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Code · CFR · Title 21 — Food and Drugs · Part 1 — General Enforcement Regulations · § 1.1385

§ 1.1385. What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?

102 words·~1 min read·/us/cfr/t21/s§ 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.
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§ 1.1385
What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
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