{"data":{"id":"us/21-cfr-1.1435","jurisdiction":"us","citation":"21 CFR 1.1435","heading":"What process applies to a petition requesting a waiver for a type of entity?","body":"(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting a waiver. An interested person may submit comments on such a petition in accordance with § 10.30(d) of this chapter.\n(b) Under § 10.30(h)(3) of this chapter, FDA will publish a notice in the Federal Register requesting information and views on a submitted petition requesting a waiver for a type of entity, including information and views from persons who could be affected by the waiver if we granted the petition.\n(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:\n(1) If we grant the petition either in whole or in part, we will publish a notice in the Federal Register setting forth any requirements we have waived and the reasons for the waiver.\n(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.\n(d) We will make readily accessible to the public, and periodically update, a list of petitions requesting waivers for types of entities, including the status of each petition (for example, pending, granted, or denied).","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 1—GENERAL ENFORCEMENT REGULATIONS","Subpart S—Additional Traceability Records for Certain Foods"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"adbcb60bdd94bbcf91673ff8c5f2998afe0659c086f82dc7885dcbed6ce14fa1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1.1430","next":"us/21-cfr-1.1440"},"notice":"GroundRules: Original legal text. Not legal advice."}