Notice2022-15737
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Manufactured 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
July 22, 2022
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 87 Issue 140 (Friday, July 22, 2022)</title>
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[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43872-43874]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15737]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0414]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Manufactured 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 August 22, 2022.
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 0910-0601. 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#46161407153227202006202227682e2e3568212930"><span class="__cf_email__" data-cfemail="9cccceddcfe8fdfafadcfaf8fdb2f4f4efb2fbf3ea">[email protected]</span></a>.
[[Page 43873]]
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.
Manufactured Food Regulatory Program Standards
OMB Control Number 0910-0601--Revision
This information collection supports the FDA's ``Manufactured Food
Regulatory Program Standards'' (2019) (<a href="https://www.fda.gov/media/131392/download">https://www.fda.gov/media/131392/download</a>). We recommend that States use these program standards
as the framework to design and manage their manufactured food programs.
There are 44 State programs enrolled in the Manufactured Food
Regulatory Program Standards (MFRPS or the program standards) under
cooperative agreements.
The goal of the MFRPS is to implement a nationally integrated,
risk-based, food safety system focused on protecting public health. The
MFRPS establish a uniform basis for measuring and improving the
performance of prevention, intervention, and response activities of
manufactured food regulatory programs in the United States. The
development and implementation of the standards will help Federal and
State programs better direct their regulatory activities toward
reducing foodborne illness. For more information, and to access the
program standards, we invite you to visit our website at: <a href="https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/regulatory-program-standards/manufactured-food-regulatory-program-standards-mfrps">https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/regulatory-program-standards/manufactured-food-regulatory-program-standards-mfrps</a>.
FDA recommends that a State program enrolled in the MFRPS use the
worksheets and forms contained in the standards; however, alternate
forms that are equivalent may be used. The State program maintains
documentation (guidance, procedures, documents, and forms) required by
the 10 standards, which must be current and fit for use. In the first
year of implementing the program standards, the State program conducts
a baseline self-assessment of the documentation to determine if it
meets the elements of each standard. The State program must participate
in additional verification audits in subsequent years. After 5 years,
FDA will conduct a comprehensive program audit of the documentation. As
part of the program audit, the auditor reviews the records and
supporting documents required by the criteria in each standard to
determine if the self-assessment and improvement plan accurately
reflect the State program's level of conformance with each of the
standards. If the State program fails to meet all program elements and
documentation requirements of a standard, it develops a strategic plan
which includes the following: (1) the individual element of
documentation requirement of the standard that was not met, (2)
improvements needed to meet the program element or documentation
requirement of the standard, and (3) projected completion dates for
each task.
In the Federal Register of January 13, 2022 (87 FR 2162), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
Subsequent to the publication of the 60-day notice, in
collaboration with the State Governments, FDA completed a revision of
the program standards. In an effort to improve program effectiveness,
understanding and clarity, changes include those to program
definitions, inspection procedures, appendices and assessment
worksheets that may be used by the States who have adopted the MFRPS. A
copy of the revised program standards is available in the docket.
The revised program standards are the result of external
collaboration and coordination between FDA and the Association of Food
and Drug Officials Manufactured Food Regulatory Program Alliance and
the Partnership for Food Protection Governing Council. We consider any
formal comments received on the previous edition of the program
standards and feedback obtained from our collaboration with the States.
Description of Respondents: Respondents are State Departments of
Agriculture or Health enrolled in the MFRPS (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 respondent; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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State Governments; Development and reporting of data consistent 44 1 44 569 25,036
with MFRPS......................................................
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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 respondent; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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State Governments; Maintenance of data records consistent with 44 10 440 40 17,600
MFRPS...........................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 43874]]
We have adjusted the number of respondents to the information
collection to reflect the enrollment of an additional State since our
last evaluation.
Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15737 Filed 7-21-22; 8:45 am]
BILLING CODE 4164-01-P
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