21 CFR §509.5
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
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.