[Federal Register Volume 76, Number 8 (Wednesday, January 12, 2011)]
[Notices]
[Pages 2124-2127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-458]


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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 March 14, 2011.

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 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, and tribal 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 
compliance with the standard (referred to in the Program Standards 
document as ``quality records'') and has one or more corresponding 
appendices that contain 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, and 
tribal government 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, and tribal 
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 and 
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, and tribal regulatory Agencies, and which 
can serve as quality records under the Program Standards.
    State, local, and tribal 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

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outlined in the Program Standards: (1) Conducting a program self 
assessment, (2) conducting a baseline survey 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 located in Appendix I of the 
Program Standards document. If a regulatory Agency follows all the 
recordkeeping recommendations in the individual standards and their 
appendices, it will have all the information needed to complete the 
forms.
    In April 2010, the Conference for Food Protection approved changes 
to the Program Standards. The changes have been incorporated into a 
draft 2011 revision, which will be available at: http://www.fda.gov/retailfoodprotection. One change was to provide an extension of time 
for completion of the three management tasks. Another change was the 
inclusion of clarifying language in Standard 9 that a jurisdiction may 
use its inspection data to conduct its study of risk factor occurrence. 
Although this was always the intent in Standard 9, it was not clear to 
jurisdictions that this was a viable option.
    FDA analyzed whether incorporation of these changes alters its 
estimate of the recordkeeping and reporting burdens. FDA concluded that 
the changes will lessen the annual recordkeeping burden estimate 
because the management tasks will be conducted on a less frequent basis 
annually. Thus, based on its experience with the Program Standards over 
the past 3 years, FDA has reduced its estimate of the hours per record 
to 94.29, from the previously estimated 157 hours per record in 2008. 
The reduced recordkeeping burden hour estimates are shown in table 4 of 
this document. FDA notes that jurisdictions that choose to analyze 
their inspection data per the Standard 9 criteria will enjoy a less 
resource intensive method for tracking risk factor trends over time. 
However, the Agency has not reduced its estimate of 333 hours for 
Standard 9 shown in table 2 of this document. The Agency will consider 
reducing this estimate in a future information collection request based 
on supporting data it expects to receive in the future from 
participating jurisdictions. 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, or tribal 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. Worksheets (Appendices) 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: (Appendix A) Completion of worksheet            16
                                              recording results of evaluations and comparison on
                                              worksheets\1\.
No. 2--Trained Regulatory Staff............  Self Assessment: (Appendix B-2 and B-4) \1\ Completion         19.3
                                              of CFP Field Training Manual and Documentation of
                                              Successful Completion--Field Training Process;
                                              completion of summary worksheet of each employee
                                              training records\2\.
No. 3--HACCP Principles....................  Self Assessment: (Appendix C \1\) Completion of                   4
                                              worksheet documentation.
No. 4--Uniform Inspection Program..........  Self Assessment: (Appendix D \1\) Completion of                  19
                                              worksheet documentation of jurisdiction's quality
                                              assurance procedures\2\.
No. 5--Foodborne Illness Investigation.....  Self Assessment: (Appendix E \1\) Completion of                   5
                                              worksheet documentation.
No. 6--Compliance Enforcement..............  Self Assessment: (Appendix F \1\).....................           19
                                             Selection and review of 20 to 70 establishment files @
                                              25 minutes per file. Estimate is based on a mean
                                              number of 45. Completion of worksheet.
No. 7--Industry & Community Relations......  Self Assessment: (Appendix G\1\) Completion of                    2
                                              worksheet.
No. 8--Program Support and Resources.......  Self Assessment: (Appendix H \1\) Selection and review            8
                                              of establishment files.
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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...................  Baseline Data Collection (Appendices I & J) Selection           333
                                              and inspection of randomly selected statistical
                                              sample of 9 to 87 establishments from each of 9
                                              facility types\1\.
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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 2126]]


                                           Table 3--Verification Audit
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                                                                                                      Hours per
           Standard                                    Recordkeeping activity                           record
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No. 9.........................  Verification Audit (Appendices I & J)\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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                                                      Annual
       FDA worksheets \2\            Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
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Appendices A through J..........             500               1             500           94.29          47,145
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    Total.......................  ..............  ..............  ..............  ..............          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 3 years. FDA estimates that approximately 500 regulatory 
jurisdictions will participate in the Program Standards. 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, baseline data 
collection, 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). As noted, based on its experience 
with the Program Standards over the past 3 years, FDA has reduced its 
estimate of the number of recordkeeping hours that enrolled 
jurisdictions will perform annually to 94.29, from the previously 
estimated 157 hours per record in 2008. FDA estimates that, annually, 
500 recordkeepers will spend 94.29 hours performing the required 
recordkeeping for a total of 47,145 hours.

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, baseline 
survey (original and update), and verification audit; names of the 
person(s) who completed the self-assessment, verification audit, 
baseline survey, baseline survey update, and action plan; signature of 
the program manager; and date the form was completed. Form FDA 3520 
requires the name of the jurisdiction, completion date of the self 
assessment, date of the verification audit report, name of the auditor, 
signature and title 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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                                                      Annual
          Form FDA No.               Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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3519............................             500               1             500             0.1              50
3520............................             500               1             500             0.1              50
Conference for Food Protection               500               3           1,500             0.1             150
 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.

    FDA bases its estimates of the number of respondents and the hours 
per response on its experience with the Program Standards over the past 
3 years. As explained previously in this document, FDA estimates that 
500 regulatory jurisdictions will enroll in the Program Standards. 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

[[Page 2127]]

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 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-458 Filed 1-11-11; 8:45 am]
BILLING CODE 4160-01-P