Notice2021-21367
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety; 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
October 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) 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
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<title>Federal Register, Volume 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54454-54455]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21367]
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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; Food Safety; 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 we) 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 November 1, 2021.
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#f8a8aab9ab8c999e9eb89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="e5b5b7a4b691848383a5838184cb8d8d96cb828a93">[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.
Food Safety; Federal-State Food Regulatory Program Standards
OMB Control Number 0910-0760--Revision
This information collection supports implementation of FDA's
Federal-State Regulatory Program Standards, part of our National
Integrated Food Safety System (IFSS) Programs and Initiatives. For more
information we invite you to visit our website at: <a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives</a>. In the
United States, Federal and State governments work cooperatively to
ensure the safety of food intended for both human and animal
consumption. Part of this effort includes developing and maintaining
uniform review criteria by which to assess food safety. FDA has
established and maintains a number of program standards aimed at
improving the safety evaluation for certain food products including
manufactured foods and animal feed. Similarly, we are establishing
regulatory program standards for eggs and have developed the ``Eggs
Regulatory Program Standards'' (ERPS). The ERPS is intended for use by
State and local regulatory officials and identifies 10 elements we
believe are essential to the effective regulatory assessment of egg
safety. States are encouraged to build systems that are sustainable and
implement plans corresponding to the IFSS.
In the course of their normal duties, State, local, Territorial,
and Tribal governments collect information pertaining to compliance
with the respective State, local, Territorial, and Tribal food safety
requirements within their jurisdictions. Although content and format of
the information collected may vary, these activities are a usual and
customary part of routine regulatory oversight. Respondents to the
information collection are State, local, Territorial, and Tribal
regulatory agencies.
The ERPS offers forms, worksheets, and templates to help
respondents assess and meet the program elements identified and
discussed. Respondents are not required to use the sample collection
instruments included in the ERPS, however all data elements should be
submitted to FDA and supporting documentation retained. The ERPS is
[[Page 54455]]
not intended to address any performance appraisal processes that any
State, local, Territorial, or Tribal agency may use to evaluate its
employees' performance. Funding opportunities are available to
respondents who choose to implement the ERPS; however, these
opportunities are limited and contingent upon the availability of
funds, and are available to those respondents who currently have an egg
inspection contract with FDA and thus are subject to auditing. A copy
of the ERPS has been posted to FDA-2021-N-0341 and is available at
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
In the Federal Register of May 14, 2021 (86 FR 26528), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--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/or Tribal Governments; submission of 10 10 100 50 5,000
data elements to FDA consistent with ERPS.........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our experience with similar information collection, we
estimate an initial 10 respondents will participate in the ERPS, and
assume an average of 50 burden hours per response is necessary for the
attendant recordkeeping and submission of data elements to FDA. We
expect participation in the ERPS to increase. Finally, upon submission
of the Information Collection Request, we are correcting an inadvertent
calculation error in the total burden hours as displayed on page 26530,
in Table 1, in our 60-day notice in the Federal Register of May 14,
2021 (86 FR 26528).
Dated: September 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21367 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
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