[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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