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View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

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
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

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