Regulatory Counsel

0910-AG26 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 21 CFR 10.20 21 CFR 10.30 21 CFR 10.31 21 CFR 10.35 21 U.S.C. 321 21 U.S.C. 505 No NPRM 01/03/2012 77 FR 25 NPRM Comment Period End 04/20/2012 Final Action 11/00/2016 No None No No No No Darren Eicken Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-0978 301 827-8440 darren.eicken@fda.hhs.gov Room 3037, (HFD-7), Center for Drug Evaluation and Research, Building 51, Room 6206, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002