[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