0910-AB27 200310 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 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. Other Significant Previously Published in The Unified Agenda Long-Term Actions No No 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 42 USC 216 42 USC 243 42 USC 263a 42 USC 264 42 USC 271 No 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 No Businesses State NA Not Collected Paula McKeever S. 0910 Food and Drug Administration FDA 301 827-1520 301 443-9718 paula.mckeever@fda.hhs.gov Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville MD 20857-0001