[Federal Register Volume 63, Number 170 (Wednesday, September 2, 1998)]
[Notices]
[Page 46801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23573]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Recombinant DNA Advisory Committee; Notice of Meeting
Pursuant to Public Law 92-463, notice is hereby given of a meeting
of the Recombinant DNA Advisory Committee on September 24-25, 1998. The
meeting will be held at the National Institutes of Health, Building
31C, 6th Floor, Conference Room 10, 9000 Rockville Pike, Bethesda,
Maryland 20892, starting on September 24, 1998, at approximately 9
a.m., and will recess at approximately 5 p.m. The meeting will
reconvene on September 25, 1998, at approximately 8:30 a.m. and will
adjourn at approximately 5:00 p.m. The meeting will be open to the
public. Agenda items will include: (1) Discussions of recently
submitted human gene transfer protocols, including two prototypic in
utero transfer protocols, (2) data management activities related to
human gene transfer clinical trials, and (3) other matters to be
considered by the Committee. The two prototypic in utero gene transfer
protocols are entitled: In Utero Gene Transfer for the Treatment of
ADA-Deficient SCID and In Utero Gene Transfer for the Treatment of
Alpha-Thalassemia. The purpose for discussing these two protocols are:
(1) To provide a framework for continued discussion of the science,
safety, and ethical issues at the December 7-8 Gene Therapy Policy
Conference (GTPC) entitled: Gene Transfer in Prenatal Medicine; and (2)
to stimulate the development of a guidance document for this novel area
of research within the context of the NIH Guidelines. The discussion at
this meeting should be considered as the first of many deliberations on
these two protocols, as well as on the general issue of in utero gene
transfer research; subsequent discussions will deal more substantively
with each of the issues identified in this initial discussion.
Attendance by the public will be limited to space available.
Debra W. Knorr, Acting Director, Office of Recombinant DNA
Activities, National Institutes of Health, MSC 7010, 6000 Executive
Boulevard, Suite 302, Bethesda, Maryland 20892-7010, Phone (301) 496-
9838, FAX (301) 496-9839, will provide summaries of the meeting and a
roster of committee members upon request. Individuals who plan to
attend and need special assistance, such as sign language
interpretation or other reasonable accommodations, should contact Ms.
Knorr in advance of the meeting.
OMB's ``Mandatory Information Requirements for Federal Assistance
Program Announcements'' (45 FR 39592, June 11, 1980) requires a
statement concerning the official government programs contained in the
Catalog of Federal Domestic Assistance. Normally NIH lists in its
announcements the number and title of affected individual programs for
the guidance of the public. Because the guidance in this notice covers
virtually every NIH and Federal research program in which DNA
recombinant molecule techniques could be used, it has been determined
not to be cost effective or in the public interest to attempt to list
these programs. Such a list would likely require several additional
pages. In addition, NIH could not be certain that every Federal program
would be included as many Federal agencies, as well as private
organizations, both national and international, have elected to follow
the NIH Guidelines. In lieu of the individual program listing, NIH
invites readers to direct questions to the information address above
about whether individual programs listed in the Catalog of Federal
Domestic Assistance are affected.
Dated: August 26, 1998.
LaVerne Y. Stringfield,
Committee Management Officer, NIH.
[FR Doc. 98-23573 Filed 9-1-98; 8:45 am]
BILLING CODE 4140-01-M
