[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Notices]
[Pages 40126-40127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Evaluation of In Vivo Efficacy of Platelet Transfusion Products 
and Platelet Substitutes; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop: Evaluation of In Vivo Efficacy of Platelets and 
Platelet Substitutes. This workshop is cosponsored by FDA, the United 
States Army, and the National Institutes of Health. The topics to be 
discussed include: Current methodology for efficacy assessment of 
transfused platelets; definition of efficacy for platelet substitutes; 
animal models of platelet efficacy; discussion of the therapeutic 
``cost versus benefit'' of using platelets treated with novel 
decontamination treatments or stored with novel media/methods, or of 
using platelet substitutes.
    Date and Time: The public workshop will be held on Monday, 
September 28, 1998, 8 a.m. to 5 p.m.
    Location: The public workshop will be held at Wilson Hall, Bldg. 1, 
National

[[Page 40127]]

Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892.
    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 and Request for Oral Presentations: Mail or fax 
registration information (including name, title, firm name, address, 
telephone, and fax number) to the contact person by August 28, 1998. 
Registration at the site will be done on a space available basis on the 
day of the workshop beginning at 7:30 a.m. There is no registration fee 
for the workshop. Requests for oral presentations should be sent to 
Jaroslav G. Vostal, Division of Hematology (HFM-335), Center for 
Biologics Evaluation and Research, Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-496-2577, FAX 301-402-
2780, e-mail ``<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="4a1c05191e0b060a0b7b6409080f18640c0e0b640d051c">[email protected]</a>''. Space is limited, therefore 
interested parties are encouraged to register early.
    If you need special accommodations due to disability, please 
contact Joseph Wilczek at least 7 days in advance.
    Agenda: The goals of the workshop include the following: (1) Review 
current methodology for measuring platelet clinical efficacy; (2) 
define the clinical efficacy of a platelet transfusion; (3) discuss 
similarities and differences between intact platelets and platelet 
substitutes; (4) present animal models used for measuring platelet 
substitute efficacy; and (5) discuss design of clinical trials to 
establish clinical efficacy for platelets and platelet substitutes. The 
information obtained from these presentations will assist FDA in 
developing standards to evaluate novel platelet products and to assure 
the safety and effectiveness of these products.I11Transcripts: 
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 
days after the workshop at a cost of 10 cents per page.

    Dated: July 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-19896 Filed 7-24-98; 8:45 am]
BILLING CODE 4160-01-F


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