---
kind: "section"
citation: "21 C.F.R. § 1.1385"
title: "21"
number: "1.1385"
heading: "What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?"
url: "https://uscodex.org/cfr/21/1.1385"
---

# §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.

## Notes

### Source

Source: 87 FR 71077, Nov. 21, 2022, unless otherwise noted.

### Authority

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.

### Source

Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.