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HHS/FDA RIN: 0910-AI75 Publication ID: Spring 2024 
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 is issuing a rule to amend the prior notice (PN) regulation at 21 CFR 1.281(b) to add a requirement for people submitting PN to provide the name of the mail service and mail tracking number for articles of food imported or offered for import by international mail.  This rule will also amend 1.280(a)(2) to remove the requirement that the PN for articles of food arriving by international mail be submitted through the FDA Prior Notice System Interface (FDA PNSI), and amend 1.283 and 1.285 to create a timeframe for submitting post-refusal/hold submissions which, if not met, will require the article to be dealt with as set forth in CBP regulations related to general order merchandise, except that, unless otherwise agreed to by CBP and FDA, it may only be sold for export or destroyed. Section 801(m) of the FD&C Act (21 U.S.C. 381(m)) directs FDA to issue regulations requiring PN to FDA of an article of food that is imported or offered for import into the U.S. The information in PN enables FDA to target import inspections more effectively, thereby helping to protect our nation's food supply against bioterrorism 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: Final 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. 381(l)    21 U.S.C. 371(b)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/01/2023  88 FR 74939   
NPRM Comment Period End  01/30/2024 
Final Rule  07/00/2024 
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:
Christopher Henderson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
12420 Parklawn Drive,
Rockville, MD 20857
Phone:240 402-8186
Email: christopher.henderson@fda.hhs.gov