[Federal Register Volume 69, Number 68 (Thursday, April 8, 2004)]
[Notices]
[Pages 18593-18594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Use of Radiolabeled Platelets for Assessment of In Vivo Viability 
of Platelet Products; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Use of Radiolabeled Platelets for Assessment of the 
In Vivo Viability of Platelet Products''. The goal of the workshop is 
to orient the transfusion community to a new approach for assessing the 
quality of platelet products through radiolabeling studies in healthy 
human volunteers.
    Date and Time: The public workshop will be held on May 3, 2004, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at Lister Hill 
Auditorium, Building 38A, National Institutes of Health, 8600 Rockville 
Pike, Bethesda, MD 20894.

[[Page 18594]]

    Contact Person: Joseph Wilczek, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, e-mail: 
[email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to the contact person by 
April 23, 2004. Early registration is recommended because seating is 
limited to 176 participants. Registration will be done on a space 
available basis on the day of the workshop, beginning at 7:15 a.m. 
There is no registration fee.
    If you need special accommodations due to a disability, please 
contact Joseph Wilczek (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA, in co-sponsorship with the Hitchcock 
Foundation, is sponsoring a public workshop on the development of a new 
standard for assessing the in vivo quality of platelet products through 
radiolabeling studies. The workshop objectives are to review current 
methods in radiolabeling studies, to propose a new approach that will 
set the performance of fresh platelets as a gold standard, to present 
data on application of a new standard, and to discuss the development 
of a novel experimental protocol. The public workshop agenda is posted 
on FDA's Internet at http://www.fda.gov/cber/meetings/radioplt0504.htm.
    Transcripts: Transcripts of the 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. In addition, the transcript will be placed on FDA's Internet 
at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: April 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8023 Filed 4-7-04; 8:45 am]
BILLING CODE 4160-01-S