Notice2026-04940
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food and Egg 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
March 13, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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 91 Issue 49 (Friday, March 13, 2026)</title>
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[Federal Register Volume 91, Number 49 (Friday, March 13, 2026)]
[Notices]
[Pages 12420-12421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-04940]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2548]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Food and Egg Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 April 13, 2026.
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 0910-0760. The docket number is FDA-
2025-N-2548.
FOR FURTHER INFORMATION CONTACT: Patrick Clouser, Office of Operations,
Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20852,
240-402-5276, <a href="/cdn-cgi/l/email-protection#66363427351207000026000207480e0e1548010910"><span class="__cf_email__" data-cfemail="e7b7b5a6b493868181a7818386c98f8f94c9808891">[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.
Animal Food and Egg Regulatory Program Standards
OMB Control Number 0910-0760--Extension
This information collection helps implement FDA's Egg Regulatory
Program Standards (ERPS) and Animal Food Regulatory Program Standards
(AFRPS). The current submission seeks to revise this information
collection related to the ERPS. No revisions were made to the AFRPS.
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 the manufacturing/processing, packing, or
holding of food for consumption in the United States.
The ERPS identifies and includes resource and training material for
the following ten standards: regulatory foundation; training program;
inspection program; audit program; egg-related illness, outbreak and
emergency response; compliance and enforcement program; outreach
program; program planning and resources; assessment and improvement;
and laboratory services. We recommend using the worksheets and forms
contained in the standards, however, alternate forms that are
equivalent may be used. The educational worksheets and resource
materials include recordkeeping and reporting activities that help FDA
verify participation and successful completion of the respective
requirements. In the first year of enrollment, information is used to
conduct a baseline self-assessment to determine whether the materials
meet the elements of each standard. In subsequent years, we use the
information to conduct a comprehensive review and evaluate program
effectiveness and participation. We modify the program standards based
on the ongoing assessments as well as comments and informal feedback
obtained from participants. For more information, including access the
program standards, we invite you to 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>.
In collaboration with the state governments, the FDA recently
completed a revision of the egg regulatory standards that incorporated
the most current knowledge and lessons learned in the application of
the 2021 ERPS by state partners and program assessment by FDA. To
improve program effectiveness, understanding and clarity, changes to
the ERPS include those to program definitions, all 10 program
standards, appendices and assessment worksheets that may be used by the
states who have adopted the ERPS. Other changes include streamlining
both the standards and appendices to be less prescriptive in nature.
This process results in an overall reduction of appendices (most of
which provided more program specific guidance or examples and therefore
are not expected to change the burden) and a reformatting of the
remaining appendices to be more uniform, succinct, and tabular in
structure.
The ERPS is a critical component in establishing FDA's IFSS. The
ERPS, henceforth also referred to as ``program standards,'' establishes
a uniform foundation for regulatory agencies responsible for oversight
of eggs and egg products. When fully implemented, the program standards
define a set of best practices of a regulatory system. The revised
program standards are the result of external collaboration and
coordination between FDA, the National Egg Regulatory Officials (NERO)
and state governments in which we consider any formal comments received
on the 2021 edition of the program standards. A copy of the revised
program standards and accompanying worksheets and forms is available in
the Federal Register docket for this notice.
In the Federal Register of August 22, 2025 (90 FR 41083), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Two comments were received. Both comments
were unrelated to the Paperwork Reduction Act.
Description of Respondents: Respondents are State Departments of
Agriculture or Health regulatory officials who enroll in the AFRPS or
ERPS (State or Territorial governments). Our respondent estimates are
based on expected participation.
FDA estimates the burden of this collection of information as
follows:
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Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Type of respondents; activity Number of responses per annual burden per Total
respondents respondent responses response hours1
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State, local, Territorial, and/or Tribal 2 1 2 569 1,138
Governments; submission of data elements
to FDA consistent with ERPS..............
State, local, Territorial, and/or Tribal 25 1 25 569 14,225
Governments; submission of data elements
to FDA consistent with AFRPS.............
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Total................................. ........... .............. ........... .............. 15,363
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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 Average
Type of respondents; activity Number of records per annual burden per Total
recordkeepers recordkeeper records recordkeeping hours
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State, local, Territorial and/or Tribal 2 10 20 40 800
Governments; submission of data elements
to FDA consistent with ERPS.............
State, local, Territorial and/or Tribal 25 11 275 40 11,000
Governments; submission of data elements
to FDA consistent with AFRPS............
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Total................................ .............. .............. ........... .............. 11,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
To demonstrate conformance with the standards prior to and after
enrollment in the grant programs, State and Territorial governments
participating in the program standards (respondents) submit
comprehensive program assessments and evaluations to their technical
advisors at FDA using a dedicated email. The information required for
these submissions is outlined in the provided worksheets. Additionally,
the program standards require ongoing documentation to verify
conformance. We base our estimates on the historical performance of
these standards programs and informal consultation with the affected
State and Territorial governments. We have consolidated our estimates
to account for burden attributable to reporting tasks in the
recordkeeping table.
Our estimated burden for the information collection reflects no
change, as enrollment and participation in both programs remains
steady.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04940 Filed 3-12-26; 8:45 am]
BILLING CODE 4164-01-P
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