[Federal Register Volume 66, Number 82 (Friday, April 27, 2001)]
[Notices]
[Page 21160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10451]


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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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    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 May 16, 2001, from 8 
a.m. to 6:30 p.m., and May 17, 2001, from 8 a.m. to 1:30 p.m.
    Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Nancy T. Cherry or Denise H. Royster, Center for Biologics 
Evaluations 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 May 16, 2001, the committee will discuss adventitious 
agent testing, tumorigenicity testing, and issues related to residual 
cell substrate deoxyribonucleic acid (DNA) of novel and neoplastic cell 
substrates used to manufacture viral vaccines.
    Procedure: On May 16, 2001, from 9 a.m. to 6:30 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 
May 8, 2001. Oral presentations from the public will be held between 
approximately 2:30 p.m. and 3:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 8, 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 May 16, 2001, from 8 a.m. to 9 
a.m. and on May 17, 2001, from 8 a.m. to 1:30 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)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 19, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-10451 Filed 4-26-01; 8:45 am]
BILLING CODE 4160-01-S