Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards, 14369-14372 [2017-05414]
Download as PDF
Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
[FR Doc. 2017–05415 Filed 3–17–17; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or we) 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 May 19, 2017.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0017 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Voluntary National Retail Food
Regulatory Program Standards.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
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14369
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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,
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Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
when appropriate, and other forms of
information technology.
Voluntary National Retail Food
Regulatory Program Standards
OMB Control Number 0910–0621—
Extension
The 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 the
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
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.
In April 2016, the Conference for
Food Protection (CFP) recommended
that FDA make a change in Program
Standard #4—Uniform Inspection
Program, more specifically to change
Program Standard #4’s Program SelfAssessment and Verification Audit
Form. Once changes have been
incorporated into the 2017 version, it
will be available on FDA’s Web site.
With this change, in order to achieve
conformance to Program Standard #4,
jurisdictions must achieve an overall
inspection program performance rating
for 20 elements as opposed to 10
elements that were previously required.
The previous 10 elements had several
criteria under one program element. The
change to 20 elements allows the
Standard to clearly delineate out each
criterion individually rather than having
several criteria under one program
element. This streamlines and clarifies
the process in meeting the Standard. As
a result, the assessment review of each
inspector’s work will now be required
for three joint inspections as opposed to
the previously required two.
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 on forms
formerly known as Form FDA 3519 and
Form FDA 3520. Currently FDA is
working to consolidate both Forms FDA
3519 ‘‘FDA National Registry Report’’
and FDA 3520 ‘‘Permission to Publish
in National Registry’’ into one form
thereby reducing the burden by 50
percent. The new Form FDA 3958 will
be provided in the Program Standards
document, and will also be 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.
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), FDA considered responses
from four State and three local
jurisdictions that participated in an FDA
Program Standards Pilot study. Table 2
shows the estimated recordkeeping
burden for the completion of the
baseline data collection, and table 3
shows the estimated recordkeeping
burden for the verification audit.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—SELF-ASSESSMENT
Hours per
record
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Standard
Recordkeeping activity
No. 1: Regulatory Foundation ....................
Self-Assessment: Completion of worksheet recording results of evaluations and comparison on worksheets 1.
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 ........................................
No. 2: Trained Regulatory Staff .................
No. 3: HACCP Principles ...........................
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Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
14371
TABLE 1—SELF-ASSESSMENT—Continued
Hours per
record
Standard
Recordkeeping activity
No. 4: Uniform Inspection Program ...........
19
No. 7: Industry & Community Relations ....
No. 8: Program Support and Resources ...
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 ....................................................
.........................................................................................................................................
92.3
No. 5: Foodborne Illness Investigation ......
No. 6: Compliance Enforcement ................
1 Or
5
19
2
8
comparable documentation.
will vary depending on number of regulated food establishments and the number of inspectors employed by the jurisdiction.
2 Estimates
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.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(hours)
Total Hours
Recordkeeping for FDA Worksheets 2 .................................
500
1
500
94.29
47,145
1 There
sradovich on DSK3GMQ082PROD with NOTICES
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 16
years. As of September 30, 2016, 711
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
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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.
Reporting
Previously, FDA required 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.’’ FDA created a new
consolidated FDA Form 3958 that has
four parts: Part 1 requires the name and
address of the jurisdiction; name and
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contact information for the contact
person for this jurisdiction; the
jurisdictions Web site address and if the
jurisdiction is willing to serve as an
auditor for another jurisdiction. Part 2
requires information about enrollment,
whether this jurisdiction is a new
enrollee and the date of enrollment;
indication whether this jurisdiction
would like to be removed from the
jurisdiction listing; indication of
updated findings to the self-assessment
or verification audit. Part 3 requires
information about self-assessment
findings and verification audit findings;
dates when self-assessment was
completed; which standards have been
met as determined by the selfassessment; which standards have been
met as verified by a verification audit
including the completion dates. Part 4
requires permission to publish
information on FDA’s Web site by
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checking the appropriate box(es) to
indicate what information FDA may
publish on the Web site.
The reporting burden in table 5
includes only the time necessary to fill
out and send the form, as compiling the
underlying information (including selfassessment reports, Risk Factor Study
data collection, outside audits, and
supporting documentation) is accounted
for under the recordkeeping estimates in
table 4.
FDA estimates the reporting burden
for this collection of information as
follows:
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(hours)
Total annual
responses
Activity
FDA form
Submission of ‘‘FDA National Registry Report’’.
Request for documentation
of successful completion
of staff training.
3598 ..................................
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 ...........................
...........................................
........................
........................
........................
...........................
200
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. 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 6 minutes
annually for each enrolled jurisdiction
to complete the form. FDA bases its
estimate on the small number of data
elements on the form and the ease of
availability of the information. FDA
estimates that, annually, 500 regulatory
jurisdictions will submit one Form FDA
3598 for a total of 500 annual responses.
Each submission is estimated to take 0.1
hour (or 6 minutes) per response for a
total of 50 hours. In addition, 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
(or 6 minutes) per response for a total
of 150 hours. Thus, the total reporting
burden for this information collection is
200 hours.
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05414 Filed 3–17–17; 8:45 am]
BILLING CODE 4164–01–P
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Total hours
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
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Proposed Project: Notification of Intent
To Use Schedule III, IV, or V Opioid
Drugs for the Maintenance and
Detoxification Treatment of Opiate
Addiction by a ‘‘Qualifying Other
Practitioner’’—(OMB No. 0930–0369)—
Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) is requesting a revision from
the Office of Management and Budget
(OMB) for approval of the Notification
of Intent to Use Schedule III, IV, or V
Opioid Drugs for the Maintenance and
Detoxification Treatment of Opiate
Addiction by a ‘‘Qualifying Other
Practitioner. The Notification of Intent
would allow SAMHSA to determine
whether other practitioners are eligible
to prescribe certain approved narcotic
treatment medications for the
maintenance or detoxification treatment
of opioid addiction.
This Notification of Intent is a result
of the Comprehensive Addiction and
Recovery Act (Pub. L. 114–198), which
was signed into law on July 22, 2016.
The law establishes criteria for nurse
practitioners (NPs) and physician
assistants (PAs) to qualify for a waiver
to prescribe covered medications. To be
eligible for a waiver, the NP or PA must:
Be licensed under State law to prescribe
schedule III, IV, or V medications for the
treatment of pain; fulfill qualification
requirements in the law for training and
experience; and fulfill qualification
requirements in the law for appropriate
supervision by a qualifying physician.
SAMHSA has the responsibility to
receive, review, approve, or deny waiver
requests.
Practitioners who meet the statutory
requirements will be eligible to
prescribe only those opioid treatment
medications that are controlled in
Schedules III, IV, or V, under the
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Agencies
[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14369-14372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05414]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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 May 19, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0017 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary National Retail Food
Regulatory Program Standards.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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,
[[Page 14370]]
when appropriate, and other forms of information technology.
Voluntary National Retail Food Regulatory Program Standards
OMB Control Number 0910-0621--Extension
The 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 the 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 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.
In April 2016, the Conference for Food Protection (CFP) recommended
that FDA make a change in Program Standard #4--Uniform Inspection
Program, more specifically to change Program Standard #4's Program
Self-Assessment and Verification Audit Form. Once changes have been
incorporated into the 2017 version, it will be available on FDA's Web
site.
With this change, in order to achieve conformance to Program
Standard #4, jurisdictions must achieve an overall inspection program
performance rating for 20 elements as opposed to 10 elements that were
previously required. The previous 10 elements had several criteria
under one program element. The change to 20 elements allows the
Standard to clearly delineate out each criterion individually rather
than having several criteria under one program element. This
streamlines and clarifies the process in meeting the Standard. As a
result, the assessment review of each inspector's work will now be
required for three joint inspections as opposed to the previously
required two.
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 on forms
formerly known as Form FDA 3519 and Form FDA 3520. Currently FDA is
working to consolidate both Forms FDA 3519 ``FDA National Registry
Report'' and FDA 3520 ``Permission to Publish in National Registry''
into one form thereby reducing the burden by 50 percent. The new Form
FDA 3958 will be provided in the Program Standards document, and will
also be 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.
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), FDA considered responses from four State and three local
jurisdictions that participated in an FDA Program Standards Pilot
study. Table 2 shows the estimated recordkeeping burden for the
completion of the baseline data collection, and table 3 shows the
estimated recordkeeping burden for the verification audit.
FDA estimates the burden of this collection of information as
follows:
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\.
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\.
[[Page 14371]]
No. 4: Uniform Inspection Program Self-Assessment: 19
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 & 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.
Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
Activity recordkeepers records per records recordkeeping Total Hours
recordkeeper (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 over the
past 16 years. As of September 30, 2016, 711 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.
Reporting
Previously, FDA required 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.'' FDA created a new consolidated FDA Form
3958 that has four parts: Part 1 requires the name and address of the
jurisdiction; name and contact information for the contact person for
this jurisdiction; the jurisdictions Web site address and if the
jurisdiction is willing to serve as an auditor for another
jurisdiction. Part 2 requires information about enrollment, whether
this jurisdiction is a new enrollee and the date of enrollment;
indication whether this jurisdiction would like to be removed from the
jurisdiction listing; indication of updated findings to the self-
assessment or verification audit. Part 3 requires information about
self-assessment findings and verification audit findings; dates when
self-assessment was completed; which standards have been met as
determined by the self-assessment; which standards have been met as
verified by a verification audit including the completion dates. Part 4
requires permission to publish information on FDA's Web site by
[[Page 14372]]
checking the appropriate box(es) to indicate what information FDA may
publish on the Web site.
The reporting burden in table 5 includes only the time necessary to
fill out and send the form, as compiling the underlying information
(including self-assessment reports, Risk Factor Study data collection,
outside audits, and supporting documentation) is accounted for under
the recordkeeping estimates in table 4.
FDA estimates the reporting burden for this collection of
information as follows:
Table 5--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA form Number of responses per Total annual Average burden per Total hours
respondents respondent responses response (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of ``FDA National 3598.................. 500 1 500 0.1 (6 minutes)............ 50
Registry Report''.
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.......................... ...................... .............. .............. .............. ........................... 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. 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 6 minutes annually for each
enrolled jurisdiction to complete the form. FDA bases its estimate on
the small number of data elements on the form and the ease of
availability of the information. FDA estimates that, annually, 500
regulatory jurisdictions will submit one Form FDA 3598 for a total of
500 annual responses. Each submission is estimated to take 0.1 hour (or
6 minutes) per response for a total of 50 hours. In addition, 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 (or 6
minutes) per response for a total of 150 hours. Thus, the total
reporting burden for this information collection is 200 hours.
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05414 Filed 3-17-17; 8:45 am]
BILLING CODE 4164-01-P