# Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
> **Food and Drug Administration** · Final rule. · Published 2016-11-08 · Effective 2017-01-09 · 81 FR 78500
## Document
- **Document number:** 2016-26912
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 81 FR 78500
- **CFR reference:** 21 CFR 10
- **Publication date:** 2016-11-08
- **Effective date:** 2017-01-09
- **HHS docket:** Docket No. FDA-2011-N-0697
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is amending certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which concern certain citizen petitions and PSAs that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA), 505(b)(2) application, or certain applications submitted under the Public Health Service Act (PHS Act). We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Food and Drug Administration Safety and Innovation Act (FDASIA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2016/11/08/2016-26912/amendments-to-regulations-on-citizen-petitions-petitions-for-stay-of-action-and-submission-of)
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