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 2015_register executive 2015-02-19 article Notices D09002ee1c7f7ea1d D09002ee1c7f7ea59 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 announcing the availability of a draft document entitled "Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271" dated February 2015. The draft guidance document is intended to provide manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/ Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The draft guidance, when finalized, is intended to supplement section XXII of FDA's guidance entitled "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated December 2011 and supersede the guidance entitled "Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated November 2005. 80 FR 9267 https://www.govinfo.gov/app/details/FR-2015-02-20/2015-03490 2015-03490 fr20fe15-28 4164-01-P Docket No. FDA-2015-D-0349 https://www.govinfo.gov/app/details/FR-2015-02-20/2015-03490 https://www.govinfo.gov/content/pkg/FR-2015-02-20/html/2015-03490.htm https://www.govinfo.gov/content/pkg/FR-2015-02-20/pdf/2015-03490.pdf 2 p. 9267 9268 80 FR 9267 Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability; Federal Register Vol. 80, Issue NOTICE 2015-03490 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2015-D-0349 4164-01-P 2015-03490 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271" dated February 2015. The draft guidance document is intended to provide manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/ Ps) for which no premarket submissions are required because they are not also regulated as drugs, devices, and/or biological products, with recommendations for complying with the requirements for investigating and reporting adverse reactions involving communicable disease in recipients of these HCT/Ps. The draft guidance, when finalized, is intended to supplement section XXII of FDA's guidance entitled "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated December 2011 and supersede the guidance entitled "Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated November 2005.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 21, 2015. Lori J. Churchyard, 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. Guidance for Industry and Staff: Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 80, no. 34 Office of the Federal Register, National Archives and Records Administration 2015-02-20 continuing daily deposited born digital 176 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-02-20 P0b002ee18b20d8dd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr20fe15 https://www.govinfo.gov/app/details/FR-2015-02-20 https://www.govinfo.gov/content/pkg/FR-2015-02-20/pdf/FR-2015-02-20.pdf https://www.govinfo.gov/content/pkg/FR-2015-02-20/xml/FR-2015-02-20.xml fdlp 9189 9358 DGPO 2015-02-19 2024-06-02 FR-2015-02-20 machine generated eng FR FR-2015-02-20 80 34