[Federal Register: August 25, 2003 (Volume 68, Number 164)]
[Notices]
[Page 51024-51025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au03-49]
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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 September 29 and 30,
2003, from 8:30 a.m. to 5 p.m.
Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Shalini Jain, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, e-mail: jains@cder.fda.gov, 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. Background materials for this meeting when
available will be posted on the Web site 1 business day before the
meeting at: www.fda.gov/ohrms/dockets/ac/acmenu.htm.
Agenda: On September 29, 2003, the committee will discuss issues
relevant to the conduct of clinical trials and outcome measures for
consideration of approval of drug products for the indications of
induction of ovulation and pregnancy in anovulatory, infertile women
and development of multiple follicles, and pregnancy in ovulatory women
participating in assisted reproductive technology (ART) programs. On
September 30, 2003, the committee will discuss new drug application
(NDA) 21-322, Luveris (lutropin alfa for injection) Serono, Inc., a
recombinant human luteinizing
[[Page 51025]]
hormone (r-hLH) drug product, proposed for concomitant administration
with recombinant human follicle stimulating hormone (r-hFSH), for the
proposed indication of induction of ovulation in infertile women with
severe luteinizing hormone and follicle stimulating hormone deficiency.
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 September 22,
2003. Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. on September 29, 2003, and
between approximately 1:30 p.m. and 2:30 p.m. on September 30, 2003.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
September 22, 2003, 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.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Shalini Jain at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 18, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-21628 Filed 8-22-03; 8:45 am]
BILLING CODE 4160-01-S