Gene Therapy Policy Conference; Notice of Conference

[Federal Register Volume 63, Number 245 (Tuesday, December 22, 1998)]
[Notices]
[Page 70788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33765]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Gene Therapy Policy Conference; Notice of Conference

    Notice is hereby given of a meeting of a Gene Therapy Policy 
Conference entitled: Prenatal Gene Transfer: Scientific, Medical, and 
Ethical Issues on January 7-8, 1999. The conference will be held at the 
Hyatt Regency Bethesda Hotel, One Bethesda Metro Center, Bethesda, 
Maryland 20814, starting on January 7 at approximately 8:00 a.m., and 
will recess at approximately 5:30 p.m. The conference will reconvene on 
January 8 at approximately 8:00 a.m. and will adjourn at approximately 
6:00 p.m. The conference will be open to the public and free of charge; 
however, registration is required. Registration is available online at 
www.nih.gov/od/orda or you can contact Ms. Anne Dunne, Strategic 
Results, 6004 Lakeview Road, Baltimore, Maryland 21210, Phone 410-377-
0110, Fax 410-377-6429. Ms. Dunne will provide conference information 
upon request. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should contact Ms. Dunne in advance of the conference.
    On July 8, 1996, the NIH Director published a Notice of Intent to 
Propose Amendments to the NIH Guidelines for Research Involving 
Recombinant DNA Molecules Regarding Enhanced Oversight of Recombinant 
DNA Activities (61 FR 3577). One significant component of the NIH 
Director's proposal was to establish Gene Therapy Policy Conferences 
(GTPC). These conferences are intended to offer the unique advantage of 
assembling numerous participants who possess significant scientific, 
ethical, and legal expertise and/or interest that is directly 
applicable to specific recombinant DNA issues. In order to enhance the 
depth and value of scientific and ethical/social discussion, each GTPC 
will be devoted to a single issue relevant to scientific merit and/or 
safety as it relates to research on the use of novel gene delivery 
vehicles and applications to human gene therapy, novel applications of 
gene transfer, or relevant ethical/social implications of a particular 
application of gene transfer technology.
    The findings and recommendations of each GTPC will be made 
available to multiple Department of Health and Human Services (DHHS) 
components, including the Food and Drug Administration (FDA) and the 
Office for Protection from Research Risks (OPRR). The NIH Director 
anticipates that this expanded public policy forum will serve as a 
model of interagency communication and collaboration, concentrated 
expert discussion of novel scientific issues and their potential 
societal implications, and enhanced opportunity for public discussion 
of specific issues and the potential impact of such applications on 
human health and the environment.
    On January 7-8, 1999, the NIH will hold its third GTPC entitled: 
Prenatal Gene Transfer: Scientific, Medical, and Ethical Issues. Topics 
will include preclinical studies of prenatal gene transfer; prenatal 
genetic screening and diagnostic tools; optimal clinical trial design 
focusing on patient safety and measurements of outcome; ethical, legal, 
and social issues raised by prenatal gene transfer; diagnostic testing 
and clinical care of patients post gene transfer; and patient 
education, informed consent, and eligibility.
    The findings and recommendations of this conference will be 
submitted in the form of a report to the NIH Director.

    Dated: December 15, 1998.
LaVerne Y. Stringfield,
Committee Management Officer, NIH.
[FR Doc. 98-33765 Filed 12-21-98; 8:45 am]
BILLING CODE 4140-01-M