United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2005_register executive 2010-09-23 article Rules and Regulations D09002ee1c8117eee D09002ee1c8117fa2 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue- based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding the impracticability of complying with certain regulations as they affect particular HCT/Ps. 70 FR 29949 https://www.govinfo.gov/app/details/FR-2005-05-25/05-10583 05-10583 fr25my05-16 4160-01-S Docket No. 1997N-0484T https://www.govinfo.gov/app/details/FR-2005-05-25/05-10583 https://www.govinfo.gov/content/pkg/FR-2005-05-25/html/05-10583.htm https://www.govinfo.gov/content/pkg/FR-2005-05-25/pdf/05-10583.pdf 4 p. 29949 29952 70 FR 29949 Title 21 Part 1271 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Federal Register Vol. 70, Issue RULE 05-10583 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2005-05-25 2005-08-23 Docket No. 1997N-0484T 4160-01-S 05-10583 Interim final rule; opportunity for public comment.

The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue- based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding the impracticability of complying with certain regulations as they affect particular HCT/Ps.

The interim final rule is effective May 25, 2005. Submit written or electronic comments on the interim final rule by August 23, 2005. 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. Human cells, tissues, and cellular and tissue-based products; donor screening and testing, and related labeling, fdadockets@oc.fda.gov http://www.fda.gov/dockets/ecomments http://www.fda.gov/ohrms/dockets/default.htm http://www.regulations.gov Vol. 70, no. 100 Office of the Federal Register, National Archives and Records Administration 2005-05-25 continuing daily deposited born digital 425 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2005-05-25 P0b002ee18099844e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25my05 https://www.govinfo.gov/app/details/FR-2005-05-25 https://www.govinfo.gov/content/pkg/FR-2005-05-25/pdf/FR-2005-05-25.pdf https://www.govinfo.gov/content/pkg/FR-2005-05-25/xml/FR-2005-05-25.xml fdlp 29915 30327 DGPO 2010-09-23 2024-06-06 FR-2005-05-25 machine generated eng FR FR-2005-05-25 70 100