[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