[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43872-43874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0601. 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, 
[email protected].

[[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) (https://www.fda.gov/media/131392/download). 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: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/regulatory-program-standards/manufactured-food-regulatory-program-standards-mfrps.
    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