[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]


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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.

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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 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\
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                                                     Number of
  Type of respondents; activity      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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
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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                    Average burden
  Type of respondents; activity      Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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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
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\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


