21 CFR § 1.1385 - What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?

---
identifier: "/us/cfr/t21/s1.1385"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.1385 - What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.1385"
section_name: "What process will FDA follow when adopting modified requirements or granting an exemption 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"
---


# 1.1385 What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?

(a) If FDA, on our own initiative, determines that adopting modified requirements or granting an exemption from the requirements for a food or type of entity is appropriate, we will publish a notice in the *Federal Register* setting forth the proposed modified requirements or exemption and the reasons for the proposal. 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 adopting modified requirements or granting an exemption, and the reasons for our decision.