§1.1380. What process applies to a petition requesting modified requirements or an exemption?
21 C.F.R. § 1.1380
In general, the procedures set forth in § 10.30 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) of this chapter.
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, including information and views from persons who could be affected by the modified requirements or exemption if we granted the petition.
Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing, as follows:
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.
If we deny the petition (including a partial denial), our written response to the petitioner will explain the reasons for the denial.
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, amendments, and revision history
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.