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.

Proposed Rules Federal Register

20568 

Vol. 76, No. 71 

Wednesday, April 13, 2011 

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expanded, or repealed so as to make 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 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 


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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Proposed Rules 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 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 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] 

BILLING CODE 4150–03–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 11 

[Docket No. APHIS–2011–0006] 

Horse Protection Act; Petition for 

Amendments to Regulations 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: 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. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://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 

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 

http://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 

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 


srobinson on DSKHWCL6B1PROD with PROPOSALS