[Federal Register Volume 90, Number 161 (Friday, August 22, 2025)]
[Notices]
[Pages 41083-41085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-16064]
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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 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 revisions to the collections of information
associated with our Animal Food Regulatory Program Standards and Egg
Regulatory Program Standards.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 21, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
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 October 21, 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-2548 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Animal Food and Egg 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 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
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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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Animal Food and Egg Regulatory Program Standards (Formerly Entitled
Federal-State Food 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). 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;
inspection program; inspection audit program; egg-related illness,
outbreak and emergency response; compliance and enforcement program;
outreach activities; program resources; program assessment; and
laboratory support. 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 to
the program standards, we invite you to visit our website at https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards.
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. In an
effort 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 Integrated
Food Safety (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
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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.
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:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Type of respondents; activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
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State, local, Territorial, and/ 2 1 2 569 1,138
or Tribal Governments;
submission of data elements to
FDA consistent with ERPS......
State, local, Territorial, and/ 25 1 25 569 14,225
or Tribal 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
Type of respondents; activity Number of records per Total annual Average burden per Total hours
recordkeepers recordkeeper records recordkeeping
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State, local, Territorial and/ 2 10 20 40 800
or Tribal Governments;
submission of data elements to
FDA consistent with ERPS......
State, local, Territorial and/ 25 11 275 40 11,000
or Tribal 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.
Dated: August 15, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16064 Filed 8-21-25; 8:45 am]
BILLING CODE 4164-01-P