0910-AF16 200604 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Distribution of Blood Derivatives by Registered Blood Establishments That Qualify as Health Care Entities; PDMA of 1987; PDA of 1992; Policies, Requirements, and Administrative Procedures FDA is proposing to amend certain limited provisions of the implementing regulations of the Prescription Drug Marketing Act (PDMA) of 1987, as modified by the Prescription Drug Amendments (PDA) of 1992 and the FDA Modernization Act of 1997. Certain provisions of that final rule that published on December 3, 1999, (64 FR 67720), do not allow a registered blood establishment that provides health care services to concurrently distribute blood derivatives. The effective date of those provisions of that rule is December 1, 2006, as published on February 23, 2004, (69 FR 8105). FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services related to its activities as a blood establishment to also distribute blood derivatives. Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 203.3(q) 21 CFR 203.22(h) 21 CFR 205.3(h) 21 USC 351 to 353 21 USC 371 21 USC 374 No NPRM 02/01/2006 71 FR 5200 NPRM Comment Period End 05/02/2006 Final Action 12/00/2006 Delayed effective date of portion of rule to 12/01/06, effective date of non-stayed portion of final rule, 64 FR 67720, December 3, 1999 No None NA Not Collected Kathleen Swisher E. 0910 Food and Drug Administration FDA 301 827-0372 Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-10), Rockville MD 20852