[Federal Register: November 25, 2003 (Volume 68, Number 227)]
[Page 66113-66114]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2001P-0075]

Joint Meeting of the Nonprescription Drugs Advisory Committee and 
the Advisory Committee for Reproductive Health Drugs; Notice of Meeting

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 Committees: Nonprescription Drugs Advisory Committee and 
the Advisory Committee for Reproductive Health Drugs.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 16, 2003, from 
8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``01P-0075--Switch Status of 
Emergency Contraceptives from Rx to OTC'' and follow the prompts to 
submit your statement. Written comments should be submitted to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Karen M. Templeton-Somers, 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 e-mail: SomersK@cder.fda.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area) codes 12541 and 12537. Please call the 
Information Line for up to date information on this meeting.
    Agenda: The committees will consider the safety and efficacy of new 
drug application 21-045, proposing over-the-counter use of Plan B 
(levonorgestrel), Women's Capitol Corp., for reducing the chance of 
pregnancy after unprotected sex (if contraceptive failed or if birth 
control was not used). The sponsor proposes a 0.75 milligram (mg) 
tablet taken as soon as possible, but no later than 72 hours after 

[[Page 66114]]

sex with a second 0.75 mg tablet taken 12 hours after the first tablet.
    The background material will become available no later than the day 
before the meeting and will be posted under the Nonprescription Drugs 
Advisory Committee (NDAC) docket 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 NDAC 
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions must be made to the contact person by December 5, 
2003. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before December 5, 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 
    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 Karen Templeton-
Somers 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: November 17, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-29334 Filed 11-24-03; 8:45 am]