[Federal Register Volume 62, Number 161 (Wednesday, August 20, 1997)]
[Notices]
[Page 44386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22028]



[[Page 44385]]

_______________________________________________________________________

Part VI





Department of Health and Human Services





_______________________________________________________________________



National Institutes of Health



_______________________________________________________________________



Office of Recombinant DNA Activities: Gene Therapy Policy Conference; 
Recombinant DNA Advisory Committee Meeting; and Proposed Recombinant 
DNA Research Actions Under NIH Guidelines; Notices

Federal Register / Vol. 62, No. 161 / Wednesday, August 20, 1997 / 
Notices

[[Page 44386]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of Recombinant DNA Activities; Notice of Gene Therapy 
Policy Conference

    Notice is hereby given of a Gene Therapy Policy Conference 
entitled: Human Gene Transfer--Beyond Life-threatening Disease, on 
September 11, 1997. The conference will be held at the Bethesda Holiday 
Inn Hotel, 8120 Wisconsin Avenue, Bethesda, Maryland, 20814, starting 
on September 11, 1997, at approximately 8:00 a.m., and will recess at 
approximately 5:30 p.m. The conference will be open to the public and 
free of charge; however, registration is required. Registration is 
available online at http://www.nih.gov/od/orda or you can contact Dr. 
Elham-Eid Alldredge, REDA International, 11141 Georgia Avenue, Suite 
517, Wheaton, Maryland 20902, Phone 301-946-9790, Fax 301-946-1911. Dr. 
Alldredge 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 Dr. 
Alldredge in advance of the meeting.
    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 of 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.
    At its March 6-7, 1997 meeting, the RAC recommended that the first 
Gene Therapy Policy Conference (GTPC) should be held to discuss the 
scope of ethical and scientific issues regarding genetic enhancement 
and the inclusion of normal subjects in human gene transfer protocols.
    The first CTPC is scheduled for September 11, 1997. The title of 
this first GTPC is: Human Gene Transfer--Beyond Life-threatening 
Disease. The tentative topics for discussion during this conference 
are: (1) Scientific prospects for enhancement through gene therapy. 
This topic will cover the following issues: (a) Historical perspective, 
current state, and theoretical feasibility; (b) prospects for 
``preventive'' gene therapies that enhance organ or system function; 
and (c) assessing the long-term safety and efficacy of enhancement gene 
therapies. (2) The treatment/enhancement distinction: conceptual, 
ethical and social issues. This topic will cover the following issues: 
(a) Ethical and social concerns; and (b) conceptual clarification of 
treatment/enhancement distinction, and (3) Development of a 
``treatment/enhancement'' distinction as part of a guidance document. 
This topic will cover the following issues: (a) Operational criteria 
for treatment/enhancement distinction; (b) current regulatory 
significance of the distinction; and (c) development of a guidance 
framework/document.
    The findings and recommendations of this conference will be 
submitted in the form of a report to the NIH Director.

    Dated: August 11, 1997.
LaVerne Y. Stringfield,
Committee Management Officer, NIH.
[FR Doc. 97-22028 Filed 8-19-97; 8:45 am]
BILLING CODE 4140-01-M