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

---
identifier: "/us/cfr/t21/s1.1435"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.1435 - What process applies to a petition requesting a waiver for a type of entity?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.1435"
section_name: "What process applies to a petition requesting a waiver for a type of entity?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---


# 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).