[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Notices]
[Page 7054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3490]



[[Page 7053]]

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Part II





Department of Health and Human Services





_______________________________________________________________________



National Institutes of Health



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



Recombinant DNA Advisory Committee Meeting; Notice



Recombinant DNA Research; Proposed Actions Under the Guidelines; Notice

  Federal Register / Vol. 63, No. 28 / Wednesday, February 11, 1998 / 
Notices  

[[Page 7054]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

    Notice is hereby given of a Gene Therapy Policy Conference 
entitled: Lentiviral Vectors for Gene Delivery, on March 9, 1998. The 
conference will be held at the Bethesda Marriott Hotel, 5151 Pooks Hill 
Road, Bethesda, Maryland 20892, starting on March 9, 1998, at 
approximately 8:30 a.m., and will recess at approximately 5:00 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 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 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 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 March 9, 1998, the NIH will hold its second GTPC entitled: 
Lentiviral Vectors for Gene Delivery. Tentative topics for discussion 
include: (1) Vector design and genetic requirements for lentivirus-
based systems; (2) in vivo gene transfer and issues relating to vector 
distribution and gene expression; (3) packaging cell line strategies; 
(4) issues related to testing for replication-competent virus; (5) 
strategies for patient monitoring, e.g., possible seroconversion; (6) 
potential clinical applications (both in vivo and ex vivo); (7) 
potential for mobilization (by recombination) with wild-type HIV in 
infected hosts; and (8) relevant social and ethical issues.
    The findings and recommendations of this conference will be 
submitted in the form of a report to the NIH Director.

    Dated: February 2, 1998.
LaVerne Y. Stringfield,
Committee Management Officer, NIH.
[FR Doc. 98-3490 Filed 2-10-98; 8:45 am]
BILLING CODE 4140-01-P