[Federal Register: February 4, 2004 (Volume 69, Number 23)]
[Rules and Regulations]               
[Page 5272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe04-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. 97N-484R]

 
Human Cells, Tissues, and Cellular and Tissue-Based Products; 
Establishment Registration and Listing; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; correction

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SUMMARY: The Food and Drug Administration (FDA) is correcting an 
interim final rule that published in the Federal Register on January 
27, 2004 (69 FR 3823). The interim final rule excepted human dura mater 
and human heart valve allografts, currently subject to application or 
notification requirements under the Federal Food, Drug, and Cosmetic 
Act from the scope of the definition of ``human cells, tissues, or 
cellular or tissue-based products (HCT/P's)'' subject to the 
registration and listing requirements contained in 21 CFR Part 1271. 
That definition became effective on January 21, 2004. The interim final 
rule published with some errors. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: In the FR Doc. 04-1733, appearing on page 
3824 in the Federal Register of Tuesday, January 27, 2004, the 
following corrections are made:
    1. On page 3824, in the DATES section, by removing the sentence 
``The compliance date is March 29, 2004.''
    2. On page 3824, under SUPPLEMENTARY INFORMATION in the I. 
Background section, the phrase ``FDA understands that many 
establishments may have reasonably expected FDA to delay the effective 
date of this provision again, since the donor suitability and GTP rules 
are not yet finalized'' is revised to read:
    ``FDA understands that many establishments may have reasonably 
expected FDA to delay the effective date of this provision again, since 
the donor suitability and GTP rules are not yet finalized. Accordingly, 
FDA expects that affected firms will be in compliance with these 
requirements by March 29, 2004, and not on January 21, 2004, the 
effective date of the definition regulation.''

    Dated: January 29, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-2312 Filed 1-30-04; 3:49 pm]

BILLING CODE 4160-01-S