21 CFR § 509.5
Petitions
June 25, 2020
The Commissioner of Food and Drugs, either on his own initiative or on behalf of any interested person who has submitted a petition, may issue a proposal to establish, revoke, or amend a regulation under this part. Any such petition shall include an adequate factual basis to support the petition, shall be in the form set forth in §10.30 of this chapter, and will be published in the Federal Register for comment if it contains reasonable grounds for the proposed regulation.
[42 FR 52821, Sept. 30, 1977, as amended at 54 FR 18280, Apr. 28, 1989]