Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee With the Pregnancy Labeling Subcommittee of 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.

Names of Committees: Joint meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee with the Pregnancy Labeling Subcommittee of 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 September 12, 2000, 1 p.m. to 5:30 p.m.

Location: Hyatt Regency, Baccarat/Haverford Rooms, One Bethesda Metro Center, Bethesda, MD.

Contact Person: Jayne E. Peterson, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: PETERSONJ@CDER.FDA.GOV, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12530. Please call the Information Line for up-to-date information on this meeting.

Agenda: The subcommittees will meet jointly to discuss existing information and needs with respect to prescription drug therapy in nursing mothers.

Procedure: Interested persons may present data, information, or views, orally or in writing on issues pending before the subcommittees. Written submissions may be made to the contact person by September 6, 2000. Oral presentations from the public will be scheduled between approximately 3:15 p.m. and 4:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 6, 2000, 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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).