[Federal Register Volume 62, Number 118 (Thursday, June 19, 1997)]
[Notices]
[Pages 33417-33418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Availability of Report of NIH Panel To Define Principles of
Therapy of HIV Infection and Guidelines for the Use of Antiretroviral
Agents in HIV-Infected Adults
AGENCY: Office of Public Health and Science, HHS.
ACTION: Request for comments.
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SUMMARY: The Department of Health and Human Services (DHHS), Office of
Public Health and Science, is requesting comments from all interested
parties on the following two documents: ``Report of the NIH Panel to
Define Principles of Therapy of HIV Infection'' developed by the
subject NIH Panel and ``Guidelines for the Use of Antiretroviral Agents
in HIV-Infected Adults and Adolescents,'' developed by the Panel on
Clinical Practices for Treatment of HIV Infection, convened by the
Department of Health and Human Services and the Henry J. Kaiser Family
Foundation. The principles of therapy document describes 11 scientific
principles that define the fundamental HIV pathogenic-based rationale
for guiding therapeutic decisions. The guidelines document contains
recommendations for practitioners in conjunction with patients to use
in providing appropriate treatment regimens in light of new combination
therapies. The guidelines cover the following areas: methods for
testing to establish HIV infection; considerations for when to initiate
therapy; methods for and frequency of monitoring the effectiveness of
therapy; therapy in patients with established and advanced stage
disease; the treatment of acute HIV infection; interruption of therapy;
considerations for changing therapy and available therapeutic options;
and considerations for therapy in the HIV-infected pregnant woman.
DATES: Written comments should be written on or before July 21, 1997.
ADDRESSES: Written comments to this notice should be submitted to: The
HIV/AIDS Treatment Information Service, P.O. Box 6363, Rockville, MD
20849-6303. Due to the significantly large response expected, only
written comments will be accepted. After consideration of the comments,
the final documents will be published in the Centers for Disease
Control and Prevention (CDC) ``Morbidity and Mortality Weekly Report''
(MMWR). A notice of their availability will also be published in the
Federal Register.
FOR FURTHER INFORMATION CONTACT:
Copies of the ``Report of the NIH Panel to Define Principles of
Therapy'' and ``Guidelines for the Use of Antiretroviral Agents in HIV-
Infected Adults and Adolescents'' are available from the National AIDS
Clearinghouse (1-800-458-5231) and on the Clearinghouse website (hhtp:/
/www.cdcnac.org) and from the HIV/AIDS Treatment Information Service
(1-800-448-0400; FAX 301-529-6616; TTY: (1-800-243-7012) and on their
website (http://www.hivatis.org).
SUPPLEMENTARY INFORMATION: The NIH Panel to Define Principles of
Therapy of HIV Infection was convented to conduct a review of the
current status of the clinical studies of HIV antiretroviral therapy
with the goal of delineating scientific principles that would guide
therapeutic decisions. The NIH Panel was chaired by Charles Carpenter,
M.D., Professor of Medicine, Brown University School of Medicine. The
Panel on Clinical Practice for Treatment of HIV Infection is a three-
year public/private partnership convened in December 1996 by Eric P.
Goosby, M.D., Director, Office of HIV/AIDS Policy, DHHS, and Mark
Smith, M.D., former Vice President of the Henry J. Kaiser Family
Foundation, at the request of DHHS Secretary Donna E. Shalala. The
Panel's mission is to develop an initial set of comprehensive clinical
practices providing current state-of-the-art recommendations, options
and guidance to practitioners, patients, and payers regarding effective
and appropriate treatment for HIV infection on a variety of areas. The
Panel is cochaired by Anthony S. Fauci, M.D., Director,
[[Page 33418]]
National Institute of Allergy and Infectious Diseases, and John G.
Bartlett, M.D. Professor of Medicine and Chief of Infectious Diseases
at Johns Hopkins University School of Medicine. The 32-member panel
includes Federal, private sector and academic experts in the clinical
treatment and care HIV-infected people and representatives of AIDS
interest groups, health policy groups and payer organizations.
Dated: June 16, 1997.
John M. Eisenberg,
Principal Deputy Assistant Secretary for Health, U.S. Department of
Health and Human Services.
[FR Doc. 97-16228 Filed 6-17-97; 1:39 pm]
BILLING CODE 4160-17-M
