[Federal Register Volume 65, Number 40 (Tuesday, February 29, 2000)]
[Notices]
[Pages 10811-10812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pregnancy Labeling Subcommittee 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: 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 March 28, 2000, 9 a.m. 
to 5 p.m. and on March 29, 2000, 8 a.m. to 5 p.m.
    Location: Hilton Hotel, Crystals Ballroom, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact: Jayne E. Peterson or Robin M. Spencer, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
[email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-44-30572 in the Washington, DC area), code 12537. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: On March 28, 2000, the subcommittee presentations and 
discussions will include the following topics: (1) The status of 
proposed pregnancy labeling changes, (2) the status of activities 
related to preclinical assessment of reproductive toxicity, and (3) FDA 
draft guidance for industry entitled ``Establishing Pregnancy 
Registries'' (see 64 FR 30041, June 4, 1999, including solicitation for 
comments [Docket No. 99D-1541], see also the FDA Internet at 
www.fda.gov.cder/guidance/index.htm under the heading ``Clinical/
Medical

[[Page 10812]]

(Draft)''). The subcommittee will also address the methodological and 
operational challenges in developing and running a pregnancy registry. 
On March 29, 2000, the subcommittee presentations and discussions will 
address strategies for monitoring drug risks in pregnant women.
    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 March 14, 
2000. On March 28, 2000, oral presentations from the public will be 
scheduled between approximately 10:15 a.m. and 10:45 a.m. and 2:45 p.m. 
and 3 p.m. On March 29, 2000, oral presentations from the public will 
be scheduled between approximately 1:30 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 March 14, 
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: February 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-4666 Filed 2-28-00; 8:45 am]
BILLING CODE 4160-01-F