[Federal Register Volume 67, Number 3 (Friday, January 4, 2002)]
[Notices]
[Pages 599-600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-239]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Secretary's Advisory Committee on Regulatory Reform; Request for 
Public Input

ACTION: Request for public input.

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SUMMARY: This notice seeks input from the public--including individuals 
and organizations--on ways to reduce current burdens imposed by 
existing regulations of the Department of Health and Human Services 
(HHS) that inhibit the delivery of high quality, timely, and efficient 
health care, inhibit the development of pharmaceuticals and other 
medical products, or inhibit biomedical research.

FOR FURTHER INFORMATION CONTACT: Christy Schmidt, Executive 
Coordinator, Secretary's Advisory Committee on Regulatory Reform, 
Office of the Assistant Secretary for Planning and Evaluation: (202) 
401-5182.

SUPPLEMENTARY INFORMATION: On June 8, 2001, Health and Human Services 
Secretary Tommy G. Thompson announced a department-wide initiative to 
reduce regulatory burdens in health care and respond faster to the 
concerns of patients, health care providers, state and local 
governments, other institutions, and other individual Americans who are 
affected by HHS rules. On September 4, 2001, the Department published a 
Notice of Intent in the Federal Register announcing its plans to 
establish an Advisory Committee on Regulatory Reform to provide 
findings and recommendations to the Secretary regarding potential 
regulatory changes. The Advisory Committee will commence its activities 
early in 2002.
    Regulations play an important role in implementing statutes. 
Regulations establish and communicate rules and procedures for 
participation in public programs, for approval of products, and for the 
awarding of grants and contracts. The regulatory process also allows 
for public examination of proposed rules, comment on those proposals, 
and an explanation of how those comments were factored into final 
decisions by government agencies.
    At the same time, in accomplishing these important tasks, 
regulations may impose a burden on individuals and organizations 
participating in public programs or seeking government approval or 
support. Some or most of these burdens may be necessary to carry out 
the statutory requirements and quite reasonable and appropriate in 
governing the expenditure of public funds and protecting the health and 
safety of individuals and the nation as a whole. But some of these 
burdens may be unnecessary, excessive, or inappropriate because they 
interfere with the operation of the programs to which they relate, are 
unduly intrusive, or are inconsistent with other requirements and thus 
unduly reduce flexibility, inhibit innovation, or impede efforts to 
improve quality of health care and access to health services or other 
rights and benefits for patients and consumers that are provided by 
law.
    The Advisory Committee's ultimate goal is to (a) identify and 
prioritize regulations that impose barriers to delivering high quality, 
safe and effective care services, products and research, and (b) to 
recommend improvements or other ways to remove these barriers. To help 
the Committee achieve this goal, we are inviting the public to provide 
us with written comments on regulatory burdens created by HHS 
regulations. Those interested in responding to this request are asked 
to focus their comments on regulatory burdens in one or more of the 
following areas:
     Health care delivery,
     Health care operations,
     Development of pharmaceuticals and other medical products, 
and
     Biomedical and health services research
    We encourage individuals as well as organizations to respond to 
this invitation, including but not limited to consumers, patients, 
researchers, clinicians and other health care professionals, employers, 
health care administrators, professional societies, trade associations, 
state and local governments, and universities. We encourage those who 
wish to respond to consider ways in which regulations or program 
requirements interfere with the delivery or receipt of care, innovation 
in health care delivery operations, or research, or the development of 
new products and treatments. In this regard respondents may find it 
helpful to consider their most recent interactions with HHS programs in 
order identify specific issues.
    Because of the broad nature of the Committee's charge, it will be 
essential that comments be as specific as possible and focus on 
concerns related to burdens imposed by regulations or regulatory 
processes rather than the underlying statutes enacted by the Congress.
    We ask that responses be limited to no more than five (5) one-
sided, single-spaced pages and be accompanied by and IBM-compatible 3.5 
inch diskette in WordPerfect or MS Word format. Additional attachments 
can be included but the Committee cannot guarantee that all of these 
materials can be read and considered. Therefore, major points should be 
made in the letter.
    The Committee would appreciate it if those who respond would 
consider some or all of the following matters:
    1. Which HHS regulations in the above-cited areas impose an 
unnecessary or unreasonable burden on individuals, groups, or 
organizations because these regulations:
     Are confusing;
     Impose unnecessary or excessive costs;
     Require an excessive number of reports or unreasonable 
record keeping;
     Impose requirements on the wrong individual or group;
     Carry excessive penalties;
     Are conflicting (examples include but are not limited to 
conflicts between

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HHS and State regulations, public and private sectors);
     Impede access to care or impede delivery of care;
     Impede efforts to innovate
     Are obsolete; and/or
     Interfere with the public or private sector's ability to 
respond to and prepare for emergencies.
    2. What alternative approaches could be taken to achieve or 
accomplish the same goal with a lesser burden? For example, are there 
less burdensome approaches that are used by other entities such as 
state governments or private companies that could be adopted by HHS to 
achieve its goal with less burdensome requirements?
    For each of the regulations discussed, the Committee asks you to 
include the following whenever possible:
     Citation of regulation involved or description of the 
regulation in as much detail as possible.
     Citation of relevant statute on which the regulation is 
based.
     A clear statement of the problem or concern.
     Identification of potential solutions to this problem or 
concern.
     A statement of how the proposed solutions would maintain 
the original intent of the statute (if possible, please provide 
citation of the original statute).
    We recognize that many individuals may not be able to provide a 
full or accurate citation to particular regulations or statutes. That 
should not stop them from commenting. However, professional 
organizations and institutions, will probably have access to this 
information and are encouraged to provide specific citations.
    We would also appreciate information on how you interact with the 
health care system (e.g., Are you a patient/consumer, physician, nurse, 
researcher, university, employer, health plan, hospital, nursing home, 
home health agency, pharmaceutical manufacturer, medical device, 
manufacturer?).
    We will accept comments on regulatory reform if we receive them at 
the appropriate address, as provided below, by 5pm on March 5, 2002.
    Individuals or organizations wishing to respond to this request may 
do so in writing by sending their comments to: Christy Schmidt, 
Executive Coordinator, Regulatory Reform Initiative, Office of the 
Assistant Secretary for Planning and Evaluation, 200 Independence Ave., 
SW., Washington, DC 20201. Responses also can be made electronically on 
the Committee's website: www.regreform.hh.gov. Those who respond should 
recognize that their comments would be part of the public record of the 
Committee and, under the Freedom of Information Act, available to 
anyone who wishes to read them. The Committee will make attempts to 
segregate those comments that are of a personal nature but cannot 
guarantee that all such comments will be recognized.
    Comments will be available for public inspection by appointment as 
they are received, generally beginning approximately January 25, 2002 
in Room 801 of the Department's offices at 200 Independence Avenue, 
SW., Washington, DC on Monday through Friday of each week from 8:30 am 
to 5 pm. Appointments may be made by telephoning 202-401-5182.
    After the close of the comment period, comments that are 
technically able to convert will be posted on the Regulatory Reform web 
site specified above.

    Dated: December 26, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 02-239 Filed 1-3-02; 8:45 am]
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