[Federal Register: September 18, 2003 (Volume 68, Number 181)]
[Notices]
[Page 54733-54734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18se03-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biological Response Modifiers Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committee: Biological Response Modifiers Advisory
Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on October 9, 2003, from 8
a.m. to 6 p.m.; and on October 10, 2003, from 8 a.m. to 2 p.m.
Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Gail Dapolito or Rosanna Harvey, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 12389. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On October 9 and 10, 2003, the committee will discuss the
following topics: (1) Issues related to manufacturing data and clinical
evidence to be provided in a biologics license application (BLA) for
marketing approval of allogeneic islet transplantation to treat type 1
diabetes mellitus, (2) hear updates of individual research programs in
the Office of Cellular, Tissue and Gene Therapies, and (3) reports of
internal research programs in the Office of Cellular, Tissue and Gene
Therapies.
Procedure: On October 9, 2003, from 8 a.m. to approximately 5:15
p.m.; and on October 10, 2003, from 8 a.m. to approximately 2 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending
[[Page 54734]]
before the committee. Written submissions may be made to the contact
person by October 2, 2003. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 1:30 p.m. on October 9 and
between approximately 10:30 a.m. and 11 a.m. on October 10. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
October 2, 2003, and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation.
Closed Committee Deliberations: On October 9, 2003, from
approximately 5:15 p.m. to 6 p.m., the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)).
The committee will discuss a report of a review of internal
research programs in the Office of Cellular, Tissue and Gene Therapies,
Center for Biologics Evaluation and Research.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Gail Dapolito at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 9, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23780 Filed 9-17-03; 8:45 am]
BILLING CODE 4160-01-S