[Federal Register Volume 90, Number 125 (Wednesday, July 2, 2025)]
[Notices]
[Pages 29025-29027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-12308]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0339]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mitigation Strategies To Protect Food Against
Intentional Adulteration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 collections of information
applicable to mitigation strategies to protect food against intentional
adulteration.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
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untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 2, 2025. 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:
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-2025-N-0339 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Mitigation Strategies To Protect
Food Against Intentional Adulteration.'' 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 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 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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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.
Mitigation Strategies To Protect Food Against Intentional
Adulteration--21 CFR Part 21
OMB Control Number 0910-0812--Extension
This information collection helps support the implementation of
statutory and regulatory requirements intended to ensure the safety of
food. Section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 350g) governs the assessment and evaluation of hazard
analyses and risk-based preventive controls intended to provide
assurances that food is not adulterated under section 402 of the FD&C
Act (21 U.S.C. 342). Similarly, section 419 of the FD&C Act (21 U.S.C.
350h) establishes standards for produce safety, and section 420 of the
FD&C Act (21 U.S.C. 350i) requires the mitigation against intentional
adulteration of high-risk foods (exempting farms except for farms that
produce milk).
Agency regulations in part 121 (21 CFR part 121) establish
requirements applicable to owners, operators, or agents in charge of
domestic or foreign food facilities that manufacture/process, pack, or
hold food for consumption in the United States. The regulations,
require the preparation, retention and
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maintenance, and implementation of written mitigation strategies and
procedures for defense monitoring, corrective actions, and food defense
verification procedures.
To help facilitate the submission to FDA of required information
and reduce burden on respondents, we have developed resources,
including an ``FDA Food Defense Plan Builder,'' (version 2.0) available
at https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials. Other resources made available to respondents
include two draft guidance documents entitled ``Mitigation Strategies
To Protect Food Against Intentional Adulteration: Draft Guidance for
Industry'' (84 FR 8103, March 6, 2019), and ``Supplemental Draft
Guidance for Industry: Mitigation Strategies To Protect Food Against
Intentional Adulteration'' (85 FR 8599, February 14, 2020), which are
available at https://www.fda.gov/food/food-defense. The guidance
documents are intended to assist respondents in developing and
implementing requisite elements of a food defense plan. All Agency
guidance documents are issued in accordance with our good guidance
practice regulations in 21 CFR 10.115, which provide for public comment
at any time. Finally, we developed the small entity compliance guide
entitled ``Mitigation Strategies To Protect Food Against Intentional
Adulteration'' (82 FR 40484, August 25, 2017), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-mitigation-strategies-protect-food-against-intentional-adulteration.
Description of Respondents: The respondents to this information
collection are manufacturers, processors, packers, and holders of
retail food products marketed in the United States.
We estimate the burden of the collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total
Information collection Number of responses per annual Average burden per Total
activity; 21 CFR section respondents respondent responses response hours
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Exemption requests for very 18,080 1 18,080 0.5 (30 minutes)......... 9,040
small businesses; Sec.
121.5.
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total
Activity; 21 CFR section Number of records per annual Average burden per recordkeeping Total
recordkeepers recordkeeper records hours
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Food Defense Plan; Sec. 121.126............... 3,247 1 3,247 23......................................... 74,681
Actionable Process Steps; Sec. 121.130........ 9,759 1 9,759 20......................................... 195,180
Mitigation Strategies; Sec. 121.135(b)........ 9,759 1 9,759 20......................................... 195,180
Monitoring, Corrective Actions, Verification; 9,759 1 9,759 175........................................ 1,707,825
Sec. Sec. 121.140(a), 121.145(a)(1), and
121.150(b).
Training; Sec. 121.4.......................... 367,203 1 367,203 0.67 (40 minutes).......................... 246,026
Records; Sec. Sec. 121.305 and 121.310....... 9,759 1 9,759 10......................................... 97,590
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Total....................................... ............... .............. ........... ........................................... 2,516,482
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12308 Filed 7-1-25; 8:45 am]
BILLING CODE 4164-01-P