06-2841. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Correcting amendment.

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

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

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

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

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

2. Amend paragraph (d)(1) of § 1271.75 by removing “(a)(1)(i)” and adding in its place “(a)(1)”.

Dated: March 17, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.