[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
