[Federal Register: October 14, 2003 (Volume 68, Number 198)]
[Notices]
[Page 59190]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc03-74]
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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://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 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