[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Rules and Regulations]
[Pages 70887-70889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0179]


Prior Notice of Imported Food Questions and Answers (Edition 4): 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a final guidance entitled ``Prior Notice 
of Imported Food Questions and Answers (Edition 4): Guidance for 
Industry.'' The guidance document updates the current version of the 
guidance by including 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 to a submitter or transmitter of prior notice of an FDA refusal 
for inadequate prior notice or hold, if the food article is from a 
foreign facility that is not registered and addresses the timeframe for 
making requests for FDA review of such refusal or hold. FDA is also 
making other technical editorial changes. The guidance announced in 
this notice finalizes the draft guidance of the same title dated 
September 13, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on October 13, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0179 for ``Prior Notice of Imported Food Questions and 
Answers (Edition 4): Guidance for Industry.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit

[[Page 70888]]

both copies to the Dockets Management Staff. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Division of Operational Policy, Office of Regulatory Affairs, Food and 
Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, 
MD 20852. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Peter Ajuonuma, Office of Regulatory 
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn 
Dr., Rockville, MD 20852, 301-796-2277, [email protected].

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 Sec.  1.283 
(21 CFR 1.283)) for inadequate prior notice or a hold under 801(l) (in 
accordance with Sec.  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

[[Page 70889]]

holds. Under Sec. Sec.  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.

    Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22649 Filed 10-12-23; 8:45 am]
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