[Federal Register: February 28, 2002 (Volume 67, Number 40)]
[Page 9304-9305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Allergenic Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 
    Persons attending FDA advisory committee meetings are advised that 
the agency is not responsible for providing access to electrical 
    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 
[FR Doc. 02-4686 Filed 2-27-02; 8:45 am]