[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\.
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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
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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
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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