Notice2025-17056
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
September 5, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 170 (Friday, September 5, 2025)</title>
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[Federal Register Volume 90, Number 170 (Friday, September 5, 2025)]
[Notices]
[Pages 42972-42973]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17056]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0734]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 6, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0601. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD
[[Page 42973]]
20852, 301-796-8867, <a href="/cdn-cgi/l/email-protection#3e6e6c7f6d4a5f58587e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="336361726047525555735557521d5b5b401d545c45">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Manufactured Food Regulatory Program Standards
OMB Control Number 0910-0601--Revision
This information collection helps implement FDA's ``Manufactured
Food Regulatory Program Standards'' (MFRPS). 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 Food 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 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
provides 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 MFRPS 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.
In the Federal Register of June 16, 2025 (90 FR 25309), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17056 Filed 9-4-25; 8:45 am]
BILLING CODE 4164-01-P
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