[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Notices]
[Pages 2162-2163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0414]


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions of 
the Manufactured Food Regulatory Program Standards.

DATES: Submit either electronic or written comments on the collection 
of information by March 14, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 14, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 14, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0414 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Manufactured Food Regulatory 
Program Standards.'' Received comments, those filed in a timely manner 
(see ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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#f5a5a7b4a681949393b5939194db9d9d86db929a83"><span class="__cf_email__" data-cfemail="aefefceffddacfc8c8eec8cacf80c6c6dd80c9c1d8">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites

[[Page 2163]]

comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Manufactured Food Regulatory Program Standards

OMB Control Number 0910-0601--Extension

    This information collection supports 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 currently enrolled in the Manufactured Food 
Regulatory Program Standards (MFRPS) 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 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.
    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.

    We have adjusted the number of respondents to the information 
collection to reflect the enrollment of an additional State since our 
last evaluation.

    Dated: January 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-00559 Filed 1-12-22; 8:45 am]
BILLING CODE 4164-01-P


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