98-3490. Office of Recombinant DNA Activities; Gene Therapy Policy Conference, Notice of Conference  

  • [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
    
    
    
    
    
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    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
    
    
    

Document Information

Published:
02/11/1998
Department:
National Institutes of Health
Entry Type:
Notice
Document Number:
98-3490
Pages:
7054-7054 (1 pages)
PDF File:
98-3490.pdf