[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