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HHS/FDA

RIN: 0910-AB27

Publication ID: Fall 2003

Title: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
Abstract: The Food and Drug Administration is requiring certain manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps) to screen and test the donors of cells and tissues used in those products for evidence of, or risk factors for, relevant communicable disease. As part of this action, the agency is amending the current good manufacturing practice regulations that apply to HCT/Ps regulated as drugs, medical devices, and/or biological products to incorporate the new donor eligibility requirements into existing good manufacturing practice regulations for those products.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: No	Unfunded Mandates: No
CFR Citation: 21 CFR 210.1(c) 21 CFR 210.2(a) 21 CFR 210.2(b) 21 CFR 211.1(b) 21 CFR 820.1(a)(1) 21 CFR 820.1(c) 21 CFR 1271
Legal Authority: 42 USC 216 42 USC 243 42 USC 263a 42 USC 264 42 USC 271

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	09/30/1999	64 FR 52696
NPRM Comment Period End	12/29/1999
NPRM Comment Period Reopened	04/18/2000	65 FR 20774
NPRM Comment Period Reopened End	07/17/2000
Final Action	To Be Determined

Regulatory Flexibility Analysis Required: No	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