[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17132-17135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7191]


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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 (the PRA).

DATES: Fax written comments on the collection of information by April 
27, 2011.

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 e-mailed to [email protected]. 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 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

[[Page 17133]]

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). 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 1 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 1-8, 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.
    In the Federal Register of January 12, 2011 (76 FR 2124), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received six comment letters in response 
to the notice. One comment was generally supportive of the necessity of 
the information collection and its practical utility. Five letters 
contained comments outside the scope of the four collections of 
information topics on which the notice solicits comments and thus, will 
not be addressed here.
    FDA estimates the burden for this collection of information as 
follows:

                                            Table 1--Self Assessment
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                  Standard                                Recordkeeping activity               Hours per record
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No. 1. Regulatory Foundation................  Self Assessment: (Appendix A) Completion of                   16
                                               worksheet recording results of evaluations
                                               and comparison on worksheets \1\.
No. 2. Trained Regulatory Staff.............  Self Assessment: (Appendix B-2 and B-4)\1\                    19.3
                                               Completion of the Center for Food Protection
                                               Field Training Manual and Documentation of
                                               Successful Completion--Field Training
                                               Process; completion of summary worksheet of
                                               each employee training records \2\.
No. 3. Hazard Analysis and Critical Control   Self Assessment: (Appendix C \1\) Completion                   4
 Point.                                        of worksheet documentation.
No. 4. Uniform Inspection Program...........  Self Assessment: (Appendix D \1\) Completion                  19
                                               of worksheet documentation of jurisdiction's
                                               quality assurance procedures \2\.
No. 5. Foodborne Illness Investigation......  Self Assessment: (Appendix E \1\) Completion                   5
                                               of worksheet documentation.
No. 6. Compliance Enforcement...............  Self Assessment: (Appendix F \1\) Selection                   19
                                               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                   2
                                               of worksheet.

[[Page 17134]]

 
No. 8. Program Support and Resources........  Self Assessment: (Appendix H \1\) Selection                    8
                                               and review of establishment files.
    Subtotal................................  ..............................................                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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                  Standard                                Recordkeeping activity               Hours per record
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No. 9. Program Assessment...................  Baseline Data Collection (Appendices I & J)                    333
                                               Selection 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.


                                           Table 3--Verification Audit
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                  Standard                                Recordkeeping activity               Hours per 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.

    Thus, FDA estimates the recordkeeping burden for this collection of 
information as follows:

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
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                                                                                                                      Average burden
                    FDA Worksheets \2\                         Number of      Number of records     Total annual    per recordkeeping     Total hours
                                                             recordkeepers     per recordkeeper       records           (in hours)
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Appendices A-J...........................................                500                  1                500              94.29             47,145
                                                          ----------------------------------------------------------------------------------------------
    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 1 of this document.
    FDA estimates the reporting burden for this collection of 
information as follows:

[[Page 17135]]



                                                     Table 5--Estimated Annual Reporting Burden \1\
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                                                                                  Number of                           Average burden
                       Form FDA No.                            Number of        responses per       Total annual     per response (in     Total hours
                                                              respondents         respondent        respondents         Hours) \2\
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3519.....................................................                500                  1                500               1/60                 50
3520.....................................................                500                  1                500               1/60                 50
CFP Training Plan and Log................................                500                  3              1,500               1/60                150
    Total................................................  .................  .................  .................  .................                250
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of minutes per response]/60''.

    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 
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: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7191 Filed 3-25-11; 8:45 am]
BILLING CODE 4160-01-P