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

194 words·~1 min read·/us/cfr/t21/s§ 1.1380

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)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.

(b)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.

(c)Under § 10.30(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).