Periodic Review of Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

20 CFR Ch. III

21 CFR Ch. I

42 CFR Ch. I-V

45 CFR Subtitle A, Ch. II-IV, X, XIII

48 CFR Ch. III

Periodic Review of Rules

AGENCY: Office of the Secretary, HHS.

ACTION: Plan for periodic review of rules.

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SUMMARY: This document describes the Department's plan for periodic

review of rules to minimize burden and improve effectiveness, as

required by Executive Order 12866 and the Regulatory Flexibility Act.

This document also invites the submission of data, information, and

views to assist the Department in deciding priority order of the review

and in identifying rules to develop or review using negotiated

rulemaking.

DATES: Data, information, and views due date: February 28, 1994 for

initial suggestions and any date thereafter for additional suggestions.

ADDRESSES: Addresses for submitting comments and information in

response to this document are listed at the end of the document.

FOR FURTHER INFORMATION CONTACT:

Walton Francis, Director for Policy and Regulatory Analysis, Office of

the Assistant Secretary for Planning and Evaluation, Office of the

Secretary, Department of Health and Human Services, Washington, DC

20201, (202) 690-8291 or the contact person for a specific division or

agency of the Department listed at the end of this notice.

SUPPLEMENTARY INFORMATION:

Background

The President issued Executive Order 12866 on September 30, 1993.

The basic purpose of the Executive Order is to make regulations less

burdensome, more effective, and in greater alignment with the

President's priorities and regulatory principles. Section 5 of the

Executive Order requires that each agency periodically review its

existing significant regulations to determine whether these rules

should be modified or eliminated so as to make the agencies' regulatory

programs more effective. Section 6(a) of the order directs each agency

to explore and, where appropriate, use consensual mechanisms for

developing regulations, including negotiated rule-making.

The Regulatory Flexibility Act, Public Law 96-354, was enacted on

September 19, 1980. Section 610 of the Act requires each agency to

review rules issued by the agency which have or will have a significant

economic impact on a substantial number of small entities. The

Department must review all such rules within ten years of their

publication as final rules. The purpose of the periodic reviews is to

determine whether such rules should be continued without change, or

should be amended or rescinded, to minimize any significant economic

impact of the rules upon a substantial number of small entities. In

1981, HHS issued a notice similar to this one and has since regularly

reviewed rules with the goal of reducing their burden overall and on

small entities.

Review Plan

To implement E.O. 12866 and to continue implementation the

Regulatory Flexibility Act, the operating divisions of the Department

and those staff divisions which administer rules will review all

regulations for the purpose of selecting those that should receive

early, in-depth review and revisions to reduce regulatory burdens.

Existing regulations will be scheduled for review and reviewed in an

order of priority established by each division, subject to Secretarial

approval.

In prioritizing existing regulations for review, agencies and

offices of the Department will seek to identify for earliest review

those regulations for which revision will most advance the following

principles:

Reduce regulatory burden on the American people, their

families, their communities, their State, local, and tribal

governments, and their industries;

Create consistency with the President's priorities and

regulatory principles;

Ensure compatibility among regulations, and eliminate

those which are duplicative or burdensome in the aggregate;

Eliminate requirements which have become unjustified or

unnecessary as a result of changed circumstances.

The Secretary has selected four themes to focus Departmental

action. These priorities will also guide selection of regulations for

review:

Prevention: Preventing future problems. This requires anticipating

problems, identifying problems while they are manageable, and

supporting early interventions to avoid or correct them. For example,

this includes ensuring that children are ready for school, reducing

teen pregnancy and encouraging life style changes and other actions

that prevent illness or disability.

Independence: Fostering independence through empowering the people

we serve. Examples include developing strategies to ensure that welfare

recipients have the means to become as self-sufficient as possible,

seeking to help persons with disabilities to engage in meaningful

activity, looking for available alternatives to institutional long-term

care, and providing the public with information necessary to foster

independent decisions.

Customer Service: Improving services to our customers. Our

customers include the people we serve and the entities we do business

with. Service improvements include enhanced access to needed services,

reduced waiting times for disability determination, better

responsiveness to requests for assistance, and including customers'

needs and desires in the policy making process.

Modern Management: Achieving these goals through modern management

techniques. Achieving these goals and making the department as

effective and efficient as possible will require modern management

techniques. These include empowering employees and managers to achieve

results; effectively using new technology; moving authority,

responsibility, and accountability to the most appropriate levels; and

seeking continuous improvement in quality and program integrity to

avoid unnecessary administrative expenses, and prevent fraud and

program abuses.

Health care reform and welfare reform are themselves major

initiatives that focus on fundamental reform of HHS regulations. In

programs directly affected by those reforms, we will not plan

additional reforms except in those instances where interim reforms are

consistent with achieving the President's plan.

Careful review of regulations can require a significant amount of

time and resources. Regulations that have been developed and amended

over many years may have economic impacts that cannot be readily or

hastily assessed. Therefore, a division may review only a few of its

more complex regulations each year or it may review several less

complex regulations. In deciding how much review activity can be

undertaken each year, the Department will consider what is practicable

and reasonable in light of its current resources and other

responsibilities and comments made in response to this Notice. Although

the Department will prioritize regulations for review, establishing

long range schedules with specific dates for the beginning and ending

of reviews is not feasible at this time. However, the Department will

continue to meet the objective of screening those regulations that may

affect small entities within 10 years of their publication date as

required by the Act. Information on the Department's progress in

reviewing existing regulations and in the selection of regulations for

review will be published in the semi-annual Regulatory Agenda.

Agencies within the Department may issue supplementary notices or

take other initiatives to help implement the regulation review

requirements of the Act and Executive Order 12866. The Food and Drug

Administration is issuing a notice, which accompanies this one,

announcing its plan for review of its rules to minimize regulatory

burdens while maintaining an acceptable level of consumer protection.

Public Participation

To achieve the maximum benefit from the review and modification of

existing rules, we intend to the extent possible, to review the more

costly and burdensome rules first. This, in turn, requires information

on the potential for burden reduction. We believe that the public,

especially those most affected by existing rules, is uniquely able to

advise us on this potential. Accordingly, we are inviting data,

information, and views to assist us in deciding priority order of

review. We specifically encourage State, local, and tribal governments

to assist in the identification of regulations that impose significant

or unique burdens and that appear to have outlived their justification

or be otherwise inconsistent with the public interest. We are

particularly interested in reforms leading to the reduction of unfunded

mandates, a Presidential priority communicated in his Executive Order

12875 on Enhancing the Intergovernmental Partnership.

Comments will be most helpful when they clearly identify the

regulation to which the comment is addressed and specifically explain

why and how the regulation imposes unnecessary or disproportionately

burdensome demands on those regulated. Also, many regulations reflect

statutory mandates and are not subject to Departmental discretion. The

submission of information or references to information, particularly

data concerning the costs of the regulation, that supports the comment

is encouraged. Comments should identify, where possible, what statutory

changes would be necessary to implement suggested regulatory reforms.

The Department particularly invites nominations for future rules or

reviews of existing rules that would be good candidates for a

negotiated rule-making. Negotiated rulemaking is a process that brings

together the Federal Government and external interests who would be

significantly affected by a new rule, to reach consensus through open

discussion on some or all issues under consideration before a rule is

formally proposed in the Federal Register. Because negotiated rule-

making is a resource intensive process, we believe it is more efficient

to use it with rules for which (1) a limited number of adversarial

interests can be identified, (2) the external parties have technical

expertise and information not readily available to the Federal

Government, and (3) there is a significant chance of litigation unless

external parties' interests can be addressed through the negotiation

process. Commenters should explain why a rule-making would be a good

candidate for a negotiation.

Comments should be sent directly to the division of the Department

which administers the particular rule(s) discussed. The major divisions

of the Department are (1) The Administration for Children and Families

which administers a broad range of programs that address the needs of

children and families including child welfare services, Aid to Families

with Dependent Children, Head Start, and Child Support Enforcement; (2)

the Public Health Service, which stimulates and assists states and

communities with the development of local health resources and the

further development of education for health professions; assists with

improvement of the delivery of health services to all Americans;

conducts and supports research in the medical and related sciences and

disseminates scientific information; provides national leadership for

the prevention and control of communicable disease and other public

health functions; and protects the health of the Nation against impure

and unsafe foods, drugs and cosmetics, and other potential hazards

(Food and Drug Administration); and (3) the Health Care Financing

Administration, which oversees the Medicare program, which provides

basic health benefits to recipients of social security, and the

Medicaid program, which provides grants to states for medical services

for the needy and medically needy; and the Federal Qualifications

Program for Health Maintenance Organizations; (4) the Social Security

Administration, which administers the national program of contributory

social insurance, the supplemental security income program for the

aged, blind, and disabled, and the black lung benefits provisions of

the Federal Coal Mine Health and Safety Act of 1969; (5) the

Administration on Aging, which administers programs under the Older

Americans Act and serves as the advocate for older persons with the

Department and the Federal Government; and (6) the Office of the

Secretary, which administers civil rights compliance and enforcement

policies pertaining to programs of the Department, Department-wide

rules concerning grants and contracts. It also includes the Office of

the Inspector General.

Comments should be sent to the addressees listed below, depending

on the regulations addressed. Comments may be sent to the Office of the

Secretary when the responsible division is not known, or when the

comment covers several regulatory areas crossing agency lines.

Health Care Financing Administration: Mary Ann Troanovitch,

Director, Regulations Management Unit, Office of Executive Operations,

Health Care Financing Administration, room 309G, Hubert H. Humphrey

Building, Washington, DC 20201. Phone 202-690-7890.

Administration on Children and Families: Madeline Mocko, Director,

Division of Policy and Legislation, 7th Floor, 370 L'Enfant Promenade,

SW., Washington, DC 20447. Phone 202-401-9223.

Social Security Administration: Alan H. Wilder, Director, Office of

Regulations, Social Security Administration, room 3-A-6 Operations

Building, 6401 Security Boulevard, Baltimore, Maryland 21235. Phone

410-965-1749.

Administration on Aging: David Bunoski, Executive Secretariat, room

4753 Wilbur H. Cohen Building, 330 Independence Avenue, SW.,

Washington, DC 20201, phone: 202-260-0669.

Public Health Service (other than FDA): John Gallivan, Office of

Health Planning and Evaluation, the Public Health Service, room 740G,

Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington,

DC 20201. Phone 202-690-8484.

Food and Drug Administration: See the Federal Register notice

appearing in this issue for information on submission of comments to

the FDA.

Office of the Secretary: Jacquelyn Y. White, Deputy Executive

Secretary, Office of the Executive Secretariat, room 603H, Hubert H.

Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.

Dated: January 1, 1994.

Donna E. Shalala,

Secretary.

[FR Doc. 94-1160 Filed 1-19-94; 8:45 am]

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