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 2001_register executive 2015-05-28 article Rules and Regulations D09002ee1c81e7836 D09002ee1c81e78be 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 a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products. FDA is also amending the registration and listing regulations that currently apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, devices, and/or biological products. These actions are being taken to establish a unified registration and listing program for human cells, tissues, and cellular and tissue-based products. 66 FR 5447 https://www.govinfo.gov/app/details/FR-2001-01-19/01-1126 01-1126 fr19ja01-4 4160-01-F Docket No. 97N-484R https://www.govinfo.gov/app/details/FR-2001-01-19/01-1126 https://www.govinfo.gov/content/pkg/FR-2001-01-19/html/01-1126.htm https://www.govinfo.gov/content/pkg/FR-2001-01-19/pdf/01-1126.pdf Human Cells Tissue-Based Products Drugs Reporting and Recordkeeping Requirements Confidential Business Information Imports Medical Devices 23 p. 5447 5469 66 FR 5447 Title 21 Part 1271 21 CFR Part 1271 Title 21 Part 207 21 CFR Part 207 Title 21 Part 807 21 CFR Part 807 Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Federal Register Vol. 66, Issue RULE 01-1126 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2001-04-04 Docket No. 97N-484R 4160-01-F 01-1126 Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to require human cells, tissue, and cellular and tissue-based product establishments to register with the agency and list their human cells, tissues, and cellular and tissue-based products. FDA is also amending the registration and listing regulations that currently apply to human cells, tissues, and cellular and tissue-based products regulated as drugs, devices, and/or biological products. These actions are being taken to establish a unified registration and listing program for human cells, tissues, and cellular and tissue-based products.

The regulation is effective April 4, 2001, except for 21 CFR 207.20(f), 807.20(d), and 1271.3(d)(2), which are effective on January 21, 2003. Valerie A. Butler, 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 Tissue-Based Products Drugs Reporting and Recordkeeping Requirements Confidential Business Information Imports Medical Devices Biological products: Human cells, tissues, and cellular and tissue-based products; establishment registration and listing, http://forms.psc.gov/forms/FDA/fda.html http://www.fda.gov/cber/tissue/trg.htm Vol. 66, no. 13 Office of the Federal Register, National Archives and Records Administration 2001-01-19 continuing daily deposited born digital 1013 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2001-01-19 P0b002ee18c7ecff2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19ja01 https://www.govinfo.gov/app/details/FR-2001-01-19 https://www.govinfo.gov/content/pkg/FR-2001-01-19/pdf/FR-2001-01-19.pdf https://www.govinfo.gov/content/pkg/FR-2001-01-19/xml/FR-2001-01-19.xml fdlp 5421 6426 DGPO 2015-05-28 2024-06-08 FR-2001-01-19 machine generated eng FR FR-2001-01-19 66 13