[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
[[Page 2125]]
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
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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]
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