SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a document entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry.” In the Federal Register of September 13, 2022 (87 FR 55932), FDA announced the availability of the draft guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4); Draft Guidance for Industry.” FDA received no comments on the draft guidance. As a result, we are publishing the guidance as drafted, with minor editorial changes to improve clarity, such as replacing the term “animal feed” with “animal food.” The guidance announced in this notice finalizes the draft guidance dated September 13, 2022, and replaces “Prior Notice of Imported Food Questions and Answers (Edition 3): Guidance for Industry,” dated June 2016.

FDA continues to believe that it is reasonable to maintain responses to questions concerning prior notice of imported food in a single document that is periodically updated in response to additional questions or regulatory or policy changes. As in the previous editions, the following indicators are used to help users identify revisions: (1) the guidance is identified as a revision of a previously issued document; (2) the revision date appears on the cover of the guidance; (3) the edition number of the guidance is included in its title; and (4) revised or added questions and answers are identified as such in the body of the guidance.

On November 7, 2008, we published a final rule in the Federal Register requiring submission to FDA of prior notice of food, including food for animals, that is imported or offered for import into the United States (73 FR 66294). The rule implements section 801(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188) and requires that FDA receive prior notice of food imported or offered for import into the United States.

On December 16, 2003, FDA issued a guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 1).” FDA issued a second edition of the guidance on May 3, 2004, and a third edition on June 16, 2016. FDA issued a draft fourth edition, which was published for public comment from September 13, 2022, to November 14, 2022. We are issuing this guidance entitled “Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry” as a level 1 guidance, finalizing the draft guidance issued on September 13, 2022.

The fourth edition of the prior notice guidance adds three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice of a refusal under 801(m)(1) of the FD&C Act (in accordance with § 1.283 (21 CFR 1.283)) for inadequate prior notice or a hold under 801(l) (in accordance with § 1.285 (21 CFR 1.285)) if the food article is from a foreign facility that is not registered, as well as address the timeframe for making requests for FDA review of such a refusal or hold. The guidance is intended to help clarify whether food imported from a country with which FDA has a Systems Recognition Arrangement or equivalence determination is exempted from prior notice requirements. The guidance also clarifies when FDA will provide notice of the refusal or hold to the relevant party, and when the 5-calendar-day clock to request a review of the refusal or hold begins.

We are also making other technical amendments to the guidance due to the expanded capabilities of the U.S. Customs and Border Protection's (CBP) Automated Broker Interface of the Automated Commercial Environment (ABI/ACE) system and FDA's 2017 technical amendments to the prior notice rule (82 FR 15627, March 30, 2017), such as replacing references to the Automated Commercial System (ACS) and successor system with the ABI/ACE system, removing references to requirements that certain prior notice submissions be submitted in FDA's Prior Notice System Interface (FDA PNSI), and updating outdated links and FDA contact information. The fourth edition guidance clarifies that the existence of a Systems Recognition Arrangement with or an equivalence determination of a foreign country does not exempt foods imported from that country from FDA's prior notice requirements.

FDA's policy on and practice of communicating prior notice refusals and holds has changed over time. FDA previously stated that we intended to provide notice regarding refusals to carriers. Those carriers could then notify others, such as the entity that hired the carrier to transport the article of food, of a problem with the prior notice (see 73 FR 66294 at 66365). Subsequently, FDA's Guidance for Industry “Prior Notice of Imported Food Questions and Answers (Edition 3)” was published with the explanation that FDA will communicate the decision to examine articles of food to CBP.

The fourth edition clarifies that notification of these prior notice refusals and holds will be communicated to CBP and provided to the relevant party ( i.e., the submitter or transmitter of prior notice) upon arrival of the article. FDA is clarifying its policy because providing advanced notice of a refusal or hold to a submitter or transmitter could create incentives for bad actors, who may attempt to reroute their entries for the purpose of evading FDA requirements and importing unsafe food.

The fourth edition of the guidance also clarifies the 5-calendar-day clock to request a review of these refusals and ( printed page 70889) holds. Under §§ 1.283(d) and 1.285(j), certain parties may, for the enumerated reasons, request reviews of the prior notice refusals and holds within 5 calendar days of the hold or refusal. The fourth edition clarifies that FDA considers the 5-calendar-day clock to begin when FDA provides notice of the refusal or hold to the submitter or transmitter.

Additionally, in 2016, CBP issued a notice announcing that ABI/ACE would replace ACS as the sole electronic data interchange system authorized by CBP for the processing of electronic entries of FDA-regulated products (see 81 FR 30320, May 16, 2016). ABI/ACE became the successor system to ACS. In 2017, we amended 21 CFR part 1, subpart I to replace references to ACS and successor system with ABI/ACE (see 82 FR 15627). As part of this rulemaking, we eliminated some requirements for submitting prior notice due to the expanded capabilities of ABI/ACE, such as the requirement to submit articles that have been refused under section 801(m)(1) of the FD&C Act or subpart I in FDA PNSI. Further, ABI/ACE can now accommodate entries it previously could not, such as articles of food arriving through international mail. Therefore, to reflect these changes that were implemented in the rulemaking and the expanded capabilities of ABI/ACE, we are replacing references in the prior notice guidance to ACS with the successor system ABI/ACE. In addition, we are providing clarification regarding how persons may submit prior notice for articles of food imported or offered for import by international mail.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on guidance for industry on the prior notice requirements. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR 1.278 to 1.282 have been approved under OMB control number 0910-0520.

III. Electronic Access

Persons with access to the internet may obtain the guidance at https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics/​biologics-guidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.