[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Notices]
[Page 50996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pregnancy Labeling Subcommittee Advisory Committee for 
Reproductive Health Drugs; 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: Pregnancy Labeling Subcommittee of the Advisory 
Committee for Reproductive Health Drugs.
    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 September 12, 2000, 10 
a.m. to 12 noon.
    Location: Hyatt Regency, One Bethesda Metro Center, Bethesda, MD.
    Contact Person: Jayne E. Peterson, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, or by e-mail: at 
[email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12537. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: The subcommittee will meet to identify and discuss those 
drug and biologic products for which improved pregnancy labeling is 
critical for: (1) Effective prescribing during pregnancy, or (2) proper 
counseling of pregnant women who have been inadvertently exposed.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing on issues pending before the subcommittee. 
Written submissions may be made to the contact person by September 6, 
2000. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before September 6, 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: August 10, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-21249 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F