[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Notices]
[Pages 6200-6203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02191]


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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) 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 4, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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, 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 those 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.
    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 to FDA on 
Form FDA 3519, ``FDA National Registry Report'' and Form FDA 3520, 
``Permission to Publish in National Registry.'' These forms are 
provided in the Program Standards document, and are also provided on 
FDA's Web site at: http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/default.htm. If a

[[Page 6201]]

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.
    In April 2012, the Conference for Food Protection recommended that 
FDA make two changes to the Program Standards. The changes have been 
incorporated into the 2013 version, the draft of which is available on 
FDA's Web site. The first change was the addition of a new criterion in 
Standard 9. In order to show conformance with Standard 9, jurisdictions 
must implement an intervention strategy to address risk factors 
identified in the risk factor study, and then assess the effectiveness 
of the intervention strategy through subsequent risk factor studies or 
other similar tools. The second change was the creation of an 
Administrative Procedures document. The procedures for enrolling and 
participating in the Program Standards were previously included in 
Standard 9, along with other criteria specific to conducting a risk 
factor study. Stakeholders requested that information pertaining to 
enrollment and participation in the Program Standards be included in a 
separate, stand-alone document. Therefore, the information about the 
administration of the Program Standards, previously in Standard 9, is 
now provided in the Administrative Procedures document.
    FDA analyzed whether incorporation of these two changes alters its 
estimate of the recordkeeping and reporting burdens. FDA concluded that 
there will be no change to the annual recordkeeping burden estimate. In 
the course of their normal activities, State, local, territorial, 
tribal, and Federal regulatory agencies already implement and document 
intervention strategies to address identified risk factors at regulated 
food establishments. The intention of the new criterion in Standard 9 
is twofold: (1) To ensure that development and implementation of the 
intervention strategy is guided by data collected through the risk 
factor study, or other similar tools and (2) to ensure that the 
regulatory agency considers the effectiveness of the implemented 
intervention strategy in light of subsequent data. FDA notes that 
jurisdictions have the option to analyze their inspection data as 
indicated by the Standard 9 criteria, in lieu of conducting a risk 
factor study. This is a less resource-intensive method for tracking 
risk factor trends over time. However, the Agency has not changed its 
estimate of 333 hours for Standard 9 shown in Table 2 of this document. 
The Agency will reevaluate its estimate based on data it receives in 
the future from participating jurisdictions. As stated in the preceding 
paragraph, the second change resulted in the relocation of existing 
information from Standard 9 to the Administrative Procedures document 
in the 2013 version of the Program Standards. Because there were no 
changes to content, there will be no changes to the annual 
recordkeeping burden. The two noted changes had no effect on the 
reporting burden hour estimates shown in Table 2 of this document.

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 of this document), FDA considered responses from four State and three 
local jurisdictions that participated in an FDA Program Standards Pilot 
study. Table 2 of this document shows the estimated recordkeeping 
burden for the completion of the baseline data collection, and Table 3 
of this document shows the estimated recordkeeping burden for the 
verification audit.

                                            Table 1--Self-Assessment
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                                                                                                     Hours per
                 Standard                                  Recordkeeping activity                     record
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No. 1: Regulatory Foundation.............  Self-Assessment: Completion of worksheet recording                 16
                                            results of evaluations and comparison on
                                            worksheets.\1\
No. 2: Trained Regulatory Staff..........  Self-Assessment: Completion of CFP Field Training                19.3
                                            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: Completion of worksheet                            4
                                            documentation \1\.
No. 4: Uniform Inspection Program........  Self-Assessment: Completion of worksheet                           19
                                            documentation of jurisdiction's quality assurance
                                            procedures.1 2
No. 5: Foodborne Illness Investigation...  Self-Assessment: Completion of worksheet                            5
                                            documentation \1\.
No. 6: Compliance Enforcement............  Self-Assessment: Selection and review of 20 to 70                  19
                                            establishment files at 25 minutes per file. Estimate
                                            is based on a mean number of 45. Completion of
                                            worksheet.\1\
No. 7: Industry & Community Relations....  Self-Assessment: Completion of worksheet \1\.........               2
No. 8: Program Support and Resources.....  Self-Assessment: Selection and review of                            8
                                            establishment files \1\.
                                          ----------------------------------------------------------------------
    Total................................  .....................................................            92.3
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\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
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                                                                                                     Hours per
                 Standard                                  Recordkeeping activity                     record
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No. 9: Program Assessment................  Risk Factor Study and Intervention Strategy \1\......             333
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\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 6202]]


                                           Table 3--Verification Audit
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                                                                                                     Hours per
                 Activity                                  Recordkeeping activity                     record
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Administrative Procedures................  Verification Audit \1\...............................           46.15
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\1\ We estimate that no more than 50% of time spent to complete self-assessment of all 9 Standards is spent
  completing verification audit worksheets. Time will be considerably less if less than 9 standards require
  verification audits.

    FDA estimates the burden of this collection of information as 
follows:

                               Table 4--Estimated Annual Recordkeeping Burden \1\
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                                                     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. As of 
September 30, 2013, 563 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 of this document.

Reporting

    FDA requires 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.'' Form FDA 3519 requires the name and address of 
the jurisdiction; completion dates for the self-assessment, risk factor 
study (original and update), and verification audit; names of the 
person(s) who completed the self-assessment, verification audit, risk 
factor study (baseline report), risk factor study (update), and action 
plan; signature of the program manager; and date the form was 
completed. Form FDA 3520 requires the name and address of the 
jurisdiction, contact information for the enrollee's designated contact 
person, completion date of the self-assessment, date of the 
verification audit report, name of the auditor, signature of the 
official completing the form, and date the form was completed.
    The reporting burden in Table 5 of this document includes only the 
time necessary to fill out and send the forms, as compiling the 
underlying information (including self-assessment reports, baseline 
surveys, outside audits, and supporting documentation) is accounted for 
under the recordkeeping estimates in Table 4 of this document.
    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    Total hours
                                                                            respondents     respondent       responses     per response
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Submission of ``FDA National Registry Report''..........            3519             500               1             500             0.1              50
Submission of ``Permission to Publish in National                   3520             500               1             500             0.1              50
 Registry''.............................................
Request for documentation of successful completion of     Conference for             500               3           1,500             0.1             150
 staff training.........................................            Food
                                                              Protection
                                                           Training Plan
                                                                 and Log
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............             250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 6203]]

    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 12 minutes annually for each 
enrolled jurisdiction to complete both forms. FDA bases its estimate on 
the small number of data elements on the two forms and the ease of 
availability of the information. FDA estimates that, annually, 500 
regulatory jurisdictions will submit one Form FDA 3519 for a total of 
500 annual responses. Each submission is estimated to take 0.1 hour per 
response for a total of 50 hours. FDA estimates that, annually, 500 
regulatory jurisdictions will submit one Form FDA 3520 for a total of 
500 annual responses. Each of these submissions is estimated to take 
0.1 hour per response for a total of 50 hours. 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 per response for a total of 
150 hours. Thus, the total reporting burden for this information 
collection is 250 hours.

    Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02191 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P