Office of the Comptroller of the
Currency (OCC) charters, regulates, and
supervises all national banks and
Federal savings associations (FSAs). The
agency also supervises the Federal
branches and agencies of foreign banks.
The OCC’s mission is to ensure that
national banks and FSAs operate in a
safe and sound manner, provide fair
access to financial services, treat
customers fairly, and comply with
applicable laws and regulations.
Regulatory priorities for fiscal year
2022 are described below.
• Amendments to Bank Secrecy Act
Compliance Program Rule (12 CFR part
21).
The OCC, the Board of Governors of
the Federal Reserve System (FRB), and
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the Federal Deposit Insurance
Corporation (FDIC) plan to issue a
notice of proposed rulemaking
amending their respective Bank Secrecy
Act Compliance Program Rules.
• Basel III Revisions (12 CFR part 3).
The OCC, the FRB, and the FDIC plan
to issue a notice of proposed rulemaking
that would comprehensively revise the
agencies’ risk-based capital rules,
including revisions to the current
standardized and advanced approaches
capital rules.
• Capital Requirements for Market
Risk; Fundamental Review of the
Trading Book (12 CFR part 3).
The OCC, the FRB, and the FDIC plan
to issue a notice of proposed rulemaking
to revise their respective capital
requirements for market risk, which are
generally applied to banking
organizations with substantial trading
activity. The banking agencies expect
the proposal to be generally consistent
with the standards set forth in the
Fundamental Review of the Trading
Book published by the Basel Committee
on Bank Supervision.
• Community Reinvestment Act
Regulations (12 CFR parts 25 and 195).
The OCC plans to issue a proposal to
replace the current Community
Reinvestment Act (CRA) rule with
revised rules largely based on the 1995
CRA regulations.
• Community Reinvestment Act
Regulations (12 CFR part 25).
Along with the Federal Deposit
Insurance Agency and the Board of
Governors of the Federal Reserve, the
OCC plans to issue a joint rule to
modernize the Community
Reinvestment Act regulations.
• Computer-Security Incident
Notification (12 CFR part 53).
The OCC, FRB, and FDIC plan to issue
a final rule that would require a banking
organization to notify its primary federal
regulator of significant computersecurity incidents on a timely basis. The
rule would also require a bank service
provider to promptly notify banking
organization customers of certain
significant computer-security incidents.
The notice of proposed rulemaking was
published on January 12, 2021 (86 FR
2299).
• Exemptions to Suspicious Activity
Report Requirements (12 CFR parts 21
and 163).
The OCC plans to issue a final rule to
modify the requirements for national
banks and Federal savings associations
to file Suspicious Activity Reports. The
rule would amend the OCC’s Suspicious
Activity Report regulations to allow the
OCC to issue exemptions from the
requirements of those regulations. The
rule would make it possible for the OCC
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to grant relief to national banks or
federal savings associations that develop
innovative solutions to meet Bank
Secrecy Act requirements more
efficiently and effectively. The notice of
proposed rulemaking was published on
January 22, 2021 (86 FR 6572).
• Implementation of Emergency
Capital Investment Program (12 CFR
part 3).
Section 104A of the Community
Development Banking and Financial
Institutions Act of 1994, which was
added by the Consolidated
Appropriations Act, 2021, authorizes
the Secretary of the Treasury to
establish the Emergency Capital
Investment Program (ECIP) through
which the Department of the Treasury
(Treasury) can make capital investments
in low- and moderate-income
community financial institutions. The
purpose of ECIP is to support the efforts
of such financial institutions to, among
other things, provide financial
intermediary services for small
businesses, minority-owned businesses,
and consumers, especially in lowincome and underserved communities.
In order to support and facilitate the
timely implementation and acceptance
of ECIP and promote its purpose, the
OCC, FRB, and FDIC plan to issue a
final rule that provides that preferred
stock issued to Treasury under ECIP
qualifies as additional tier 1 capital and
that subordinated debt issued to
Treasury under ECIP qualifies as tier 2
capital under the agencies’ capital rule.
The interim final rule was published on
March 22, 2021 (86 FR 15076).
• Rules of Practice and Procedure (12
CFR part 19).
The OCC, FRB, and FDIC plan to issue
a proposed rule to amend their rules of
practice and procedure to reflect
modern filing and communication
methods and improve or clarify other
procedures.
• Tax Allocation Agreements (12 CFR
part 30).
The OCC, FRB, and FDIC plan to issue
a final rule requiring banks that file
income taxes as part of a consolidated
group to develop and maintain tax
allocation agreements with other
members of the consolidated group. The
notice of proposed rulemaking was
published on May 10, 2021 (86 FR
24755).
Customs Revenue Functions
The Homeland Security Act of 2002
(the Act) provides that, although many
functions of the former United States
Customs Service were transferred to the
Department of Homeland Security, the
Secretary of the Treasury retains sole
legal authority over customs revenue
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functions. The Act also authorizes the
Secretary of the Treasury to delegate any
of the retained authority over customs
revenue functions to the Secretary of
Homeland Security. By Treasury
Department Order No. 100–16, the
Secretary of the Treasury delegated to
the Secretary of Homeland Security
authority to prescribe regulations
pertaining to the customs revenue
functions subject to certain exceptions,
but further provided that the Secretary
of the Treasury retained the sole
authority to approve such regulations.
During fiscal year 2021, CBP and
Treasury plan to give priority to
regulatory matters involving the
customs revenue functions which
streamline CBP procedures, protect the
public, or are required by either statute
or Executive Order. Examples of these
efforts are described below.
• Investigation of Claims of Evasion
of Antidumping and Countervailing
Duties.
Treasury and CBP plan to finalize
interim regulations (81 FR 56477) which
amended CBP regulations implementing
section 421 of the Trade Facilitation and
Trade Enforcement Act of 2015, which
set forth procedures to investigate
claims of evasion of antidumping and
countervailing duty orders.
• Enforcement of Copyrights and the
Digital Millennium Copyright Act.
Treasury and CBP plan to finalize
proposed amendments to the CBP
regulations pertaining to importations of
merchandise that violate or are
suspected of violating the copyright
laws, including the Digital Millennium
Copyright Act (DMCA), in accordance
with Title III of the Trade Facilitation
and Trade Enforcement Act of 2015
(TFTEA) and Executive Order 13785,
‘‘Establishing Enhanced Collection and
Enforcement of Anti-dumping and
Countervailing Duties and Violations of
Trade and Customs Laws.’’ The
proposed amendments are intended to
enhance CBP’s enforcement efforts
against increasingly sophisticated
piratical goods, clarify the definition of
piracy, simplify the detention process
relative to goods suspected of violating
the copyright laws, and prescribe new
regulations enforcing the DMCA.
• Inter Partes Proceedings Concerning
Exclusion Orders Based on Unfair
Practices in Import Trade.
Treasury and CBP plan to publish a
proposal to amend its regulations with
respect to administrative rulings related
to the importation of articles in light of
exclusion orders issued by the United
States International Trade Commission
(‘‘Commission’’) under section 337 of
the Tariff Act of 1930, as amended. The
proposed amendments seek to promote
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the speed, accuracy, and transparency of
such rulings through the creation of an
inter partes proceeding to replace the
current ex parte process.
• Merchandise Produced by Convict
or Forced Labor or Indentured Labor
under Penal Sanctions.
Treasury and CBP plan to publish a
proposed rule to update, modernize,
and streamline the process for enforcing
the prohibition in 19 U.S.C. 1307
against the importation of merchandise
that has been mined, produced, or
manufactured, wholly or in part, in any
foreign country by convict labor, forced
labor, or indentured labor under penal
sanctions. The proposed rule would
generally bring the forced labor
regulations and detention procedures
into alignment with other statutes,
regulations, and procedures that apply
to the enforcement of restrictions
against other types of prohibited
merchandise.
• Non-Preferential Origin
Determinations for Merchandise
Imported From Canada or Mexico for
Implementation of the Agreement
Between the United States of America,
the United Mexican States, and Canada
(USMCA).
Treasury and CBP plan to finalize a
proposed rule to harmonize nonpreferential origin determinations for
merchandise imported from Canada or
Mexico. Such determinations would be
made using certain tariff-based rules of
origin to determine when a good
imported from Canada or Mexico has
been substantially transformed resulting
in an article with a new name,
character, or use. Once finalized, the
rule is intended to reduce
administrative burdens and
inconsistency for non-preferential origin
determinations for merchandise
imported from Canada or Mexico for
purposes of the implementation of the
USMCA.
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Financial Crimes Enforcement Network
As administrator of the Bank Secrecy
Act (BSA), the Financial Crimes
Enforcement Network (FinCEN) is
responsible for developing and
implementing regulations that are the
core of the Department’s anti-money
laundering (AML) and countering the
financing of terrorism (CFT) efforts.
FinCEN’s responsibilities and objectives
are linked to, and flow from, that role.
In fulfilling this role, FinCEN seeks to
enhance U.S. national security by
making the financial system
increasingly resistant to abuse by money
launderers, terrorists and their financial
supporters, and other perpetrators of
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The Secretary of the Treasury,
through FinCEN, is authorized by the
BSA to issue regulations requiring
financial institutions to file reports and
keep records that are highly useful in
criminal, tax, or regulatory
investigations, risk assessments, or
proceedings, or intelligence or counterintelligence activities, including
analysis, to protect against terrorism.
The BSA also authorizes FinCEN to
require that designated financial
institutions establish AML/CFT
programs and compliance procedures.
To implement and realize its mission,
FinCEN has established regulatory
objectives and priorities to safeguard the
financial system from the abuses of
financial crime, including terrorist
financing, proliferation financing,
money laundering, and other illicit
activity.
These objectives and priorities
include: (1) Issuing, interpreting, and
enforcing compliance with regulations
implementing the BSA; (2) supporting,
working with, and as appropriate
overseeing compliance examination
functions delegated by FinCEN to other
Federal regulators; (3) managing the
collection, processing, storage, and
dissemination of data related to the
BSA; (4) maintaining a governmentwide access service to that same data for
authorized users with a range of
interests; (5) conducting analysis in
support of policymakers, law
enforcement, regulatory and intelligence
agencies, and (for compliance purposes)
the financial sector; and (6) coordinating
with and collaborating on AML/CFT
initiatives with domestic law
enforcement and intelligence agencies,
as well as foreign financial intelligence
units.
FinCEN’s regulatory priorities for
fiscal year 2022 include:
• Section 6110. BSA Application to
Dealers in Antiquities and Assessment
of BSA Application to Dealers in Art.
On September 24, 2021, FinCEN
issued an Advance Notice of Proposed
Rulemaking (ANPRM) in order to
implement Section 6110 of the AntiMoney Laundering Act of 2020 (the
AML Act). This section amends the BSA
(31 U.S.C. 5312(a)(2)) to include as a
financial institution a person engaged in
the trade of antiquities, including an
advisor, consultant, or any other person
who engages as a business in the
solicitation or the sale of antiquities,
subject to regulations prescribed by the
Secretary of the Treasury. The section
further requires the Secretary of the
Treasury to issue proposed rules to
implement the amendment within 360
days of enactment of the AML Act.
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• Reports of Foreign Financial
Accounts Civil Penalties (Technical
Change).
FinCEN is amending 31 CFR 1010.820
to withdraw the reports of foreign
financial accounts (FBAR) civil
monetary penalties language at 31 CFR
1010.820(g), which was made obsolete
with the enactment of the American
Jobs Creation Act of 2004. The
American Jobs Creation Act of 2004
amended 31 U.S.C. 5321(a)(5) to allow
for a greater maximum penalty for a
willful violation of 31 U.S.C. 5314 than
was previously authorized.
• Clarification of the requirement to
collect, retain, and transmit information
on transactions involving convertible
virtual currency and digital assets with
legal tender status.
The Board of Governors of the Federal
Reserve System and FinCEN
(collectively, the ‘‘Agencies’’) intend to
issue a revised proposal to clarify the
meaning of ‘‘money’’ as used in the
rules implementing the BSA requiring
financial institutions to collect, retain,
and transmit information on certain
funds transfers and transmittals of
funds. The Agencies intend that the
revised proposal will ensure that the
rules apply to domestic and crossborder transactions involving
convertible virtual currency, which is a
medium of exchange (such as
cryptocurrency) that either has an
equivalent value as currency, or acts as
a substitute for currency, but lacks legal
tender status. The Agencies further
intend that the revised proposal will
clarify that these rules apply to
domestic and cross-border transactions
involving digital assets that have legal
tender status.
• Real Estate Transaction Reports
and Records.
FinCEN will issue an Advanced
Notice of Proposed Rulemaking
(ANPRM) to seek guidance on a future
rulemaking that would require certain
legal entities involved in real estate
transactions to submit reports and keep
records. Specifically, the ANPRM will
seek comment to assist FinCEN in
preparing a proposed rule that would
potentially impose nationwide
recordkeeping and reporting
requirements on financial institutions
and nonfinancial trades and businesses
participating in purchases of real estate
by certain legal entities that are not
financed by a loan, mortgage, or other
similar instrument.
• Section 6212. Pilot Program on
Sharing Information Related to
Suspicious Activity Reports (SARs)
Within a Financial Group.
FinCEN intends to issue a Notice of
Proposed Rulemaking (NPRM) in order
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to implement Section 6212 the AML
Act. This section amends the BSA (31
U.S.C. 5318(g)) to establish a pilot
program that permits financial
institutions to SAR information with
their foreign branches, subsidiaries, and
affiliates for the purpose of combating
illicit finance risks. The section further
requires the Secretary of the Treasury to
issue rules to implement the
amendment within one year of
enactment of the AML Act.
• Section 6101. Establishment of
National Exam and Supervision
Priorities.
FinCEN intends to issue a NPRM to
implement Section 6101 the AML Act.
That section, among other things,
amends section 5318(h) to title 31 of the
United States Code to: (1) Require
financial institutions to establish CFT
programs in addition to AML programs;
(2) require FinCEN to establish national
AML/CFT Priorities and, as appropriate,
promulgate implementing regulations
within 180 days of the issuance of those
priorities; and (3) provide that the duty
to establish, maintain, and enforce a
BSA AML/CFT program remains the
responsibility of, and must be
performed by, persons in the United
States who are accessible to, and subject
to oversight and supervision by, the
Secretary of the Treasury and the
appropriate Federal functional
regulator. Additionally, FinCEN intends
to propose other changes, including
regulatory amendments to establish that
all financial institutions subject to an
AML/CFT program requirement must
maintain an effective and reasonably
designed AML/CFT program, and that
such a program must include a risk
assessment process.
• Sec. 6305. No Action Letter
Program.
FinCEN will issue an ANPRM
following the implementation of Section
6305 of the AML Act. This section
required FinCEN to conduct an
assessment on whether to issue noaction letters in response to specific
conduct requests from third parties, and
propose rulemaking if appropriate. The
assessment concluded that FinCEN
should issue no-action letters, subject to
sufficient resources, and proposed
rulemaking to follow the issuance of the
report. The ANPRM will seek guidance
on the contours of a FinCEN no-action
letter process, and, if necessary and
appropriate, may be followed by a
NPRM establishing regulations to
govern the process. The ANPRM will
also solicits feedback on FinCEN’s
current forms of regulatory guidance
and relief.
• Voluntary Information Sharing
Among Financial Institutions Under
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Section 314(b) of the USA PATRIOT
Act.
FinCEN is considering issuing this
rule to strengthen the administration of
the regulation implementing the
statutory safe harbor that allows eligible
financial institutions and associations of
financial institutions to voluntarily
share information regarding activities
that may involve terrorist acts or money
laundering.
• Sec. 6314. Updating Whistleblower
Incentives and Protection.
FinCEN intends to issue a NPRM
relating to Section 6314 of the AML Act.
Section 6314 of AML Act amends
Section 5323 of title 31, United States
Code. Section 6314, enacted on January
1, 2021, established a whistleblower
program that requires FinCEN to pay an
award, under regulations prescribed by
FinCEN and subject to certain
limitations, to eligible whistleblowers
who voluntarily provide FinCEN or the
Department of Justice (DOJ) with
original information about a violation of
the Bank Secrecy Act that leads to the
successful enforcement of a covered
judicial or administrative action, or
related action, and requires that FinCEN
preserve the confidentiality of a
whistleblower.
Additionally, section 6314 of the
AML Act repealed 31 U.S.C. 5328, the
previous whistleblower protection
provision, and replaced it with a new
subsection to 31 U.S.C. 5323:
Subsection (g) ‘‘Protection of
Whistleblowers.’’ The new subsection
(g) prohibits retaliation by employers
against individuals that provide FinCEN
or the DOJ with information about
potential Bank Secrecy Act violations;
any individual alleging retaliation may
seek relief by filing a complaint with the
Department of Labor.
• Section 6403. Corporate
Transparency Act.
On April 5, 2021, FinCEN issued an
ANPRM entitled ‘‘Beneficial Ownership
Information Reporting Requirements,’’
relating to the Corporate Transparency
Act (Sections 6401–6403 of the AML
Act), and intends to issue a NPRM.
Section 6403 of the AML Act amends
the BSA by adding new Section 5336 to
title 31 of the United States Code. New
Section 5336 requires FinCEN to issue
rules requiring: (i) Reporting companies
to submit certain information about the
individuals who are beneficial owners
of those entities and the individuals
who formed or registered those entities;
(ii) establishing a mechanism for issuing
FinCEN identifiers to entities and
individuals that request them; (iii)
requiring FinCEN to maintain the
information in a confidential, secure,
non-public database; and (iv)
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authorizing FinCEN to disclose the
information to certain government
agencies and financial institutions for
purposes specified in the legislation and
subject to protocols to protect the
confidentiality of the information.
Section 5336 requires that the first of
these requirements, notably the
beneficial ownership information
reporting regulation for legal entities
(the ‘‘reporting regulation’’), be
published in final form by January 1,
2022. The ANPRM solicited comments
on a wide range of questions having to
do with the possible shape of the
reporting regulation, as well as
questions that concern the interaction of
the requirements of this regulation and
the shape and functionality of the
database that will be populated with the
information reported under Section
5336.
• Orders Imposing Additional
Reporting and Recordkeeping
Requirements (Technical Change).
On November 15, 2021, FinCEN
issued a final rule to update the
regulation set forth at 31 CFR 1010.370
to reflect amendments to the underlying
statute, 31 U.S.C. 5326, concerning the
authority of FinCEN to issue orders
imposing additional reporting and
recordkeeping requirements on financial
institutions and nonfinancial trades or
businesses in a geographic area.
• Requirements for Certain
Transactions Involving Convertible
Virtual Currency or Digital Assets.
FinCEN is proposing to amend the
regulations implementing the BSA to
require banks and money service
businesses to submit reports, keep
records, and verify the identity of
customers in relation to transactions
involving convertible virtual currency
(CVC) or digital assets with legal tender
status (‘‘legal tender digital assets’’ or
‘‘LTDA’’) held in unhosted wallets, or
held in wallets hosted in a jurisdiction
identified by FinCEN.
• Report of Foreign Bank and
Financial Accounts.
FinCEN is proposing to amend the
regulations implementing the BSA
regarding reports of foreign financial
accounts (FBARs). The proposed
changes are intended to clarify which
persons will be required to file reports
of foreign financial accounts and what
information is reportable. The proposed
changes are intended to amend two
provisions of the FBAR regulation: (1)
Signature or other authority; and (2)
special rules. Treasury is considering
whether the relevant statutory objectives
can be achieved at a lower cost.
• Withdraw Obsolete Civil Money
Penalty Provisions for BSA Violations.
(Technical Change)
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FinCEN is amending 31 CFR 1010.820
to withdraw the civil money penalty
provisions for BSA violations that are
obsolete. Statutory amendments have
been made to specific civil BSA
penalties since the regulation was last
revised. In addition, the Federal Civil
Penalties Inflation Adjustment Act of
1990 as amended, 28 U.S.C. 2461 note,
requires agencies to issue regulations
making annual adjustments reflecting
the effect of inflation for civil penalties
expressed in terms of a dollar amount.
Those inflation adjustments are
correctly captured in a separate
regulation, and therefore the obsolete
and inconsistent provisions will be
withdrawn.
• Amendments to the Definitions of
Broker or Dealer in Securities.
FinCEN is finalizing amendments to
the regulatory definitions of ‘‘broker or
dealer in securities’’ under the
regulations implementing the BSA. The
changes are intended to expand the
current scope of the definitions to
include funding portals. In addition,
these amendments would require
funding portals to implement policies
and procedures reasonably designed to
achieve compliance with all of the BSA
requirements that are currently
applicable to brokers or dealers in
securities. The rule to require these
organizations to comply with the BSA
regulations is intended to help prevent
money laundering, terrorist financing,
and other financial crimes.
• Other Requirements.
FinCEN also will continue to issue
proposed and final rules pursuant to
section 311 of the USA PATRIOT Act,
as appropriate. Finally, FinCEN expects
that it may propose various technical
and other regulatory amendments in
conjunction with ongoing efforts with
respect to a comprehensive review of
existing regulations to enhance
regulatory efficiency required by
Section 6216 of the AML Act.
Bureau of the Fiscal Service
The Bureau of the Fiscal Service
(Fiscal Service) administers regulations
pertaining to the Government’s financial
activities, including: (1) Implementing
Treasury’s borrowing authority,
including regulating the sale and issue
of Treasury securities; (2) administering
Government revenue and debt
collection; (3) administering
government-wide accounting programs;
(4) managing certain Federal
investments; (5) disbursing the majority
of Government electronic and check
payments; (6) assisting Federal agencies
in reducing the number of improper
payments; and (7) providing
administrative and operational support
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to Federal agencies through franchise
shared services.
During fiscal year 2022, Fiscal Service
will accord priority to the following
regulatory projects:
• Surety Companies Doing Business
with the United States.
Fiscal Service is proposing to amend
its regulations governing surety
companies doing business with the
United States, found at 31 CFR part 223.
When a federal law requires a person to
post a bond through a surety, the person
satisfies the requirement if the bond is
underwritten by a company that is
certified by Treasury to write federal
bonds. Fiscal Service administers the
regulations governing the issuance,
renewal, and revocation of certificates of
authority to surety companies to write
or reinsure federal bonds. Fiscal Service
proposes to amend its regulations
governing how it values the assets and
liabilities of sureties to keep pace with
changes in regulation of the surety
industry occurring at the state and
international levels.
• Government Participation in the
Automated Clearing House.
The Fiscal Service is proposing to
amend its regulation at 31 CFR part 210
governing the government’s
participation in the Automated Clearing
House (ACH). The proposed amendment
would address changes to the National
Automated Clearing House
Association’s (Nacha) private-sector
ACH rules that have been adopted since
those rules were last incorporated by
reference in part 210. Among other
things, the amendment would address
the increase in the Same-Day ACH
transaction limit from $100,000 per
transaction to $1,000,000 per
transaction.
• Re-Write of DCIA Offset Regulations
in 31 CFR part 285 subpart A.
The Fiscal Service is proposing to
amend its offset regulations currently
codified in 31 CFR part 285 subpart A.
These regulations govern how Fiscal
Service administers the offset of federal
and state payments to collect federal
and state debt through the Treasury
Offset Program. Through the
amendment, Fiscal Service will re-write
and reorganize the current regulations.
The main purpose of the amendment
will be to improve the clarity of the
regulations. A second purpose will be to
restore flexibility where previouslyissued regulations may have
unintentionally narrowed statutory
authority.
Internal Revenue Service
The Internal Revenue Service (IRS),
working with the Office of Tax Policy,
promulgates regulations that interpret
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and implement the Internal Revenue
Code (Code), and other internal revenue
laws of the United States. The purpose
of these regulations is to carry out the
tax policy determined by Congress in a
fair, impartial, and reasonable manner,
taking into account the intent of
Congress, the realities of relevant
transactions, the need for the
Government to administer the rules and
monitor compliance, and the overall
integrity of the Federal tax system. The
goal is to make the regulations practical
and as clear and simple as possible,
which reduces the burdens on taxpayers
and the IRS.
During fiscal year 2022, the IRS and
Treasury’s Office of Tax Policy’s priority
is to continue providing guidance
regarding implementation of key
provisions of the American Rescue Plan
Act of 2021, Public Law 117–2, the
Coronavirus Aid, Relief, and Economic
Security Act (CARES Act), Public Law
116–136, Public Law 115–97, known as
the Tax Cuts and Jobs Act, as well as the
Taxpayer First Act, Public Law 116–25,
Division O of the Further Consolidated
Appropriations Act, 2020, and Public
Law 116–94, known as the Setting Every
Community Up for Retirement
Enhancement Act of 2019 (SECURE
Act).
Every year, Treasury and the IRS
identify guidance projects that are
priorities for allocation of the resources
during the year in the Priority Guidance
Plan (PGP) (available on irs.gov and
regulations.gov). The plan represents
projects that Treasury and the IRS
intend to actively work on during the
plan year. See, for example, the 2021–
2022 Priority Guidance Plan (September
9, 2021). To help facilitate and
encourage suggestions, Treasury and the
IRS have developed an annual process
for soliciting public input for guidance
projects. The annual solicitation is done
through the issuance of a notice inviting
recommendations from the public for
items to be included on the PGP for the
upcoming plan year. See, for example,
Notice 2021–28 (April 14, 2021). We
also invite the public to continue
throughout the year to provide us with
their comments and suggestions for
guidance projects.
BILLING CODE 4810–25–P
DEPARTMENT OF VETERANS
AFFAIRS (VA)
Statement of Regulatory Priorities
The Department of Veterans Affairs
(VA) administers services and benefit
programs that recognize the important
public obligations to those who served
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this Nation. VA’s regulatory
responsibility is almost solely confined
to carrying out mandates of the laws
enacted by Congress relating to
programs for veterans and their families.
VA’s major regulatory objective is to
implement these laws with fairness,
justice, and efficiency.
Most of the regulations issued by VA
involve at least one of three VA
components: The Veterans Benefits
Administration, the Veterans Health
Administration, and the National
Cemetery Administration. The primary
mission of the Veterans Benefits
Administration is to provide highquality and timely nonmedical benefits
to eligible veterans and their
dependents. The primary mission of the
Veterans Health Administration is to
provide high-quality health care on a
timely basis to eligible veterans through
its system of medical centers, nursing
homes, domiciliaries, and outpatient
medical and dental facilities. The
primary mission of the National
Cemetery Administration is to bury
eligible veterans, members of the
Reserve components, and their
dependents in VA National Cemeteries
and to maintain those cemeteries as
national shrines in perpetuity as a final
tribute of a grateful Nation to
commemorate their service and sacrifice
to our Nation.
VA’s regulatory priority plan consists
of three high priority regulations:
(1) RIN 2900–AQ30 Proposed Rule—
Modifying Copayments for Veterans at
High Risk for Suicide.
The Department of Veterans Affairs
(VA) proposes to amend its medical
regulations that govern copayments for
outpatient medical care and
medications for at-risk veterans.
(2) RIN 2900–AR01 Proposed Rule—
VA Pilot Program on Graduate Medical
Education and Residency.
The Department of Veterans Affairs
proposes to revise its medical
regulations to establish a new pilot
program on graduate medical education
and residency, as required by section
403 of the John S. McCain III, Daniel K.
Akaka, and Samuel R. Johnson VA
Maintaining Internal Systems and
Strengthening Integrated Outside
Network Act of 2018.
(3) RIN 2900–AR16 Interim Final
Rule—Staff Sergeant Parker Gordon Fox
Suicide Prevention Grant Program.
The Department of Veterans Affairs
(VA) is issuing this interim final rule to
implement legislation authorizing VA
initiate a three-year community-based
grant program to award grants to eligible
entities to provide or coordinate the
provision of suicide prevention services
to eligible individuals and their
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families. This rulemaking specifies grant
eligibility criteria, application
requirements, scoring criteria,
constraints on the allocation and use of
the funds, and other requirements
necessary to implement this grant
program.
VA
Proposed Rule Stage
141. Modifying Copayments for
Veterans at High Risk for Suicide
Priority: Other Significant.
Legal Authority: 38 U.S.C. 1710(g); 38
U.S.C. 1722A
CFR Citation: 38 CFR 17.108; 38 CFR
17.110.
Legal Deadline: None.
Abstract: The Department of Veterans
Affairs (VA) proposes to amend its
medical regulations that govern
copayments for outpatient medical care
and medications for at-risk veterans.
Statement of Need: This rulemaking is
needed because a change in the current
regulation is called for by the policy
outlined in Executive Order 13822,
which provides that our Government
must improve mental healthcare and
access to suicide prevention resources
available to veterans. Healthcare
research has provided extensive
evidence that copayments can be
barriers to healthcare for vulnerable
patients, which places the proposed
change in line with the goals of the
Executive Order.
Summary of Legal Basis: Executive
Order 13822.
Alternatives: The express intent of the
rulemaking is to reduce barriers to
mental health care for Veterans at high
risk for suicide. To defer
implementation of the regulation would
be to undermine its purpose. However,
alternative regulatory approaches were
considered. It was considered whether
VHA national or local policy changes
could effectively meet the intent of the
proposed regulation. It was found that
policy change is not a viable alternative
due to regulatory constraints that
prevent changes to copayment
requirements. The timing of rulemaking
was considered. There were no potential
cost savings or other net benefits
identified that would lead to a more
beneficial option.
A phase-in period for the regulation
was considered. There were no burdens,
likely failures, or negative comments
identified that a phase-in period would
help mitigate. There were no potential
cost savings or other net benefits
identified that would make phasing in
the regulation a more beneficial option.
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Anticipated Cost and Benefits:
Outpatient medical care and medication
copayments will be reduced for
Veterans determined to be at high risk
for suicide. VA strongly believes, based
on extensive empirical evidence, that
the provisions of this rulemaking will
decrease the likelihood of fatal or
medically serious overdoses from VA
prescribed medications among Veterans
who are at a high risk of suicide. VA
also strongly believes, based on the
evidence, that the provisions of this
rulemaking will significantly increase
the engagement of Veterans who are at
a high risk of suicide in outpatient
health care, which is known to decrease
the risk of suicide and other adverse
outcomes.
VA has determined that there are
transfers associated with this
rulemaking and a loss of revenue to VA
from the reduction of specific veteran
copayments. The transfers are estimated
to be $9.43M in FY2022 and $54.35M
over a 5-year period. The loss of revenue
to VA is estimated to be $0.21M in
FY2022 and $1.11M over a five-year
period. The total budgetary impact of
this rulemaking is estimated to be
$9.63M in FY2022 and $55.47M over a
five-year period.
Risks: None.
Timetable:
Action
NPRM ..................
Date
FR Cite
11/00/21
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
Agency Contact: Julie Wildman,
Informatics Educator, Department of
Veterans Affairs, 795 Willow Road,
Building 321, Room A124, Menlo Park,
CA 94304, Phone: 650 493–5000, Email:
julie.wildman@va.gov.
RIN: 2900–AQ30
VA
142. VA Pilot Program on Graduate
Medical Education and Residency
Priority: Other Significant.
Legal Authority: Pub. L. 115–182, sec.
403
CFR Citation: 38 CFR 17.243 to
17.248.
Legal Deadline: None.
Abstract: The Department of Veterans
Affairs proposes to revise its medical
regulations to establish a new pilot
program on graduate medical education
and residency, as required by section
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403 of the John S. McCain III, Daniel K.
Akaka, and Samuel R. Johnson VA
Maintaining Internal Systems and
Strengthening Integrated Outside
Network Act of 2018.
Statement of Need: This rulemaking is
needed to implement section 403 of the
John S. McCain III, Daniel K. Akaka, and
Samuel R. Johnson VA Maintaining
Internal Systems and Strengthening
Integrated Outside Network Act of 2018
(hereafter referred to as the MISSION
Act). Section 403 of the MISSION Act
requires the Department of Veterans
Affairs (VA) create a pilot program to
establish additional medical residency
positions authorized under section
301(b)(2) of Public Law 113–146 (note to
section 7302 of title 38 United States
Code (U.S.C.)) at certain covered
facilities, to include non-VA facilities.
Prior to section 403 of the MISSION Act,
VA’s authority in 38 U.S.C. 7302
permitted VA to establish medical
residency programs in VA facilities and
ensure that such programs have a
sufficient number of residents, where
VA’s graduate medical education (GME)
programming was limited to funding
resident salaries and benefits only if
such residents were in VA facilities,
caring for Veterans, and supervised by
VA staff, with some additional support
to the affiliated educational institutions
for educational costs.
Summary of Legal Basis: Section 403
of the MISSION Act expanded on this
authority by creating a pilot to allow VA
to fund residents regardless of whether
they are in VA facilities, and to pay for
certain costs of new residency programs
that might also not be in VA facilities.
Alternatives: VA analyzed whether
this pilot program could be
implemented without regulations,
because the administration of resident
stipends and benefits, as well as the
reimbursement of certain costs of new
residency programs, would be
controlled by contracts or agreements
outside of regulations. However,
regulations were thought necessary to:
Better characterize selection criteria for
the covered facilities in which residents
will be placed, and to establish priority
placement at certain covered facilities as
required by section 403; establish
criteria for defining new residency
programs; qualify the resident activities
that would be reimbursable; and qualify
the reimbursable costs for new
residency programs if VA places a
resident in a new residency program.
Regulations were also thought necessary
to clarify that this pilot program, unlike
many other VA pilot programs, is not a
grant program or a cooperative
agreement program through which
entities may apply to be considered for
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resident funding or reimbursement of
new residency program costs.
Anticipated Cost and Benefits:
Increasing the number of residents and
residency programs in underserved
regions may improve the number of
physicians practicing there after
residency training and also will increase
access to healthcare for veterans and
possibly non-Veterans residing in those
regions.
VA estimates that costs of this
program will be $4,160,259 in FY22 and
13,691,052 over a 5-year period.
Transfers will be zero in FY22 and
$25,687,106 over a 5-year period.
Combined, this results in a budget
impact of $4,160,259 in FY 22 and
$39,378,158 over a 5-year window.
Risks: None.
Timetable:
Action
Date
NPRM ..................
FR Cite
02/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information:
www.regulations.gov.
Agency Contact: Marjorie A. Bowman,
Chief, Office of Academic Affiliations
(10X1), Department of Veterans Affairs,
810 Vermont Avenue NW, Washington,
DC 20420, Phone: 202 461–9490, Email:
marjorie.bowman@va.gov.
RIN: 2900–AR01
VA
Final Rule Stage
143. Staff Sergeant Parker Gordon Fox
Suicide Prevention Grant Program
Priority: Other Significant.
Legal Authority: Pub. L. 116–171, sec.
201; 38 U.S.C. 1720F; 38 U.S.C. 501
CFR Citation: 38 CFR 62.2; 38 CFR
50.1(d); 38 CFR 78.45.
Legal Deadline: Other, Statutory,
December 31, 2025, Required
consultation pursuant to section 201 of
Pub. L. 116–171. Required consultation
pursuant to section 201 of Pub. L. 116–
171. This grant program is authorized by
section 201 of Public Law 116–171. VA
must publish regulations for matters
related to grants as required by 38
U.S.C. 501(d).
Abstract: The Department of Veterans
Affairs (VA) is issuing this interim final
rule to implement legislation
authorizing VA to initiate a three-year
community-based grant program to
award grants to eligible entities to
provide or coordinate the provision of
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suicide prevention services to eligible
individuals and their families. This
rulemaking specifies grant eligibility
criteria, application requirements,
scoring criteria, constraints on the
allocation and use of the funds, and
other requirements necessary to
implement this grant program.
Statement of Need: The Department of
Veterans Affairs (VA) is issuing
regulations for the implementation of
section 201 of Public Law 116–171, the
Commander John Scott Hannon
Veterans Mental Health Care
Improvement Act of 2019 (the Act).
Title 38 of United States Code (U.S.C.)
section 501(d) requires VA to publish
regulations for matters related grants,
notwithstanding section 553(a)(2) of the
Administration Procedure Act.
Summary of Legal Basis: This grant
program is authorized by section 201 of
Public Law 116–171. VA must publish
regulations for matters related to grants
as required by 38 U.S.C. 501(d).
Alternatives: VHA initially was
planning to implement the pilot
program without any collaboration or
planning with our internal or external
partners. As an alternative, VHA intends
to collaborate with other grant programs
to examine certain costs which may be
shared such as FTE, IT systems, and
utilizing internal VA offices and
infrastructure for certain aspect of grants
management. This will maximize the
effectiveness of the program and
minimize any inefficiencies which
would have otherwise arisen. VA
determined the best course of action
was to work with internal and external
partners to develop the best grant
program possible for suicide prevention
among our Veteran population.
Anticipated Cost and Benefits: VA has
estimated that there are both transfers
and costs associated with the provisions
of this rulemaking. The transfers are
estimated to be $51.7M in FY2023 and
$156 7M through FY2025. The costs are
estimated to be $1.6M in FY2021 and
$16.8M over five years (FY2021–
FY2025).
Risks: None.
Timetable:
Action
Request For Information (RFI).
RFI Comment Period End.
Interim Final Rule
Date
04/01/21
FR Cite
86 FR 17268
04/22/21
04/00/22
Regulatory Flexibility Analysis
Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
URL For More Information: https://
www.federalregister.gov
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Agency Contact: Juliana Hallows,
Associate Director, VACO Suicide
Prevention Program, Department of
Veterans Affairs, 810 Vermont Avenue
NW, Washington, DC 20420, Phone: 406
475–0624, Email: juliana.hallows@
va.gov.
RIN: 2900–AR16
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY (EPA)
Statement of Priorities
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Overview
EPA works to ensure that all
Americans are protected from
significant risks to human health and
the environment, including climate
change, and that overburdened and
underserved communities and
vulnerable individuals—including lowincome communities and communities
of color, children, the elderly, tribes,
and indigenous people—are
meaningfully engaged and benefit from
focused efforts to protect their
communities from pollution. EPA acts
to ensure that all efforts to reduce
environmental harms are based on the
best available scientific information,
that federal laws protecting human
health and the environment are
enforced equitably and effectively, and
that the United States plays a leadership
role in working with other nations to
protect the global environment. EPA is
committed to environmental protection
that builds and supports more diverse,
equitable, sustainable, resilient, and
productive communities and
ecosystems.
By taking advantage of the latest
science, the newest technologies and the
most cost-effective and sustainable
solutions, EPA and its federal, tribal,
state, local, and community partners
have made important progress in
addressing pollution where people live,
work, play, and learn. By cleaning up
contaminated waste sites, reducing
greenhouse gases, lowering emissions of
mercury and other air pollutants, and
investing in water and wastewater
treatment, EPA’s efforts have resulted in
tangible benefits to the American
public. Efforts to reduce air pollution
alone have produced hundreds of
billions of dollars in benefits in the
United States, and tremendous progress
has been made in cleaning up our
nation’s land and waterways. But much
more needs to be done to implement the
nation’s environmental statutes and
ensure that all individuals and
communities benefit from EPA’s efforts
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to protect human health and the
environment and to address the climate
crisis.
EPA has initiated cross-Agency efforts
to address our most complex
environmental challenges including
PFAS pollution. Per- and
polyfluoroalkyl substances (PFAS) are a
group of man-made chemicals,
including PFOA and PFOS, that have
been manufactured and used in a
variety of industries around the globe,
including in the United States, since the
1940s. Both chemicals persist in the
environment and in the human body.
The EPA Administrator established a
Council on PFAS, comprised of a group
of senior agency leaders who are
charged with accelerating the Agency’s
progress on PFAS. EPA is committed to
using all the Agency’s authorities to
address PFAS pollution including Safe
Drinking Water Act, Clean Water Act,
and the Comprehensive Environmental
Response, Compensation, and Liability
Act. EPA also is expanding our existing
data collection efforts to better
understand the environmental and
human health impacts of PFAS.
Similarly, EPA has developed a crossAgency strategy to coordinate the
Agency’s efforts to reduce lead exposure
and protect children and families from
the harmful effects of lead.
EPA will use its regulatory
authorities, along with grant- and
incentive-based programs, technical and
compliance assistance, and research and
educational initiatives, to address the
following priorities set forth in EPA’s
upcoming Strategic Plan:
• Tackle the Climate Crisis
• Advance Environmental Justice and
Civil Rights
• Ensure Clean and Healthy Air for
All Communities
• Ensure Clean and Healthy Water for
All Communities
• Safeguard and Revitalize
Communities
• Ensure Safety of Chemicals for
People and the Environment
All this work will be undertaken with
a strong commitment to scientific
integrity, the rule of law and
transparency, the health of children and
other vulnerable populations, and with
special focus on supporting and
achieving environmental justice at
federal, tribal, state, and local levels.
Highlights of EPA’s Regulatory Plan
This Regulatory Plan highlights our
most important upcoming regulatory
actions. As always, our Semiannual
Regulatory Agenda contains information
on a broader spectrum of EPA’s
upcoming regulatory actions.
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Tackle the Climate Crisis
EPA must take bold and decisive
steps to respond to the severe and
urgent threat of climate change,
including taking appropriate regulatory
action under existing statutory
authorities to reduce emissions from our
nation’s largest sources of greenhouse
gases (GHG). The impacts of climate
change are affecting people in every
region of the country, threatening lives
and livelihoods and damaging
infrastructure, ecosystems, and social
systems. Overburdened and
underserved communities and
individuals are particularly vulnerable
to these impacts, including low-income
communities and communities of color,
children, the elderly, tribes, and
indigenous people. Exercising its
authority under the Clean Air Act
(CAA), EPA will address major sources
of GHGs that are driving these impacts
by taking regulatory action to minimize
emissions of methane from new and
existing sources in the oil and natural
gas sector; reduce GHGs from new and
existing fossil fuel-fired power plants;
limit GHGs from new light-duty
vehicles and heavy-duty trucks; and set
requirements for the use of renewable
fuel. EPA will also carry out the
mandates of the recently enacted
American Innovation and
Manufacturing (AIM) Act to implement,
and where appropriate accelerate, a
national phasedown in the production
and consumption of hydrofluorocarbons
(HFCs), which are highly potent GHGs.
• Emission Guidelines for Oil and
Natural Gas Sector. The oil and natural
gas industry are the largest industrial
source of U.S. emissions of methane, a
GHG more than 25 times as potent as
carbon dioxide at trapping heat in the
atmosphere. Executive Order 13990,
‘‘Protecting Public Health and the
Environment and Restoring Science to
Tackle the Climate Crisis,’’ states that
the Administrator of EPA should
consider proposing new regulations to
establish emission guidelines for
methane emissions from existing
operations in the oil and gas sector,
including the exploration and
production, transmission, processing,
and storage segments. The purpose of
this action is to propose new emission
guidelines for existing sources in the oil
and gas sector by October 2021.
• New Source Performance Standards
for Crude Oil and Natural Gas Facilities:
Review of Policy and Technical Rules.
Executive Order 13990 further directs
EPA to review the new source
performance standards (NSPS) issued in
2020 for the oil and gas sector about
methane and volatile organic compound
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(VOC) emissions and, as appropriate
and consistent with applicable law,
consider publishing for notice and
comment a proposed rule suspending,
revising, or rescinding the NSPS. The
Executive Order also directs EPA to
consider proposing new regulations to
establish comprehensive NSPS for
methane and VOC emissions from the
exploration and production,
transmission, processing, and storage
segments. The purpose of this action is
to review the existing NSPS and
propose new standards as necessary.
• Emission Guidelines for
Greenhouse Gas Emissions from Fossil
Fuel-Fired Existing Electric Generating
Units. On January 19, 2021, the D.C.
Circuit Court vacated the Affordable
Clean Energy Rule (40 CFR part 60,
subpart UUUUa) and remanded the rule
to EPA for further consideration
consistent with its decision. On
February 12, 2021, considering the
court’s decision, the EPA published a
memorandum on the status of the
Affordable Clean Energy (ACE) rule and
informed states not to continue the
development or submittal of state plans
in accordance with CAA section 111(d)
guidelines for GHG emissions from
power plants at this time. EPA
continues to review the court’s vacatur
and remand of these actions. The
anticipated proposal date for this action
is by July 2022, and promulgation by
July 2023.
• Amendments to the NSPS for GHG
Emissions from New, Modified, &
Reconstructed Stationary Sources:
EGUs. Under CAA section 111(b), EPA
sets New Source Performance Standards
(NSPS) for GHG emissions from new,
modified, and reconstructed fossil fuelfired power plants. In 2015, EPA
finalized regulations to limit GHG
emissions from new fossil-fuel fired
utility boilers and from natural gas-fired
stationary combustion turbines. In 2018,
EPA proposed to revise the NSPS for
coal fired EGUs. To date, that proposed
action has not been finalized. The 2018
proposed rule would have revised the
2015 NSPS finalized in conjunction
with the Clean Power Plan (80 FR
64510). Litigation remains in abeyance
for the 2015 final NSPS. The purpose of
this action is to review the NSPS and,
if appropriate, amend the standards for
new fossil fuel fired EGUs. Anticipated
timing of the proposed rule is by June
2022 and promulgation by June 2023.
• Restrictions on Certain Uses of
Hydrofluorocarbons under Subsection
(i) of the American Innovation and
Manufacturing Act. EPA intends to
propose a rule that, in part, responds to
petitions granted under subsection (i) of
the AIM Act. Subsection (i) of the AIM
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Act provides that a person may petition
EPA to promulgate a rule for the
restriction on use of a regulated
substance in a sector or subsector. EPA
will consider a rule restricting, fully,
partially, or on a graduated schedule,
the use of HFCs in sectors or subsectors
including the refrigeration, air
conditioning, aerosol, and foam sectors
informed by petitions received from
environmental groups, trade
associations, and individual companies.
Additionally, EPA will consider
establishing recordkeeping and
reporting requirements and addressing
other related elements of the AIM Act.
• Phasedown of Hydrofluorocarbons:
Updates to the Allowance Allocation
and Trading Program under the
American Innovation and
Manufacturing Act for 2024 and Later
Years. As noted above, the AIM Act
directs EPA to sharply reduce
production and consumption of HFCs,
which are harmful and potent
greenhouse gases, by using an allowance
allocation and trading program. This
phasedown will decrease the
production and import of HFCs in the
United States by 85% over the next 15
years. The first regulation under the
AIM Act established the allowance
allocation and trading program for 2022
and 2023. To continue phasing down
the production and consumption of
listed HFCs on the schedule listed in the
AIM Act, this rulemaking will provide
the framework for how the Agency will
issue allowances in 2024 and beyond.
• Revised 2023 and Later Model Year
Light-Duty Vehicle Greenhouse Gas
Emissions Standards. Executive Order
13990 directed EPA to review the Safer
Affordable Fuel-Efficient (SAFE)
Vehicles Rule for Model Years 2021–
2026 Passenger Cars and Light Trucks
(April 30, 2020). In August 2021, EPA
proposed to revise existing national
GHG emissions standards for passenger
cars and light trucks for Model Years
2023–2026. The proposed standards
would achieve significant GHG
emissions reductions along with
reductions in other criteria pollutants.
The proposal would result in substantial
public health and welfare benefits,
while providing consumers with savings
from lower fuel costs.
• Volume Requirements for 2023 and
Beyond under the Renewable Fuel
Standard Program. CAA statutory
provisions governing the Renewable
Fuel Standard (RFS) program provide
target volumes of renewable fuel for the
RFS program only through 2022. For
years 2023 and thereafter, the statute
requires EPA to set those volumes based
on an analysis of specified factors. If
EPA does not set those volumes, there
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will be no applicable requirement to
blend renewable fuel into gasoline and
diesel. This rulemaking will establish
volume requirements for 2023 and some
years beyond. The proposal will provide
the public with an opportunity to
provide feedback on various alternative
volume requirements.
• Renewable Fuel Standard (RFS)
Program: RFS Annual Rules. CAA
section 211 requires EPA to set
renewable fuel percentage standards
every year. This action establishes the
annual percentage standards for
cellulosic biofuel, biomass-based diesel,
advanced biofuel, and total renewable
fuel that apply to gasoline and diesel
transportation fuel.
Ensure Clean and Healthy Air for All
Communities
All people regardless of race,
ethnicity, national origin, or income
deserve to breathe clean air. EPA has the
responsibility to protect the health of
vulnerable and sensitive populations,
such as children, the elderly, and
persons overburdened by pollution or
adversely affected by persistent poverty
or inequality. Since enactment of the
CAA, EPA has made significant progress
in reducing harmful air pollution even
as the U.S. population and economy
have grown. Between 1970 and 2020,
the combined emissions of six key
pollutants dropped by 78%, while the
U.S. economy remained strong growing
272% over that time period. As required
by the CAA, EPA will continue to build
on this progress and work to ensure
clean air for all Americans, including
those in underserved and overburdened
communities. Among other things, EPA
will take regulatory action to review and
implement health-based air quality
standards for criteria pollutants such as
particulate matter (PM); limit emissions
of harmful air pollution from both
stationary and mobile sources; address
sources of hazardous air pollution
(HAP), such as ethylene oxide, that
disproportionately affect communities
with environmental justice concerns;
and protect downwind communities
from sources of air pollution that cross
state lines. Along with the full set of
CAA actions listed in the regulatory
agenda, the following high priority
actions will allow EPA to continue its
progress in reducing harmful air
pollution.
• Review of the National Ambient Air
Quality Standards for Particulate
Matter. Under the CAA Amendments of
1977, EPA is required to review and if
appropriate revise the air quality criteria
for the primary (health-based) and
secondary (welfare-based) national
ambient air quality standards (NAAQS)
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every 5 years. In December 2020, EPA
published its final decision in the
review of the PM NAAQS, retaining the
existing standard established in 2013.
The review included the preparation of
an Integrated Review Plan, an Integrated
Science Assessment (ISA), and a Policy
Assessment with opportunities for
review by EPA’s Clean Air Scientific
Advisory Committee (CASAC) and the
public. These documents informed the
Administrator’s decision in the PM
NAAQS review. On June 10, 2021, EPA
notified the public that it will
reconsider the 2020 decision to retain
the PM NAAQS. As part of this
reconsideration, EPA intends to develop
a supplement to the ISA and a revised
policy assessment to consider the most
up-to-date science on public health and
welfare impacts of PM and to engage
with the CASAC and a newly
constituted expert PM panel.
Additionally, on July 7, 2020, EPA
notified the public that it was initiating
an update of the ISA for lead as part of
the periodic review of the lead NAAQS.
• NESHAP: Coal- and Oil-Fired
Electric Utility Steam Generating
Units—Revocation of the 2020
Reconsideration, and Affirmation of the
Appropriate and Necessary
Supplemental Finding. Executive Order
13990 directs EPA to take certain
actions by August 2021, including
considering publishing, as appropriate
and consistent with applicable law, a
proposed rule suspending, revising, or
rescinding the ‘‘National Emission
Standards for Hazardous Air Pollutants:
Coal- and Oil-Fired Electric Utility
Steam Generating Units—
Reconsideration of Supplemental
Finding and Residual Risk and
Technology Review,’’ 85 FR 31286 (May
22, 2020). The May 2020 final action is
the latest amendment to the February
16, 2012, National Emission Standards
for Hazardous Air Pollutants for Coaland Oil-fired Electric Utility Steam
Generating Units (77 FR 9304). That
2012 rule (40 CFR part 63, subpart
UUUUU), commonly referred to as the
Mercury and Air Toxics Standards
(MATS), includes standards to control
HAP emissions from new and existing
coal- and oil-fired steam EGUs located
at both major and area sources of HAP
emissions. In the May 22, 2020 action,
EPA found that it is not appropriate and
necessary to regulate coal- and oil-fired
EGUs under CAA section 112. As
directed by E.O. 13990, EPA will review
the May 22, 2020, finding and, under
this action, will take appropriate action
resulting from its review of the May
2020 finding that it is not appropriate
and necessary to regulate coal- and oil-
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fired EGUs under Clean Air Act section
112. Results of EPA’s review of the May
2020 RTR will be presented in a
separate action.
• Interstate Transport Rule for 2015
Ozone NAAQS. This action would
apply in certain states for which EPA
has either disapproved a ‘‘good
neighbor’’ state implementation plan
(SIP) submission under CAA section
110(a)(2)(D)(i)(I) or has made a finding
of failure to submit such a SIP
submission for the 2015 ozone NAAQS.
This action would determine whether
and to what extent upwind sources of
ozone-precursor emissions need to
reduce these emissions to prevent
interference with downwind states’
maintenance or attainment of the 2015
8-hour ozone NAAQS. For upwind
states that EPA determines to be linked
to a downwind nonattainment or
maintenance receptor, EPA would
conduct further analysis to determine
what (if any) additional emissions
controls are required in such states and
develop an enforceable program for
implementation of such controls.
• Control of Air Pollution from New
Motor Vehicles: Heavy-Duty Engine and
Vehicle Standards. Heavy-duty engines
have been subject to emission standards
for criteria pollutants, including PM,
hydrocarbon (HC), carbon monoxide
(CO), and oxides of nitrogen (NOX), for
nearly half a century. Current data
suggest that existing standards should
be revised to ensure full, in-use
emission control. NOX emissions are
major precursors of ozone and
significant contributors to secondary
PM2.5 formation. Ozone and ambient
PM2.5 concentrations continue to be a
nationwide health and air quality issue.
Reducing NOX emissions from onhighway, heavy-duty trucks and buses is
an important component of improving
air quality nationwide and reducing
public health and welfare effects
associated with these pollutants,
especially for vulnerable populations
and in highly impacted regions.
Through this action, EPA will evaluate
data on current NOX emissions from
heavy-duty vehicles and engines and
propose options to improve control of
criteria pollutant emissions through
revised emissions standards.
Additionally, this action will propose
updates to the existing greenhouse gas
emissions standards for heavy-duty
vehicles.
• National Emission Standards for
Hazardous Air Pollutants: Ethylene
Oxide Commercial Sterilization and
Fumigation Operations. In response to
EPA’s most recent National Air Toxics
Assessment (NATA), which identified
several areas across the country as
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having the potential for elevated cancer
risk due to emissions of ethylene oxide
to the outdoor air, EPA has initiated a
review of its existing air rules for source
categories that emit this chemical. This
includes reviewing the current National
Emission Standards for Hazardous Air
Pollutants (NESHAP) for Ethylene
Oxide Commercial Sterilization and
Fumigation Operations, which were
finalized in December 1994 (59 FR
62585). The standards require existing
and new major sources to control
emissions to the level achievable by the
maximum achievable control
technology (MACT) and require existing
and new area sources to control
emissions using generally available
control technology (GACT). In this
action, EPA will conduct a statutorily
required technology review for the
NESHAP and will also consider the
cancer risks of ethylene oxide emissions
from this source category. To aid in this
effort, EPA issued an advance notice of
proposed rulemaking (ANPRM) on
December 12, 2019 (84 FR 67889) that
solicited comment from stakeholders,
developed important emissions-related
data through data collection activities,
and undertook a Small Business
Advocacy Review (SBAR) panel, which
is needed when there is the potential for
significant economic impacts to small
businesses from any regulatory actions
being considered.
• Review of Final Rule
Reclassification of Major Sources as
Area Sources Under Section 112 of the
Clean Air Act. This rulemaking will
address the review of the final rule,
‘‘Reclassification of Major Sources as
Area Sources Under Section 112 of the
Clean Air Act’’ (Major MACT to Area, or
MM2A final rule). See 85 FR 73854,
November 19, 2020. Pursuant to
Executive Order 13990, EPA has
decided to review the MM2A final rule
and, as appropriate and consistent with
the CAA section 112, to publish for
comment a notice of proposed
rulemaking either suspending, revising,
or rescinding the MM2A final rule. The
MM2A final rule became effective on
January 19, 2021 and provides that a
major source can be reclassified to area
source status at any time upon reducing
its potential to emit (PTE) HAP to below
the major source thresholds (MST) of 10
tons per year (tpy) of any single HAP
and 25 tpy of any combination of HAP.
Major sources that reclassify to area
source status will no longer be subject
to CAA section 112 major source
requirements and, instead, will be
subject to any applicable area source
requirements. The MM2A final rule also
included an interim ministerial revision
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that removed the word ‘‘federally’’ from
the phrase ‘‘federally enforceable’’ in
the PTE definition in 40 CFR 63.2.
Ensure Clean and Healthy Water for All
Communities
The Nation’s water resources are the
lifeblood of our communities,
supporting our health, economy, and
way of life. Clean and safe water is a
vital resource that is essential to the
protection of human health. The EPA is
committed to ensuring clean and safe
water for all, including low-income
communities and communities of color,
children, the elderly, tribes, and
indigenous people. Since the enactment
of the Clean Water Act (CWA) and the
Safe Drinking Water Act (SDWA), EPA
and its state and tribal partners have
made significant progress toward
improving the quality of our waters and
ensuring a safe drinking water supply.
Along with the full set of water actions
listed in the regulatory agenda, the
regulatory initiatives listed below will
help ensure that this important progress
continues.
• Revised Definition of ‘‘Waters of the
United States’’—Rule 1: In April 2020,
the EPA, and the Department of the
Army (‘‘the agencies’’) published the
Navigable Waters Protection Rule
(NWPR) that revised the previouslycodified definition of ‘‘waters of the
United States’’ (85 FR 22250, April 21,
2020). The agencies are now initiating
this new rulemaking process that
restores the regulations in place prior to
the 2015 ‘‘Clean Water Rule: Definition
of ‘Waters of the United States’ ’’ (80 FR
37054, June 29, 2015), updated to be
consistent with relevant Supreme Court
decisions. The agencies intend to
consider further revisions in a second
rule in light of additional stakeholder
engagement and implementation
considerations, scientific developments,
and environmental justice values. This
effort will also be informed by the
experience of implementing the pre2015 rule, the 2015 Clean Water Rule,
and the 2020 Navigable Waters
Protection Rule.
• Revised Definition of ‘‘Waters of the
United States’’—Rule 2: The EPA and
the Department of the Army (‘‘the
agencies’’) intend to pursue a second
rule defining ‘‘Waters of the United
States’’ to consider further revisions to
the agencies’ first rule (RIN 2040–AG13)
which proposes to restore the
regulations in place prior to the 2015
‘‘Clean Water Rule: Definition of ‘Waters
of the United States’ ’’ (80 FR 37054,
June 29, 2015), updated to be consistent
with relevant Supreme Court Decisions.
This second rule proposes to include
revisions reflecting on additional
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stakeholder engagement and
implementation considerations,
scientific developments, and
environmental justice values. This effort
will also be informed by the experience
of implementing the pre-2015 rule, the
2015 Clean Water Rule, and the 2020
Navigable Waters Protection Rule.
• Clean Water Act Section 401: Water
Quality Certification. In accordance
with Executive Order 13990, EPA has
completed its review of the 2020 Clean
Water Act Section 401 Certification Rule
(85 FR 42210, July 13, 2020) and has
determined that it erodes state and tribal
authority as it relates to protecting water
quality. Through the new rulemaking,
EPA intends to restore the balance of
state, tribal, and federal authorities
while retaining elements that support
efficient and effective implementation
of section 401. Congress provided
authority to states and tribes under
CWA section 401 to protect the quality
of their waters from adverse impacts
resulting from federally licensed or
permitted projects. Under section 401, a
federal agency may not issue a license
or permit to conduct any activity that
may result in any discharge into
navigable waters unless the affected
state or tribe certifies that the discharge
is in compliance with the CWA and
state law or waives certification. EPA
intends to strengthen the authority of
states and tribes to protect their vital
water resources.
• Effluent Limitations Guidelines and
Standards for the Steam Electric Power
Generating Point Source Category. On
July 26, 2021, EPA announced its
decision to conduct a rulemaking to
potentially strengthen the Steam
Electric Effluent Limitations Guidelines
(ELGs) (40 CFR 423). This rulemaking
process could result in more stringent
ELGs for waste streams addressed in the
2020 final rule, as well as waste streams
not covered in the 2020 rule. The former
could address petitioners’ claims in
current litigation pending in the Fourth
Circuit Court of Appeals. Appalachian
Voices v. EPA, No. 20–2187 (4th Cir.).
EPA revised the Steam Electric ELGs in
2015 and 2020.
• Per- and polyfluoroalkyl substances
(PFAS): Perfluorooctanoic acid (PFOA)
and perfluorooctanesulfonic acid
(PFOS) National Primary Drinking
Water Regulation Rulemaking. On
March 3, 2021, EPA published the
Fourth Regulatory Determinations (86
FR 12272), including a determination to
regulate perfluorooctanoic acid (PFOA)
and perfluorooctanesulfonic acid
(PFOS) in drinking water. With this
action, EPA intends to develop a
proposed national primary drinking
water regulation for PFOA and PFOS,
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and, as appropriate, take final action.
Additionally, EPA will continue to
consider other PFAS as part of this
action.
• National Primary Drinking Water
Regulations for Lead and Copper:
Regulatory Revisions.