[Federal Register Volume 64, Number 83 (Friday, April 30, 1999)]
[Notices]
[Page 23340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Subcommittee Meeting of the 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: Subcommittee of the Advisory Committee for 
Reproductive Health Drugs, Pregnancy Labeling.
    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 June 3, 1999, 8 a.m. to 
5 p.m..
    Location: Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Ave., 
Silver Spring, MD 20910-3763.
    Contact Person: Kimberly L. Topper, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD, 301-827-7001, FAX 301-827-6776, 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 discuss possible changes to pregnancy 
labeling as a result of the September 12, 1997, part 15 (21 CFR part 
15) public hearing (see 62 FR 41061), the development of various draft 
guidance documents, and risk communications.
    Procedure: 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 21, 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 May 21, 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.
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 23, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-10799 Filed 4-29-99; 8:45 am]
BILLING CODE 4160-01-F