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HHS/FDA | RIN: 0910-AG26 | Publication ID: Fall 2016 |
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. |
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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 |
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Timetable:
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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 Email: darren.eicken@fda.hhs.gov |