[Federal Register Volume 59, Number 167 (Tuesday, August 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21469]


[[Page Unknown]]

[Federal Register: August 30, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Gene Therapy Production Issues; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss gene therapy production issues. The meeting is 
designed to obtain public testimony from biomedical researchers, 
academia, biotechnology associations, governmental agencies, and 
individuals and organizations with relevant information concerning gene 
vector production issues.

DATES: The public meeting will be held on Monday, September 12, 1994, 
from 6 p.m. to 7:30 p.m., immediately following the National Institutes 
of Health, Recombinant DNA Advisory Committee meeting.

ADDRESSES: The public meeting will be held at the National Institutes 
of Health, Bldg. 31C, 9000 Rockville Pike, conference room 7, Bethesda, 
MD. No registration is required.

FOR FURTHER INFORMATION CONTACT:
    For information regarding the meeting: John G. Bishop, Center for 
Biologics Evaluation and Research (HFM-515), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-402-
1336, FAX 301-496-7027.
    For information regarding this notice: Stephen M. Ripley, Center 
for Biologics Evaluation and Research (HFM-635), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: The field of gene therapy is rapidly 
evolving. New approaches to genetic modification of somatic cells for 
the mitigation of human disease are being developed in ever increasing 
numbers. The investigators who wish to pursue gene therapy approaches 
are also increasing in number. FDA is interested in exploring with the 
public and industry means to overcome impediments to the development of 
useful therapeutics for a variety of human diseases without diminishing 
patient safety.
    As part of this process, FDA's Center for Biologics Evaluation and 
Research is holding a public meeting to discuss practical concerns 
relating to gene therapy vector production issues. The objectives of 
the meeting will be to: (1) Solicit public testimony from biomedical 
researchers, university faculty members and administrators, 
biotechnology associations, Federal and government agencies, and 
individuals and organizations with relevant information concerning gene 
vector production experience; (2) solicit public testimony from the 
participants concerning potential barriers to gene therapy vector 
product development and innovation, and the means to overcome these 
barriers; (3) discuss quality control issues that have arisen for gene 
therapy vector products; and (4) discuss current good manufacturing 
practices and good laboratory practices and their application to gene 
therapy vector production from the earliest phases of the 
investigational new drug application process through the manufacture of 
licensed products.
    In addition to the participants mentioned above, patient and/or 
consumer organizations and other interested parties are invited to 
participate in the meeting.
    Information presented at the meeting will be considered by FDA in 
the development of future points to consider and other guidance 
documents.

    Dated: August 24, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-21469 Filed 8-26-94; 11:45 am]
BILLING CODE 4160-01-F