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HHS/FDA | RIN: 0910-AI75 | Publication ID: Fall 2023 |
Title: 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 | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1.280 21 CFR 1.281 21 CFR 1.283 21 CFR 1.285 | |
Legal Authority: 21 U.S.C. 381(m) 21 U.S.C. 371(b) |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Data Printed in the FR: No | |
Related Agencies: Joint: DHS/USCBP; | |
Agency Contact: Peter Uchenna Ajuonuma Regulatory Counsel Department of Health and Human Services Food and Drug Administration 12420 Parklawn Drive, Room 4404, Rockville, MD 20857 Phone:301 796-2277 Email: peter.ajuonuma@fda.hhs.gov |