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 2016_register executive 2016-06-22 article Rules and Regulations D09002ee1c7f60a46 D09002ee1c7f60ada 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 or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos. 81 FR 40512 https://www.govinfo.gov/app/details/FR-2016-06-22/2016-14721 2016-14721 fr22jn16-11 4164-01-P Docket No. FDA-2014-N-1484 https://www.govinfo.gov/app/details/FR-2016-06-22/2016-14721 https://www.govinfo.gov/content/pkg/FR-2016-06-22/html/2016-14721.htm https://www.govinfo.gov/content/pkg/FR-2016-06-22/pdf/2016-14721.pdf Biologics Drugs Human Cells and Tissue-Based Products Medical Devices Reporting and Recordkeeping Requirements 7 p. 40512 40518 81 FR 40512 Title 21 Part 1271 21 CFR Part 1271 Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products; Federal Register Vol. 81, Issue RULE 2016-14721 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-08-22 Docket No. FDA-2014-N-1484 4164-01-P 2016-14721 Final rule.

The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.

This rule is effective August 22, 2016. Jessica T. Walker, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. Biologics Drugs Human Cells and Tissue-Based Products Medical Devices Reporting and Recordkeeping Requirements Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products , http://www.regulations.gov Vol. 81, no. 120 Office of the Federal Register, National Archives and Records Administration 2016-06-22 continuing daily deposited born digital 312 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-06-22 P0b002ee190044a70 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr22jn16 https://www.govinfo.gov/app/details/FR-2016-06-22 https://www.govinfo.gov/content/pkg/FR-2016-06-22/pdf/FR-2016-06-22.pdf https://www.govinfo.gov/content/pkg/FR-2016-06-22/xml/FR-2016-06-22.xml fdlp 40473 40774 DGPO 2016-06-22 2024-06-01 FR-2016-06-22 machine generated eng FR FR-2016-06-22 81 120