[Federal Register: August 25, 2003 (Volume 68, Number 164)]
[Page 51024-51025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Advisory Committee for Reproductive Health Drugs; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 
    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 
    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]