---
kind: "section"
citation: "21 C.F.R. § 1.1380"
title: "21"
number: "1.1380"
heading: "What process applies to a petition requesting modified requirements or an exemption?"
url: "https://uscodex.org/cfr/21/1.1380"
---

# §1.1380. What process applies to a petition requesting modified requirements or an exemption?

- (a) In general, the procedures set forth in [§ 10.30](/cfr/21/10.30.md) of this chapter govern FDA's response to a petition requesting modified requirements or an exemption. An interested person may submit comments on such a petition in accordance with [§ 10.30(d)](/cfr/21/10.30.md?p=d) of this chapter.
- (b) Under [§ 10.30(h)(3)](/cfr/21/10.30.md?p=h-3) of this chapter, FDA will publish a notice in the Federal Register requesting information and views on a submitted petition, including information and views from persons who could be affected by the modified requirements or exemption if we granted the petition.
- (c) Under [§ 10.30(e)(3)](/cfr/21/10.30.md?p=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 modified requirements or exemptions and the reasons for them.
  - (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 modified requirements or exemptions, including the status of each petition (for example, pending, granted, or denied).

## 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.