Food and Drug Administration, HHS.
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.
Effective on March 24, 2006.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects in 21 CFR Part 1271
- Human cells and tissue-based products
- Medical devices
- Reporting and recordkeeping requirements
Accordingly,End Amendment Part Start Part
PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTSEnd Part Start Amendment Part
1. The authority citation for part 1271 continues to read as follows:End Amendment Part Start Amendment Part
2. Amend paragraph (d)(1) of § 1271.75 by removing “(a)(1)(i)” and adding in its place “(a)(1)”.End Amendment Part Start Signature
Dated: March 17, 2006.
Assistant Commissioner for Policy.
[FR Doc. 06-2841 Filed 3-23-06; 8:45 am]
BILLING CODE 4160-01-S