[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26528-26530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0341]


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of

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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 revision 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 
associated with FDA's Federal-State Food Regulatory Program Standards.

DATES: Submit either electronic or written comments on the collection 
of information by July 13, 2021.

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 July 13, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 13, 2021. 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:
     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.
     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:
     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.
     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-2021-N-0341 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food Safety; Federal-State 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.
     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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 revision 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 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.

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

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visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/national-integrated-food-safety-system-ifss-programs-and-initiatives. 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 
ten 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, Tribal, and 
Federal regulatory agencies participating in FDA's Voluntary National 
Retail Food Regulatory Program Standards (information collection 
currently approved under OMB control number 0910-0621). Consistent with 
the ERPS, respondents will submit the following information to FDA: (1) 
Program self-assessment; (2) risk factor study of the regulated 
industry; and (3) independent outside audit (verification audit).
    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 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 to those respondents 
who currently have an egg inspection contract with FDA and thus subject 
to auditing. A copy of the ERPS has been posted to FDA-2021-N-0341 and 
is available at https://www.regulations.gov.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
            Respondents; information collection activity                Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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State, Local, Territorial, and/or Tribal Governments; submission of              10               10              100              500          500,000
 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 500 hours is necessary for the attendant 
recordkeeping and submission of data elements to FDA. We expect 
participation in the ERPS to increase.

    Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10180 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P


