[Federal Register Volume 64, Number 187 (Tuesday, September 28, 1999)]
[Notices]
[Page 52331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25228]
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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's regulatory issues.
Date and Time: The meeting will be held on October 18, 1999, 9 a.m.
to 5 p.m.
Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: 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, 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. Current information may also be accessed on the Internet at
FDA's website http://www.fda.gov/cder/coe.htm.
Agenda: Presentations and committee discussions will address the
following draft FDA guidance documents: (1) Draft guidance for
reviewers entitled ``Evaluation of Human Pregnancy Outcome Data'' (see
64 FR 30040, June 4, 1999, including solicitation for comments [Docket
No. 99D-1540]), and (2) draft guidance for industry entitled ``Guidance
for Industry, Establishing Pregnancy Registries Data'' (see 64 FR
30041, June 4, 1999, including solicitation for comments [Docket No.
99D-1541]). The application and impact of these guidances on drugs
reviewed by the Division of Reproductive and Urologic Drug Products
will be considered with specific emphasis on drugs used in assisted
reproductive technology (infertility treatment regimens). In addition,
if revised guidances are available at the time of the meeting, the
topics of labeling for non-contraceptive estrogen drug products and the
clinical evaluation of estrogen and estrogen/progestin-containing drugs
used for hormone replacement therapy in postmenopausal women will be
discussed. Any revised draft guidances will be made available to the
public near the time of the October 18, 1999, advisory committee
meeting.
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 October 13,
1999. Oral presentations from the public will be scheduled between
approximately 9 a.m. and 9:30 a.m. and 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 October 13,
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: September 22, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-25228 Filed 9-27-99; 8:45 am]
BILLING CODE 4160-01-F