02-15279. Protection of Human Subjects in Clinical Trials; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting.

The Food and Drug Administration (FDA) is announcing the following meeting: Protection of Human Subjects in Clinical Trials. The topics to be discussed are the role of FDA, institutional review boards, and other stakeholders in the protection of human subjects in clinical trials as it relates to minority participation.

Date and Time: The meeting will be held on August 22, 2002, from 7:30 p.m. to 9 p.m.

Location: The meeting will be held at Meharry Medical School, West Basic Science Building Auditorium, rm. M001, 21st Avenue North at Meharry Blvd., Nashville, TN 37208.

Contact: Sandra S. Baxter, Southeast Region, New Orleans District Office, Food and Drug Administration, 297 Plus Park Blvd., Nashville, TN 37217, 615-781-5385, ext. 122, FAX [phone], e-mail: [e-mail].

Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), and written material and requests to make oral presentations, to the contact person by August 8, 2002.

If you need special accommodations due to a disability, please contact Sandra S. Baxter at least 7 days in advance.

Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page.

Dated: June 10, 2002.

John Marzilli,

Acting Senior Associate Commissioner for Regulatory Affairs.