[Federal Register: August 16, 2007 (Volume 72, Number 158)]
[Notices]
[Page 46092]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au07-102]
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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: CBERTrainingSuggestions@fda.hhs.gov (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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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