HHS Plan for Retrospective Review Under Executive Order 13563, 20568-20569 [2011-8780]
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20568
Proposed Rules
Federal Register
Vol. 76, No. 71
Wednesday, April 13, 2011
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Submit electronic comments in the
following way:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
HHS will post all comments received
before the close of the comment period
as soon as possible after they have been
received:
Written Submissions
Submit written submissions in the
5 CFR Chapter XLV
following ways:
FAX: (202) 690–7203.
Mail/Hand delivery/Courier (for
21 CFR Chapter I
paper, disk, or CD–ROM submissions):
200 Independence Avenue, SW., Room
25 CFR Chapter V
639G, Washington, DC 20201.
42 CFR Chapters I, IV and V
FOR FURTHER INFORMATION CONTACT:
Oliver Potts at (202) 690–6392.
45 CFR Subtitle A and Chapters II, III,
SUPPLEMENTARY INFORMATION:
IV, X, XIII
On January 18, 2011, President
Obama issued Executive Order 13563 to
48 CFR Chapter 3
improve regulation and regulatory
review by requiring Federal agencies to
HHS Plan for Retrospective Review
design cost effective, evidence-based
Under Executive Order 13563
regulations that are compatible with
economic growth, job creation, and
AGENCY: Department of Health and
competitiveness, and which rely on the
Human Services.
best, most innovative, and least
ACTION: Notice; request for information.
burdensome tools to achieve regulatory
ends. To meet that objective, the
SUMMARY: In accordance with Executive
President directs each Executive Branch
Order 13563, ‘‘Improving Regulation and agency to consider how best to promote
Regulatory Review,’’ the Department of
periodic retrospective review of existing
Health and Human Services (HHS) seeks significant rules to determine if they are
comment from interested parties to
outmoded, ineffective, insufficient, or
assist in the development of its
excessively burdensome. Each agency is
preliminary plan to review existing
to develop and submit to the Office of
regulations. The purpose of the plan is
Management and Budget’s Office of
to establish a process by which HHS can Information and Regulatory Affairs a
determine whether any such regulations preliminary plan under which the
should be modified, streamlined,
agency will periodically review existing
expanded, or repealed so as to make
rules to determine whether any such
HHS’s regulatory program more
regulations should be modified,
effective or less burdensome in
streamlined, expanded, or repealed.
achieving its regulatory objectives.
Background
DATES: Submit electronic or written
HHS is the Federal Government’s
comments on this notice by May 12,
principal agency charged with
2011.
protecting the health of all Americans
Instructions: All submissions received and providing essential human services.
must include the Agency name HHS–
HHS’ responsibilities include: Medicare,
ES–2011–001 for this notice. All
Medicaid, increasing access to care and
comments received may be posted
insurance coverage, support for public
without change to https://
health preparedness and emergency
www.regulations.gov, including any
response, biomedical research,
personal information provided.
substance abuse and mental health
treatment and prevention, assurance of
ADDRESSES: You may submit comments,
identified by HHS–ES–2011–001 by any safe and effective drugs and other
medical products, protection of our
of the following methods:
srobinson on DSKHWCL6B1PROD with PROPOSALS
2 CFR Chapters III and XXX
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18:03 Apr 12, 2011
Jkt 223001
PO 00000
Frm 00001
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Nation’s food supply, assistance to low
income families, the Head Start
program, services to older Americans,
and direct health services delivery. HHS
is comprised of 18 staff divisions and 12
operating divisions, many of which
have responsibility for promulgating
regulations pursuant to HHS’s statutory
authority. Although many components
of HHS, currently conduct periodic
retrospective reviews, until now there
has been no single HHS-wide plan for
ongoing review of HHS regulations.
HHS’s goal is to establish a robust and
resilient framework for each HHS
agency to undertake a periodic
thoughtful analysis of its significant
existing regulations, resulting in a more
streamlined, flexible, less burdensome
regulatory structure. HHS seeks
comments from the public on various
aspects of the framework that might be
considered as HHS develops its plan.
Request for Information
HHS has determined that the plan
called for by the President should reflect
HHS’s overall approach to regulatory
review, leaving implementation of that
plan to each individual regulatory
agency. Accordingly, HHS solicits
comments on the following elements to
be included in its preliminary plan:
• Schedule for Ongoing Review—The
public is first asked to comment on how
HHS should determine a schedule for
review. Understanding that an effective
review process can be time consuming,
comments might address how best to
schedule periodic reviews that will be
meaningful, yet not unduly burden
individual agencies within HHS, or how
best to integrate mandatory reviews of
HHS regulations—for example, reviews
of regulations at least every ten years
that have a significant economic impact
on a substantial number of small
businesses as required by the Regulatory
Flexibility Act; annual reviews of
hospital, physician, nursing facility,
dialysis facility, and other provider
payment rules setting reimbursement
rates under Medicare for each fiscal
year; or reviews every five years of
regulations establishing relative value
units for health care provider activities
for Medicare reimbursement purposes—
with the retrospective reviews called for
under the new Executive Order.
• Process for Setting Priorities—HHS
solicits comments about factors it
should consider and the process it
should use in setting priorities and
E:\FR\FM\13APP1.SGM
13APP1
srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Proposed Rules
selecting rules for review. For example,
should the amount of time a regulation
is in effect be criteria for review? If so,
how much time should that be? Should
HHS involve outside experts in setting
its review priorities? What metrics
should HHS use to evaluate regulations
after they have been implemented? For
example, should review be limited to
rules based on their projected or actual
impact?
• Public Participation—HHS solicits
comments on ways to further engage
and increase public comment in its
rulemaking. Comments might suggest
ways to improve HHS’ continuing
efforts to use online technologies to
facilitate greater participation in the
rulemaking process, particularly social
media and regulations.gov. Comments
might also suggest ways to increase
open exchanges of information by
interested parties, or ways to allow
interested parties the opportunity to
react to (and benefit from) the
comments, arguments, and information
of others during the rulemaking process.
HHS also welcomes comments on how
it can remain informed on new
technologies, events or processes that
may render significant rules potentially
obsolete, outdated, or require
modification.
• Analysis of Costs and Benefits—
HHS invites public comment on how it
ought to develop its analysis of costs
and benefits of those rules under
consideration for retrospective review.
The metrics used to assess costs and
benefits at the time a rule is
promulgated are likely to be different
from those available or necessary to
assess costs and benefits of a rule in its
present form. Comments might usefully
address data sources that will help
assess the cost benefit analysis of a
regulation after the initial projection has
been made or whether there are existing
sources of data that HHS should use to
evaluate the post-promulgation effects
of regulations over time. Additionally,
HHS is interested in comments on ways
to quantify values that are difficult or
impossible to quantify, including
equity, human dignity, fairness, and
distributive impacts.
• Coordination with Other
Departments—HHS is interested in
public comment on ways that HHS can
consider the combined effects of
regulations (together with those of other
agencies) on particular sectors and
industries, particularly small
businesses, and State, local and tribal
governments; and ways to promote
greater coordination across agencies,
harmonization of regulatory
requirements, and the identification of
VerDate Mar<15>2010
18:03 Apr 12, 2011
Jkt 223001
regulations that are redundant,
inconsistent or overlapping.
• General Comments on What HHS
Should Include in Its Plan—HHS seeks
comment on how best to structure its
framework for conducting ongoing
retrospective reviews, and other criteria
that should be considered in
preparation of its preliminary plan.
HHS notes that this RFI is issued
solely for information and programplanning purposes. HHS will not
respond to individual comments, but
will consider them as it formulates its
preliminary plan. While responses to
this RFI do not bind HHS to any further
actions related to the response, all
submissions will be made publicly
available on https://www.regulations.gov.
Dated: April 7, 2011.
Dawn L. Smalls,
Executive Secretary to the Department.
[FR Doc. 2011–8780 Filed 4–12–11; 8:45 am]
BILLING CODE 4150–03–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
20569
to Docket No. APHIS–2011–0006,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road, Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2011–0006.
Reading Room: You may read any
comments that we receive on the
petition in our reading room. The
reading room is located in room 1141 of
the USDA South Building, 14th Street
and Independence Avenue, SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Rachel Cezar, Horse Protection Program
National Coordinator, Animal Care,
APHIS, 4700 River Road, Unit 84,
Riverdale, MD 20737–1238; (301) 734–
5784.
SUPPLEMENTARY INFORMATION:
Background
9 CFR Part 11
[Docket No. APHIS–2011–0006]
Horse Protection Act; Petition for
Amendments to Regulations
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are notifying the public
that the Animal and Plant Health
Inspection Service has received a
petition requesting changes to our horse
protection regulations and our current
enforcement practices and related
policies regarding those regulations. We
are making this petition available to the
public for review and comment. We are
noting, however, that certain requests in
the petition lack authority in the Horse
Protection Act to implement.
DATES: We will consider all comments
that we receive on or before June 13,
2011.
SUMMARY:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/main?main=DocketDetail&
d=APHIS-2011-0006 to submit or view
comments and to view supporting and
related materials available
electronically.
• Postal Mail/Commercial Delivery:
Please send one copy of your comment
ADDRESSES:
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
The Horse Protection Act (HPA, 15
U.S.C. 1821–1831) authorizes the
Secretary of Agriculture to promulgate
regulations prohibiting the showing,
exhibition, transport, or sale of horses
subjected to soring, a practice of
accentuating a horses’ gait through the
infliction of pain. The Secretary of
Agriculture has delegated the
responsibility for enforcing the HPA to
the Administrator of the Animal and
Plant Health Inspection Service
(APHIS). Exercising its rulemaking
authority under the Act, APHIS enforces
regulations that are contained in 9 CFR
part 11, referred to below as the
regulations, that prohibit, among other
things, devices and methods that might
sore horses.
In a petition sent on August 4, 2010,
The Humane Society of the United
States, the American Society for the
Prevention of Cruelty to Animals, the
American Horse Protection Association,
Inc., Friends of Sound Horses, Inc., and
former Senator Joseph D. Tydings
(referred to below as the petitioners)
requested that APHIS change its
regulations and policies regarding the
protection of horses from the practice of
soring. The petitioners’ requests
included permanently disqualifying
horses that have been scarred from
soring from competitions, permanently
disqualifying repeat violators of the
HPA, requiring horse industry
E:\FR\FM\13APP1.SGM
13APP1
Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Proposed Rules]
[Pages 20568-20569]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8780]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 /
Proposed Rules
[[Page 20568]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
2 CFR Chapters III and XXX
5 CFR Chapter XLV
21 CFR Chapter I
25 CFR Chapter V
42 CFR Chapters I, IV and V
45 CFR Subtitle A and Chapters II, III, IV, X, XIII
48 CFR Chapter 3
HHS Plan for Retrospective Review Under Executive Order 13563
AGENCY: Department of Health and Human Services.
ACTION: Notice; request for information.
-----------------------------------------------------------------------
SUMMARY: In accordance with Executive Order 13563, ``Improving
Regulation and Regulatory Review,'' the Department of Health and Human
Services (HHS) seeks comment from interested parties to assist in the
development of its preliminary plan to review existing regulations. The
purpose of the plan is to establish a process by which HHS can
determine whether any such regulations should be modified, streamlined,
expanded, or repealed so as to make HHS's regulatory program more
effective or less burdensome in achieving its regulatory objectives.
DATES: Submit electronic or written comments on this notice by May 12,
2011.
Instructions: All submissions received must include the Agency name
HHS-ES-2011-001 for this notice. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided.
ADDRESSES: You may submit comments, identified by HHS-ES-2011-001 by
any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments. HHS will post all comments
received before the close of the comment period as soon as possible
after they have been received:
Written Submissions
Submit written submissions in the following ways:
FAX: (202) 690-7203.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): 200 Independence Avenue, SW., Room 639G, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT: Oliver Potts at (202) 690-6392.
SUPPLEMENTARY INFORMATION:
On January 18, 2011, President Obama issued Executive Order 13563
to improve regulation and regulatory review by requiring Federal
agencies to design cost effective, evidence-based regulations that are
compatible with economic growth, job creation, and competitiveness, and
which rely on the best, most innovative, and least burdensome tools to
achieve regulatory ends. To meet that objective, the President directs
each Executive Branch agency to consider how best to promote periodic
retrospective review of existing significant rules to determine if they
are outmoded, ineffective, insufficient, or excessively burdensome.
Each agency is to develop and submit to the Office of Management and
Budget's Office of Information and Regulatory Affairs a preliminary
plan under which the agency will periodically review existing rules to
determine whether any such regulations should be modified, streamlined,
expanded, or repealed.
Background
HHS is the Federal Government's principal agency charged with
protecting the health of all Americans and providing essential human
services. HHS' responsibilities include: Medicare, Medicaid, increasing
access to care and insurance coverage, support for public health
preparedness and emergency response, biomedical research, substance
abuse and mental health treatment and prevention, assurance of safe and
effective drugs and other medical products, protection of our Nation's
food supply, assistance to low income families, the Head Start program,
services to older Americans, and direct health services delivery. HHS
is comprised of 18 staff divisions and 12 operating divisions, many of
which have responsibility for promulgating regulations pursuant to
HHS's statutory authority. Although many components of HHS, currently
conduct periodic retrospective reviews, until now there has been no
single HHS-wide plan for ongoing review of HHS regulations.
HHS's goal is to establish a robust and resilient framework for
each HHS agency to undertake a periodic thoughtful analysis of its
significant existing regulations, resulting in a more streamlined,
flexible, less burdensome regulatory structure. HHS seeks comments from
the public on various aspects of the framework that might be considered
as HHS develops its plan.
Request for Information
HHS has determined that the plan called for by the President should
reflect HHS's overall approach to regulatory review, leaving
implementation of that plan to each individual regulatory agency.
Accordingly, HHS solicits comments on the following elements to be
included in its preliminary plan:
Schedule for Ongoing Review--The public is first asked to
comment on how HHS should determine a schedule for review.
Understanding that an effective review process can be time consuming,
comments might address how best to schedule periodic reviews that will
be meaningful, yet not unduly burden individual agencies within HHS, or
how best to integrate mandatory reviews of HHS regulations--for
example, reviews of regulations at least every ten years that have a
significant economic impact on a substantial number of small businesses
as required by the Regulatory Flexibility Act; annual reviews of
hospital, physician, nursing facility, dialysis facility, and other
provider payment rules setting reimbursement rates under Medicare for
each fiscal year; or reviews every five years of regulations
establishing relative value units for health care provider activities
for Medicare reimbursement purposes--with the retrospective reviews
called for under the new Executive Order.
Process for Setting Priorities--HHS solicits comments
about factors it should consider and the process it should use in
setting priorities and
[[Page 20569]]
selecting rules for review. For example, should the amount of time a
regulation is in effect be criteria for review? If so, how much time
should that be? Should HHS involve outside experts in setting its
review priorities? What metrics should HHS use to evaluate regulations
after they have been implemented? For example, should review be limited
to rules based on their projected or actual impact?
Public Participation--HHS solicits comments on ways to
further engage and increase public comment in its rulemaking. Comments
might suggest ways to improve HHS' continuing efforts to use online
technologies to facilitate greater participation in the rulemaking
process, particularly social media and regulations.gov. Comments might
also suggest ways to increase open exchanges of information by
interested parties, or ways to allow interested parties the opportunity
to react to (and benefit from) the comments, arguments, and information
of others during the rulemaking process. HHS also welcomes comments on
how it can remain informed on new technologies, events or processes
that may render significant rules potentially obsolete, outdated, or
require modification.
Analysis of Costs and Benefits--HHS invites public comment
on how it ought to develop its analysis of costs and benefits of those
rules under consideration for retrospective review. The metrics used to
assess costs and benefits at the time a rule is promulgated are likely
to be different from those available or necessary to assess costs and
benefits of a rule in its present form. Comments might usefully address
data sources that will help assess the cost benefit analysis of a
regulation after the initial projection has been made or whether there
are existing sources of data that HHS should use to evaluate the post-
promulgation effects of regulations over time. Additionally, HHS is
interested in comments on ways to quantify values that are difficult or
impossible to quantify, including equity, human dignity, fairness, and
distributive impacts.
Coordination with Other Departments--HHS is interested in
public comment on ways that HHS can consider the combined effects of
regulations (together with those of other agencies) on particular
sectors and industries, particularly small businesses, and State, local
and tribal governments; and ways to promote greater coordination across
agencies, harmonization of regulatory requirements, and the
identification of regulations that are redundant, inconsistent or
overlapping.
General Comments on What HHS Should Include in Its Plan--
HHS seeks comment on how best to structure its framework for conducting
ongoing retrospective reviews, and other criteria that should be
considered in preparation of its preliminary plan.
HHS notes that this RFI is issued solely for information and
program-planning purposes. HHS will not respond to individual comments,
but will consider them as it formulates its preliminary plan. While
responses to this RFI do not bind HHS to any further actions related to
the response, all submissions will be made publicly available on https://www.regulations.gov.
Dated: April 7, 2011.
Dawn L. Smalls,
Executive Secretary to the Department.
[FR Doc. 2011-8780 Filed 4-12-11; 8:45 am]
BILLING CODE 4150-03-P