[Federal Register: January 15, 2008 (Volume 73, Number 10)]
[Notices]
[Page 2500-2503]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja08-68]
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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 baguilar@omb.eop.gov. 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
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Hours per Recordkeeper
Standard Recordkeeping Activity (Year One)
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No.1 Regulatory Self Assessment: 16
Foundation (Appendix A)
Completion of
worksheet recording
results of evaluations
and comparison on
worksheets.\1\
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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\
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No. 3 HACCP Principles Self Assessment: 4
(Appendix C\1\)
Completion of
worksheet
documentation.
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No. 4 Uniform Self Assessment: 19
Inspection Program (Appendix D\1\)
Completion of
worksheet
documentation of
jurisdiction's quality
assurance
procedures\2\
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No. 5 Foodborne Illness Self Assessment: 5
Investigation (Appendix E\1\)
Completion of
worksheet
documentation.
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No. 6 Compliance Self Assessment: 19
Enforcement (Appendix F\1\)
Selection and review
of 20 to 70
25 minutes per file.
Estimate is based on a
mean number of 45.
Completion of
worksheet.
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No. 7 Industry & Self Assessment: 2
Community Relations (Appendix G\1\)
Completion of
worksheet.
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No. 8 Program Support Self Assessment: 8
and Resources (Appendix H\1\)
Selection and review
of establishment files
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SUBTOTAL ....................... 92.3 Hours
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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.
[[Page 2502]]
CHART 2. YEAR TWO -- BASELINE DATA COLLECTION
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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\
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No. of Annual Frequency Total Annual Hours per
FDA Forms Respondents per Response Responses Response Total Hours
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3519 500 1 500 6 min 50 hours
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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
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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.
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