[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Notices]
[Page 40127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19892]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0497]
Hematopoietic Stem/Progenitor Cell Products: Discussion of
Unrelated Allogeneic Placental/Umbilical Cord Blood and Peripheral
Blood Cell Banking and Transplantation; Notice of 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 the following
public workshop: Hematopoietic Stem/Progenitor Cell Products:
Discussion of Unrelated Allogeneic Placental/Umbilical Cord Blood and
Peripheral Blood Cell Banking and Transplantation. This workshop, which
is cosponsored by FDA and the National Institutes of Health, will
include a discussion of the current status of clinical and nonclinical
laboratory data to support the development of standards for unrelated
allogeneic peripheral and placental/umbilical cord blood hematopoietic
stem/progenitor cell products; studies to obtain data for product
safety and effectiveness; and the notice and request for comments
entitled ``Request for Proposed Standards for Unrelated Allogeneic
Peripheral and Placental/Umbilical Cord Blood Hematopoietic Stem/
Progenitor Cell Products; Request for Comments'' that published in the
Federal Register of January 20, 1998 (63 FR 2985).
Date and Time: The public workshop will be held on Thursday,
September 10, 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.
Contact Person: Joseph Wilczek, Food and Drug Administration,
Center for Biologics Evaluation and Research (HFM-350), 1401 Rockville
Pike, Rockville, MD 20852, 301-827-6129, FAX 301-827-2843.
Supplementary Information: The goals of this workshop are to: (1)
Discuss the current status of related and unrelated allogeneic
peripheral blood hematopoietic stem/progenitor cell collection; (2)
discuss the current status of unrelated allogeneic placental/umbilical
cord blood banking and transplantation; (3) discuss issues regarding
the administration of cytokines to normal donors for the mobilization
of peripheral blood hematopoietic stem/progenitor cells and
transplantation; and (4) address questions the public may have
regarding the notice and request for comments published in the Federal
Register of January 20, 1998 (63 FR 2985). The information obtained
from these presentations will assist FDA and the interested public in
developing standards for unrelated allogeneic peripheral blood and
placental/umbilical cord blood hematopoietic stem/progenitor cell
products.
Registration and Requests for Oral Presentations: Send or fax
registration information (including name, title, firm name, address,
telephone, and fax number), written material, and requests to make oral
presentations, to the contact person by Tuesday, August 11, 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 this workshop.
If you need special accommodations due to a disability, please
contact Joseph Wilczek at least 7 days in advance.
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. 98-19892 Filed 7-24-98; 8:45 am]
BILLING CODE 4160-01-F
