[Printable PDF]
[Federal Register: March 24, 2006 (Volume 71, Number 57)]
[Rules and Regulations]
[Page 14798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr06-4]
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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.
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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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