Food and Drug Administration, HHS.
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://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 unprotected Start Printed Page 66114sex 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://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and scroll down to NDAC meetings.)
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 presentation.
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 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).Start Signature
Dated: November 17, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-29334 Filed 11-24-03; 8:45 am]
BILLING CODE 4160-01-S