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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, 10903 New Hampshire Avenue, W032, Room 5130, Silver Spring, MD 20993 Phone:301 796-8941 Email: john.weiner@fda.hhs.gov