Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards, 41588-41591 [2020-14879]
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
states, territories, and tribes are also
required to submit an APSR and a
financial report called the CFS–101. The
APSR is a yearly report that discusses
progress made by a state, territory or
tribe in accomplishing the goals and
objectives cited in its CFSP (45 CFR
1357.16(a)). The APSR contains new
and updated information about service
needs and organizational capacities
throughout the five-year plan period
and, beginning with the submission due
on June 30, 2021, will also include
information on the use of the Family
First Transition Grants and Funding
Certainty Grants authorized by the
Family First Transition Act included in
Public Law (P.L.)116–94. The CFS–101
has three parts. Part I is an annual
budget request for the upcoming fiscal
year. Part II includes a summary of
planned expenditures by program area
for the upcoming fiscal year, the
estimated number of individuals or
families to be served, and the
geographical service area. Part III
includes actual expenditures by
program area, numbers of families and
individuals served by program area, and
the geographic areas served for the last
complete fiscal year. The revisions to
the CFS–101 form are to streamline the
data entry and to remove from Part III
of the CFS–101 requests for prior year
estimates on use of funds that are not
required by law.
Respondents: States, territories, and
tribes must complete the CFSP, APSR,
and CFS–101. Tribes and territories are
exempted from the monthly caseworker
visits reporting requirement of the
CFSP/APSR. There are approximately
180 tribal entities that currently receive
IV–B funding. There are 53 states
(including the Commonwealth of Puerto
Rico, the District of Columbia, and the
Virgin Islands) that must complete the
CFSP, APSR, and CFS–101. There are a
total of 233 possible respondents.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
APSR ...................................................................................
CFSP ....................................................................................
CFS–101, Part I, II, and III ..................................................
Caseworker Visits ................................................................
233
47
233
53
Average
burden
hours per
response
3
1
3
3
82
123
5
99.33
Total burden
hours
Annual burden
hours
57,318
5,781
3,495
15,794
19,106
1,927
1,165
5,265
Estimated Total Annual Burden
Hours: 27,463.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Voluntary National Retail Food
Regulatory Program Standards
Authority: Title IV–B, subparts 1 and 2 of
the Social Security Act (the Act), and title
IV–E, section 477 of the Act; sections 106 and
108 of CAPTA (42 U.S.C. 5106a. and 5106d.);
and P.L. 116–94, the Family First Transition
Act within Section 602, Subtitle F, Title I,
Division N of the Further Consolidated
Appropriations Act, 2020.
DATES:
Submit written comments
(including recommendations) on the
collection of information by August 10,
2020.
OMB Control Number 0910–0621—
Extension
This information collection request
supports implementation of FDA’s
Voluntary National Retail Food
Regulatory Program Standards (the
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:
(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
John M. Sweet Jr,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–14881 Filed 7–9–20; 8:45 am]
BILLING CODE 4184–01–P
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.
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Total number
of responses
per respondent
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
SUMMARY:
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0621. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
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 on
FDA’s website at: https://www.fda.gov/
food/voluntary-national-retail-foodregulatory-program-standards/
voluntary-national-retail-foodregulatory-program-standardsnovember-2019. 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 reports.
41589
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.
In the Federal Register of February
21, 2020 (85 FR 10172), we 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 1—SELF-ASSESSMENT
Hours per
record
Standard
Recordkeeping activity
No. 1: Regulatory Foundation ..................
No. 7: Industry & Community Relations ...
No. 8: Program Support and Resources ..
Self-Assessment: Completion of worksheet recording results of evaluations and
comparison on worksheets.1.
Self-Assessment: Completion of Conference for Food Protection (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. 2: Trained Regulatory Staff ................
No. 3: HACCP Principles ..........................
No. 4: Uniform Inspection Program ..........
No. 5: Foodborne Illness Investigation .....
No. 6: Compliance Enforcement ...............
16
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.
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TABLE 2—RISK FACTOR STUDY DATA COLLECTION
Hours per
record
Standard
Recordkeeping activity
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.
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
TABLE 3—VERIFICATION AUDIT
Hours per
record
Activity
Recordkeeping activity
Administrative Procedures ........................
Verification Audit 1 ........................................................................................................
46.15
1 We
estimate that no more than 50 percent 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
Number of
recordkeepers
Activity
Recordkeeping for FDA Worksheets 2 .................................
Number of
records per
recordkeeper
500
Total annual
records
1
500
Average
burden per
recordkeeping
94.29
Total hours
47,145
1 There
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 over the past 16
years. 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) 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
Form FDA 3958, ‘‘Voluntary National
Retail Food Regulatory Program
Standards FDA National Registry
Report,’’ used for reporting to FDA,
consists of four parts. Part 1 requires the
name and address of the jurisdiction;
name and contact information for the
contact person for this jurisdiction; the
jurisdiction’s website 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; and 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; and 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 website by
checking the appropriate box(es) to
indicate what information FDA may
publish on the website.
The reporting burden in table 5
includes only the time necessary to
complete a report, 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
respondents
Activity
Total annual
responses
Average burden per
response
Total hours
Submission of ‘‘Voluntary National Retail
Food Regulatory Program Standards FDA
National Registry Report’’.
Request for documentation of successful
completion of staff training.
500
1
500
0.1 (6 minutes) ....................
50
500
3
1,500
0.1 (6 minutes) ....................
150
Total .........................................................
........................
........................
........................
.............................................
200
1 There
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Number of
responses per
respondent
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, FDA estimates that no more
than 500 regulatory jurisdictions will
participate in the Program Standards in
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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
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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
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Federal Register / Vol. 85, No. 133 / Friday, July 10, 2020 / Notices
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.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
AGENCY:
[FR Doc. 2020–14879 Filed 7–9–20; 8:45 am]
Food and Drug Administration
[Docket Nos. FDA–2018–N–2434, FDA–
2016–N–3535, FDA–2013–N–1619, FDA–
2016–N–0736, FDA–2019–N–3885, FDA–
2013–N–1423, FDA–2013–N–0804, FDA–
2016–N–3995, FDA–2018–D–1592, FDA–
2016–N–2066, and FDA–2017–N–0366]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
BILLING CODE 4164–01–P
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB
control No.
Title of collection
Formal Meetings Between the Food and Drug Administration and Sponsors and Applicants of Prescription
Drug User Fee Act Products ................................................................................................................................
Special Protocol Assessments ................................................................................................................................
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements ........................................................................................................................................................
Tracking Network for PETNet, LivestockNet, and SampleNet ................................................................................
Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey ...........................
Importer’s Entry Notice ............................................................................................................................................
Premarket Notification Submission 510(k), Subpart E ............................................................................................
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations ...........................................................................................................................................................
Controlled Correspondence Related to Generic Drug Development ......................................................................
Certification of Identity for Freedom of Information Act and Privacy Act Requests ...............................................
FDA Advisory Committee Membership Nominations ..............................................................................................
Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–14875 Filed 7–9–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2020–N–1391]
Office of Women’s Health Strategic
Priorities; Establishment of a Public
Docket; Request for Comments
AGENCY:
Notice; establishment of a
public docket; request for comments.
ACTION:
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You may submit comments
as follows. Please note that untimely
comments will not be considered.
Electronic comments must be submitted
on or before September 8, 2020. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
ADDRESSES:
Food and Drug Administration,
HHS.
The Food and Drug
Administration (FDA or Agency) is
opening a public docket to solicit input
and comments from stakeholders
interested in informing strategic
priorities for the Office of Women’s
Health (OWH). This will help the
Agency ensure that important health
concerns are carefully considered in
establishing OWH’s scientific,
educational, and outreach priorities.
DATES: Submit either electronic or
written comments by September 8,
2020.
SUMMARY:
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Date
approval
expires
0910–0429
0910–0470
5/31/2023
5/31/2023
0910–0606
0910–0680
0910–0887
0910–0046
0910–0120
5/31/2023
5/31/2023
5/31/2023
6/30/2023
6/30/2023
0910–0748
0910–0797
0910–0832
0910–0833
6/30/2023
6/30/2023
6/30/2023
6/30/2023
of September 8, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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,
E:\FR\FM\10JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41588-41591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14879]
-----------------------------------------------------------------------
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: Submit written comments (including recommendations) on the
collection of information by August 10, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0621. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
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
This information collection request supports implementation of
FDA's Voluntary National Retail Food Regulatory Program Standards (the
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: (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
[[Page 41589]]
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 on FDA's
website at: https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2019. 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 reports.
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.
In the Federal Register of February 21, 2020 (85 FR 10172), we
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 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
Conference for Food
Protection (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 & 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--Risk Factor Study 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.
[[Page 41590]]
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 percent 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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets 500 1 500 94.29 47,145
\2\............................
----------------------------------------------------------------------------------------------------------------
\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. 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) 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
Form FDA 3958, ``Voluntary National Retail Food Regulatory Program
Standards FDA National Registry Report,'' used for reporting to FDA,
consists of four parts. Part 1 requires the name and address of the
jurisdiction; name and contact information for the contact person for
this jurisdiction; the jurisdiction's website 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; and 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; and 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 website by checking
the appropriate box(es) to indicate what information FDA may publish on
the website.
The reporting burden in table 5 includes only the time necessary to
complete a report, 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 Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Submission of ``Voluntary 500 1 500 0.1 (6 minutes). 50
National Retail Food
Regulatory Program Standards
FDA National Registry
Report''.
Request for documentation of 500 3 1,500 0.1 (6 minutes). 150
successful completion of
staff training.
---------------------------------------------------------------------------------
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, 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
[[Page 41591]]
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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14879 Filed 7-9-20; 8:45 am]
BILLING CODE 4164-01-P
