What must be included in a petition requesting a waiver for a type of entity?
21 C.F.R. § 1.1425
in effectEffective: 2024-07-01In addition to meeting the requirements on the content and format of a citizen petition in § 10.30 of this chapter, a petition requesting a waiver for a type of entity must:
(a) Specify the type of entity to which the waiver would apply and the requirements of this subpart to which the waiver would apply;
(b) Present information demonstrating why application of the requirements requested to be waived would result in an economic hardship for the type of entity, including information about the unique circumstances faced by the type of entity that result in unusual economic hardship from the application of these requirements;
(c) Present information demonstrating why the waiver will not significantly impair FDA's ability to rapidly and effectively identify recipients of a food to prevent or mitigate a foodborne illness outbreak or to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act; and
(d) Present information demonstrating why the waiver would not otherwise be contrary to the public interest.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026