[Federal Register Volume 73, Number 10 (Tuesday, January 15, 2008)]
[Notices]
[Pages 2500-2503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-542]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0419]


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 
February 14, 2008.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-NEW and title, 
Voluntary National Retail Food Regulatory Program Standards. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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

    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 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). All three tasks must initially be completed 
within a 3-year time span. 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. The time required to complete the forms is minimal.
    In the Federal Register of November 14, 2006 (71 FR 66337), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received two letters in response to the 
notice, but the letters contained comments that were not responsive to 
the four PRA comment requests. These comments will not be addressed in 
this document.
    In April 2006, the Conference for Food Protection approved changes 
to the Program Standards that have been incorporated into a draft 2007 
revision, which is available at http://www.cfsan.fda.gov/~dms/
ret4toc.html. FDA analyzed whether incorporation of the changes alters 
its estimate of the recordkeeping and reporting burdens as set forth in 
the 60-day notice. FDA concluded that the changes cause a minor 
increase and decrease in the recordkeeping burden, resulting in no net 
change in the recordkeeping burden estimate. FDA further concluded that 
the reporting burden estimate should be increased by adding a line to 
table 2 to reflect the addition of 150 hours. This is because the 
revision to Standard 2 establishes an Assessment of Training Needs 
(ATN) process and forms that can be used by regulatory retail food 
program managers/training officers to prepare Food Safety Inspection 
officers (FSIOs) to conduct retail food and foodservice inspections 
(new Appendix B-2 and its accompanying Attachments

[[Page 2501]]

A and B). As part of the jurisdiction's usual and customary 25 joint 
field inspections, the jurisdiction's trainer will conduct at least 1 
Assessment of Training Needs (ATN) per new hire. The ATN is a 
systematic evaluation of the new hire's knowledge, skills, and 
abilities that are needed before being able to conduct independent 
inspections. Following the ATN, the jurisdiction's trainer is made 
aware of any training deficiencies that need to be corrected prior to 
allowing the new hire to conduct independent work. Regulatory 
jurisdictions have the flexibility in the ATN to customize training so 
that it reflects a jurisdiction's administrative policies, sampling 
procedures, and inspection protocol. The ATN provides two forms to 
assist food program managers/trainers e forms provide both the 
candidate and the trainer feedback on specific elements of effective 
institutional foodservice, restaurant, and retail food store 
inspections. The forms are (1) Retail Food, Restaurant, and 
Institutional Foodservice -- Food Safety Inspection Officer, Field 
Training Worksheet [this form provides a representative baseline of 
competencies (criteria) expected to be performed by regulatory retail 
food program FSIOs]. It is to be used during joint field training 
inspections and is completed as a part of the usual duties of the 
jurisdiction]; and (2) Retail Food, Restaurant, and Institutional 
Foodservice -- Food Safety Inspection Officer, Documentation of 
Successful Completion [this form provides verification that the FSIO 
has successfully demonstrated the ability to perform all the required 
competencies (criteria) needed to conduct independent retail food and 
foodservice inspections. It is completed once at the end of the joint 
field training process.] FDA estimates that an additional 150 reporting 
burden hours will result from this change, as discussed later this 
document. In addition, FDA has increased the recordkeeping burden hour 
estimate from 157 to 157.1 based on the changes to the 2007 document in 
the areas of Self Assessment and Verification Audit.

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 1-8, shown in chart 1 of this document), 
FDA considered responses from four state and three local jurisdictions 
that participated in an FDA Program Standards Pilot study. Chart 2 of 
this document shows the estimated recordkeeping burden for the 
completion of the baseline data collection and chart 3 of this document 
shows the estimated recordkeeping burden for the verification audit.
    The overall program improvement cycle is a 3-year period for 
completion of all three management tasks.

                  CHART 1. YEAR ONE -- SELF ASSESSMENT
------------------------------------------------------------------------
                                                  Hours per Recordkeeper
        Standard          Recordkeeping Activity        (Year One)
------------------------------------------------------------------------
No.1 Regulatory          Self Assessment:         16
 Foundation               (Appendix A)
                          Completion of
                          worksheet recording
                          results of evaluations
                          and comparison on
                          worksheets.\1\
------------------------------------------------------------------------
No. 2 Trained            Self Assessment:         19.3
 Regulatory Staff         (Appendix B-2 and B-
                          4)\1\ Completion of
                          ATN Field Training
                          Worksheet and
                          Documentation of
                          Successful Completion
                          -- Field Training
                          Process; completion of
                          summary worksheet of
                          each employee training
                          records.\2\
------------------------------------------------------------------------
No. 3 HACCP Principles   Self Assessment:         4
                          (Appendix C\1\)
                          Completion of
                          worksheet
                          documentation.
------------------------------------------------------------------------
No. 4 Uniform            Self Assessment:         19
 Inspection Program       (Appendix D\1\)
                          Completion of
                          worksheet
                          documentation of
                          jurisdiction's quality
                          assurance
                          procedures\2\
------------------------------------------------------------------------
No. 5 Foodborne Illness  Self Assessment:         5
 Investigation            (Appendix E\1\)
                          Completion of
                          worksheet
                          documentation.
------------------------------------------------------------------------
No. 6 Compliance         Self Assessment:         19
 Enforcement              (Appendix F\1\)
                          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 &         Self Assessment:         2
 Community Relations      (Appendix G\1\)
                          Completion of
                          worksheet.
------------------------------------------------------------------------
No. 8 Program Support    Self Assessment:         8
 and Resources            (Appendix H\1\)
                          Selection and review
                          of establishment files
------------------------------------------------------------------------
SUBTOTAL                 .......................  92.3 Hours
------------------------------------------------------------------------
\1\ Or comparable documentation
\2\ Estimates will vary depending on number of regulated food
  establishments and the number of inspectors employed by the
  jurisdiction.


[[Page 2502]]


              CHART 2. YEAR TWO -- BASELINE DATA COLLECTION
------------------------------------------------------------------------
                                                  Hours per Recordkeeper
        Standard          Recordkeeping Activity        (Year Two)
------------------------------------------------------------------------
No. 9 Program            Baseline Data            333
 Assessment               Collection (Appendices
                          I & J) Selection and
                          inspection of randomly
                          selected statistical
                          sample of 9 to 87
                          establishments from
                          each of 9 facility
                          types.\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.


                CHART 3. YEAR THREE -- VERIFICATION AUDIT
------------------------------------------------------------------------
                                                  Hours per Recordkeeper
        Standard          Recordkeeping Activity       (Year Three)
------------------------------------------------------------------------
No. 9                    Verification Audit       46.15
                          (Appendices I & J)\1\
------------------------------------------------------------------------
\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 estimated the annual hours per recordkeeper (i.e., per enrolled 
jurisdiction) in table 1 of this document by adding the recordkeeping 
estimates for the management tasks of self assessment, baseline data 
collection, and verification audit (charts 1, 2, and 3 of this 
document) that enrolled jurisdictions must perform during a 3-year 
cycle (92.3 + 333 + 46.15 = 471.45, then dividing the total by three to 
obtain an annual average (471.45 / 3 = 157.1). The estimates in tables 
1 and 2 of this document are based on the estimated participation of 
500 regulatory jurisdictions in the Program Standards. Table 1 shows an 
increase of 50 hours in the overall recordkeeping burden estimate based 
on a 0.1 increase in the estimate of annual hours per recordkeeper in 
the 2007 document. 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 in the 
near future. In its 2002 operational plan, the FDA National Retail Food 
Team established a goal of enrolling 15 percent of eligible agencies, 
or 450 programs, in the Program Standards by the year 2010. For 
purposes of this burden estimate, it is reasonable to take into account 
the possibility that this goal could be exceeded by approximately 10 
percent, for a total of approximately 500 participating agencies.
    Thus, FDA estimates the recordkeeping burden for this collection of 
information as follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                  FDA Worksheets\2\                       Recordkeepers      per Recordkeeping        Records          Recordkeeper       Total Hours
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Appendices A-J                                                        500                     1                500                157             78,550
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Total Burden Hours                                                                                                                                78,550
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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.

Reporting

    Based on the number and nature of the items that need to be 
completed, FDA estimates a total of 12 minutes annually for each 
enrolled jurisdiction to complete both FDA Form 3519, ``FDA National 
Registry Report,'' and Form 3520, ``Permission to Publish in National 
Registry.'' Form 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 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.
    FDA has added a line and 150 hours to table 2, due to the changes 
to the Program Standards approved by the 2006 Conference for Food 
Protection. Based on the two forms required for the ATN, the nature of 
the items that need to be completed, and the number of new hires, FDA 
estimates a total of 150 hours annually for completion of the 
completion ATN Field Training Worksheet and Documentation of Successful 
Completion -- Field Training Process; (500 jurisdictions with 3 new 
hires per year at 6 minutes for completion of all forms equals 150 
hours per year for completion of both Summary forms). As explained 
previously in this document, FDA estimates that 500 regulatory 
jurisdictions will enroll in the Program Standards. The reporting 
burden in table 2 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 1 of this document.
    Thus, FDA estimates the reporting burden for this collection of 
information as follows:

[[Page 2503]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                       FDA Forms                           Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3519                                                                  500                     1                500              6 min           50 hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
3520                                                                  500                     1                500               6min           50 hours
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Retail Food, Restaurant,                                              500                     3              1,500              6 min          150 hours
and Institutional Foodservice -- FSIO,
Documentation of Successful Completion
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Burden Hours                                                                                                                                78,550
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-542 Filed 1-14-08; 8:45 am]
BILLING CODE 4160-01-S