[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
