[Federal Register: February 28, 2002 (Volume 67, Number 40)]
[Notices]
[Page 9304-9305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe02-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Allergenic Products 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: Allergenic Products 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 March 15, 2002, from 8
a.m. to 4:15 p.m.
[[Page 9305]]
Location: Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: William Freas or Pearline Muckelvene, 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 12388. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On March 15, 2002, the committee will hear updates on: (1)
Personnel and lot release activities of the Laboratory of
Immunobiochemistry (LIB), (2) LIB research programs, (3) particulates
in allergen extracts, (4) reduction of possible risk of exposure to
transmissible spongiform encephalopathy (TSE) agents in allergen
extracts, and (5) the statistical power of clinical studies used to
assess bioequivalence of allergen extracts. The committee will discuss:
(1) Considerations for the regulation of recombinant allergens for the
diagnosis and treatment of allergic disease, and (2) glycerol in
allergen extracts.
Procedure: On March 15, 2002, from 8 a.m. to 3:15 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
March 7, 2002. Oral presentations from the public will be scheduled
between approximately 11:30 a.m. and 12 noon, and between 2:45 p.m. and
3:15 p.m. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before March 7, 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 March 15, 2002, from
approximately 3:15 p.m. to 4:15 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)). This
portion will be closed to permit discussion of the report of the site
visit review of the Laboratory of Immunobiochemistry, in the Division
of Bacterial, Parasitic & Allergenic Products, in the Office of
Vaccines Research and Review, Center for Biologics Evaluation and
Research.
Persons attending FDA 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 William Freas or
Pearline Muckelvene at least 7 days in advance of meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: February 22, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent
Relations.
[FR Doc. 02-4686 Filed 2-27-02; 8:45 am]
BILLING CODE 4160-01-S