[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Notices]
[Page 40126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19955]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Granulocytes for Transfusion: Research and Clinical Experience; 
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: Granulocytes for Transfusion: Research and Clinical 
Experience. This workshop, which is cosponsored by FDA and the National 
Institutes of Health (NIH), will include a discussion of the effects of 
cytokine administration on normal donors, the functional properties of 
the transfusion product, the effects of storage conditions on the 
product, and the safety and effectiveness of the product.
    Date and Time: The public workshop will be held on Friday, 
September 11, 1998, 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Jack Masur 
Auditorium, Bldg. 10, National 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 Requests for Oral Presentations: Send or fax 
registration information (including name, title, firm name, address, 
telephone, and fax number) and written material and requests to make 
oral presentations to the contact person by Wednesday, August 12, 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.
    If you need special accommodations due to a disability, please 
contact Joseph Wilczek at least 7 days in advance.
    Agenda: The findings that administration of Granulocyte-Colony 
Stimulating Factor or Granulocyte-Macrophage Colony Stimulating Factor 
to normal volunteers results in the peripheral mobilization of high 
concentrations of granulocytes has renewed an interest in the 
collection of granulocytes for transfusion. The goals of the workshop 
are to discuss: (1) The current scientific and clinical experience with 
cytokine mobilized granulocyte transfusion products; (2) the effects of 
cytokine administration on normal donors; (3) the functional properties 
of transfusion product; and (4) studies needed to establish the safety 
and effectiveness of the transfusion product. The information obtained 
from these presentations will assist FDA in assessing the safety and 
effectiveness of the product and will assist NIH in identifying areas 
in need of further research.
    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 workshop at a cost of 10 cents 
per page.

    Dated: July 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-19955 Filed 7-24-98; 8:45 am]
BILLING CODE 4160-01-F