Skip to Content

During the funding lapse, is not being supported. If data feeds are not available from GPO, will not be updated, so please use the official edition of the Federal Register on Govinfo ( If there is a technical issue with the Public Inspection List, you can view the documents on public inspection at our office in Washington, DC or on


Processing Methods for Orthopedic, Cardiovascular, and Skin Allografts; Public Workshop

Document Details

Information about this document as published in the Federal Register.

Document Statistics
Document page views are updated periodically throughout the day and are cumulative counts for this document including its time on Public Inspection. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble


Food and Drug Administration, HHS.


Notice of public workshop.

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: (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.

End Preamble Start Supplemental 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​cber/​minutes/​workshop-min.htm.

Start Signature

Dated: August 10, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. E7-16182 Filed 8-15-07; 8:45 am]