[Federal Register: October 23, 2001 (Volume 66, Number 205)]
[Notices]               
[Page 53616-53617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc01-78]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 53617]]

    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: Vaccines and Related Biological 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 November 28, 2001, from 
8:30 a.m. to 5:15 p.m.; and on November 29, 2001, from 8:30 a.m. to 
2:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact: Nancy T. Cherry or Denise H. Royster, 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 12391. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On November 28 and 29, 2001, the committee will review 
issues surrounding efficacy trial endpoints for vaccines for the 
prevention of Human Papilloma Virus. On November 29, 2001, the 
committee will discuss the intramural scientific research of the 
Laboratory of Bacterial Toxins.
    Procedure: On November 28, 2001, from 12:30 p.m. to 5:15 p.m.; and 
on November 29, 2001, from 8:30 a.m. to 1:40 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 by 
November 16, 2001. Written submissions may be made to the contact 
person by November 16, 2001. On November 28, 2001, oral presentations 
will be held between approximately 3:15 p.m. and 4:15 p.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
November 16, 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 November 28, 2001, from 8:30 
a.m. to 12:30 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)). On November 29, 2001, from 1:45 p.m. to 2:30 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)). The meeting will be closed to discuss personal information 
concerning individuals associated with the research program.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26576 Filed 10-22-01; 8:45 am]
BILLING CODE 4160-01-S