Improved Agency Guidance Documents, 51337-51340 [2020-17878]
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Rules and Regulations
regulatory flexibility analysis is required
and none has been prepared.
List of Subjects in 15 CFR Part 744
Exports, Reporting and recordkeeping
requirements, Terrorism.
Accordingly, part 744 of the Export
Administration Regulations (15 CFR
parts 730–774) is amended as follows:
PART 744—CONTROL POLICY: ENDUSE AND END-USER BASED
1. The authority citation for part 744
is revised to read as follows:
■
Authority: 50 U.S.C. 4801–4852; 50 U.S.C.
4601 et seq.; 50 U.S.C. 1701 et seq.; 22 U.S.C.
3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201
et seq.; 22 U.S.C. 7210; E.O. 12058, 43 FR
20947, 3 CFR, 1978 Comp., p. 179; E.O.
12851, 58 FR 33181, 3 CFR, 1993 Comp., p.
608; E.O. 12938, 59 FR 59099, 3 CFR, 1994
Comp., p. 950; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13099, 63 FR
45167, 3 CFR, 1998 Comp., p. 208; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; E.O. 13224, 66 FR 49079, 3 CFR, 2001
Comp., p. 786; Notice of September 19, 2019,
84 FR 49633 (September 20, 2019); Notice of
November 12, 2019, 84 FR 61817 (November
13, 2019).
2. Section 744.11 is amended by
revising paragraph (a) to read as follows:
■
§ 744.11 License requirements that apply
to entities acting contrary to the national
security or foreign policy interests of the
United States.
*
*
*
*
*
(a) License requirement, availability of
license exceptions, and license
application review policy. A license is
required, to the extent specified on the
Entity List, to export, reexport, or
transfer (in-country) any item subject to
the EAR when an entity that is listed on
the Entity List is a party to the
transaction as described in § 748.5(c)
through (f). License exceptions may not
be used unless authorized in the Entity
List entry for the entity that is party to
the transaction. Applications for
licenses required by this section will be
evaluated as stated in the Entity List
entry for the entity that is party to the
transaction, in addition to any other
applicable review policy stated
elsewhere in the EAR.
*
*
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*
■ 3. Section 744.16 is amended by
revising paragraph (a) to read as follows:
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§ 744.16
Entity List.
*
*
*
*
*
(a) License requirements. In addition
to the license requirements for items
specified on the Commerce Control List
(CCL), you may not, without a license
from BIS, export, reexport, or transfer
(in-country) any items included in the
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License Requirement column of an
entity’s entry on the Entity List
(supplement No. 4 to this part) when
that entity is a party to a transaction as
described in § 748.5(c) through (f) of the
EAR. The specific license requirement
for each listed entity is identified in the
license requirement column on the
Entity List in Supplement No. 4 to this
part.
*
*
*
*
*
■ 4. Supplement No. 4 to part 744 is
amended by revising the introductory
text of the supplement to read as
follows:
Supplement No. 4 to Part 744—Entity
List
This Supplement lists certain entities
subject to license requirements for specified
items under this part 744 and part 746 of the
EAR. License requirements for these entities
include exports, reexports, and transfers (incountry) unless otherwise stated. A license is
required, to the extent specified on the Entity
List, to export, reexport, or transfer (incountry) any item subject to the EAR when
an entity that is listed on the Entity List is
a party to the transaction as described in
§ 748.5(c) through (f). This list of entities is
revised and updated on a periodic basis in
this Supplement by adding new or amended
notifications and deleting notifications no
longer in effect.
*
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*
*
Matthew S. Borman,
Deputy Assistant Secretary for Export
Administration.
[FR Doc. 2020–17908 Filed 8–17–20; 2:30 pm]
BILLING CODE 3510–33–P
SOCIAL SECURITY ADMINISTRATION
20 CFR Part 426
[Docket No. SSA–2020–0002]
RIN 0960–AI47
Improved Agency Guidance
Documents
Social Security Administration.
Final rule.
AGENCY:
ACTION:
This final rule explains our
process for issuing guidance documents
under Executive Order (E.O.) 13891,
‘‘Promoting the Rule of Law Through
Improved Agency Guidance
Documents.’’ We will follow this
process when we issue future guidance
documents that meet the criteria set
forth in the E.O. and the Office of
Management and Budget’s (OMB)
guidance on the E.O.
DATES: This final rule will be effective
September 21, 2020.
FOR FURTHER INFORMATION CONTACT:
Jennifer Dulski, Office of Regulations
SUMMARY:
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51337
and Reports Clearance, Social Security
Administration, 6401 Security
Boulevard, Baltimore, MD 21235–6401,
(410) 966–2341. For information on
eligibility or filing for benefits, call our
national toll-free number, 1–800–772–
1213 or TTY 1–800–325–0778, or visit
our internet site, Social Security Online,
at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION: On
October 9, 2019, President Trump
issued E.O. 13891.1 E.O. 13891
mandates that agencies, consistent with
applicable law, finalize regulations, or
amend existing regulations as necessary,
to explain the process for issuing
guidance documents as defined by the
E.O. We are publishing this final rule to
fulfill E.O. 13891’s requirements.
As defined in E.O. 13891, guidance
documents are agency statements of
general applicability, intended to have
future effect on the behavior of
regulated parties, that set forth a policy
on a statutory, regulatory, or technical
issue, or an interpretation of a statute or
regulation. Unless the document falls
within an enumerated exclusion to this
definition,2 any document that satisfies
this definition would qualify as a
guidance document, regardless of name
or format.
The documents that we issue include
Program Operations Manual System
(POMS) instructions; the Hearings,
Appeals and Litigation Law (HALLEX)
manual; Social Security Rulings (SSR);
and Acquiescence Rulings.3 Most of the
documents that we issue do not qualify
as guidance documents under E.O.
13891; however, some may. We will use
1 84 FR 55235, available at: https://
www.federalregister.gov/documents/2019/10/15/
2019-22623/promoting-the-rule-of-law-throughimproved-agency-guidance-documents.
2 E.O. 13891 section 2 (b) lists the following as
exclusions to the definition of guidance document:
(i) Rules promulgated pursuant to notice and
comment under section 553 of title 5, United States
Code, or similar statutory provisions; (ii) rules
exempt from rulemaking requirements under
section 553(a) of title 5, United States Code; (iii)
rules of agency organization, procedure, or practice;
(iv) decisions of agency adjudications under section
554 of title 5, United States Code, or similar
statutory provisions; (v) internal guidance directed
to the issuing agency or other agencies that is not
intended to have substantial future effect on the
behavior of regulated parties; and (vi) internal
executive branch legal advice or legal opinions
addressed to executive branch officials. See 84 FR
at 55235–36.
3 See other written guidelines in 20 CFR 404.1602
and 416.1002 for more information about POMS
and SSRs. See 20 CFR 402.35 for information about
where we publish SSRs and ARs. See 20 CFR
404.985 and 416.1485 for more information about
ARs. Additionally, our POMS instructions are
publicly available at https://secure.ssa.gov/
poms.nsf/Home?readform, our HALLEX manual is
publicly available at https://www.ssa.gov/OP_
Home/hallex/hallex.html, and our SSRs and ARs
are publicly available at https://www.ssa.gov/OP_
Home/rulings/rulings.html.
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Rules and Regulations
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the process in this final rule for the
documents we issue, as appropriate.
As required by E.O. 13891, this final
rule includes:
• A requirement that each guidance
document clearly state that it does not
bind the public, except as authorized by
law or as incorporated into a contract.
• Procedures for the public to petition
for withdrawal or modification of a
particular guidance document,
including a designation of the official to
whom the public should direct
petitions.
• Specific requirements for a
guidance document that qualifies as
‘‘significant,’’ unless an exemption
applies.4
For significant guidance documents,
absent an exemption from some or all
requirements, this final rule sets forth
the following requirements, as
prescribed by E.O. 13891:
• A period of public notice and
comment of at least 30 days before
issuance, and a public response to major
concerns raised in comments, except
when we find, for good cause, that
notice and public comment are
impracticable, unnecessary, or contrary
to the public interest.
• Approval on a non-delegable basis
by our agency head or by the head of
one of our components whom the
President appoints, before issuance.
• Review by the Office of Information
and Regulatory Affairs under Executive
Order 12866, before issuance.
• Compliance with the applicable
requirements for regulations or rules,
including significant regulatory actions,
set forth in Executive Orders 12866
(Regulatory Planning and Review),
13563 (Improving Regulation and
Regulatory Review), 13609 (Promoting
International Regulatory Cooperation),
13771 (Reducing Regulation and
Controlling Regulatory Costs), and
4 A significant guidance document is a guidance
document that may reasonably be anticipated to: (i)
Lead to an annual effect on the economy of $100
million or more or 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; (ii) create a serious
inconsistency or otherwise interfere with an action
taken or planned by another agency; (iii) materially
alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and
obligations of recipients thereof; or (iv) raise novel
legal or policy issues arising out of legal mandates,
the President’s priorities, or the principles of
Executive Order 12866. E.O. 13891, section 2(c), 84
FR at 55236. The Administrator of the Office of
Management and Budget’s Office of Information
and Regulatory Affairs determines if a guidance
document is significant. An exemption applies
when the agency and the Administrator agree that
exigency, safety, health, or other compelling cause
warrants an exemption from some or all
requirements. E.O. 13891, section 4(a)(iii), 84 FR at
55237.
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13777 (Enforcing the Regulatory Reform
Agenda).
On October 31, 2019, OMB issued a
memorandum, M–20–02 ‘‘Guidance
Implementing Executive Order 13891,
Titled ‘Promoting the Rule of Law
Through Improved Agency Guidance
Documents’’’ (Memorandum M–20–
02).5 Memorandum M–20–02 directs
that an agency’s regulations should
require guidance documents to, at
minimum:
• Include the term ‘‘guidance.’’
• Identify the agency or office issuing
the document.
• Identify the activities to which and
the persons to whom the document
applies.
• Include the date of issuance.
• Note if it is a revision to a
previously issued guidance document
and, if so, identify the guidance
document that it replaces.
• Provide the title of the guidance
and the document identification
number.
• Include the citation to the statutory
provision or regulation to which it
applies or which it interprets.
• Include the disclaimer that the
guidance document does not have the
force and effect of law and is not meant
to bind the public, except as authorized
by law or incorporated into a contract.
• Include a short summary of the
subject matter covered in the guidance
document at the top of the document.
Based on the requirements of E.O.
13891 and consistent with the guidance
in Memorandum M–20–02, we are
adding a new part to our regulations—
20 CFR chapter III part 426.
For more information about the
documents that we issue, please see
www.socialsecurity.gov/guidance.
Rulemaking Analyses and Notices
Regulatory Procedures
We follow the Administrative
Procedure Act (APA) rulemaking
procedures in 5 U.S.C. 553 when we
develop regulations. Generally, the APA
requires that an agency provide prior
notice and opportunity for public
comment before issuing a final rule.
Under 5 U.S.C. 553 (b)(3)(A), agencies
are not required to provide prior notice
and opportunity for the public to
comment for a rule that is an
interpretative rule, a general statement
of policy, or a rule of agency
organization, procedure, or practice. We
find this rule is exempt from the
requirement to provide prior notice and
opportunity for public comment
5 Available at https://www.whitehouse.gov/wpcontent/uploads/2019/10/M-20-02-GuidanceMemo.pdf.
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because it is a rule of ‘‘agency
organization, procedure, or practice.’’ It
merely explains the process we will
follow when issuing guidance
documents as defined by the E.O., and
how we will comply with the
requirements of the E.O. Accordingly,
we are issuing this final rule without
prior public comment.
Executive Order 12866, as
Supplemented by Executive Order
13563
We consulted with OMB and
determined that this final rule does not
meet the requirements for a significant
regulatory action under Executive Order
12866, as supplemented by Executive
Order 13563. Therefore, OMB did not
review it.
Executive Order 13771
This final rule is not an Executive
Order 13771 regulatory action because it
results in costs that are de minimis.
Regulatory Flexibility Act
We certify that this final rule will not
have a significant economic impact on
a substantial number of small entities,
because it affects individuals only.
Therefore, a regulatory flexibility
analysis is not required under the
Regulatory Flexibility Act, as amended.
Executive Order 13132
We analyzed this final rule in
accordance with the principles and
criteria established by Executive Order
13132, and determined that the rule will
not have sufficient Federalism
implications to warrant the preparation
of a Federalism assessment. We also
determined that this final rule would
not preempt any State law or State
regulation or affect the States’ abilities
to discharge traditional State
governmental functions.
Paperwork Reduction Act
This final rule does not impose any
new requirements under the Paperwork
Reduction Act (PRA), nor does it require
modification to any of SSA’s existing
OMB PRA-approved information
collections. If in the future SSA
publishes individual guidance
documents that involve public
information collection, we will seek
PRA approval for them in advance of
collecting the information.
(Catalog of Federal Domestic Assistance
Program Nos. 9601, Social Security—
Disability Insurance; 96.006 Supplemental
Security Income)
List of Subjects for 20 CFR Part 426
Social security, Guidance.
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Federal Register / Vol. 85, No. 162 / Thursday, August 20, 2020 / Rules and Regulations
The Commissioner of the Social
Security Administration, Andrew Saul,
having reviewed and approved this
document, is delegating the authority to
electronically sign this document to
Faye I. Lipsky, who is the primary
Federal Register Liaison for SSA, for
purposes of publication in the Federal
Register.
Faye I. Lipsky,
Federal Register Liaison, Office of Legislation
and Congressional Affairs, Social Security
Administration.
For the reasons set out in the
preamble, we amend 20 CFR chapter III
by adding part 426 to read as follows:
■
PART 426—GUIDANCE DOCUMENTS
Sec.
426.5 Purpose.
426.10 Explanation of agency guidance
documents.
426.15 When guidance documents are
nonbinding.
426.20 Procedures for the public to request
withdrawal or modification of a
guidance document.
426.25 Significant guidance documents.
Authority: Secs. 205(a)–(b) and (d)–(h),
and 702(a)(5) of the Social Security Act (42
U.S.C., 405(a)–(b) and (d)–(h) and 902(a)(5));
and E.O. 13891, 84 FR 55235.
§ 426.5
Purpose.
We established this part to comply
with the requirements of Executive
Order 13891 of October 9, 2019,
Promoting the Rule of Law Through
Improved Agency Guidance Documents.
The rules in this part relate to agency
guidance documents. They explain what
constitutes guidance documents,
describe the non-binding nature of
guidance documents, the procedures to
request withdrawal or modification of
guidance documents, and the additional
requirements and procedures for
significant guidance documents.
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§ 426.10 Explanation of agency guidance
documents.
(a) Guidance documents. Guidance
documents are agency statements of
general applicability, intended to have
future effect on the behavior of
regulated parties, that set forth a policy
on a statutory, regulatory, or technical
issue, or an interpretation of a statute or
regulation.
(b) Documents not classified as
guidance. Guidance documents do not
include:
(1) Agency statements of specific,
rather than general, applicability.
(2) Agency statements that do not set
forth a policy on a statutory, regulatory,
or technical issue or an interpretation of
a statute or regulation.
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(3) Legislative rules promulgated
under 5 U.S.C. 553 (or similar statutory
provisions), or exempt from rulemaking
requirements under 5 U.S.C. 553(a).
(4) Rules of agency organization,
procedure, or practice.
(5) Decisions of agency adjudication.
(6) Documents or agency statements
that are directed solely to the issuing
agency or other agencies (or personnel
of such agencies) that are not
anticipated to have substantial future
effect on the behavior of regulated
parties or the public.
(7) Legal briefs and other court filings.
(8) Legal opinions by the Office of
Legal Counsel at the Department of
Justice.
(9) Legal advice or opinions from our
Office of the General Counsel.
(c) Elements of guidance documents.
In general, each published guidance
document should, at a minimum:
(1) Include the term ‘‘guidance.’’
(2) Identify the agency or office
issuing the document.
(3) Identify the activities to which and
the persons to whom the document
applies.
(4) Include the date of issuance.
(5) Note if it is a revision to a
previously issued guidance document
and, if so, identify the guidance
document that it replaces.
(6) Provide the title of the guidance
and the unique document identification
number.
(7) Include the citation to the
statutory provision or regulation to
which it applies or which it interprets.
(8) Include the disclaimer in 20 CFR
426.15(b).
(9) Include a short summary of the
subject matter covered in the guidance
document at the top of the document.
(d) Our guidance documents. Any
document that satisfies the definition in
paragraph (a) of this section and that
does not meet an exclusion in paragraph
(b) of this section qualifies as a guidance
document, regardless of name or format.
On our internet site, we maintain an
indexed, searchable web page, which
contains links to all of our guidance
documents in effect.
(e) Rescinded guidance documents.
We will not cite, use, or rely on
guidance documents that are rescinded,
except to establish historical facts. Any
guidance documents that do not appear
on our internet site as described in
paragraph (d) of this section, will be
considered rescinded.
§ 426.15 When guidance documents are
nonbinding.
(a) Guidance documents lack the force
and effect of law, unless expressly
authorized by law or incorporated into
a contract.
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51339
(b) We will include a disclaimer on
guidance documents clarifying that they
do not have the force and effect of law
and are not meant to bind the public in
any way, and are intended only to
provide clarity to the public regarding
existing requirements under the law or
agency policies. When a guidance
document is binding because the law
authorizes binding guidance or because
a contract incorporates the guidance, we
will modify the disclaimer to reflect
either of those facts.
§ 426.20 Procedures for the public to
request withdrawal or modification of a
guidance document.
The public may ask us to consider
withdrawing or modifying an existing
guidance document. The public may
direct these requests to the
Commissioner of the Social Security
Administration by sending an email to
Regulations@ssa.gov or mail to 3100
West High Rise, 6401 Security
Boulevard, Baltimore, Maryland 21235–
6401. We will respond within 90 days
of receipt.
§ 426.25
Significant guidance documents.
(a) Significant guidance documents.
Significant guidance documents are
guidance documents that may be
reasonably anticipated to do one or
more of the following:
(1) Lead to an annual effect on the
economy of $100 million or more, or
adversely and materially affect the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities.
(2) Create a serious inconsistency or
otherwise interfere with an action
another agency has taken or planned.
(3) Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs or the rights and
obligations of recipients thereof.
(4) Raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
of Executive Order 12866.
(b) Significance determination. We
will refer to the Administrator of the
Office of Information and Regulatory
Affairs within the Office of Management
and Budget, or the Administrator’s
designee, the question of whether a
guidance document is significant.
(c) Actions we will take before issuing
significant guidance documents. For
significant guidance documents, unless
we and the Administrator of the Office
of Information and Regulatory Affairs
agree that exigency, safety, health, or
other compelling cause warrants an
exemption from some or all
requirements, we will do the following:
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(1) Submit the guidance document for
review by the Office of Information and
Regulatory Affairs under Executive
Order 12866.
(2) Publish a document in the Federal
Register announcing the availability of
a significant guidance document and
make the draft guidance document
available on our website.
(3) Provide a public notice and
comment period of at least 30 days
before issuance of a final guidance
document, and a public response to
major concerns raised in comments,
except when we for good cause find
(and incorporate such finding and a
brief statement of reasons therefor into
the guidance document) that notice and
public comment thereon are
impracticable, unnecessary, or contrary
to the public interest.
(4) Obtain approval on a nondelegable basis from the Commissioner
of Social Security, or from a component
head the President appoints (with or
without confirmation by the Senate), or
from an official who is serving in an
acting capacity as either of the
foregoing.
(5) Comply with the applicable
requirements for regulations or rules,
including significant regulatory actions,
set forth in Executive Orders 12866
(Regulatory Planning and Review),
13563 (Improving Regulation and
Regulatory Review), 13609 (Promoting
International Regulatory Cooperation),
13771 (Reducing Regulation and
Controlling Regulatory Costs), and
13777 (Enforcing the Regulatory Reform
Agenda).
[FR Doc. 2020–17878 Filed 8–19–20; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–581]
Schedules of Controlled Substances:
Placement of Cenobamate in Schedule
V
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
This final rule adopts,
without change, an interim final rule
with request for comments published in
the Federal Register on March 10, 2020,
placing cenobamate [(1R)-1-(2chlorophenyl)-2-(tetrazol-2-yl)ethyl]
carbamate, including its salts, in
schedule V of the Controlled Substances
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SUMMARY:
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Act (CSA). With the issuance of this
final rule, the Drug Enforcement
Administration maintains cenobamate,
including its salts, in schedule V of the
CSA.
DATES: The effective date of this
rulemaking is August 20, 2020.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Regulatory Drafting and
Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 362–3261.
SUPPLEMENTARY INFORMATION:
Background and Legal Authority
Under the Controlled Substances Act
(CSA), as amended in 2015 by the
Improving Regulatory Transparency for
New Medical Therapies Act (Pub. L.
114–89), when the Drug Enforcement
Administration (DEA) receives
notification from the Department of
Health and Human Services (HHS) that
the Secretary has approved a certain
new drug and HHS recommends control
in the CSA schedule II–V, DEA is
required to issue an interim final rule,
with opportunity for public comment
and to request a hearing, controlling the
drug within a specified 90-day
timeframe and subsequently to issue a
final rule. 21 U.S.C. 811(j). When
controlling a drug pursuant to
subsection (j), DEA must apply the
scheduling criteria of 21 U.S.C. 811 (b)
through (d) and 812(b). 21 U.S.C.
811(j)(3).
On March 10, 2020, DEA published
an interim final rule in the Federal
Register to make cenobamate (including
its salts) a schedule V controlled
substance. 85 FR 13741. The interim
final rule provided an opportunity for
interested persons to submit comments,
as well as file a request for hearing or
waiver of hearing, on or before April 9,
2020. DEA received two comments and
did not receive any requests for hearing
or waiver of hearing.
Comments Received
In response to the interim final rule,
DEA received two comments. One
comment was blank and the second
comment was not related to the
scheduling of cenobamate. Therefore,
DEA has no responses to those
comments.
Based on the rationale set forth in the
interim final rule, DEA adopts the
interim final rule, without change.
Requirements for Handling Cenobamate
As indicated above, cenobamate has
been a schedule V controlled substance
by virtue of an interim final rule issued
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by DEA in March 2020. Thus, this final
rule does not alter the regulatory
requirements applicable to handlers of
cenobamate that have been in place
since that time. Nonetheless, for
informational purposes, we restate here
those requirements. Cenobamate is
subject to the CSA’s schedule V
regulatory controls and administrative,
civil, and criminal sanctions applicable
to the manufacture, distribution, reverse
distribution, dispensing, importing,
exporting, research, and conduct of
instructional activities and chemical
analysis with, and possession involving
schedule V substances, including the
following:
1. Registration. Any person who
handles (manufactures, distributes,
reverse distributes, dispenses, imports,
exports, engages in research, or
conducts instructional activities or
chemical analysis with, or possesses)
cenobamate, or who desires to handle
cenobamate, must be registered with
DEA to conduct such activities pursuant
to 21 U.S.C. 822, 823, 957, and 958 and
in accordance with 21 CFR parts 1301
and 1312. Any person who intends to
handle cenobamate, and is not
registered with DEA, must submit an
application for registration and may not
continue to handle cenobamate, unless
DEA has approved that application for
registration, pursuant to 21 U.S.C. 822,
823, 957, and 958, and in accordance
with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who
obtains a schedule V registration to
handle cenobamate and subsequently
determines they are no longer willing or
able to maintain such registration must
surrender all quantities of currently
held cenobamate, or may transfer all
quantities of cenobamate to a person
registered with DEA in accordance with
21 CFR part 1317, in addition to all
other applicable Federal, State, local,
and tribal laws.
3. Security. Cenobamate is subject to
schedule III–V security requirements
and must be handled and stored in
accordance with 21 CFR 1301.71–
1301.93. Non-practitioners handling
cenobamate must also comply with the
employee screening requirements of 21
CFR 1301.90–1301.93.
4. Labeling and Packaging. All labels,
labeling, and packaging for commercial
containers of cenobamate must comply
with 21 U.S.C. 825 and 958(e), and be
in accordance with 21 CFR part 1302.
5. Inventory. Since March 10, 2020,
every DEA registrant who possesses any
quantity of cenobamate was required to
keep an inventory of cenobamate on
hand, pursuant to 21 U.S.C. 827 and
958(e), and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
E:\FR\FM\20AUR1.SGM
20AUR1
Agencies
[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Rules and Regulations]
[Pages 51337-51340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17878]
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SOCIAL SECURITY ADMINISTRATION
20 CFR Part 426
[Docket No. SSA-2020-0002]
RIN 0960-AI47
Improved Agency Guidance Documents
AGENCY: Social Security Administration.
ACTION: Final rule.
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SUMMARY: This final rule explains our process for issuing guidance
documents under Executive Order (E.O.) 13891, ``Promoting the Rule of
Law Through Improved Agency Guidance Documents.'' We will follow this
process when we issue future guidance documents that meet the criteria
set forth in the E.O. and the Office of Management and Budget's (OMB)
guidance on the E.O.
DATES: This final rule will be effective September 21, 2020.
FOR FURTHER INFORMATION CONTACT: Jennifer Dulski, Office of Regulations
and Reports Clearance, Social Security Administration, 6401 Security
Boulevard, Baltimore, MD 21235-6401, (410) 966-2341. For information on
eligibility or filing for benefits, call our national toll-free number,
1-800-772-1213 or TTY 1-800-325-0778, or visit our internet site,
Social Security Online, at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION: On October 9, 2019, President Trump issued
E.O. 13891.\1\ E.O. 13891 mandates that agencies, consistent with
applicable law, finalize regulations, or amend existing regulations as
necessary, to explain the process for issuing guidance documents as
defined by the E.O. We are publishing this final rule to fulfill E.O.
13891's requirements.
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\1\ 84 FR 55235, available at: https://www.federalregister.gov/documents/2019/10/15/2019-22623/promoting-the-rule-of-law-through-improved-agency-guidance-documents.
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As defined in E.O. 13891, guidance documents are agency statements
of general applicability, intended to have future effect on the
behavior of regulated parties, that set forth a policy on a statutory,
regulatory, or technical issue, or an interpretation of a statute or
regulation. Unless the document falls within an enumerated exclusion to
this definition,\2\ any document that satisfies this definition would
qualify as a guidance document, regardless of name or format.
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\2\ E.O. 13891 section 2 (b) lists the following as exclusions
to the definition of guidance document: (i) Rules promulgated
pursuant to notice and comment under section 553 of title 5, United
States Code, or similar statutory provisions; (ii) rules exempt from
rulemaking requirements under section 553(a) of title 5, United
States Code; (iii) rules of agency organization, procedure, or
practice; (iv) decisions of agency adjudications under section 554
of title 5, United States Code, or similar statutory provisions; (v)
internal guidance directed to the issuing agency or other agencies
that is not intended to have substantial future effect on the
behavior of regulated parties; and (vi) internal executive branch
legal advice or legal opinions addressed to executive branch
officials. See 84 FR at 55235-36.
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The documents that we issue include Program Operations Manual
System (POMS) instructions; the Hearings, Appeals and Litigation Law
(HALLEX) manual; Social Security Rulings (SSR); and Acquiescence
Rulings.\3\ Most of the documents that we issue do not qualify as
guidance documents under E.O. 13891; however, some may. We will use
[[Page 51338]]
the process in this final rule for the documents we issue, as
appropriate.
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\3\ See other written guidelines in 20 CFR 404.1602 and 416.1002
for more information about POMS and SSRs. See 20 CFR 402.35 for
information about where we publish SSRs and ARs. See 20 CFR 404.985
and 416.1485 for more information about ARs. Additionally, our POMS
instructions are publicly available at https://secure.ssa.gov/poms.nsf/Home?readform, our HALLEX manual is publicly available at
https://www.ssa.gov/OP_Home/hallex/hallex.html, and our SSRs and ARs
are publicly available at https://www.ssa.gov/OP_Home/rulings/rulings.html.
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As required by E.O. 13891, this final rule includes:
A requirement that each guidance document clearly state
that it does not bind the public, except as authorized by law or as
incorporated into a contract.
Procedures for the public to petition for withdrawal or
modification of a particular guidance document, including a designation
of the official to whom the public should direct petitions.
Specific requirements for a guidance document that
qualifies as ``significant,'' unless an exemption applies.\4\
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\4\ A significant guidance document is a guidance document that
may reasonably be anticipated to: (i) Lead to an annual effect on
the economy of $100 million or more or 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; (ii) create a
serious inconsistency or otherwise interfere with an action taken or
planned by another agency; (iii) materially alter the budgetary
impact of entitlements, grants, user fees, or loan programs or the
rights and obligations of recipients thereof; or (iv) raise novel
legal or policy issues arising out of legal mandates, the
President's priorities, or the principles of Executive Order 12866.
E.O. 13891, section 2(c), 84 FR at 55236. The Administrator of the
Office of Management and Budget's Office of Information and
Regulatory Affairs determines if a guidance document is significant.
An exemption applies when the agency and the Administrator agree
that exigency, safety, health, or other compelling cause warrants an
exemption from some or all requirements. E.O. 13891, section
4(a)(iii), 84 FR at 55237.
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For significant guidance documents, absent an exemption from some
or all requirements, this final rule sets forth the following
requirements, as prescribed by E.O. 13891:
A period of public notice and comment of at least 30 days
before issuance, and a public response to major concerns raised in
comments, except when we find, for good cause, that notice and public
comment are impracticable, unnecessary, or contrary to the public
interest.
Approval on a non-delegable basis by our agency head or by
the head of one of our components whom the President appoints, before
issuance.
Review by the Office of Information and Regulatory Affairs
under Executive Order 12866, before issuance.
Compliance with the applicable requirements for
regulations or rules, including significant regulatory actions, set
forth in Executive Orders 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review), 13609 (Promoting
International Regulatory Cooperation), 13771 (Reducing Regulation and
Controlling Regulatory Costs), and 13777 (Enforcing the Regulatory
Reform Agenda).
On October 31, 2019, OMB issued a memorandum, M-20-02 ``Guidance
Implementing Executive Order 13891, Titled `Promoting the Rule of Law
Through Improved Agency Guidance Documents''' (Memorandum M-20-02).\5\
Memorandum M-20-02 directs that an agency's regulations should require
guidance documents to, at minimum:
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\5\ Available at https://www.whitehouse.gov/wp-content/uploads/2019/10/M-20-02-Guidance-Memo.pdf.
---------------------------------------------------------------------------
Include the term ``guidance.''
Identify the agency or office issuing the document.
Identify the activities to which and the persons to whom
the document applies.
Include the date of issuance.
Note if it is a revision to a previously issued guidance
document and, if so, identify the guidance document that it replaces.
Provide the title of the guidance and the document
identification number.
Include the citation to the statutory provision or
regulation to which it applies or which it interprets.
Include the disclaimer that the guidance document does not
have the force and effect of law and is not meant to bind the public,
except as authorized by law or incorporated into a contract.
Include a short summary of the subject matter covered in
the guidance document at the top of the document.
Based on the requirements of E.O. 13891 and consistent with the
guidance in Memorandum M-20-02, we are adding a new part to our
regulations--20 CFR chapter III part 426.
For more information about the documents that we issue, please see
www.socialsecurity.gov/guidance.
Rulemaking Analyses and Notices
Regulatory Procedures
We follow the Administrative Procedure Act (APA) rulemaking
procedures in 5 U.S.C. 553 when we develop regulations. Generally, the
APA requires that an agency provide prior notice and opportunity for
public comment before issuing a final rule. Under 5 U.S.C. 553
(b)(3)(A), agencies are not required to provide prior notice and
opportunity for the public to comment for a rule that is an
interpretative rule, a general statement of policy, or a rule of agency
organization, procedure, or practice. We find this rule is exempt from
the requirement to provide prior notice and opportunity for public
comment because it is a rule of ``agency organization, procedure, or
practice.'' It merely explains the process we will follow when issuing
guidance documents as defined by the E.O., and how we will comply with
the requirements of the E.O. Accordingly, we are issuing this final
rule without prior public comment.
Executive Order 12866, as Supplemented by Executive Order 13563
We consulted with OMB and determined that this final rule does not
meet the requirements for a significant regulatory action under
Executive Order 12866, as supplemented by Executive Order 13563.
Therefore, OMB did not review it.
Executive Order 13771
This final rule is not an Executive Order 13771 regulatory action
because it results in costs that are de minimis.
Regulatory Flexibility Act
We certify that this final rule will not have a significant
economic impact on a substantial number of small entities, because it
affects individuals only. Therefore, a regulatory flexibility analysis
is not required under the Regulatory Flexibility Act, as amended.
Executive Order 13132
We analyzed this final rule in accordance with the principles and
criteria established by Executive Order 13132, and determined that the
rule will not have sufficient Federalism implications to warrant the
preparation of a Federalism assessment. We also determined that this
final rule would not preempt any State law or State regulation or
affect the States' abilities to discharge traditional State
governmental functions.
Paperwork Reduction Act
This final rule does not impose any new requirements under the
Paperwork Reduction Act (PRA), nor does it require modification to any
of SSA's existing OMB PRA-approved information collections. If in the
future SSA publishes individual guidance documents that involve public
information collection, we will seek PRA approval for them in advance
of collecting the information.
(Catalog of Federal Domestic Assistance Program Nos. 9601, Social
Security--Disability Insurance; 96.006 Supplemental Security Income)
List of Subjects for 20 CFR Part 426
Social security, Guidance.
[[Page 51339]]
The Commissioner of the Social Security Administration, Andrew
Saul, having reviewed and approved this document, is delegating the
authority to electronically sign this document to Faye I. Lipsky, who
is the primary Federal Register Liaison for SSA, for purposes of
publication in the Federal Register.
Faye I. Lipsky,
Federal Register Liaison, Office of Legislation and Congressional
Affairs, Social Security Administration.
0
For the reasons set out in the preamble, we amend 20 CFR chapter III by
adding part 426 to read as follows:
PART 426--GUIDANCE DOCUMENTS
Sec.
426.5 Purpose.
426.10 Explanation of agency guidance documents.
426.15 When guidance documents are nonbinding.
426.20 Procedures for the public to request withdrawal or
modification of a guidance document.
426.25 Significant guidance documents.
Authority: Secs. 205(a)-(b) and (d)-(h), and 702(a)(5) of the
Social Security Act (42 U.S.C., 405(a)-(b) and (d)-(h) and
902(a)(5)); and E.O. 13891, 84 FR 55235.
Sec. 426.5 Purpose.
We established this part to comply with the requirements of
Executive Order 13891 of October 9, 2019, Promoting the Rule of Law
Through Improved Agency Guidance Documents. The rules in this part
relate to agency guidance documents. They explain what constitutes
guidance documents, describe the non-binding nature of guidance
documents, the procedures to request withdrawal or modification of
guidance documents, and the additional requirements and procedures for
significant guidance documents.
Sec. 426.10 Explanation of agency guidance documents.
(a) Guidance documents. Guidance documents are agency statements of
general applicability, intended to have future effect on the behavior
of regulated parties, that set forth a policy on a statutory,
regulatory, or technical issue, or an interpretation of a statute or
regulation.
(b) Documents not classified as guidance. Guidance documents do not
include:
(1) Agency statements of specific, rather than general,
applicability.
(2) Agency statements that do not set forth a policy on a
statutory, regulatory, or technical issue or an interpretation of a
statute or regulation.
(3) Legislative rules promulgated under 5 U.S.C. 553 (or similar
statutory provisions), or exempt from rulemaking requirements under 5
U.S.C. 553(a).
(4) Rules of agency organization, procedure, or practice.
(5) Decisions of agency adjudication.
(6) Documents or agency statements that are directed solely to the
issuing agency or other agencies (or personnel of such agencies) that
are not anticipated to have substantial future effect on the behavior
of regulated parties or the public.
(7) Legal briefs and other court filings.
(8) Legal opinions by the Office of Legal Counsel at the Department
of Justice.
(9) Legal advice or opinions from our Office of the General
Counsel.
(c) Elements of guidance documents. In general, each published
guidance document should, at a minimum:
(1) Include the term ``guidance.''
(2) Identify the agency or office issuing the document.
(3) Identify the activities to which and the persons to whom the
document applies.
(4) Include the date of issuance.
(5) Note if it is a revision to a previously issued guidance
document and, if so, identify the guidance document that it replaces.
(6) Provide the title of the guidance and the unique document
identification number.
(7) Include the citation to the statutory provision or regulation
to which it applies or which it interprets.
(8) Include the disclaimer in 20 CFR 426.15(b).
(9) Include a short summary of the subject matter covered in the
guidance document at the top of the document.
(d) Our guidance documents. Any document that satisfies the
definition in paragraph (a) of this section and that does not meet an
exclusion in paragraph (b) of this section qualifies as a guidance
document, regardless of name or format. On our internet site, we
maintain an indexed, searchable web page, which contains links to all
of our guidance documents in effect.
(e) Rescinded guidance documents. We will not cite, use, or rely on
guidance documents that are rescinded, except to establish historical
facts. Any guidance documents that do not appear on our internet site
as described in paragraph (d) of this section, will be considered
rescinded.
Sec. 426.15 When guidance documents are nonbinding.
(a) Guidance documents lack the force and effect of law, unless
expressly authorized by law or incorporated into a contract.
(b) We will include a disclaimer on guidance documents clarifying
that they do not have the force and effect of law and are not meant to
bind the public in any way, and are intended only to provide clarity to
the public regarding existing requirements under the law or agency
policies. When a guidance document is binding because the law
authorizes binding guidance or because a contract incorporates the
guidance, we will modify the disclaimer to reflect either of those
facts.
Sec. 426.20 Procedures for the public to request withdrawal or
modification of a guidance document.
The public may ask us to consider withdrawing or modifying an
existing guidance document. The public may direct these requests to the
Commissioner of the Social Security Administration by sending an email
to [email protected] or mail to 3100 West High Rise, 6401 Security
Boulevard, Baltimore, Maryland 21235-6401. We will respond within 90
days of receipt.
Sec. 426.25 Significant guidance documents.
(a) Significant guidance documents. Significant guidance documents
are guidance documents that may be reasonably anticipated to do one or
more of the following:
(1) Lead to an annual effect on the economy of $100 million or
more, or adversely and materially affect the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities.
(2) Create a serious inconsistency or otherwise interfere with an
action another agency has taken or planned.
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof.
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles of Executive
Order 12866.
(b) Significance determination. We will refer to the Administrator
of the Office of Information and Regulatory Affairs within the Office
of Management and Budget, or the Administrator's designee, the question
of whether a guidance document is significant.
(c) Actions we will take before issuing significant guidance
documents. For significant guidance documents, unless we and the
Administrator of the Office of Information and Regulatory Affairs agree
that exigency, safety, health, or other compelling cause warrants an
exemption from some or all requirements, we will do the following:
[[Page 51340]]
(1) Submit the guidance document for review by the Office of
Information and Regulatory Affairs under Executive Order 12866.
(2) Publish a document in the Federal Register announcing the
availability of a significant guidance document and make the draft
guidance document available on our website.
(3) Provide a public notice and comment period of at least 30 days
before issuance of a final guidance document, and a public response to
major concerns raised in comments, except when we for good cause find
(and incorporate such finding and a brief statement of reasons therefor
into the guidance document) that notice and public comment thereon are
impracticable, unnecessary, or contrary to the public interest.
(4) Obtain approval on a non-delegable basis from the Commissioner
of Social Security, or from a component head the President appoints
(with or without confirmation by the Senate), or from an official who
is serving in an acting capacity as either of the foregoing.
(5) Comply with the applicable requirements for regulations or
rules, including significant regulatory actions, set forth in Executive
Orders 12866 (Regulatory Planning and Review), 13563 (Improving
Regulation and Regulatory Review), 13609 (Promoting International
Regulatory Cooperation), 13771 (Reducing Regulation and Controlling
Regulatory Costs), and 13777 (Enforcing the Regulatory Reform Agenda).
[FR Doc. 2020-17878 Filed 8-19-20; 8:45 am]
BILLING CODE 4191-02-P