[Federal Register Volume 59, Number 13 (Thursday, January 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1160]


[[Page Unknown]]

[Federal Register: January 20, 1994]


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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]
BILLING CODE 4510-04-M