[Federal Register Volume 72, Number 197 (Friday, October 12, 2007)]
[Notices]
[Page 58102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20191]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


In Vitro Analysis of Cell/Scaffold Medical Products; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    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: 301-827-
3079, e-mail: [email protected] (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 athttp://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: October 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20191 Filed 10-11-07; 8:45 am]
BILLING CODE 4160-01-S