[Federal Register Volume 64, Number 26 (Tuesday, February 9, 1999)]
[Notices]
[Page 6367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3149]
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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 February 22, 1999, 8
a.m. to 5 p.m.
Location: Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: William Freas or Pearline K. Muckelvene, Center for
Biologics Evaluation and Research (HFM-21), 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: The committee will discuss: (1) The current organization
and the research programs of the Laboratory of Immunobiochemistry,
Division of Allergenic Products and Parasitology, Office of Vaccines
Research and Review; (2) regulatory proposals concerning the potency
limits for standardized allergen vaccines and the requirements for
protein content of these vaccines; (3) modifications of the competitive
ELISA assay; (4) proposed package insert for allergen extracts; (5)
issues regarding use of pure allergens versus U.S. standards; and (6)
an update on the status of class IIIA allergen extracts.
Procedure: On February 22, 1999, from 8 a.m. to 3 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
February 16, 1999. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before February 16,
1999, 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 February 22, 1999, from 3 p.m.
to 5 p.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4))
regarding applications under FDA review.
FDA regrets that it was unable to publish this notice 15 days prior
to the February 22, 1999, Allergenic Products Advisory Committee
meeting. Because the agency believes there is some urgency to bring
these issues to public discussion and qualified members of the
Allergenic Products Advisory Committee were available at this time, the
Commissioner 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: February 3, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-3149 Filed 2-5-99; 8:45 am]
BILLING CODE 4160-01-F
