[Federal Register Volume 65, Number 183 (Wednesday, September 20, 2000)]
[Notices]
[Page 56914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Streamlining the Blood Donor History Questionnaire; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Streamlining the Blood Donor History 
Questionnaire.'' The purpose of the public workshop is to streamline 
the blood donor history questionnaire without compromising the safety 
of the nation's blood supply. The public workshop is jointly sponsored 
by FDA and the American Association of Blood Banks.
    Date and Time: The public workshop will be held on October 16, 
2000, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Lister Hill 
Conference Center, National Institutes of Health, Building 38A, 8600 
Rockville Pike, Bethesda, MD 20894.
    Contact: Joseph Wilczek, Center for Biologics Evaluation and 
Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, FAX 301-827-2843.
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax number) to Joseph 
Wilczek (address above) by Friday, October 6, 2000. There is no 
registration fee for the public workshop. Seating is limited, therefore 
interested parties are encouraged to register early. Registration at 
the site will be done on a space available basis on the day of the 
public workshop, beginning at 7:30 a.m. If you need special 
accommodations due to a disability, please contact Joseph Wilczek at 
least 7 days in advance.
    Agenda: The public workshop is expected to address, but is not 
limited to, the following issues and topics: (1) The role of the blood 
donor interview in assuring blood safety; (2) overview of past efforts 
to improve the donor history questionnaire; (3) different methodologies 
in performing donor history evaluations; (4) validating the donor 
history questionnaire as a tool for reducing and eliminating risks to 
the blood supply; (5) analysis of error and accident reports and post 
donation information that resulted from inaccurate or misleading donor 
history responses; and (6) suggestions on how the donor questionnaire 
can be streamlined without compromising either donor, product, or 
recipient safety.
    The public workshop agenda will be posted on the FDA Internet as 
soon as the information becomes available. The FDA Internet address is 
http://www.fda.gov/cber/whatsnew.htm.
    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 meeting at a cost of 10 cents 
per page. The transcript will also be available on the FDA Internet 
site at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: September 14, 2000.
William K. Hubbard,
Senior Associate, Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24124 Filed 9-19-00; 8:45 am]
BILLING CODE 4160-01-F