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HHS/FDA RIN: 0910-AF16 Publication ID: Fall 2003 
Title: ●Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures; Derivatives of Blood 
Abstract: FDA is proposing to amend the implementing regulation of the Prescription Drug Marketing Act of 1987, as modified by the Prescription Drug Amendments of 1992 and the FDA Modernization Act of 1997. The final rule (12/3/99; 64 FR 67720), does not allow a registered blood establishment that provides health care services related to its activities as a blood establishment to concurrently distribute derivatives of blood. The effective date of that rule is April 1, 2004. FDA is amending the final rule to allow a registered blood establishment that concurrently provides health care services to also distribute derivatives of blood. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  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:
Action Source Description Date
Other  Statutory  Effective date of final rule, 64 FR 67720, December 3, 1999  04/01/2004 

Overall Description of Deadline: Date final rule takes effect: “Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; Policies, Requirements, and Administrative Procedures."

Timetable:
Action Date FR Cite
ANPRM  07/00/2004   
Regulatory Flexibility Analysis Required: Undetermined  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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