[Federal Register Volume 61, Number 83 (Monday, April 29, 1996)]
[Notices]
[Pages 18749-18750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10484]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
1996 Gene Therapy Conference: Development and Evaluation of Phase
I Products and Workshop on Vector Development; Notice of Public
Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
conference entitled ``1996 Gene Therapy Conference: Development and
Evaluation of Phase I Products and Workshop on Vector Development.''
The objective of this conference is to educate investigators on the
[[Page 18750]]
investigational new drug (IND) process, points-to-consider documents,
resources available from the National Institutes of Health (NIH) to
bring gene therapy from the research laboratory to clinical trials, and
to conduct a series of workshops on various issues concerning the
development, production, and use of viral vectors for gene therapy. FDA
believes that the conference will benefit interested parties, including
industry, NIH, and FDA, involved in this rapidly advancing and changing
field of gene therapy.
DATES: The public conference will be held on Thursday and Friday, July
11 and 12, 1996, 8 a.m. to 5 p.m. Preregistration is requested by June
28, 1996. Registration will be held on both days from 7:30 a.m. to 8
a.m.
ADDRESSES: The public conference will be held at NIH, Bldg. 45, Natcher
Auditorium, 9000 Rockville Pike, Bethesda, MD. There is no registration
fee. For a complete description of the conference, agendas, speakers,
and session chairs check the FDA Biologics Home Page at http://
www.fda.gov/cber/cberftp.html. The home page will be updated as the
conference gets closer.
FOR FURTHER INFORMATION CONTACT:
Regarding information on registration: Margaret Fanning, NCI-FCRDC,
P.O. Box B, Frederick, MD 21702-1201, 301-846-5865, or FAX 301-846-
5866.
Regarding information on the conference agenda: Bette A. Goldman,
Center for Biologics Evaluation and Research (HFM-500), 1401 Rockville
Pike, Rockville, MD 20852-1448, 301-594-2860.
SUPPLEMENTARY INFORMATION: Gene therapy is a dynamic and rapidly
advancing field of scientific study. The purpose of this conference is
twofold. On July 11, 1996, FDA hopes to provide the gene therapy
community with an education and understanding of the IND review
process. Many academic investigators and researchers involved in the
research and development of gene therapies are not familiar with the
regulatory process for the review of IND's. This lack of knowledge of
the IND process may decrease the efficiency of pre-IND meetings and
increase the review burden on FDA staff. In order to address this
problem, the conference will include a description of the IND process,
the use of ``points-to-consider'' and guideline documents, and
resources available from NIH to bring gene therapy from the research
laboratory to clinical trials. On July 12, 1996, the conference will
serve as an opportunity for FDA to hear concerns, issues, and ideas
from the gene therapy community. There will be presentations of the
available scientific data from various groups, followed by discussions,
in order to improve understanding of scientific issues that are the
foundation of regulatory guidelines. Breakout sessions will address the
following: Adenoviral vectors, ancillary products, facilities and
manufacturing, information on getting started in gene therapy
development, retroviral vectors, pharmacology, toxicology, and the
development of new vector systems.
The information obtained from this conference may assist in the
development of future scientific and regulatory policy or guidance.
Dated: April 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-10484 Filed 4-26-96; 8:45 am]
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