Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards, 30616-30619 [2014-12289]
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
use a real TV show clip that is closer to
5 minutes long, which is the length of
a typical news story segment. Third, we
will include two additional, ‘‘real’’
advertisements, rather than just showing
the experimental ad.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Eye tracking study of DTC prescription drug advertisement viewing
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden per response
Total hours
Pilot Study Screener .........................
Main Study Screener ........................
Pilot Study .........................................
Main Study ........................................
200
2,000
30
300
1
1
1
1
200
2,000
30
300
0.03 (2 minutes) ...............................
0.03 (2 minutes) ...............................
1 .......................................................
0.50 (30 minutes) .............................
6
60
30
150
Total ...........................................
........................
........................
........................
...........................................................
246
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0606. The
approval expires on May 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–12281 Filed 5–27–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
February 27, 2014, the Agency
submitted a proposed collection of
information entitled ‘‘Current Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
emcdonald on DSK67QTVN1PROD with NOTICES
16:58 May 27, 2014
[FR Doc. 2014–12293 Filed 5–27–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0017]
SUMMARY:
VerDate Mar<15>2010
Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Jkt 232001
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.
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 June 27,
2014.
SUMMARY:
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,
ADDRESSES:
PO 00000
Frm 00078
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OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. 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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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 Voluntary National Retail Food
Regulatory Program Standards (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,
territorial, tribal, and Federal 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
conformance with the standard (referred
to in the Program Standards document
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
as ‘‘quality records’’) and has one or
more corresponding 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, territorial, tribal, and potentially
other Federal regulatory 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, territorial, tribal,
and Federal 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, 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, territorial, tribal, and
Federal regulatory agencies, and which
can serve as quality records under the
Program Standards.
State, local, territorial, tribal, and
Federal 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 risk factor study 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,
‘‘Release Record and Agreement—
Permission to Publish in National
Registry (Permission to Publish in
National Registry).’’ These forms are
provided in the Program Standards
document, and are also provided on
FDA’s Web site at: https://www.fda.gov/
Food/GuidanceRegulation/
RetailFoodProtection/
ProgramStandards/default.htm. If a
regulatory agency follows all the
recordkeeping recommendations in the
individual standards and their sample
worksheets, it will have all the
information needed to complete the
forms.
In April 2012, the Conference for
Food Protection (CFP) recommended
that FDA make two changes to the
Program Standards. The changes have
been incorporated into the 2013 version,
the draft of which will be available on
FDA’s Web site. The first change was
the addition of a new criterion in
Standard 9. In order to show
conformance with Standard 9,
jurisdictions must implement an
intervention strategy to address risk
factors identified in the risk factor
study, and then assess the effectiveness
of the intervention strategy through
subsequent risk factor studies or other
similar tools. The second change was
the creation of an Administrative
Procedures document. The procedures
for enrolling and participating in the
Program Standards were previously
included in Standard 9, along with
other criteria specific to conducting a
risk factor study. Stakeholders requested
that information pertaining to
enrollment and participation in the
Program Standards be included in a
separate, stand-alone document.
Therefore, the information about the
administration of the Program
Standards, previously in Standard 9, is
now provided in the Administrative
Procedures document.
FDA analyzed whether incorporation
of these two changes alters its estimate
of the recordkeeping and reporting
burdens. FDA concluded that there will
be no change to the annual
recordkeeping burden estimate. In the
course of their normal activities, State,
local, territorial, tribal, and Federal
regulatory agencies already implement
and document intervention strategies to
address identified risk factors at
regulated food establishments. The
intention of the new criterion in
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Standard 9 is two-fold: (1) To ensure
that development and implementation
of the intervention strategy is guided by
data collected through the risk factor
study or other similar tools and (2) to
ensure that the regulatory agency
considers the effectiveness of the
implemented intervention strategy in
light of subsequent data. FDA notes that
jurisdictions have the option to analyze
their inspection data as indicated by the
Standard 9 criteria, in lieu of
conducting a risk factor study. This is a
less resource-intensive method for
tracking risk factor trends over time.
However, the Agency has not changed
its estimate of 333 hours for Standard 9
shown in table 2 of this document. The
Agency will reevaluate its estimate
based on data it receives in the future
from participating jurisdictions. As
stated in the preceding paragraph, the
second change resulted in the relocation
of existing information from Standard 9
to the Administrative Procedures
document in the 2013 version of the
Program Standards. Because there were
no changes to content, there will be no
changes to the annual recordkeeping
burden. 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,
territorial, tribal, or Federal 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. Sample worksheets
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
Hours per
record
Standard
Recordkeeping activity
No. 1: Regulatory Foundation ..................
Self-Assessment: Completion of worksheet recording results of evaluations and
comparison on worksheets 1.
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
TABLE 1—SELF-ASSESSMENT—Continued
Hours per
record
Standard
Recordkeeping activity
No. 2: Trained Regulatory Staff ...............
No. 7: Industry and Community Relations
No. 8: Program Support and Resources ..
Self-Assessment: Completion of CFP Field Training Manual and Documentation of
Successful Completion—Field Training Process; completion of summary worksheet of each employee training records 1 2.
Self-Assessment: Completion of worksheet documentation 1 ....................................
Self-Assessment: Completion of worksheet documentation of jurisdiction’s quality
assurance procedures 1 2.
Self-Assessment: Completion of worksheet documentation 1 ...................................
Self-Assessment: Selection and review of 20 to 70 establishment files at 25 minutes per file, estimate is based on a mean number of 45; completion of worksheet 1.
Self-Assessment: Completion of worksheet 1 ............................................................
Self-Assessment: Selection and review of establishment files 1 ................................
Total ...................................................
.....................................................................................................................................
No. 3: HACCP Principles .........................
No. 4: Uniform Inspection Program ..........
No. 5: Foodborne Illness Investigation .....
No. 6: Compliance Enforcement ..............
19.3
4
19
5
19
2
8
92.3
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
Standard
Recordkeeping activity
Hours per
record
No. 9: Program Assessment .....................
Risk Factor Study and Intervention Strategy 1 .............................................................
333
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
Activity
Recordkeeping activity
Hours per
record
Administrative Procedures ........................
Verification Audit 1 ........................................................................................................
46.15
1 We
estimate that no more than 50% of time spent to complete self-assessment of all nine Standards is spent completing verification audit
worksheets. Time will be considerably less if less than nine Standards require verification audits.
FDA estimates the burden of this
collection of information as follows:
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping for FDA Worksheets 2 .................................
500
1
500
94.29
47,145
1 There
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2 Or
are no capital costs or operating and maintenance costs associated with this collection of information.
comparable documentation.
FDA bases its estimates of the number
of recordkeepers and the hours per
record on its experience with the
Program Standards. As of September 30,
2013, 563 jurisdictions were enrolled in
the Program Standards. However, based
upon the level of ongoing support
provided by FDA to enrolled
jurisdictions and the number of forms
submitted annually, FDA estimates that
no more than 500 jurisdictions actively
participate in the Program Standards
during any given year. There are
approximately 3,000 jurisdictions in the
United States and its territories that
have retail food regulatory programs.
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
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, risk factor study, 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). Enrolled jurisdictions must
conduct the work described in tables 1,
2, and 3 over a 5-year period. Therefore,
FDA estimates that annually 500
recordkeepers will spend 94.29 hours
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(471.45 ÷ 5 = 94.29) performing the
required recordkeeping for a total of
47,145 hours as shown in table 4 of this
document.
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, risk factor study
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Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Notices
(original and update), and verification
audit; names of the person(s) who
completed the self-assessment,
verification audit, risk factor study
(baseline report), risk factor study
(update), and action plan; signature of
the program manager; and date the form
was completed. Form FDA 3520
requires the name and address of the
jurisdiction, contact information for the
enrollee’s designated contact person,
completion date of the self-assessment,
date of the verification audit report,
name of the auditor, signature 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
30619
supporting documentation) is accounted
for under the recordkeeping estimates in
table 4 of this document.
In the Federal Register of February 3,
2014 (79 FR 6200), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Activity
Form FDA
Submission of ‘‘FDA National Registry Report’’.
Submission of ‘‘Permission
to Publish in National
Registry’’.
Request for Documentation
of Successful Completion of Staff Training.
3519 ..................................
500
1
500
0.1 (6 minutes)
50
3520 ..................................
500
1
500
0.1 (6 minutes)
50
Conference for Food Protection Training Plan
and Log.
500
3
1,500
0.1 (6 minutes)
150
Total ...........................
...........................................
........................
........................
........................
...........................
250
emcdonald on DSK67QTVN1PROD with NOTICES
1 There
Total hours
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 14
years. As explained previously in this
document, FDA estimates that no more
than 500 regulatory jurisdictions will
participate in the Program Standards in
any given year. 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
(6 minutes) 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 (6 minutes) per response for a total
of 50 hours. FDA estimates that
annually 500 regulatory jurisdictions
will submit 3 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 (6 minutes) per
response for a total of 150 hours. Thus,
the total reporting burden for this
information collection is 250 hours.
VerDate Mar<15>2010
16:58 May 27, 2014
Jkt 232001
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12289 Filed 5–27–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0639]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Notification of the
Intent To Use an Accredited Person
Under the Accredited Persons
Inspection Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 eligibility criteria and the process to
SUMMARY:
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be followed by establishments when
notifying FDA of a manufacturer’s intent
to have an accredited third party
conduct a quality systems regulation
inspection of their establishment
instead of FDA, under the Accredited
Persons (AP) Inspection Program.
DATES: Submit either electronic or
written comments on the collection of
information by July 28, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30616-30619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12289]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 June
27, 2014.
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 emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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 Voluntary National Retail Food Regulatory Program Standards
(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, territorial, tribal, and Federal
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 conformance with the standard (referred to
in the Program Standards document
[[Page 30617]]
as ``quality records'') and has one or more corresponding 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, territorial, tribal, and potentially
other Federal regulatory 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,
territorial, tribal, and Federal 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, 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,
territorial, tribal, and Federal regulatory agencies, and which can
serve as quality records under the Program Standards.
State, local, territorial, tribal, and Federal 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 risk factor
study 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,
``Release Record and Agreement--Permission to Publish in National
Registry (Permission to Publish in National Registry).'' These forms
are provided in the Program Standards document, and are also provided
on FDA's Web site at: https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/default.htm. If a regulatory
agency follows all the recordkeeping recommendations in the individual
standards and their sample worksheets, it will have all the information
needed to complete the forms.
In April 2012, the Conference for Food Protection (CFP) recommended
that FDA make two changes to the Program Standards. The changes have
been incorporated into the 2013 version, the draft of which will be
available on FDA's Web site. The first change was the addition of a new
criterion in Standard 9. In order to show conformance with Standard 9,
jurisdictions must implement an intervention strategy to address risk
factors identified in the risk factor study, and then assess the
effectiveness of the intervention strategy through subsequent risk
factor studies or other similar tools. The second change was the
creation of an Administrative Procedures document. The procedures for
enrolling and participating in the Program Standards were previously
included in Standard 9, along with other criteria specific to
conducting a risk factor study. Stakeholders requested that information
pertaining to enrollment and participation in the Program Standards be
included in a separate, stand-alone document. Therefore, the
information about the administration of the Program Standards,
previously in Standard 9, is now provided in the Administrative
Procedures document.
FDA analyzed whether incorporation of these two changes alters its
estimate of the recordkeeping and reporting burdens. FDA concluded that
there will be no change to the annual recordkeeping burden estimate. In
the course of their normal activities, State, local, territorial,
tribal, and Federal regulatory agencies already implement and document
intervention strategies to address identified risk factors at regulated
food establishments. The intention of the new criterion in Standard 9
is two-fold: (1) To ensure that development and implementation of the
intervention strategy is guided by data collected through the risk
factor study or other similar tools and (2) to ensure that the
regulatory agency considers the effectiveness of the implemented
intervention strategy in light of subsequent data. FDA notes that
jurisdictions have the option to analyze their inspection data as
indicated by the Standard 9 criteria, in lieu of conducting a risk
factor study. This is a less resource-intensive method for tracking
risk factor trends over time. However, the Agency has not changed its
estimate of 333 hours for Standard 9 shown in table 2 of this document.
The Agency will reevaluate its estimate based on data it receives in
the future from participating jurisdictions. As stated in the preceding
paragraph, the second change resulted in the relocation of existing
information from Standard 9 to the Administrative Procedures document
in the 2013 version of the Program Standards. Because there were no
changes to content, there will be no changes to the annual
recordkeeping burden. 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, territorial, tribal, or Federal 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. Sample worksheets 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
------------------------------------------------------------------------
Hours per
Standard Recordkeeping activity record
------------------------------------------------------------------------
No. 1: Regulatory Foundation... Self-Assessment: 16
Completion of
worksheet recording
results of
evaluations and
comparison on
worksheets \1\.
[[Page 30618]]
No. 2: Trained Regulatory Staff Self-Assessment: 19.3
Completion of CFP
Field Training Manual
and Documentation of
Successful
Completion--Field
Training Process;
completion of summary
worksheet of each
employee training
records 1 2.
No. 3: HACCP Principles........ Self-Assessment: 4
Completion of
worksheet
documentation \1\.
No. 4: Uniform Inspection Self-Assessment: 19
Program. Completion of
worksheet
documentation of
jurisdiction's
quality assurance
procedures 1 2.
No. 5: Foodborne Illness Self-Assessment: 5
Investigation. Completion of
worksheet
documentation \1\.
No. 6: Compliance Enforcement.. Self-Assessment: 19
Selection and review
of 20 to 70
establishment files
at 25 minutes per
file, estimate is
based on a mean
number of 45;
completion of
worksheet \1\.
No. 7: Industry and Community Self-Assessment: 2
Relations. Completion of
worksheet \1\.
No. 8: Program Support and Self-Assessment: 8
Resources. Selection and review
of establishment
files \1\.
----------------
Total...................... ...................... 92.3
------------------------------------------------------------------------
\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
------------------------------------------------------------------------
Hours per
Standard Recordkeeping activity record
------------------------------------------------------------------------
No. 9: Program Assessment...... Risk Factor Study and 333
Intervention Strategy
\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.
Table 3--Verification Audit
------------------------------------------------------------------------
Hours per
Activity Recordkeeping activity record
------------------------------------------------------------------------
Administrative Procedures...... Verification Audit \1\ 46.15
------------------------------------------------------------------------
\1\ We estimate that no more than 50% of time spent to complete self-
assessment of all nine Standards is spent completing verification
audit worksheets. Time will be considerably less if less than nine
Standards require verification audits.
FDA estimates the burden of this collection of information as
follows:
Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets \2\............................... 500 1 500 94.29 47,145
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. As of
September 30, 2013, 563 jurisdictions were enrolled in the Program
Standards. However, based upon the level of ongoing support provided by
FDA to enrolled jurisdictions and the number of forms submitted
annually, FDA estimates that no more than 500 jurisdictions actively
participate in the Program Standards during any given year. 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, risk factor
study, 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). Enrolled jurisdictions must conduct the work
described in tables 1, 2, and 3 over a 5-year period. Therefore, FDA
estimates that annually 500 recordkeepers will spend 94.29 hours
(471.45 / 5 = 94.29) performing the required recordkeeping for a total
of 47,145 hours as shown in table 4 of this document.
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, risk factor
study
[[Page 30619]]
(original and update), and verification audit; names of the person(s)
who completed the self-assessment, verification audit, risk factor
study (baseline report), risk factor study (update), and action plan;
signature of the program manager; and date the form was completed. Form
FDA 3520 requires the name and address of the jurisdiction, contact
information for the enrollee's designated contact person, completion
date of the self-assessment, date of the verification audit report,
name of the auditor, signature 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.
In the Federal Register of February 3, 2014 (79 FR 6200), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 5--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Form FDA Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of ``FDA National 3519.................. 500 1 500 0.1 (6 minutes)............ 50
Registry Report''.
Submission of ``Permission to 3520.................. 500 1 500 0.1 (6 minutes)............ 50
Publish in National Registry''.
Request for Documentation of Conference for Food 500 3 1,500 0.1 (6 minutes)............ 150
Successful Completion of Staff Protection Training
Training. Plan and Log.
--------------------------------------------------------------------------------------------
Total.......................... ...................... .............. .............. .............. ........................... 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
14 years. As explained previously in this document, FDA estimates that
no more than 500 regulatory jurisdictions will participate in the
Program Standards in any given year. 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 (6 minutes) 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 (6 minutes) per response for
a total of 50 hours. FDA estimates that annually 500 regulatory
jurisdictions will submit 3 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 (6 minutes) per response for a total of 150 hours. Thus, the
total reporting burden for this information collection is 250 hours.
Dated: May 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12289 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P
