[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Proposed Rules]
[Pages 20568-20569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8780]
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Proposed Rules
Federal Register
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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.
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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.
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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expanded, or repealed so as to make HHS's regulatory program more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 http://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: http://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 http://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]
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