
[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30616-30619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12289]


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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: Fax written comments on the collection of information by June 
27, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0621. 
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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

    The Voluntary National Retail Food Regulatory Program Standards 
(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

[[Page 30617]]

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, 
``Release Record and Agreement--Permission to Publish in National 
Registry (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 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 (CFP) recommended 
that FDA make two changes to the Program Standards. The changes have 
been incorporated into the 2013 version, the draft of which will be 
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 two-fold: (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
------------------------------------------------------------------------
                                                            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\.

[[Page 30618]]

 
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 and 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.

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

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         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. 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

[[Page 30619]]

(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.
    In the Federal Register of February 3, 2014 (79 FR 6200), FDA 
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 5--Estimated Annual Reporting Burden \1\
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                                                                                Number of
              Activity                      Form FDA            Number of     responses per   Total annual   Average burden per response    Total hours
                                                               respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of ``FDA National         3519..................             500               1             500  0.1 (6 minutes)............              50
 Registry Report''.
Submission of ``Permission to        3520..................             500               1             500  0.1 (6 minutes)............              50
 Publish in National Registry''.
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..........................  ......................  ..............  ..............  ..............  ...........................             250
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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 over the past 
14 years. 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 (6 minutes) 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 (6 minutes) per response for 
a total of 50 hours. FDA estimates that annually 500 regulatory 
jurisdictions will submit 3 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 (6 minutes) per response for a total of 150 hours. Thus, the 
total reporting burden for this information collection is 250 hours.

    Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12289 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P


