[Federal Register Volume 65, Number 75 (Tuesday, April 18, 2000)]
[Notices]
[Page 20825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0497]


Request for Proposed Standards for Unrelated Allogeneic 
Peripheral and Placental/Umbilical Cord Blood Hematopoietic Stem/
Progenitor Cell Products; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 90 
days the comment period for the notice requesting the submission of 
proposed product standards for unrelated allogeneic peripheral and 
placental/umbilical cord blood hematopoietic stem/progenitor cells. The 
notice was published in the Federal Register of January 20, 1998 (63 FR 
2985). FDA is taking this action in response to a request for an 
extension and to allow interested parties additional time for review 
and to submit comments on proposed product standards.

DATES: Submit written comments by July 17, 2000.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 20, 1998 
(63 FR 2985), FDA published a notice requesting proposed product 
standards intended to ensure the safety and effectiveness of minimally 
manipulated hematopoietic stem/progenitor cells derived from peripheral 
and cord blood for unrelated allogeneic use. Interested persons were 
given until January 20, 2000, to submit written comments. On January 
18, 2000, a comment requesting that the agency extend the comment 
period was submitted to the docket. The comment noted that 
comprehensive standards that cover all aspects of cord blood banking 
have been drafted. However, additional editing and final review is 
required before submission to the docket. FDA finds it appropriate to 
reopen the comment period to permit interested persons additional time 
to submit proposed product standards intended to ensure the safety and 
effectiveness of minimally manipulated hematopoietic stem/progenitor 
cells derived from peripheral and cord blood for unrelated allogeneic 
use. Therefore the agency is reopening the comment period for an 
additional 90 days, until July 17, 2000, to allow the public more time 
to submit proposed product standards.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on proposing product standards 
intended to ensure the safety and effectiveness of minimally 
manipulated hematopoietic stem/progenitor cells derived from peripheral 
and cord blood for unrelated allogeneic use by July 17, 2000. Two 
copies of any comments are to be submitted, except individuals may 
submit one copy. Comments are to be identified with the docket number 
found in the brackets in the heading of this document. A copy of the 
document and received comments are available for public examination in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: April 10, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-9582 Filed 4-17-00; 8:45 am]
BILLING CODE 4160-01-F