[Federal Register Volume 65, Number 15 (Monday, January 24, 2000)]
[Notices]
[Page 3722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1543]


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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). The meeting will 
be open 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 10, 2000, 8:30 
a.m. to 3:30 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-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: The committee will receive an update on the organizational 
changes of the Laboratory of Immunobiochemistry, its regulatory 
activities (including reference replacements and lot release 
statistics) and its research activities. The committee will hear 
presentations and discuss the following regulatory issues: (1) Potency 
limits for standardized allergen vaccines, (2) selection of allergen 
extracts for standardization, and (3) a proposed algorithm for the 
standardization of new allergens.
    Procedure: On February 10, 2000, from 8:30 a.m. to 3:30 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 
January 26, 2000. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12 m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 3, 2000, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 11, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-1543 Filed 1-21-00; 8:45 am]
BILLING CODE 4160-01-F