Notice2026-19281
Agency Information Collection Activities; Proposed Collection; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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Published
September 21, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Full Text
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<title>Federal Register, Volume 91 Issue 181 (Monday, September 21, 2026)</title>
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[Federal Register Volume 91, Number 181 (Monday, September 21, 2026)]
[Notices]
[Pages 59785-59788]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19281]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-10033]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prior Notice of Imported Food Under the Public Health
Security and Bioterrorism Preparedness and Response Act of 2002
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 20, 2026.
[[Page 59786]]
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 20, 2026. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2026-N-10033 for ``Prior Notice of Imported Food Under the Public
Health Security and Bioterrorism Preparedness and Response Act of
2002.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#055557445671646363456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="7f2f2d3e2c0b1e19193f191b1e5117170c51181009">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.278 to
1.285
OMB Control Number 0910-0520--Extension
The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (Bioterrorism Act) added section 801(m) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)),
which requires that FDA receive prior notice for food, including food
for animals, that is imported or offered for import into the United
States. Sections 1.278 to 1.282 of FDA regulations (21 CFR 1.278 to
1.282) set forth the requirements for submitting prior notice;
Sec. Sec. 1.283(d) and 1.285(j) (21 CFR 1.283(d) and 1.285(j)) set
forth the procedure for requesting Agency review after FDA has refused
admission of an article of food under section 801(m)(1) of the FD&C Act
or placed an article of food under hold under section 801(l) of the
FD&C Act; and Sec. 1.285(i) sets forth the procedure for post-hold
submissions.
Section 304 of the FDA Food Safety Modernization Act (Pub. L. 111-
353)
[[Page 59787]]
amended section 801(m) of the FD&C Act to require a person submitting
prior notice of imported food, including food for animals, to report,
in addition to other information already required, ``any country to
which the article has been refused entry.'' Advance notice of imported
food allows FDA, with the support of the U.S. Customs and Border
Protection (CBP), to target import inspections more effectively and
help protect the nation's food supply against terrorist acts and other
public health emergencies. By requiring that a prior notice contain
specific information that indicates prior refusals by any country and
identifies the country or countries, the Agency may better identify
imported food shipments that may pose safety and security risks to U.S.
consumers.
This information collection enables FDA to make better informed
decisions in managing the potential risks of imported food shipments
into the United States. Any person with knowledge of the required
information may submit prior notice for an article of food. Thus, the
respondents to this information collection may include importers,
owners, ultimate consignees, shippers, and carriers.
FDA regulations require that prior notice of imported food be
submitted electronically using CBP's Automated Broker Interface of the
Automated Commercial Environment (ABI/ACE) (Sec. 1.280(a)(1)) or the
FDA Prior Notice System Interface (PNSI) (Form FDA 3540) (Sec.
1.280(a)(2)). PNSI is an electronic submission system available on the
FDA Industry Systems page at <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>. Information
the Agency collects in the prior notice submission includes: (1) the
submitter and transmitter (if different from the submitter); (2) entry
type and CBP entry identifier; (3) the article of food, including
complete FDA product code, common or usual name or market name, and
quantity; (4) the manufacturer, for an article of food no longer in its
natural state; (5) the grower, if known, for an article of food that is
in its natural state; (6) the FDA Country of Production; (7) the name
of any country that has refused entry of the article of food; (8) the
shipper; (9) the country from which the article of food is shipped or,
if the food is imported by international mail, the anticipated date of
mailing and country from which the food is mailed; (10) the anticipated
arrival information or, if the food is imported by international mail,
the U.S. recipient; (11) the importer, owner, and ultimate consignee,
except for food imported by international mail or transshipped through
the United States; (12) the carrier and mode of transportation, or name
of the mail service for international mail shipments; and (13) planned
shipment information, or mail tracking number for food imported by
international mail (Sec. 1.281).
Much of the information collected for prior notice is identical to
the information collected for FDA importer's entry notice, which has
been approved under OMB control number 0910-0046. The information in an
importer's entry notice is collected electronically via CBP's ABI/ACE
at the same time the respondent files an entry for import with CBP. To
avoid double-counting the burden hours already counted in the
importer's entry notice information collection, the burden hour
analysis in table 1 reflects FDA's estimate of the reduced burden for
prior notice submitted through ABI/ACE in column 6 entitled ``Average
Burden per Response.''
In addition to submitting a prior notice, a submitter should cancel
a prior notice and must resubmit the information to FDA if information
changes after the Agency has confirmed a prior notice submission for
review (e.g., if the identity of the manufacturer changes) (Sec.
1.282). However, changes in the estimated quantity, anticipated arrival
information, or planned shipment information do not require
resubmission of prior notice after the Agency has confirmed a prior
notice submission for review (Sec. 1.282(a)(1)(i) to (iii)). If FDA
refuses admission of an article of food under section 801(m)(1) of the
FD&C Act, Sec. 1.283(c) sets forth the procedure for submitting prior
notice after refusal. In the event that FDA refuses admission to an
article of food under section 801(m)(1) or the Agency places it under
hold under section 801(l) of the FD&C Act, Sec. Sec. 1.283(d) and
1.285(j) set forth the procedure for requesting FDA's review and the
information required in a request for review. In the event that the
Agency places an article of food under hold under Sec. 801(l) of the
FD&C Act, Sec. 1.285(i) sets forth the procedure for, and the
information to be included in, a post-hold submission.
This information collection incorporates the reporting requirements
established by the final rule, Prior Notice: Adding Requirement to
Submit Mail Tracking Number for Articles of Food Arriving by
International Mail and Timeframe for Post-refusal and Post-hold
Submissions (90 FR 46046, September 25, 2025). The final rule amended
Sec. 1.281(b)(10) (21 CFR 1.281(b)(10)) to require submitters of prior
notice for articles of food arriving by international mail to provide
the name of the mail service and the mail tracking number beginning
October 1, 2026. The rule also amended Sec. Sec. 1.283 and 1.285 (21
CFR 1.283 and 1.285) to establish timeframes for post-refusal prior
notice submissions and post-hold food facility registration
submissions. These reporting requirements are incorporated into this
information collection and reflected in the burden estimates below.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section FDA form Number of responses per Total annual Average burden per response Total hours
No. respondents respondent responses
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Prior Notice Submissions:
Through ABI/ACE.....................
1.280 through 1.281..................... N/A 3,294 5,898 19,428,012 0.167 (10 minutes).................. 3,244,478
Through PNSI............................
1.280 through 1.281................. \3\ 3540 225,075 24 5,401,800 0.384 (23 minutes).................. 2,074,291
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Subtotal............................ .......... .............. .............. .............. .................................... 5,318,769
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Cancellations:
Through ABI/ACE
1.282................................... N/A 27,666 1 27,666 0.25 (15 minutes)................... 6,917
Through PNSI:...........................
[[Page 59788]]
1.282 and 1.283(a)(5)............... 3540 64,621 1 64,621 0.25 (15 minutes)................... 16,155
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Subtotal........................ .......... .............. .............. .............. .................................... 23,072
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Requests for Review and Post-hold
Submissions:
1.283(d) and 1.285(j)............... N/A 1 0 1 8................................... 8
1.285(i)............................ N/A 189 1 189 1................................... 189
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Subtotal........................ .......... .............. .............. .............. .................................... 189
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Mail Service and Tracking Number:
One-Time Burden..................... .......... 5,460 1 5,460 0.50 (30 minutes)................... 2,730
Recurring Burden.................... .......... .............. 143 780,780 0.07 (4 minutes).................... 54,655
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Subtotal........................ .......... .............. .............. .............. .................................... 57,385
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Overall Total............... .......... 331,765 .............. 25,761,671 .................................... 5,419,656
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3540'' refers to the electronic submission system known as PNSI, which is available at <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>.
Since the last OMB approval, FDA has revised this information
collection to consolidate the previously approved information
collection under OMB Control No. 0910-0923, which covers the reporting
requirements for the mail service and mail tracking number associated
with prior notice submissions for articles of food arriving by
international mail. Our estimated burden for this information
collection reflects an overall increase of 7,629,528 hours and a
corresponding increase of 1,721,959 responses. We attribute this
adjustment to the overall growth in United States food importation,
changes in de minimis exemptions, and the aforementioned new
requirements for international mail shipments.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19281 Filed 9-18-26; 8:45 am]
BILLING CODE 4164-01-P
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