[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
________________________________________________________________________

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expanded, or repealed so as to make HHS's regulatory program more 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:
    <bullet> 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.
    <bullet> 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?
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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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