Regulatory Counsel

0910-AI75 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-refusal and Post-hold Submissions

FDA proposes to amend the prior notice (PN) regulation at 21 CFR 1.281(b) to add a requirement for PN submitters to provide the name of the mail service and mail tracking number for articles of food imported or offered for import by international mail. FDA also proposes to amend 1.283 and 1.285 to create a timeframe for submitting post-refusal/hold submissions and, if such submissions are not submitted within the timeframe, to clarify FDA’s and CBP’s processes for having the food exported or destroyed per CBP general order merchandise requirements. Section 801(m) of the FD&C Act (21 U.S.C. 381(m)) authorizes the FDA to issue regulations requiring prior notification to FDA of food that is imported or offered for import into the U.S. The information in prior notice enables FDA to target import inspections more effectively, thereby helping to protect our nation's food supply against terrorist acts and other public health emergencies.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 1.280 21 CFR 1.281 21 CFR 1.283 21 CFR 1.285 21 U.S.C. 381(m) 21 U.S.C. 371(b) No NPRM 09/00/2023 No Businesses Federal No No Yes 1651 U.S. Customs and Border Protection USCBP Joint Peter Ajuonuma Uchenna Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-2277 peter.ajuonuma@fda.hhs.gov 12420 Parklawn Drive, Room 4404, Rockville MD 20857