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HHS/FDA RIN: 0910-AF16 Publication ID: Fall 2004 
Title: 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 
Abstract: 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 related to its activities as a blood establishment 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 to also distribute blood derivatives. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 203.3(q)    21 CFR 203.22(h)    21 CFR 205.3(h)   
Legal Authority: 21 USC 351 to 353    21 USC 371    21 USC 374   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/00/2005    
Additional Information: 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
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Kathleen E. Swisher
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 1401 Rockville Pike, Suite 200N (HFM-10),
Rockville, MD 20852
Phone:301 827-0372

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