Notice2025-10891
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 16, 2025
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 the collection of information associated with our Manufactured Food Regulatory Program Standards (MFRPS).
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25309-25311]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10891]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0734]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Manufactured Food Regulatory Program Standards
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 the collection of information associated
with our Manufactured Food Regulatory Program Standards (MFRPS).
DATES: Either electronic or written comments on the collection of
information must be submitted by August 15, 2025.
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 August 15, 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:
<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
[[Page 25310]]
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-2025-N-0734 for ``Manufactured Food Regulatory Program Standards.''
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: 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,
<a href="/cdn-cgi/l/email-protection#87d7d5c6d4f3e6e1e1c7e1e3e6a9efeff4a9e0e8f1"><span class="__cf_email__" data-cfemail="316163706245505757715755501f5959421f565e47">[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.
Manufactured Food Regulatory Program Standards
OMB Control Number 0910-0601--Extension
This information collection helps implement FDA's ``Manufactured
Food Regulatory Program Standards.'' Section 1012 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 399c) authorizes FDA to administer
training and education programs for employees of State, local,
Territorial, and Tribal food safety authorities relating to regulatory
programs. Also, under section 205 of the FDA Safety Modernization Act
(codified in 21 U.S.C. 2224), FDA, together with the Centers for
Disease Control and Prevention, is directed to enhance foodborne
illness surveillance to improve the collection, analysis, reporting,
and usefulness of data on foodborne illnesses. As part of this effort,
we have initiated programs that include developing and instituting
regulatory standards intended to reduce the risk of foodborne illness
through coordinated efforts with our strategic partners. Regulatory
program standards establish a uniform foundation for the design and
management of State, local, Tribal, and Territorial programs that have
the responsibility for regulating human and animal food. Partnering
with other regulatory officials also helps maximize limited resources
in administering FDA regulations pertaining to manufacturing/
processing, packing, or holding of food for consumption in the United
States.
The MFRPS are the result of external collaboration and coordination
with the Association of Food and Drug Officials (AFDO) and State
manufactured food regulatory programs. FDA, AFDO, and states worked
collaboratively to develop the content of the MFRPS. A copy of the
standards and accompanying worksheets and forms is available in the
Federal Register docket for this notice. We recommend that State
manufactured food regulatory programs use these program standards as
the framework to design and manage their manufactured food regulatory
programs. The States that assisted in the development of MFRPS were
representative of the 42
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State programs enrolled currently conducting manufactured food
inspections via funding from a cooperative agreement grant entitled
``RFA-FD-18-001: Flexible Funding Model--Infrastructure Development and
Maintenance for State Manufactured Food Regulatory Programs (U18).''
For more information on this cooperative agreement, visit our website
at: <a href="https://www.fda.gov/food/regulatory-program-standards-food/manufactured-food-regulatory-program-standards-mfrps">https://www.fda.gov/food/regulatory-program-standards-food/manufactured-food-regulatory-program-standards-mfrps</a>.
The regulatory program standards provide a uniform and consistent
approach to manufactured food regulation in the United States. States
may implement the program standards on a voluntary basis. The MFRPS is
the framework that each participating State should use to design,
manage, and improve its manufactured food regulatory program. The MFRPS
provide for the following standards: (1) regulatory foundation; (2)
training program; (3) inspection program; (4) inspection audit program;
(5) food-related illness, outbreak and hazards response; (6) compliance
and enforcement program; (7) industry and community relations; (8)
program resources; (9) program assessment; and (10) laboratory support.
For more information, including access to the program standards and
appendices, visit our website at: <a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards</a>.
The MFPS includes appendices to help the State program assess and
meet the program elements in the standard. State programs are not
obligated to use the appendices provided with the standards. Other
manual or automated forms, worksheets, and templates may be used if the
pertinent data elements are present. Records and other documents
specified in the standards must be current and fit for use by the State
program and must be available to verify the implementation of each
standard. As set forth in the standards, the State program is expected
to develop or update a strategic improvement plan that aids the State
program in achieving and maintaining conformance with the program
elements of each standard and addresses any necessary corrective
actions.
Description of Respondents: Respondents are State Departments of
Agriculture or Health regulatory officials who enroll in the MFRPS. We
estimate 42 respondents to the information collection based on current
participation.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden 1 2
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Number of Average burden
Type of respondent; information collection activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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State Governments; Maintenance of data records consistent with the 42 11 462 88.09 40,698
MFRPS............................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals may not sum due to rounding.
One State program is no longer participating in the MFRPS and two
enrolled state agencies have been reorganized into one state agency
since our last evaluation. We have consolidated our estimates from the
previous request for renewal of this information collection to account
for burden attributable to reporting tasks in the recordkeeping table.
This consolidation of reporting and recordkeeping hours results in an
increase in the average burden per recordkeeping. Due to the decrease
in respondents, the total estimated burden for this collection has
decreased by 1,938 hours.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10891 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P
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