[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