[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41588-41591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14879]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 10, 2020.

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 0910-0621. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

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.

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

[[Page 41589]]

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.
    In the Federal Register of February 21, 2020 (85 FR 10172), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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
                                  Conference for Food
                                  Protection (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\.
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.


[[Page 41590]]


                       Table 3--Verification Audit
------------------------------------------------------------------------
                                                             Hours per
            Activity              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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets             500               1             500           94.29          47,145
 \2\............................
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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) 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; and 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; and 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:

                                 Table 5--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   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
----------------------------------------------------------------------------------------------------------------
\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, 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

[[Page 41591]]

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: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14879 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P


