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HHS/FDA RIN: 0910-AC55 Publication ID: Fall 2005 
Title: Positron Emission Tomography Drugs; Current Good Manufacturing Practices 
Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The proposed rule would adopt CGMPs that reflect the unique characteristics of PET drugs. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 212 
Legal Authority: PL 105-115, sec 121 
Legal Deadline:
Action Source Description Date
Final  Statutory    11/21/1999 
Timetable:
Action Date FR Cite
NPRM  09/20/2005  70 FR 55038 
NPRM Comment Period End  12/19/2005   
Final Action  12/00/2006   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Governmental Jurisdictions  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: www.fda.gov/cder/regulatory/pet  
Related RINs: Previously reported as 0910-AB63 
Agency Contact:
Wayne H. Mitchell
Regulatory Counsel, Office of Regulatory Policy
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-7,
Rockville, MD 20857
Phone:301 594-2041
Fax:301 827-0951
Email: wayne.mitchell@fda.hhs.gov

 
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