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 2004_register executive 2010-09-23 article Part IV Rules and Regulations D09002ee1c8126ea9 D09002ee1c8126faf 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 requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation. 69 FR 68612 https://www.govinfo.gov/app/details/FR-2004-11-24/04-25798 04-25798 fr24no04-9 4160-01-S Docket No. 1997N-484P https://www.govinfo.gov/app/details/FR-2004-11-24/04-25798 https://www.govinfo.gov/content/pkg/FR-2004-11-24/html/04-25798.htm https://www.govinfo.gov/content/pkg/FR-2004-11-24/pdf/04-25798.pdf Communicable Diseases HIV/AIDS Reporting and Recordkeeping Requirements Human Cells Tissues Cellular and Tissue-Based Products Administrative Practice and Procedure 77 p. 68612 68688 69 FR 68612 Title 21 Part 1270 21 CFR Part 1270 Title 21 Part 1271 21 CFR Part 1271 Title 21 Part 16 21 CFR Part 16 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Federal Register Vol. 69, Issue RULE 04-25798 IV DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2005-05-25 Docket No. 1997N-484P 4160-01-S 04-25798 Final rule.

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

This rule is effective May 25, 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. Communicable Diseases HIV/AIDS Reporting and Recordkeeping Requirements Human Cells Tissues Cellular and Tissue-Based Products Administrative Practice and Procedure Biological products: Human cellular and tissue-based products manufacturers; current good tissue practice; inspection and enforcement, http://www.bls.gov http://www.bls.gov/cpi http://www.fda.gov/cber/biodev/biodevsub.htm http://www.fda.gov/cber/biodev/bpdrform.pdf http://www.fda.gov/cber/gdlns/steraseptic.htm http://www.fda.gov/cber/tissue/docs.htm http://www.fda.gov/cber/tissue/min.htm http://www.fda.gov/cber/tissue/tisreg.htm http://www.fda.gov/medwatch http://www.fda.gov/opacom/morechoices/fdaforms/cber.html http://www.hcup-us.ahrq.gov/nisoverview.jsp http://www.hhs.gov/forms http://www.naics.com http://www.thespermbankofca.org/fees.html Vol. 69, no. 226 Office of the Federal Register, National Archives and Records Administration 2004-11-24 continuing daily deposited born digital 525 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-11-24 P0b002ee18097f450 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr24no04 https://www.govinfo.gov/app/details/FR-2004-11-24 https://www.govinfo.gov/content/pkg/FR-2004-11-24/pdf/FR-2004-11-24.pdf https://www.govinfo.gov/content/pkg/FR-2004-11-24/xml/FR-2004-11-24.xml fdlp 68237 68753 DGPO 2010-09-23 2024-06-06 FR-2004-11-24 machine generated eng FR FR-2004-11-24 69 226