Code of Federal Regulations · Section

§ 1.1385 — What Process Will Fda Follow When Adopting Modified Requirements Or Granting An Exemption On Our Own Initiative?

21 C.F.R. § 1.1385

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(a) If FDA, on our own initiative, determines that adopting modified requirements or granting an exemption from the requirements for a food or type of entity is appropriate, we will publish a notice in the Federal Register setting forth the proposed modified requirements or exemption and the reasons for the proposal. The notice will establish a public docket so that interested persons may submit written comments on the proposal.

(b) After considering any comments timely submitted, we will publish a notice in the Federal Register stating whether we are adopting modified requirements or granting an exemption, and the reasons for our decision.

21 C.F.R. § 1.1380 21 C.F.R. § 1.1390

Authorizing Statute

General orders
19 U.S.C. § 1490
Definitions; generally
21 U.S.C. § 321
Labeling
15 U.S.C. § 1333
Regulations
42 U.S.C. § 216