
[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14369-14372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05414]


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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 May 19, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management 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 Division of Dockets Management. 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.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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,

[[Page 14370]]

when appropriate, and other forms of information technology.

Voluntary National Retail Food Regulatory Program Standards

OMB Control Number 0910-0621--Extension

    The Voluntary National Retail Food Regulatory 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 as follows: (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.
    In April 2016, the Conference for Food Protection (CFP) recommended 
that FDA make a change in Program Standard #4--Uniform Inspection 
Program, more specifically to change Program Standard #4's Program 
Self-Assessment and Verification Audit Form. Once changes have been 
incorporated into the 2017 version, it will be available on FDA's Web 
site.
    With this change, in order to achieve conformance to Program 
Standard #4, jurisdictions must achieve an overall inspection program 
performance rating for 20 elements as opposed to 10 elements that were 
previously required. The previous 10 elements had several criteria 
under one program element. The change to 20 elements allows the 
Standard to clearly delineate out each criterion individually rather 
than having several criteria under one program element. This 
streamlines and clarifies the process in meeting the Standard. As a 
result, the assessment review of each inspector's work will now be 
required for three joint inspections as opposed to the previously 
required two.
    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 forms 
formerly known as Form FDA 3519 and Form FDA 3520. Currently FDA is 
working to consolidate both Forms FDA 3519 ``FDA National Registry 
Report'' and FDA 3520 ``Permission to Publish in National Registry'' 
into one form thereby reducing the burden by 50 percent. The new Form 
FDA 3958 will be provided in the Program Standards document, and will 
also be provided on FDA's Web site at: http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/default.htm. 
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 forms.

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\.

[[Page 14371]]

 
No. 4: Uniform Inspection Program  Self-Assessment:                   19
                                    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--Baseline 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
            Activity             Recordkeeping activity       record
------------------------------------------------------------------------
Administrative Procedures......  Verification Audit \1\           46.15
------------------------------------------------------------------------
\1\ We estimate that no more than 50% 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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                                                                                                                        Average  burden
                                                                        Number of        Number of       Total annual         per
                              Activity                                recordkeepers     records per        records       recordkeeping     Total Hours
                                                                                        recordkeeper                        (hours)
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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. As of September 30, 2016, 711 jurisdictions were 
enrolled in the Program Standards. However, 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

    Previously, FDA required regulatory jurisdictions that participate 
in the Program Standards to submit two forms annually: Form FDA 3519, 
``FDA National Registry Report,'' and Form FDA 3520, ``Permission to 
Publish in National Registry.'' FDA created a new consolidated FDA Form 
3958 that has four parts: Part 1 requires the name and address of the 
jurisdiction; name and contact information for the contact person for 
this jurisdiction; the jurisdictions Web site 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 Web site by

[[Page 14372]]

checking the appropriate box(es) to indicate what information FDA may 
publish on the Web site.
    The reporting burden in table 5 includes only the time necessary to 
fill out and send the form, 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\
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                                                                                Number of
              Activity                      FDA form            Number of     responses per   Total annual       Average  burden per        Total hours
                                                               respondents     respondent       responses         response  (hours)
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Submission of ``FDA National         3598..................             500               1             500  0.1 (6 minutes)............              50
 Registry Report''.
Request for documentation of         Conference for Food                500               3           1,500  0.1 (6 minutes)............             150
 successful completion of staff       Protection Training
 training.                            Plan and Log.
                                                            --------------------------------------------------------------------------------------------
    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.

    Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05414 Filed 3-17-17; 8:45 am]
BILLING CODE 4164-01-P


