E7-20191. In Vitro Analysis of Cell/Scaffold Medical Products; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research and Center for Devices and Radiological Health, and the National Institute of Standards and Technology are announcing a public workshop entitled: In Vitro Analysis of Cell/Scaffold Medical Products. The purpose of the public workshop is to discuss issues that should be considered when evaluating cell/scaffold medical products and to determine which test methods are currently available and which new analytical procedures should be further researched for the evaluation of cell/scaffold medical products.

Date and Time: The public workshop will be held on December 6 and 7, 2007, from 8:30 a.m. to 4 p.m.

Location: The public workshop will be held at the National Transportation and Safety Board, 490 L'Enfant Plaza East, SW., Washington, DC 20594.

Contact Person: Bernadette Kawaley, Center for Biologics Evaluation and Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: [phone], e-mail: [e-mail] (Subject line: Tissue Engineering Workshop).

Registration: Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by November 15, 2007. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m.

If you need special accommodations due to a disability, please contact Bernadette Kawaley (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

The public workshop will feature presentations by experts from the medical field and the government. The first day of the workshop will include discussions on in vitro assays of product performance. The second day of the workshop will include discussions on tools for quantifying the response of cells and tissues.

Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at http://www.fda.gov/​cber/​minutes/​workshop-min.htm.

Dated: October 5, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.