01-20160. Veterinary Medicine Advisory Committee; 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 Committee: Veterinary Medicine Advisory Committee.

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 September 13 and 14, 2001, from 8:30 a.m. to 5 p.m.

Location: The DoubleTree Hotel, Plaza Rooms I, II, and III, 1750 Rockville Pike, Rockville, MD.

Contact: Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-4515, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area), code 12546. Please call the Information Line for up-to-date information on this meeting.

Agenda: On September 13 and 14, 2001, the committee will seek recommendations on the issue of import tolerances under the provisions of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish drug residue tolerances (import tolerances) for imported food products of animal origin for drugs that are used in exporting countries, but that are unapproved new animal drugs in the United States. Food products of animal origin that are in compliance with the import tolerance may be imported into the United States. Elsewhere in this issue of the Federal Register, FDA is publishing an advance notice of proposed rulemaking (ANPRM) that details the consideration of proposing a regulation for establishing import tolerances. The agency intends to consider the comments made at the advisory committee meeting and the written comments received in response to the ANPRM in drafting the proposed regulation. The comments should be sent to Docket No. 01N-0284. Background information including the legislative history for import tolerances, the domestic regulation of drug residues, and enforcement issues will be made available to the Veterinary Medicine Advisory Committee members and the public in advance of the meeting and posted on the Center for Veterinary Medicine home page (http://www.fda.gov/​cvm). A limited number of paper copies of the background information will be available at the registration table on September 13, 2001.

Procedure: Interested persons may present data, information, or views, orally or in writing, on the import tolerance issue pending before the committee. Written submissions may be made to the contact person by August 31, 2001. Oral presentations from the public are tentatively scheduled for the afternoon of September 14, 2001. The time allotted for each presentation may be limited. Those desiring to make oral presentations should notify the contact person before August 31, 2001, 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. You will be notified of your allotted time prior to the meeting. Your entire statement should be submitted for the record.

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

Dated: July 13, 2001.

Bonnie H. Malkin,

Special Assistant to the Senior Associate Commissioner.