21 CFR § 1.1440 - What process will FDA follow when waiving a requirement of this subpart on our own initiative?

---
identifier: "/us/cfr/t21/s1.1440"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.1440 - What process will FDA follow when waiving a requirement of this subpart on our own initiative?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.1440"
section_name: "What process will FDA follow when waiving a requirement of this subpart on our own initiative?"
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"
---


# 1.1440 What process will FDA follow when waiving a requirement of this subpart on our own initiative?

(a) If FDA, on our own initiative, determines that a waiver of one or more requirements for an individual entity or type of entity is appropriate, we will publish a notice in the *Federal Register* setting forth the proposed waiver and the reasons for such waiver. The notice will establish a public docket so that interested persons may submit written comments on the proposal.

(b) After considering any comments timely submitted, we will publish a notice in the *Federal Register* stating whether we are granting the waiver (in whole or in part) and the reasons for our decision.

(c) Any waiver for a type of entity that FDA grants will become effective on the date that notice of the waiver is published in the *Federal Register,* unless otherwise stated in the notice.