Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 1.1435: What process applies to a petition requesting a waiver for a type of entity?

(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.
(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.
(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:
(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.
(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.
(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).

Where this section sits in the code

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

(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.

(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.

(2) If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.

(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).

Collected 2026-08-27T02:24:47Z. Source file · JSON

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