[Federal Register Volume 66, Number 35 (Wednesday, February 21, 2001)]
[Notices]
[Pages 11033-11034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4230]


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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 5, 2001, 8:30 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact: William Freas or Pearline K. 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 5, 2001, the committee will hear updates on: 
(1) The Laboratory of Immunobiochemistry personnel, (2) lot release 
statistics, (3) new guidance documents, (4) research and 
standardization programs, and (5) a compliance report. The committee 
will discuss whether master seed stocks of mold strains used for 
allergenic extracts should be rederived to reduce a theoretical risk 
of transmissible spongiform encephalopathy transmission. The 
committee will also discuss the statistical power of clinical 
studies used to assess bioequivalence as it applies to allergen 
extract studies. In the afternoon, the committee will discuss 
particulates that appear in allergen extracts and the effect of 
these particulates on the safety and efficacy on these products. In 
closed session, the committee will receive a report on the status of 
an investigational new drug application and product license 
application supplement.
    Procedure: On March 5, 2001, from 8:30 a.m. to 3:30 p.m., the 
meeting is open to the

[[Page 11034]]

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 
17, 2001. Oral presentations from the public will be scheduled 
between approximately 11:10 a.m. and 11:40 a.m., and between 
approximately 2:40 p.m. and 3:10 p.m. on March 5, 2001. Time 
allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person 
before February 21, 2001, 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 5, 2001, from 
approximately 3:30 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)). This portion will be closed to 
permit discussion of these materials.
    FDA regrets that it was unable to publish this notice 15 days 
prior to the March 5, 2001, 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 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: February 14, 2001.
Bonnie H. Malkin,
Special Assistant to the Senior Associate Commissioner.
[FR Doc. 01-4230 Filed 2-20-01; 8:45 am]
BILLING CODE 4160-01-S