[Federal Register Volume 63, Number 58 (Thursday, March 26, 1998)]
[Notices]
[Page 14719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7895]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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: Advisory Committee for Reproductive Health
Drugs.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on April 20, 1998, 8:30
a.m. to 5 p.m.
Location: Holiday Inn, Ballrooms I, II, III, and IV, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Kimberly L. Topper or Robin M. Spencer, Center for
Drug Evaluation and Research (HFD-21), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857-1000, 301-443-5455, or e-mail
[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 committee will discuss new drug application (NDA) 20-
797, Antocin (atosiban injection, R. W. Johnson) for use in the
management of premature labor.
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 April 10,
1998. 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 April 10, 1998, 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: March 19, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7895 Filed 3-25-98; 8:45 am]
BILLING CODE 4160-01-F