Prior Notice of Imported Foods
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OMB Approval Number: 0910-0520
OMB Expiration Date: 7/31/2020
See OMB Burden Statement
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.
Along with other provisions, the Act requires that FDA receive prior notification of food, including animal feed that is imported or offered for import into the United States. Advance notice of import shipments allows FDA, with the support of the U.S. Customs and Border Protection (CBP), to target import inspections more effectively and help protect that nation's food supply against terrorist acts and other public health emergencies.
The FDA Food Safety Modernization Act (FSMA) signed January 4th, 2011 aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. On May 5, 2011 the FDA published an interim final rule requiring that a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing potential risks of imported food into the United States.
Additional Overview and Background
Filing Prior Notice
For Instructions on the Prior Notice System Interface (PNSI), see Filing Prior Notice, which includes the following resources and more:
- Quick Start Guide
- Instructions for Prior Notice for Food Articles sent by International Mail
- Instructions for Prior Notice for Food Articles in PNSI
- Instructions for PNSI "Wizards"
- Instructions for Additional Capabilities in PNSI: Find, Copy and Cancel Web Entries and Prior Notices
- Product Code Builder Tutorial
Guidance Documents and Rules
- Proposed Rule: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
- Final Rule: Information Required in Prior Notice of Imported Food
- Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 4)
- Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3)
- Guidance for Industry: Prior Notice of Imported Food Contingency Plan for System Outages
- Compliance Policy Guide, Guidance for FDA and CBP Staff: Prior Notice of Imported Food
International Mail and Gifts
- Importing Gift Packs and Prior Notice
- Prior Notice Policy on Sending Gifts to Your Friends and Family
Contact FDA
System Help Desk
800-216-7331
240-247-8804 INTL
Contact for questions regarding PNSI account creation, management, password reset, and technical computer questions. (Mon–Fri 9:00 am - 6:00 pm EST)
Division of Targeting and Analysis
866-521-2297
571-468-1488 INTL
571-468-1936 Fax
prior.notice@fda.hhs.gov
Contact for questions regarding prior notice policies, procedures, and interpretations. (24/7)
Division of Import Operations & Policy
301-796-0356
Contact for import questions not related to prior notice.