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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 

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.

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
Action Date FR Cite
NPRM  11/01/2023  88 FR 74939   
NPRM Comment Period End  01/30/2024 
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