[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Pages 10172-10175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03464]



[[Page 10172]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0017]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Voluntary National Retail 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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 Voluntary National Retail Food Regulatory Program 
Standards.

DATES: Submit either electronic or written comments on the collection 
of information by April 21, 2020.

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 April 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 21, 2020. 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-2011-N-0017 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Voluntary National Retail 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.
     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.

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 extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice

[[Page 10173]]

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.

Voluntary National Retail Food Regulatory Program Standards

OMB Control Number 0910-0621--Extension

    This information collection request supports implementation of 
FDA's Voluntary National Retail Food Regulatory Program Standards (the 
Program Standards). The Program Standards define nine essential 
elements of an effective regulatory program for retail food 
establishments, establish basic quality control criteria for each 
element, and provide a means of recognition for the State, local, 
territorial, tribal and Federal regulatory programs that meet the 
Program Standards. The program elements addressed by the Program 
Standards are: (1) Regulatory foundation; (2) trained regulatory staff; 
(3) inspection program based on Hazard Analysis and Critical Control 
Point (HACCP) principles; (4) uniform inspection program, (5) foodborne 
illness and food defense preparedness and response; (6) compliance and 
enforcement; (7) industry and community relations; (8) program support 
and resources; and (9) program assessment. Each standard includes a 
list of records needed to document conformance with the standard 
(referred to in the Program Standards document as ``quality records'') 
and has one or more corresponding forms and worksheets to facilitate 
the collection of information needed to assess the retail food 
regulatory program against that standard. The respondents are State, 
local, territorial, tribal, and potentially other Federal regulatory 
agencies. Regulatory agencies may use existing available records or may 
choose to develop and use alternate forms and worksheets that capture 
the same information.
    In the course of their normal activities, State, local, 
territorial, tribal, and Federal regulatory agencies already collect 
and keep on file many of the records needed as quality records to 
document compliance with each of the Program Standards. Although the 
detail and format in which this information is collected and recorded 
may vary by jurisdiction, records that are kept as a usual and 
customary part of normal Agency activities include inspection records, 
written quality assurance procedures, records of quality assurance 
checks, staff training certificates and other training records, a log 
or database of food-related illness or injury complaints, records of 
investigations resulting from such complaints, an inventory of 
inspection equipment, records of outside audits, and records of 
outreach efforts (e.g., meeting agendas and minutes, documentation of 
food safety education activities). No new recordkeeping burden is 
associated with these existing records, which are already a part of 
usual and customary program recordkeeping activities by State, local, 
territorial, tribal and Federal regulatory agencies, and which can 
serve as quality records under the Program Standards.
    State, local, territorial, tribal and Federal regulatory agencies 
that enroll in the Program Standards and seek listing in the FDA 
National Registry are required to report to FDA on the completion of 
the following three management tasks outlined in the Program Standards: 
(1) Conducting a program self-assessment; (2) conducting a risk factor 
study of the regulated industry; and (3) obtaining an independent 
outside audit (verification audit). The results are reported on FDA's 
website at: https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2019. If a regulatory agency follows all the 
recordkeeping recommendations in the individual standards and their 
sample worksheets, it will have all the information needed to complete 
the reports.
Recordkeeping
    FDA's recordkeeping burden estimate includes time required for a 
state, local, territorial, tribal, or Federal agency to review the 
instructions in the Program Standards, compile information from 
existing sources, and create any records recommended in the Program 
Standards that are not already kept in the normal course of the 
agency's usual and customary activities. Sample worksheets are provided 
to assist in this compilation. In estimating the time needed for the 
program self-assessment (Program Standards 1 through 8, shown in table 
1), FDA considered responses from four State and three local 
jurisdictions that participated in an FDA Program Standards Pilot 
study. Table 2 shows the estimated recordkeeping burden for the 
completion of the baseline data collection, and table 3 shows the 
estimated recordkeeping burden for the verification audit.
    FDA estimates the burden of this collection of information as 
follows:

                        Table 1--Self Assessment
------------------------------------------------------------------------
                                                             Hours per
            Standard              Recordkeeping activity      record
------------------------------------------------------------------------
No. 1: Regulatory Foundation...  Self-Assessment:                     16
                                  Completion of
                                  worksheet recording
                                  results of evaluations
                                  and comparison on
                                  worksheets \1\.
No. 2: Trained Regulatory Staff  Self-Assessment:                   19.3
                                  Completion of CFP
                                  Field Training Manual
                                  and Documentation of
                                  Successful Completion--
                                  Field Training
                                  Process; completion of
                                  summary worksheet of
                                  each employee training
                                  records 1 2.
No. 3: HACCP Principles........  Self-Assessment:                      4
                                  Completion of
                                  worksheet
                                  documentation \1\.
No. 4: Uniform Inspection        Self-Assessment:                     19
 Program.                         Completion of
                                  worksheet
                                  documentation of
                                  jurisdiction's quality
                                  assurance procedures 1
                                  2.
No. 5: Foodborne Illness         Self-Assessment:                      5
 Investigation.                   Completion of
                                  worksheet
                                  documentation \1\.
No. 6: Compliance Enforcement..  Self-Assessment:                     19
                                  Selection and review
                                  of 20 to 70
                                  establishment files at
                                  25 minutes per file.
                                  Estimate is based on a
                                  mean number of 45.
                                  Completion of
                                  worksheet \1\.
No. 7: Industry & Community      Self-Assessment:                      2
 Relations.                       Completion of
                                  worksheet \1\.

[[Page 10174]]

 
No. 8: Program Support and       Self-Assessment:                      8
 Resources.                       Selection and review
                                  of establishment files
                                  \1\.
                                                         ---------------
    Total......................  .......................            92.3
------------------------------------------------------------------------
\1\ Or comparable documentation.
\2\ Estimates will vary depending on number of regulated food
  establishments and the number of inspectors employed by the
  jurisdiction.


               Table 2--Risk Factor Study Data Collection
------------------------------------------------------------------------
                                                             Hours per
            Standard              Recordkeeping activity      record
------------------------------------------------------------------------
No. 9: Program Assessment......  Risk Factor Study and               333
                                  Intervention Strategy
                                  \1\.
------------------------------------------------------------------------
\1\ Calculation based on mean sample size of 39 and average FDA
  inspection time for each establishment type. Estimates will vary
  depending on number of regulated food establishments within a
  jurisdiction and the number of inspectors employed by the
  jurisdiction.


                       Table 3--Verification Audit
------------------------------------------------------------------------
                                                             Hours per
            Standard              Recordkeeping activity      record
------------------------------------------------------------------------
Administrative Procedures......  Verification Audit \1\.           46.15
------------------------------------------------------------------------
\1\ We estimate that no more than 50 percent of time spent to complete
  self-assessment of all nine standards is spent completing verification
  audit worksheets. Time will be considerably less if less than nine
  standards require verification audits.


                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets \2\...............................             500                1              500            94.29           47,145
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Or comparable documentation.

    FDA bases its estimates of the number of recordkeepers and the 
hours per record on its experience with the Program Standards over the 
past 16 years. Based upon the level of ongoing support provided by FDA 
to enrolled jurisdictions and the number of forms submitted annually, 
FDA estimates that no more than 500 jurisdictions actively participate 
in the Program Standards during any given year. There are approximately 
3,000 jurisdictions in the United States and its territories that have 
retail food regulatory programs. Enrollment in the Program Standards is 
voluntary and, therefore, FDA does not expect all jurisdictions to 
participate.
    FDA bases its estimate of the hours per record on the recordkeeping 
estimates for the management tasks of self-assessment, risk factor 
study, and verification audit (tables 1, 2, and 3 of this document) 
that enrolled jurisdictions must perform a total of 471.45 hours (92.3 
+ 333 + 46.15 = 471.45). Enrolled jurisdictions must conduct the work 
described in tables 1, 2, and 3 over a 5-year period. Therefore, FDA 
estimates that, annually, 500 recordkeepers will spend 94.29 hours 
(471.45 / 5 = 94.29) performing the required recordkeeping for a total 
of 47,145 hours as shown in table 4.
Reporting
    Form FDA 3958, ``Voluntary National Retail Food Regulatory Program 
Standards FDA National Registry Report,'' used for reporting to FDA, 
consists of four parts. Part 1 requires the name and address of the 
jurisdiction; name and contact information for the contact person for 
this jurisdiction; the jurisdiction's website address and if the 
jurisdiction is willing to serve as an auditor for another 
jurisdiction. Part 2 requires information about enrollment, whether 
this jurisdiction is a new enrollee and the date of enrollment; 
indication whether this jurisdiction would like to be removed from the 
jurisdiction listing; indication of updated findings to the self-
assessment or verification audit. Part 3 requires information about 
self-assessment findings and verification audit findings; dates when 
self-assessment was completed; which standards have been met as 
determined by the self- assessment; which standards have been met as 
verified by a verification audit including the completion dates. Part 4 
requires permission to publish information on FDA's website by checking 
the appropriate box(es) to indicate what information FDA may publish on 
the website.
    The reporting burden in table 5 includes only the time necessary to 
complete a report, as compiling the underlying information (including 
self- assessment reports, Risk Factor Study data collection, outside 
audits, and supporting documentation) is accounted for under the 
recordkeeping estimates in table 4.
    FDA estimates the reporting burden for this collection of 
information as follows:

[[Page 10175]]



                                  Table 5--Estimated Annual Reporting Burden 1
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                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Submission of ``Voluntary                  500               1             500  0.1 (6 minutes).              50
 National Retail Food
 Regulatory Program Standards
 FDA National Registry
 Report''.
Request for documentation of               500               3           1,500  0.1 (6 minutes).             150
 successful completion of
 staff training.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA bases its estimates of the number of respondents and the hours 
per response on its experience with the Program Standards. As explained 
previously in this document, FDA estimates that no more than 500 
regulatory jurisdictions will participate in the Program Standards in 
any given year. FDA estimates a total of 6 minutes annually for each 
enrolled jurisdiction to complete the form. FDA bases its estimate on 
the small number of data elements on the form and the ease of 
availability of the information. FDA estimates that, annually, 500 
regulatory jurisdictions will submit one Form FDA 3598 for a total of 
500 annual responses. Each submission is estimated to take 0.1 hour (or 
6 minutes) per response for a total of 50 hours. In addition, FDA 
estimates that, annually, 500 regulatory jurisdictions will submit 
three requests for documentation of successful completion of staff 
training using the CFP Training Plan and Log for a total of 1,500 
annual responses. Each submission is estimated to take 0.1 hour (or 6 
minutes) per response for a total of 150 hours. Thus, the total 
reporting burden for this information collection is 200 hours.
    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: February 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03464 Filed 2-20-20; 8:45 am]
BILLING CODE 4164-01-P


