[Federal Register Volume 60, Number 31 (Wednesday, February 15, 1995)]
[Notices]
[Pages 8662-8663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-3800]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0024]


Somatic Cell and Gene Therapy Manufacturing Issues; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), is announcing a public meeting to 
discuss somatic cell and gene therapy production issues. The meeting is 
designed to discuss several issues related to the limited access to 
ancillary components on the development of somatic cell and gene 
therapies and to solicit public testimony regarding these issues.

DATES: The public meeting will be held on Monday, March 6, 1995, from 6 
p.m. to 7:30 p.m., immediately following the National Institutes of 
Health, Recombinant DNA Advisory Committee meeting. Submit written 
requests for participation and written copies or summaries of oral 
presentations, or any written comments for possible discussion at the 
meeting by February 27, 1995. Written comments may also be submitted 
after the meeting to the Dockets Management Branch (address below).

ADDRESSES: The public meeting will be held at the National Institutes 
of Health, Bldg. 31C, 9000 Rockville Pike, conference room 6, Bethesda, 
MD. No registration is required to attend the meeting. Submit to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, written requests for 
participation and written copies or summaries of oral presentations, or 
any written comments. Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document.
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 and somatic cell therapy 
is rapidly evolving. FDA is interested in exploring approaches to 
overcome barriers to the development of novel and useful therapeutics 
for a variety of human diseases without diminishing patient safety. To 
facilitate this process, FDA is holding a public meeting to discuss 
practical concerns relating to gene therapy vector production and 
somatic cell production.
    In recent months, FDA has been asked by several sponsors of 
clinical investigations conducted under investigational new drug 
applications to allow modifications to gene therapy protocols, due to 
limited access to critical reagents and products, e.g., growth factors 
used in the expansion of cells for somatic cell and gene therapies. 
Limited access to ancillary components could potentially lead to the 
adoption of suboptimal somatic cell and gene therapy procedures which 
might affect the investigation of the safety and efficacy of somatic 
cell and gene therapy products. This limited access may, in the long 
term, unduly restrict progress in the field of somatic cell and gene 
therapy in the United States.
    To obtain more information, FDA would like to discuss several 
issues related to the limited access to ancillary components on the 
development of somatic cell and gene therapies, including: (1) What are 
the ancillary [[Page 8663]] components that are most critical to 
somatic cell and gene therapy trials? (2) What are the main reasons for 
the lack of availability of ancillary components? (3) Are there 
alternate suppliers of ancillary components? and (4) What is the impact 
of the limited supply of ancillary components on somatic cell and gene 
therapy development?
    FDA is soliciting public testimony from biomedical researchers, 
university faculty and administrators, biotechnology associations, 
other Federal and government agencies, and other individuals and 
organizations with relevant information concerning limited access to 
critical ancillary componets for gene therapy and somatic cell therapy 
manufacturing. FDA also solicits testimony, in particular, from 
affected individuals and consumer organizations. All interested parties 
are invited to participate in the meeting.
    Every effort will be made to accommodate each person who wants to 
participate in the public meeting. However, because presentations will 
be limited to the first 30 minutes of the meeting, the time allotted 
for each presentation will be restricted to 5 minutes. Due to the time 
limitations of the meeting, all requests may not be granted. Therefore, 
each person who wants to participate in the meeting is encouraged, by 
close of business on February 27, 1995, to do the following: (1) File a 
written request of participation containing the name, address, phone 
number, facsimile number, affiliation, if any, of the participant, and 
topic of the presentation, and (2) submit a copy or summary of their 
presentation. The requested information, including the written notice 
of participation, may be submitted to the Dockets Management Branch 
(address above). After the presentations, the remainder of the meeting 
will be used to allow for discussion.
    Before the meeting, CBER will determine the schedule for the 
presenters. A schedule of the presenters will be filed with the Dockets 
Management Branch (address above) and mailed or FAX'ed to each 
participant before the meeting. Interested persons attending the 
meeting who did not request an opportunity to make a presentation or 
those who did request an opportunity to make a presentation but due to 
the time limitations were not granted the request will be given the 
opportunity to make an oral presentation at the conclusion the meeting, 
as time permits.
    FDA will consider information presented and discussed at the 
meeting in the developing of future points to consider and regulatory 
and guidance documents, and in identifying topics for future 
discussion.
    Transcripts of the public meeting may be requested in writing from 
the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the meeting, at a cost of 10 cents 
per page. The transcript of the public meeting and copies of 
information and comments submitted to the meeting record will be 
available for examination at the Dockets Management Branch (address 
above) approximately 15 working days after the meeting, between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: February 10, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-3800 Filed 2-10-95; 3:00 pm]
BILLING CODE 4160-01-F