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2015-12-24
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Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
Notices
D09002ee1c1a93525
D09002ee1c1a935ba
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry.'' The draft guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.
80 FR 80364
https://www.govinfo.gov/app/details/FR-2015-12-24/2015-32323
2015-32323
fr24de15-71
4164-01-P
Docket No. FDA-2015-D-4386
https://www.govinfo.gov/app/details/FR-2015-12-24/2015-32323
https://www.govinfo.gov/content/pkg/FR-2015-12-24/html/2015-32323.htm
https://www.govinfo.gov/content/pkg/FR-2015-12-24/pdf/2015-32323.pdf
2 p.
80364
80365
80 FR 80364
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-32323
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-D-4386
4164-01-P
2015-32323
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled ``Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR part 1271; Draft Guidance for Industry.'' The draft guidance document provides certain establishments that manufacture non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), regulated solely under the Public Health Service Act (PHS Act) and under FDA regulations, with recommendations and relevant examples for complying with the requirements to report HCT/P deviations.
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 March 23, 2016.
Tami Belouin, 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:
Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 247
Office of the Federal Register, National Archives and Records Administration
2015-12-24
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438 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-12-24
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https://www.govinfo.gov/app/details/FR-2015-12-24
https://www.govinfo.gov/content/pkg/FR-2015-12-24/pdf/FR-2015-12-24.pdf
https://www.govinfo.gov/content/pkg/FR-2015-12-24/xml/FR-2015-12-24.xml
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