Notice2023-08971
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Federal-State Food 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
April 28, 2023
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
<html>
<head>
<title>Federal Register, Volume 88 Issue 82 (Friday, April 28, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26320-26322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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. 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,
<a href="/cdn-cgi/l/email-protection#540406150720353232143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="742426352700151212341210155a1c1c075a131b02">[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.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 28, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.