[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Notices]
[Page 53793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25729]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Notice of Meeting

    Notice is hereby given of the meeting of the NIH AIDS Research 
Program Evaluation Working Group Area Review Panel on Clinical Trials 
on November 13-14, 1995 at the Chevy Chase Holiday Inn, 5520 Wisconsin 
Avenue, Chevy Chase, Maryland. The meeting will be open to the public 
from 8:00 a.m. to 12:00 p.m. on November 13, and the closed portions 
will be from 1:00 p.m. to 5:30 p.m. on November 13, and 8:30 a.m. to 
3:00 p.m. on November 14.
    The NIH Revitalization Act of 1993 authorizes the Office of AIDS 
Research (OAR) to evaluate the AIDS research activities of NIH. The NIH 
AIDS Research Program Evaluation Working Group was established by the 
OAR to carry out this major evaluation initiative, reviewing and 
assessing each of the components of the NIH AIDS research endeavor to 
determine whether those components are appropriately designed and 
coordinated to answer the critical scientific questions to lead to 
better treatments, preventions, and a cure for AIDS. Six Area Review 
Panels were also established to address the following research areas: 
Natural History and Epidemiology; Etiology and Pathogenesis; Clinical 
Trials; Drug Discovery; Vaccines; and Behavioral and Social Sciences 
Research.
    The purpose of the meeting is to seek input from individuals and 
organizations interested in the evaluation of AIDS research in the 
areas of therapeutics research as it pertains to clinical trials. 
Examples of areas under consideration by the panel include the 
effectiveness, efficiency, scientific productivity and clinical impact 
of NIH clinical trials programs in adults and children for HIV and its 
sequelae. This includes trials aimed at improving outcomes by limiting 
HIV replication and enhancing immune function as well as studies aimed 
at preventing and treating the complications of advanced HIV disease. 
The NIH Aids Research Program Evaluation Working Group will develop 
recommendations to be made to the Office of AIDS Research Advisory 
Council that address the overall NIH AIDS research initiatives, both 
intramural and extramural, and identify long-range goals in the 
relevant areas of science. These recommendations will provide the 
framework for future planning and budget development of the NIH AIDS 
research program.
    There will be a closed session from 1:00 p.m. to 5:30 p.m. on 
November 13 and 8:30 a.m. to 3:00 p.m. on November 14, to update the 
Panel members on privileged information on institute and center grant 
and contract portfolios.
    The open session from 8:00 a.m. to 12:00 p.m. will begin with a 
brief overview of panel activities by members of the panel. The 
remainder of the meeting will be devoted to presentations from 
individuals and organizations. The session is open to the public; 
however, attendance may be limited by seat availability.
    Comments should be confined to statements related to the current 
status of NIH AIDS research in the areas of therapeutic clinical trials 
and recommendations for consideration by the panel in assessing and 
reviewing the relevant research in these areas.
    Only one representative of an organization may present oral 
comments. Each speaker will be permitted 5 minutes for their 
presentation. Interested individuals and representatives of 
organizations must submit a letter of intent to present comments and 
three (3) typewritten copies of the presentation, along with a brief 
description of the organization represented, to the attention of Dr. 
Judith Feinberg, Office of AIDS Research, NIH, 31 Center Drive, MSC 
2340, Building 31, Room 5C08, Bethesda, MD 20892-2340, (301) 496-0358, 
FAX: (301) 402-8638. Letters of intent and copies of presentations must 
be received no later than 5:00 p.m. on Monday, October 30.
    Any person attending the meeting who does not request an 
opportunity to speak in advance of the meeting will be allowed to make 
a brief oral presentation at the conclusion of the meeting, if time 
permits, and at the discretion of the Chairperson.
    Individuals wishing to provide only written statements should send 
three (3) typewritten copies of their comments, including a brief 
description of their organization, to the above address no later than 5 
p.m. on October 30. Statements submitted after that date will be 
accepted. They may not, however, be made available to the Area Review 
Panel prior to the meeting, though they will be provided subsequently 
as written testimony.
    Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
contact Dr. Feinberg in advance of the meeting.

    Dated: October 11, 1995.
Susan K. Feldman,
Committee Management Officer, NIH.
[FR Doc. 95-25729 Filed 10-16-95; 8:45 am]
BILLING CODE 4140-01-M