[Federal Register: September 27, 2002 (Volume 67, Number 188)]
[Notices]
[Page 61142-61143]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se02-117]
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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 by teleconference on
October 10, 2002, 5:30 p.m. to approximately 7:30 p.m.
Location: National Institutes of Health, Bldg. 29B, conference room
C, 29 Lincoln Dr., Bethesda, MD. This meeting will be held by a
telephone conference call. Members of the public attending the meeting
may participate during the open session of the meeting.
Contact Person: Gail Dapolito or Rosanna L. 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 10, 2002, the committee will receive an update
on individual research programs in the Division of Cell and Gene
Therapies and the Division of Therapeutic Proteins.
Procedure: On October 10, 2002, from 5:30 p.m. to approximately 7
p.m., the meeting is open to the public. Interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. Written submissions may be made to the contact
person by October 3, 2002. Oral presentations from the public will be
scheduled between approximately 6 p.m. and 7 p.m. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before October 3, 2002,
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 10, 2002, from
approximately 7 p.m. to 7:30 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 reports of a review of individual research programs
[[Page 61143]]
in the 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the October 10, 2002, Biological Response Modifiers Advisory
Committee meeting. Because the agency believes there is some urgency to
bring these issues to public discussion and qualified members of the
Biological Response Modifiers Advisory Committee were available at this
time, the Commissioner of Food and Drugs concluded that it was in the
public interest to hold this meeting even if there was not sufficient
time for the customary 15-day public notice.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 20, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-24605 Filed 9-26-02; 8:45 am]
BILLING CODE 4160-01-S