[Federal Register: July 20, 2006 (Volume 71, Number 139)]
[Page 41220-41221]
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.


[[Page 41221]]

    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 August 29, 2006, from 8 
a.m. to 5:30 p.m.
    Location: Hilton Hotel, The Ballrooms, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Teresa Watkins, 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, FAX: 301-827-6776, e-mail: Teresa.Watkins@fda.hhs.gov or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512537. Please call the 
Information Line for up-to-date information on this meeting. When 
available, background materials for this meeting will be posted 1 
business day prior to the meeting on the FDA Website at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
 Click on the year 2006 and 

scroll down to the Advisory Committee for Reproductive Health Drugs.)
    Agenda: The committee will discuss new drug application (NDA) 21-
945, proposed trade name Gestiva, 17 alpha-hydroxyprogesterone caproate 
injection, 250 mg/mL, Adeza Biomedical, for the proposed indication 
prevention of preterm delivery in women with a history of a prior 
preterm delivery.
    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 on or before 
August 15, 2006. 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 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 
on or before August 15, 2006.
    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 Teresa Watkins 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: July 13, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11538 Filed 7-19-06; 8:45 am]