[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Proposed Rules]
[Pages 55932-55934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19724]


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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); 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Prior Notice 
of Imported Food Questions and Answers; Draft Guidance for Industry 
(Edition 4).'' The draft guidance adds three additional questions.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 to a submitter 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 address the 
timeframe for making requests for FDA review of such a refusal or hold. 
FDA is also making other technical and editorial changes.

DATES: Submit either electronic or written comments on the draft 
guidance by November 14, 2022 to ensure that we consider your comment 
on this draft guidance before we begin work on the final version of the 
guidance.

ADDRESSES: You may submit comments on any guidance 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; Draft Guidance for Industry (Edition 4).'' 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.'' FDA 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 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 draft 
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 draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory 
Affairs, Food and Drug Administration, Element Building, 12420 Parklawn 
Dr.,

[[Page 55933]]

Rockville, MD 20857 240-402-8186, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for 
industry, entitled ``Prior Notice of Imported Food Questions and 
Answers; Draft Guidance for Industry (Edition 4).'' This draft revised 
guidance is being issued for public comment and has not yet been 
finalized. Until edition 4 is finalized, ``Prior Notice of Imported 
Food Questions and Answers; Guidance for Industry (Edition 3),'' 
updated most recently in 2016, remains in effect. We are issuing the 
draft guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The draft guidance, when finalized, will represent the 
current thinking of FDA on this topic. It does not establish any rights 
for any person and is not binding on FDA or the public. You can use an 
alternate approach if it satisfies the requirements of the applicable 
statutes and regulations.
    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 (the 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 and third edition on May 3, 2004, and June 16, 2016, 
respectively. This draft will be the fourth edition of this document. 
FDA is issuing this draft guidance entitled ``Prior Notice of Imported 
Food Questions and Answers (Edition 4)'' as a level 1 guidance.
    The draft fourth edition 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 draft 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 draft guidance also 
intends to clarify 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 Automate 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 20, 
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 Systems Interface (FDA PNSI), and updating outdated 
links and FDA contact information.
    The draft fourth edition guidance clarifies that the existence of a 
Systems Recognition Arrangement with or an equivalence determination of 
a foreign country does not exempt imported foods 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 draft 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 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 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 draft fourth edition also clarifies the 5-calendar-day clock to 
request a review of these refusals and 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 draft 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.
    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 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 
guidance to ACS and successor system with 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 draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Prior Notice 
of Imported Food Questions and Answers (Edition 4).'' It does not 
establish any rights for any person and is not binding on FDA or the

[[Page 55934]]

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. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 draft guidance 
at https://www.fda.gov/food/importing-food-products-united-states/prior-notice-imported-foods, 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: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19724 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P


