[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Notices]
[Page 46092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Processing Methods for Orthopedic, Cardiovascular, and Skin 
Allografts; 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 (CBER), Center for Devices and Radiological 
Health (CDRH), and Office of Regulatory Affairs (ORA) and the Centers 
for Disease Control and Prevention (CDC) are announcing a public 
workshop entitled ``Processing Methods for Orthopedic, Cardiovascular, 
and Skin Allografts.'' The purpose of the public workshop is to discuss 
various methods used to process tissue allograft, pre- and post-
processing cultures, and disinfection and sterilization of tissues.
    Date and Time: The public workshop will be held on October 11, 
2007, from 8:30 a.m. to 5 p.m., and October 12, 2007, from 8:30 a.m. to 
1 p.m.
    Location: The public workshop will be held at the Masur Auditorium, 
Building 10 Clinical Center, National Institutes of Health, Bethesda, 
MD 20892.
    Contact: 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 
Processing Workshop).
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone and fax numbers) to the 
contact person by September 18, 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) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: The public workshop will feature 
presentations by experts from the government, the medical field and the 
tissue industry. The first day of the workshop will include discussions 
on: (1) Surgeon clinical practices, experiences, expectations, and 
assumptions regarding tissue allografts and patient safety; and (2) 
Pre- and Post-Processing cultures for microorganisms--usefulness, 
reliability, and validation. The second day of the workshop will focus 
on disinfection and sterilization of tissues--experiences, 
expectations, and challenges.
    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: August 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16182 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S