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HHS/FDA RIN: 0910-AF81 Publication ID: 2012 
Title: Current Good Manufacturing Practice for Combination Products 
Abstract: The final rule is intended to clarify and codify the current good manufacturing practice (cGMP) requirements for combination products (combinations of a drug, device, and/or biological product). The final rule is intended to ensure consistency and appropriateness in the regulation of combination products. It would avoid the necessity to fully implement both drug cGMP regulations and device quality system regulations when manufacturing combination products. 
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 4, subchapter A (To search for a specific CFR, visit the Code of Federal Regulations.
Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 360l; 21 USC 360hh to 360ss; 21 USC 360aaa to 360bbb; 21 USC 371a; 21 USC 372 to 374; 21 USC 379e; 21 USC 381; 21 USC 394; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264; 42 USC 271 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/23/2009  74 FR 48423 
NPRM Comment Period End  12/22/2009   
NPRM Extension of Comment Period   11/10/2009  74 FR 57973 
Final Action  12/00/2012   
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
John Barlow Weiner
Associate Director for Policy
Department of Health and Human Services
Food and Drug Administration
Office of Combination Products, W032, Room 5130, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8930
Fax:301 847-8619
Email: john.weiner@fda.hhs.gov

 
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