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HHS/FDA RIN: 0910-AG26 Publication ID: Fall 2010 
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 
Abstract: 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 (the Act). In particular, the proposed rule would establish new regulations to implement section 505(q) of the Act, which concerns certain citizen petitions and petitions for stay of action that involve a request for FDA to take any form of action relating to a pending application submitted under section 505(b)(2) or (j) of the Act. In particular, this proposal would codify the certification specified in section 505(q)(1)(H) that applies to initial citizen petitions and petitions for stay of action. In addition, the proposal would codify the verification specified in section 505(q)(1)(I) that applies to supplemental information or comments on a citizen petition or petition for stay of action. To avoid altering the meaning of the certification and verification specified in 505(q)(1)(H) and 505(q)(1)(I), respectively, we are proposing to require that petitioners submit the exact statutory language of the certification and verification. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 10.20    21 CFR 10.30 and 10.31    21 CFR 10.35    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 505   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2011    
Regulatory Flexibility Analysis Required: Undetermined  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
Email: darren.eicken@fda.hhs.gov