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

(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).