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HHS/FDA RIN: 0910-AG26 Publication ID: Fall 2015 
Title: Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets; Implementation of Section 505(q) of the Federal Food, Drug, and Cosmetic Act 

The Food and Drug Administration (FDA) is proposing to amend certain regulations relating to citizen petitions, petitions for stay of action, and the submission of documents to the Agency. We are making these changes to implement certain provisions of section 914 of title IX of the Food and Drug Administration Amendments Act, which added section 505(q) to the Federal Food, Drug, and Cosmetic Act.

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 10.20    21 CFR 10.30    21 CFR 10.31    21 CFR 10.35   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 505   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/03/2012  77 FR 25   
NPRM Comment Period End  04/20/2012    
Final Action  03/00/2016 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Darren Eicken
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Room 3037, (HFD-7), Center for Drug Evaluation and Research, Building 51, Room 6206, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-0978
Fax:301 827-8440