[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]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
National Institutes of Health
_______________________________________________________________________
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