04-10589. Food 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 Committees: Food Advisory Committee, Dietary Supplements Subcommittee of the Food Advisory Committee and Contaminants and Natural Toxicants Subcommittee of the Food Advisory Committee. The Food Advisory Committee and its Dietary Supplements subcommittee will meet for the first portion of the meeting; the Food Advisory Committee and its Contaminants and Natural Toxicants subcommittee will meet for the second portion of the meeting.

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: This meeting will have two parts. The first portion of the meeting will be the Food Advisory Committee and its Dietary Supplements Subcommittee and will be held on June 7, 2004, from 8 a.m. until 5 p.m.; and on June 8, 2004, from 8 a.m. until 1:45 p.m.

The second portion of the meeting will be the Food Advisory Committee and its Contaminants and Natural Toxicants Subcommittee and will be held on June 8, 2004, from 2 p.m. until 6 p.m.

Location: Bethesda Marriott, Grand Ballroom, 5150 Pooks Hill Rd., Bethesda, MD.

Contact Person: Linda L. Reed, Center for Food Safety and Applied Nutrition (HFS-006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 301-436-2397, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014510564. Please call the Information Line for up-to-date information on this meeting.

Agenda: FDA has received health claim petitions concerning the following topics: (1) Glucosamine and chondroitin sulfate and osteoarthritis, and (2) crystalline glucosamine sulfate and osteoarthritis. The purpose of the portion of the meeting of the Food Advisory Committee and its Dietary Supplements Subcommittee is to gather information and to receive advice and recommendations relating to the etiology of osteoarthritis, its modifiable risk factors, and the relevance of scientific studies cited in the petitions to substantiating the substance-disease relationship.

The purpose of the portion of the meeting of the Food Advisory Committee and its Contaminants and Natural Toxicants Subcommittee is to discuss data needs pertaining to the evaluation of furan, a chemical formed during thermal treatments of food. Elsewhere in this issue of the Federal Register, FDA is publishing a notice that requests the submission of data and information pertaining to the occurrence of furan in food, its mechanism of formation as well as its mechanism of toxicity.

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 May 24, 2004.

For the portion of the meeting of the Food Advisory Committee and its Dietary Supplements Subcommittee, oral presentations from the public will be scheduled between approximately 3:30 p.m. and 5 p.m. on June 7, 2004.

For the portion of the meeting of the Food Advisory Committee and its Contaminants and Natural Toxicants subcommittee, oral presentations from the public will be scheduled between approximately 4 p.m. and 5 p.m. on June 8, 2004.

Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 24, 2004, 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, the specific portion of the meeting at which they wish to present, 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 Linda Reed 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: April 29, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.