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HHS/FDA RIN: 0910-AC55 Publication ID: Spring 2009 
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 final 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: Final 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  08/00/2009    
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  
RIN Data Printed in the FR: Yes 
Related RINs: Previously reported as 0910-AB63 
Agency Contact:
Michael D. Bernstein
Supervisory Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Office of Regulatory Policy, 10903 New Hampshire Ave., Bldg. 51, Room 6240,
Silver Spring, MD 20993-0002
Phone:301 796-3478
Fax:301 847-8440
Email: michael.bernstein@fda.hhs.gov