[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Notices]
[Page 42671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20362]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0068]


FDA Tissue Reference Group--The Process; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``FDA Tissue Reference Group--The Process.'' This 
public workshop is intended to provide information about the tissue 
reference group history, process, and other related matters. The FDA 
public workshop follows the American Association of Tissue Banks annual 
meeting held from August 25 to August 28, 2001.
    Date and Time: The public workshop will be held on August 29, 2001, 
from 9:30 a.m. to 11:30 a.m.
    Location: The public workshop will be held at the Marriott Wardman 
Park Hotel, 2660 Woodley Rd. NW., Washington, DC 20008.
    Contact: Martha Wells, Center for Biologics Evaluation and Research 
(HFM-305), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6106, or Ruth Solomon (address 
above), 301-827-6107, FAX 301-827-2844.
    Registration: No preregistration is required. Registration at the 
site will be done on a space available basis on the day of the public 
workshop, beginning at 8:30 a.m. There is no registration fee. If you 
need special accommodations due to a disability, please contact Martha 
Wells at least 7 days in advance.
    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. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
per page. The public workshop transcript will also be available on the 
Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

SUPPLEMENTARY INFORMATION: The Tissue Reference Group (TRG) is part of 
the Tissue Action Plan, which was developed to implement the ``Proposed 
Approach to the Regulation of Cellular and Tissue-based Products'' 
dated February 28, 1997 (62 FR 9721, March 4, 1997). The purpose of the 
TRG is to provide a single reference point for product specific 
questions from sponsors or their designated representatives about 
jurisdiction, policy, and regulation of human cells, tissues, and 
cellular and tissue-based products (HCT/Ps). The agenda for the public 
workshop includes the following: (1) History of the TRG; (2) TRG 
process for making recommendations to the FDA Center Directors; (3) 
request for designation process; (4) confidentiality and the Freedom of 
Information Act process; and (5) factors for regulation of HCT/Ps 
solely under section 361 of the Public Health Service Act. The public 
workshop information is posted on the Internet at http://www.fda.gov/cber/meetings/trgproc082901.htm.

    Dated: August 8, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20362 Filed 8-13-01; 8:45 am]
BILLING CODE 4160-01-S