[Federal Register Volume 71, Number 57 (Friday, March 24, 2006)]
[Rules and Regulations]
[Page 14798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. 1997N-0484S]
RIN 0910-AB27


Eligibility Determination for Donors of Human Cells, Tissues, and 
Cellular and Tissue-Based Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Correcting amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that published in the Federal Register of May 25, 2004 (69 FR 
29786). The final rule required human cell, tissue, and cellular and 
tissue-based product (HCT/P) establishments to screen and test cell and 
tissue donors for risk factors for, and clinical evidence of, relevant 
communicable disease agents and diseases. The document was published 
with an error in the codified section. This document corrects that 
error.

DATES: Effective on March 24, 2006.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, 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: The final regulations that are the subject 
of this correction require HCT/P establishments to screen and test cell 
and tissue donors for risk factors for, and clinical evidence of, 
relevant communicable disease agents and diseases. The final 
regulations incorrectly list a cross-reference in 21 CFR 1271.75(d)(1). 
This error may prove to be misleading because it inaccurately limits a 
referenced provision. Therefore, the error needs to be corrected.

List of Subjects in 21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical 
devices, Reporting and recordkeeping requirements.

0
Accordingly, 21 CFR part 1271 is corrected by making the following 
correcting amendment:

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED 
PRODUCTS

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1. The authority citation for part 1271 continues to read as follows:

    Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

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2. Amend paragraph (d)(1) of Sec.  1271.75 by removing ``(a)(1)(i)'' 
and adding in its place ``(a)(1)''.

    Dated: March 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-2841 Filed 3-23-06; 8:45 am]
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