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HHS/FDA | RIN: 0910-AB28 | Publication ID: Spring 2005 |
Title: Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement | |
Abstract: The Food and Drug Administration (FDA) is requiring certain 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. FDA is also issuing regulations pertaining to labeling, reporting, inspections, and enforcement. | |
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Completed Actions |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 16 21 CFR 1270 21 CFR 1271 | |
Legal Authority: 42 USC 216 42 USC 243 42 USC 263a 42 USC 264 42 USC 271 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: State |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
Agency Contact: Paula S. McKeever Senior Scientific Policy Analyst Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville, MD 20857-0001 Phone:301 827-1520 Fax:301 443-9718 Email: paula.mckeever@fda.hhs.gov |