{"data":{"id":"us/21-cfr-1.1380","jurisdiction":"us","citation":"21 CFR 1.1380","heading":"What process applies to a petition requesting modified requirements or an exemption?","body":"(a) In general, the procedures set forth in § 10.30 of this chapter govern FDA's response to a petition requesting modified requirements or an exemption. 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, including information and views from persons who could be affected by the modified requirements or exemption 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 modified requirements or exemptions and the reasons for them.\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 modified requirements or exemptions, 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":"8845b620167e7e3719558d19cc23782fcb61c681945b42518f86e10097115c86","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1.1375","next":"us/21-cfr-1.1385"},"notice":"GroundRules: Original legal text. Not legal advice."}