Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability, 70887-70889 [2023-22649]
Download as PDF
Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations
or more and 18,000 total flight cycles or
fewer as of April 14, 2022 (phase-in Effective
Date of TR ALI–0763): Within 5,000 flight
cycles from April 14, 2022, or before
exceeding 20,000 total flight cycles,
whichever occurs first.
(3) For a MLG retract actuator piston rod
that has accumulated more than 18,000 total
flight cycles as of April 14, 2022 (phase-in
Effective Date of TR ALI–0763): Within 2,000
flight cycles from April 14, 2022.
(k) Material Incorporated by Reference
None.
(h) No Alternative Actions or Intervals
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
After the existing maintenance or
inspection program has been revised as
required by paragraph (g) of this AD, no
alternative actions (e.g., inspections) or
intervals may be used unless they are
approved as an alternative method of
compliance in accordance with paragraph
(i)(1) of this AD.
[Docket No. FDA–2011–N–0179]
lotter on DSK11XQN23PROD with RULES1
(j) Additional Information
(1) Refer to Transport Canada AD CF–
2022–56, dated September 26, 2022, for
related information. This Transport Canada
AD may be found in the AD docket at
regulations.gov under Docket No. FAA–
2023–1992.
(2) For more information about this AD,
contact Gabriel D. Kim, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone 516–
228–7343; email 9-avs-nyaco-cos@faa.gov.
(3) For MHI RJ service information
identified in this AD that is not incorporated
by reference, contact MHI RJ Aviation Group,
Customer Response Center, 3655 Ave. des
Grandes-Tourelles, Suite 110, Boisbriand,
Que´bec J7H 0E2 Canada; North America tollfree telephone 833–990–7272 or direct-dial
telephone 450–990–7272; fax 514–855–8501;
email thd.crj@mhirj.com; website mhirj.com.
Jkt 262001
BILLING CODE 4910–13–P
21 CFR Part 1
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Validation Branch, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
In accordance with 14 CFR 39.19, send your
request to your principal inspector or local
Flight Standards District Office, as
appropriate. If sending information directly
to the manager of the International Validation
Branch, mail it to the address identified in
paragraph (j)(3) of this AD or email to: 9AVS-AIR-730-AMOC@faa.gov. If mailing
information, also submit information by
email. Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain instructions
from a manufacturer, the instructions must
be accomplished using a method approved
by the Manager, International Validation
Branch, FAA; or Transport Canada; or MHI
RJ Aviation ULC Transport Canada Design
Approval Organization (DAO). If approved by
the DAO, the approval must include the
DAO-authorized signature.
16:00 Oct 12, 2023
[FR Doc. 2023–22486 Filed 10–12–23; 8:45 am]
Food and Drug Administration
(i) Additional AD Provisions
VerDate Sep<11>2014
Issued on October 4, 2023.
Victor Wicklund,
Deputy Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
Prior Notice of Imported Food
Questions and Answers (Edition 4):
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
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:
SUMMARY:
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
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70887
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
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Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations
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-201509-18/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 selfaddressed 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:
lotter on DSK11XQN23PROD with RULES1
Peter Ajuonuma, Office of Regulatory
Affairs, Food and Drug Administration,
Element Building, 12420 Parklawn Dr.,
Rockville, MD 20852, 301–796–2277,
Peter.Ajuonuma@fda.hhs.gov.
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
VerDate Sep<11>2014
16:00 Oct 12, 2023
Jkt 262001
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
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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 5calendar-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
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Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations
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.
lotter on DSK11XQN23PROD with RULES1
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.
VerDate Sep<11>2014
16:00 Oct 12, 2023
Jkt 262001
III. Electronic Access
SUPPLEMENTARY INFORMATION:
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
I. Table of Abbreviations
Dated: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22649 Filed 10–12–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2023–0735]
RIN 1625–AA00
Safety Zone; Atlantic Ocean,
Jacksonville Beach, FL
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone on
the waterways surrounding Jacksonville,
Florida during the 2023 Jacksonville
Beach Sea and Sky Air Show. The safety
zone is necessary to ensure the safety of
event participants and spectators. Entry
of vessels or persons into this zone is
prohibited unless specifically
authorized by the Captain of the Port
(COTP) Jacksonville or a designated
representative.
SUMMARY:
This rule is effective from 7 a.m.
until 5 p.m. on October 20, 2023,
through October 22, 2023.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2023–
0735 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
DATES:
If
you have questions on this rule, call or
email Marine Science Technician First
Class Anthony DeAngelo, Waterways
Management Division, Sector
Jacksonville, FL, U.S. Coast Guard;
telephone 904–714–7631; email
Anthony.DeAngelo@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00005
Fmt 4700
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70889
COTP Captain of the Port
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
The Coast Guard is issuing this
temporary rule without prior notice and
opportunity to comment pursuant to
authority under section 4(a) of the
Administrative Procedure Act (APA) (5
U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because it is
impracticable. The Coast Guard was
notified of the event without ample time
for the NPRM process. We must
establish the safety zone by October 20,
2023, and lack sufficient time to provide
for a reasonable comment period and
then consider those comments before
issuing this rule.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Delaying the effective date of
this rule would be contrary to the public
interest because immediate action is
needed to ensure the safety of the
participants and vessels during the 2023
Jacksonville Beach Sea and Sky Air
Show.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 46 U.S.C. 70034. The
Captain of the Port Sector Jacksonville
(COTP) has determined that potential
hazards associated with the 2023
Jacksonville Beach Sea and Sky Air
Show will be a safety concern for
persons and vessels in the regulated
area. This rule is needed to ensure the
safety of the event participants, the
general public, vessels and the marine
environment in the navigable waters
within the safety zone during the 2023
Jacksonville Beach Sea and Sky Air
Show.
IV. Discussion of the Rule
This rule establishes a safety zone on
certain waters of Jacksonville, Florida,
during the 2023 Jacksonville Beach Sea
E:\FR\FM\13OCR1.SGM
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Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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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