Date: Wed, 18 Oct 1995 15:39:40 +0500
From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com
Subject: NIH Program Working Group Meeting


F E D E R A L    R E G I S T E R
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Meeting
October 17, 1995


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 am to 12:00 pm on November 13,
and the closed portions will be from 1:00 pm to 5:30 pm 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 pm to 5:30 pm 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 am to 12:00 pm 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 pm 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 pm 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.


NIH/OD/OAR:JFEINBERG:JDELAWTER:401-3357:31/4B54:10-3-95 Official
file located in OAR:31/4B54:c:Evalreg.r