[Federal Register Volume 68, Number 198 (Tuesday, October 14, 2003)]
[Notices]
[Page 59190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25844]


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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 December 15, 2003, from 
8 a.m. to 5 p.m.
    Location: The Hilton, Grand Ballroom, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Jayne E. Peterson, 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, 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. 
When available, background materials for this meeting will be posted 1 
business day prior to the meeting on the FDA Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and 
scroll down to Advisory Committee for Reproductive Health Drugs.)
    Agenda: The committee will discuss the public health issues, 
including the safety and potential clinical benefit, associated with 
combining folic acid and an oral contraceptive into a single 
combination product.
    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 31, 
2003. 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 October 31, 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. Submissions received by October 31, 2003, will be 
distributed to the committee. All submissions will be made available to 
the public at the meeting location on the day of the committee meeting.
    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 Jayne Peterson 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: October 7, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-25844 Filed 10-10-03; 8:45 am]
BILLING CODE 4160-01-S