Date: Fri, 6 Oct 1995 19:03:23 +0500
From: ghmcleaf{CONTRACTOR/ASPEN/ghmcleaf}%NAC-GATEWAY.ASPEN@ace.aspensys.com
Subject: Federal Register Notice, October 5, 1995


Federal Register Notice
October 5, 1995

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notice of Meeting

Notice is hereby given to the meeting of the NIH AIDS Research
Program Evaluation Working Group Area Review Panel on Vaccine
Research and Development on October 16, 1995 from 9:00 am to 5:00
pm at the Days Inn Crystal City, 2000 Jefferson David Highway,
Arlington, Virginia.  The meeting will be open to the public from
2:00 pm to 5:00 pm, and the closed portion will be from 9:00 to
1:00 pm.

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 vaccine research and development.  Examples of the
areas under consideration by the panel include identification of
potential vaccine approaches, design and preclinical testing of
candidate AIDS vaccines in animals -- both small laboratory
animals and nonhuman primates, clinical testing of candidate
vaccines in human volunteers in phase I and II (safety and
immunogenicity studies) and preparation for large scale testing
in populations at high risk of acquiring HIV-1 infection.  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 9:00 am to 1 pm to update the
Panel members on privileged information on institute and center
grant and contract portfolios.

The open session from 2 pm to 5:00 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 AIDS vaccine research
and development and recommendations for consideration by the
panel in assessing sand 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. Bonnie J. Mathieson, Office of AIDS Research,
NIH, 32 center Drive, MSC 2340, Building 31, Room 4C06, Bethesda,
MD 20892-2340, (301) 496-4564, FAX: (301) 402-8638.  Letters of
intent and copies of presentations must be received no later than
4:00 pm EDT on Friday, Oct 13.

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 4 pm EDT on October 13.  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. Mathieson in advance of the
meeting.