Agency Information Collection Activities; Proposed Collection; Comment Request; Federal-State Food Regulatory Program Standards, 66307-66309 [2022-23919]
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Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
Office of New Drugs (OND) led the
development of two documents to
facilitate internal review of safety data.
The first document, ‘‘FDA Medical
Queries,’’ provides a standardized
approach to group preferred terms of
adverse events using ‘‘Medical
Dictionary for Regulatory Activities’’
(MedDRA) terminology. The second
document, ‘‘Standard Safety Tables and
Figures Integrated Guide,’’ provides
standardized methods for visualization
of clinical trial safety data into tables
and figures. FDA values transparency
and collaboration with external
stakeholders; therefore, both documents
are available for public comment
through the docket.
II. Topics Discussed at the Public
Workshop
At the public workshop entitled
‘‘Advancing Premarket Safety Analytics
Workshop,’’ CDER’s OND presented its
work and perspective related to safety
analytics. The workshop provided
presentations from FDA staff on the two
documents ‘‘FDA Medical Queries’’ and
‘‘Standard Safety Tables and Figures
Integrated Guide ’’ (meeting materials
available at https://healthpolicy.
duke.edu/events/advancing-premarketsafety-analytics). The workshop also
included panel discussions with
industry representatives on
‘‘Stakeholder Perspectives Exploring
Premarket Adverse Event Grouping’’
and ‘‘Examining Strategies for Adverse
Event Analysis.’’ FDA documents were
intended as a starting point for broader
discussions on best practices and
innovative approaches for advancing
premarket safety signal analytics. We
are also seeking comment on the topics
discussed at the workshop.
Dated: October 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23925 Filed 11–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. FDA–2021–N–0341]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Federal-State Food
Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
16:41 Nov 02, 2022
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
SUMMARY:
VerDate Sep<11>2014
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 revision 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 information
collection provisions associated with
FDA’s Federal-State Food Regulatory
Program Standards.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
January 3, 2023.
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
January 3, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Jkt 259001
Submit written/paper submissions as
follows:
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66307
• 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–
2021–N–0341 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Safety; Federal-State 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
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-201509-18/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
E:\FR\FM\03NON1.SGM
03NON1
66308
Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
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:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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 revision 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.
lotter on DSK11XQN23PROD with NOTICES1
Federal-State Food Regulatory Program
Standards
OMB Control Number 0910–0760—
Revision
This information collection supports
FDA’s Animal Food (formerly ‘‘Feed’’)
Regulatory Program Standards (AFRPS)
and Egg Regulatory Program Standards
(ERPS). In the United States, Federal
and State government agencies ensure
VerDate Sep<11>2014
16:41 Nov 02, 2022
Jkt 259001
the safety of human and animal food.
FDA is responsible for ensuring that all
human and animal food moving in
interstate commerce, except those under
the U.S. Department of Agriculture
jurisdiction, are safe, wholesome, and
labeled properly. States are responsible
for conducting inspections and
regulatory activities that help ensure
human and animal food a produced,
processed, and distributed within their
jurisdictions are safe and in compliance
with State laws and regulations. States
primarily perform inspections under
their own regulatory authority. Some
States conduct inspections of human
and animal food facilities under
contract with FDA. Because
jurisdictions may overlap, FDA and
States collaborate and share resources to
protect human and animal food.
The FDA Food Safety Modernization
Act calls for enhanced partnerships and
provides a legal mandate for developing
an Integrated Food Safety System
(IFSS). FDA is committed to
implementing an IFSS thereby
optimizing coordination of human and
animal food safety efforts with Federal,
State, local, tribal, and territorial
regulatory and public health agencies.
Model standards provide a consistent,
underlying foundation that is critical for
uniformity across State and Federal
agencies to ensure credibility of human
and animal food programs within the
IFSS. The AFRPS and ERPS provide a
uniform and consistent approach to
animal food and egg regulation in the
United States. Implementation of the
AFRPS and ERPS are voluntary.
The AFRPS and ERPS are the
frameworks that each State should use
to design, manage, and improve its
animal food or egg regulatory program.
The AFRPS standards include the
following: (1) regulatory foundation; (2)
training program; (3) inspection
program; (4) audit program; (5) animal
food-related illnesses or death and
emergency response; (6) compliance and
enforcement program; (7) outreach
program; (8) planning and resources; (9)
assessment and improvement; (10)
laboratory services; and (11) sampling
program. The ERPS include equivalent
standards for egg regulatory programs
except they do not include a separate
standard 11 sampling program. Each
standard has a purpose statement,
requirement summary, description of
program elements, projected outcomes,
and a list of required documentation.
When a state program voluntarily agrees
to implement the standards, it must
fully implement and maintain the
individual program elements and
documentation requirements in each
standard in order to fully implement the
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standard. We invite you to visit our
website (https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/national-integrated-food-safetysystem-ifss-programs-and-initiatives/
regulatory-program-standards) for more
information and to access the program
standards.
Both the AFRPS and ERPS package
include forms, worksheets, and
templates to help the State program
assess and meet the program elements
in the standard. State programs are not
obligated to use the forms, worksheets,
and templates. Other manual or
automated forms, worksheets, and
templates may be used as long as the
pertinent data elements are present.
Records and other documents specified
in the AFRPS and ERPS must be
maintained in good order by the state
program and must be available to verify
the implementation of each standard.
As set forth in the AFRPS and ERPS,
the state program is expected to review
and update its improvement plan on an
annual basis. The state program
completes an evaluation of its
implementation status at least every 3
years following the baseline evaluation
by reviewing and updating the selfassessment worksheets and required
documentation for each standard. The
evaluation is needed to determine if
each standard’s requirements are, or
remain, fully met, partially met, or not
met. The state program revises the
improvement plan based upon this
evaluation.
In collaboration with the State
Governments, FDA recently completed a
revision of the animal food program
standards that incorporated the most
current knowledge and lessons learned
in the application of the 2020 AFRPS by
State partners and program assessment
by FDA. In an effort to improve program
effectiveness, understanding and clarity,
changes to the AFRPS include those to
program definitions, all 11 program
standards, appendices and assessment
worksheets that may be used by the
States who have adopted the AFRPS.
Such changes include updates to
terminology, most notably replacing the
term ‘‘animal feed’’ with ‘‘animal food’’
consistent with the terminology of the
FDA Food Safety Modernization Act,
and minor editorial changes. Other
changes include streamlining both the
standards and appendices to be less
prescriptive in nature and better focus
on information capture needs. This
process results in an overall reduction
of 11 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
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Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 / Notices
appendices to be more uniform,
succinct and tabular in structure. The
revised program standards are the result
of external collaboration and
coordination between FDA and the
Association of American Feed Control
Officials (AAFCO) in which we consider
any formal comments received on the
2020 edition of the program standards
and feedback obtained from our
collaboration with the States. A copy of
the revised program standards is
available in the docket.
Description of Respondents:
Respondents are State Departments of
Agriculture or Health enrolled in the
AFRPS or ERPS (State Governments).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondents; activity
State, local, Territorial, and/or Tribal Governments; submission of data elements to FDA consistent with AFRPS
State, local, Territorial and/or Tribal Governments; submission of data elements to FDA consistent with ERPS ......
Total ..............................................................................
1 There
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
25
1
25
569
14,225
10
1
10
569
5,690
........................
........................
........................
........................
19,915
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of respondents; activity
State, local, Territorial, and/or Tribal Governments; submission of data elements to FDA consistent with AFRPS
State, local, Territorial and/or Tribal Governments; submission of data elements to FDA consistent with ERPS ......
Total ..............................................................................
1 There
Dated: October 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23919 Filed 11–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
Total
annual
records
Average
burden per
recordkeeping
Total
hours
25
11
275
40
11,000
10
10
100
40
4,000
........................
........................
........................
........................
15,000
are no capital costs or operating and maintenance costs associated with this collection of information.
No change in burden is expected to be
incurred with the implementation of the
revised AFRPS. However, we have
adjusted the number of respondents to
the information collection associated
with the AFRPS to reflect a reduction in
enrollment since our last evaluation. In
addition, based on the Agency’s
experience over the past 3 years, we
have added reporting burden and
adjusted the recordkeeping burden
estimates associated with the AFRPS
and ERPS, resulting in an increase in
responses and burden hours.
[Docket No. FDA–2020–D–2107]
Cross Labeling Oncology Drugs in
Combination Regimens; Guidance for
Industry; Availability
AGENCY:
Number of
records per
recordkeeper
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:41 Nov 02, 2022
Jkt 259001
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Cross
Labeling Oncology Drugs in
Combination Regimens.’’ This guidance
describes FDA’s current
recommendations on including relevant
information in labeling for oncology
drugs approved for use in combination
regimens. This guidance finalizes the
draft guidance of the same title issued
on November 20, 2020.
DATES: The announcement of the
guidance is published in the Federal
Register on November 3, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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
E:\FR\FM\03NON1.SGM
03NON1
]]>Agencies
[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Notices]
[Pages 66307-66309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23919]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0341]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Federal-State Food Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 revision 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 information collection provisions associated
with FDA's Federal-State Food Regulatory Program Standards.
DATES: Either electronic or written comments on the collection of
information must be submitted by January 3, 2023.
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 January 3, 2023. 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-2021-N-0341 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Safety; Federal-State 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 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
[[Page 66308]]
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: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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 revision 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.
Federal-State Food Regulatory Program Standards
OMB Control Number 0910-0760--Revision
This information collection supports FDA's Animal Food (formerly
``Feed'') Regulatory Program Standards (AFRPS) and Egg Regulatory
Program Standards (ERPS). In the United States, Federal and State
government agencies ensure the safety of human and animal food. FDA is
responsible for ensuring that all human and animal food moving in
interstate commerce, except those under the U.S. Department of
Agriculture jurisdiction, are safe, wholesome, and labeled properly.
States are responsible for conducting inspections and regulatory
activities that help ensure human and animal food a produced,
processed, and distributed within their jurisdictions are safe and in
compliance with State laws and regulations. States primarily perform
inspections under their own regulatory authority. Some States conduct
inspections of human and animal food facilities under contract with
FDA. Because jurisdictions may overlap, FDA and States collaborate and
share resources to protect human and animal food.
The FDA Food Safety Modernization Act calls for enhanced
partnerships and provides a legal mandate for developing an Integrated
Food Safety System (IFSS). FDA is committed to implementing an IFSS
thereby optimizing coordination of human and animal food safety efforts
with Federal, State, local, tribal, and territorial regulatory and
public health agencies. Model standards provide a consistent,
underlying foundation that is critical for uniformity across State and
Federal agencies to ensure credibility of human and animal food
programs within the IFSS. The AFRPS and ERPS provide a uniform and
consistent approach to animal food and egg regulation in the United
States. Implementation of the AFRPS and ERPS are voluntary.
The AFRPS and ERPS are the frameworks that each State should use to
design, manage, and improve its animal food or egg regulatory program.
The AFRPS standards include the following: (1) regulatory foundation;
(2) training program; (3) inspection program; (4) audit program; (5)
animal food-related illnesses or death and emergency response; (6)
compliance and enforcement program; (7) outreach program; (8) planning
and resources; (9) assessment and improvement; (10) laboratory
services; and (11) sampling program. The ERPS include equivalent
standards for egg regulatory programs except they do not include a
separate standard 11 sampling program. Each standard has a purpose
statement, requirement summary, description of program elements,
projected outcomes, and a list of required documentation. When a state
program voluntarily agrees to implement the standards, it must fully
implement and maintain the individual program elements and
documentation requirements in each standard in order to fully implement
the standard. We invite you to visit our website (https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards) for more information and to access the program
standards.
Both the AFRPS and ERPS package include forms, worksheets, and
templates to help the State program assess and meet the program
elements in the standard. State programs are not obligated to use the
forms, worksheets, and templates. Other manual or automated forms,
worksheets, and templates may be used as long as the pertinent data
elements are present. Records and other documents specified in the
AFRPS and ERPS must be maintained in good order by the state program
and must be available to verify the implementation of each standard.
As set forth in the AFRPS and ERPS, the state program is expected
to review and update its improvement plan on an annual basis. The state
program completes an evaluation of its implementation status at least
every 3 years following the baseline evaluation by reviewing and
updating the self-assessment worksheets and required documentation for
each standard. The evaluation is needed to determine if each standard's
requirements are, or remain, fully met, partially met, or not met. The
state program revises the improvement plan based upon this evaluation.
In collaboration with the State Governments, FDA recently completed
a revision of the animal food program standards that incorporated the
most current knowledge and lessons learned in the application of the
2020 AFRPS by State partners and program assessment by FDA. In an
effort to improve program effectiveness, understanding and clarity,
changes to the AFRPS include those to program definitions, all 11
program standards, appendices and assessment worksheets that may be
used by the States who have adopted the AFRPS. Such changes include
updates to terminology, most notably replacing the term ``animal feed''
with ``animal food'' consistent with the terminology of the FDA Food
Safety Modernization Act, and minor editorial changes. Other changes
include streamlining both the standards and appendices to be less
prescriptive in nature and better focus on information capture needs.
This process results in an overall reduction of 11 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
[[Page 66309]]
appendices to be more uniform, succinct and tabular in structure. The
revised program standards are the result of external collaboration and
coordination between FDA and the Association of American Feed Control
Officials (AAFCO) in which we consider any formal comments received on
the 2020 edition of the program standards and feedback obtained from
our collaboration with the States. A copy of the revised program
standards is available in the docket.
Description of Respondents: Respondents are State Departments of
Agriculture or Health enrolled in the AFRPS or ERPS (State
Governments).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondents; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
State, local, Territorial, and/ 25 1 25 569 14,225
or Tribal Governments;
submission of data elements to
FDA consistent with AFRPS......
State, local, Territorial and/or 10 1 10 569 5,690
Tribal Governments; submission
of data elements to FDA
consistent with ERPS...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 19,915
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
State, local, Territorial, and/ 25 11 275 40 11,000
or Tribal Governments;
submission of data elements to
FDA consistent with AFRPS......
State, local, Territorial and/or 10 10 100 40 4,000
Tribal Governments; submission
of data elements to FDA
consistent with ERPS...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 15,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
No change in burden is expected to be incurred with the
implementation of the revised AFRPS. However, we have adjusted the
number of respondents to the information collection associated with the
AFRPS to reflect a reduction in enrollment since our last evaluation.
In addition, based on the Agency's experience over the past 3 years, we
have added reporting burden and adjusted the recordkeeping burden
estimates associated with the AFRPS and ERPS, resulting in an increase
in responses and burden hours.
Dated: October 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23919 Filed 11-2-22; 8:45 am]
BILLING CODE 4164-01-P
