C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 1—GENERAL ENFORCEMENT REGULATIONS › Subpart S—Additional Traceability Records for Certain Foods

21 C.F.R. § 1.1385

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

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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.