[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26320-26322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08971]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0341]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Federal-State Food 
Regulatory Program Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 May 30, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Federal-State Food Regulatory Program Standards

OMB Control Number 0910-0760--Revision

    This information collection supports the 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 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 is 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. 
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#:~:text=Regulatory%20program%20standards%20establish%20a,regul
ating%20human%20and%20animal%20food) for more information and to access 
the program standards.
    Both the AFRPS and ERPS packages 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. States submit the information collected annually 
via email to the appropriate FDA program manager. 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

[[Page 26321]]

implementation status annually 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 focus more on capturing information 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 appendices to be more uniform, succinct, and tabular in 
structure. The revised program standards are the result of external 
collaboration and coordination between FDA, the Association of American 
Feed Control Officials and state governments in which we consider any 
formal comments received on the 2020 edition of the program standards.
    Description of Respondents: Respondents are state departments of 
agriculture or health enrolled in the AFRPS or ERPS (State 
Governments).
    In the Federal Register of November 3, 2022 (87 FR 66307), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received and considered three comments. 
Two comments questioned the value of transitioning from the term 
``animal feed'' to ``animal food,'' expressing concern for potential 
confusion unless other entities including member states also changed 
their terminology. The term ``food'' is defined in section 201(f) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(f)) (the FD&C 
Act) as ``articles used for food or drink for man or other animals.'' 
Section 201(w) of the FD&C Act defines ``animal feed'' more 
specifically as, ``an article which is intended for use for food for 
animals other than man and which is intended for use as a substantial 
source of nutrients in the diet of the animal, and is not limited to a 
mixture intended to be the sole ration of the animal.'' We believe the 
term ``animal feed'' is a useful distinction in some circumstances, but 
that ``food'' or ``animal food'' more accurately describes the 
regulated market.
    One comment addressed public access to government data and the 
Federal policy development process, among other topics, all of which we 
consider to be outside the scope of this information collection. 
Respondents to this information collection maintain records and provide 
procedures and other documentation to demonstrate a standardized animal 
feed regulatory program. Another comment questioned the practical 
utility of the AFRPS, suggesting that FDA should implement ``a program 
that encourages uniform enforcement of laws/regulations across all 50 
States.'' We believe the AFRPS is the best way to achieve that goal.
    We estimate 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/                2               1               2             569           1,138
 or Tribal Governments;
 submission of data elements to
 FDA consistent with ERPS.......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,363
----------------------------------------------------------------------------------------------------------------
\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; records
 maintenance for data elements
 consistent with AFRPS..........
State, local, Territorial, and/                2              10              20              40             800
 or Tribal Governments; records
 maintenance for data elements
 consistent with ERPS...........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          11,800
----------------------------------------------------------------------------------------------------------------
\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, based on a review of the 
information collection since our last submission, the estimated burden 
for the information collection reflects an overall adjustment increase 
of 188 responses and a corresponding increase of 2,817 burden hours. We

[[Page 26322]]

adjusted the number of respondents to the information collection 
associated with the AFRPS to reflect a reduction in enrollment since 
our last evaluation. Also, since the publication of the 60-day notice, 
we adjusted the number of respondents to the information collection to 
reflect a reduction in ERPS enrollment. In addition, based on the 
Agency's experience over the past 3 years, we 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: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08971 Filed 4-27-23; 8:45 am]
BILLING CODE 4164-01-P