21 CFR 1.924: What process applies to a petition requesting a waiver?

(a) In general, the procedures set forth in § 10.30 of this chapter govern our response to a petition requesting a waiver.

(b) Under § 10.30(h)(3) of this chapter, we will publish a notice in the Federal Register, requesting information and views on a filed petition, including information and views from persons who could be affected by the waiver if the petition were to be granted.

(c) Under § 10.30(e)(3) of this chapter, we will respond to the petitioner in writing.

(1) If we grant the petition, either in whole or in part, we will publish a notice in the Federal Register setting forth any waiver and the reasons for such waiver.

(2) If we deny the petition (including partial denials), our written response to the petitioner will explain the reason(s) for the denial.

(d) We will make readily accessible to the public, and periodically update, a list of filed petitions requesting waivers, including the status of each petition (for example, pending, granted, or denied).