Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards, 42372-42374 [2023-13930]
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42372
Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices
their sex assigned at birth on their
original birth certificate (male, female,
don’t know, prefer not to answer). Next,
respondents are asked to report their
current gender identity (male, female,
transgender, I use a different term,
prefer not to answer). This two-step
series aligns with recommendations
from the National Academies of
Sciences, Engineering, and Medicine’s
(NASEM’s) recent report, ‘‘Measuring
Sex, Gender Identity, and Sexual
Orientation.’’ These items have also
been cognitively tested for inclusion in
Number of
respondents
(maximum)
Respondent/data collection activity
Responses
per
respondent
Hours per
response
Annual
burden hours
Survey, Stratified Random Sample .................................................................
5,400
1
5/60
450
Total ..........................................................................................................
5,400
1
5/60
450
Dated: June 19, 2023.
Alison Barkoff,
Acting Administrator and Assistant Secretary
for Aging.
[FR Doc. 2023–13968 Filed 6–29–23; 8:45 am]
BILLING CODE 4154–01–P
11:59 p.m. Eastern Time at the end of
August 29, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2286]
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, Agency, 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 (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 information
collection associated with our Voluntary
National Retail Food Regulatory
Program (VNRFRP) Standards.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
August 29, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
the Medicare Current Beneficiaries
Survey under the MCBS Generic
Clearance and performed well.
Estimated Program Burden: ACL
estimates the burden associated with
this collection of information as follows:
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
PO 00000
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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–2286 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Voluntary National Retail Food
Regulatory Program Standards.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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 Dockets Management
Staff. 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://
E:\FR\FM\30JNN1.SGM
30JNN1
Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices
www.govinfo.gov/content/pkg/FR-201509-18/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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), 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,
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
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when appropriate, and other forms of
information technology.
Voluntary National Retail Food
Regulatory Program Standards
OMB Control Number 0910–0621—
Revision
This information collection helps
support implementation of FDA’s
Voluntary National Retail Food
Regulatory Program Standards (the
Retail Program Standards). Regulatory
Program Standards play a critical role in
an integrated food safety system and
serve as the foundation for mutual
reliance between FDA and other
regulatory agencies that work to ensure
food safety. The Retail Program
Standards define what constitutes a
highly effective and responsive program
for the regulation of foodservice and
retail food establishments. The Retail
Program Standards are intended to
provide a foundation upon which
continuous improvements can be made
with the ultimate goal to reduce the
occurrence of factors that cause and
contribute to foodborne illness. In
support of this goal, FDA works
cooperatively with our State, local,
Territorial, and Tribal partners using a
risk-based approach to leverage limited
resources. We engage in education and
outreach efforts to facilitate
collaboration with our partners in food
safety. The Retail Program Standards
represent an important component of a
comprehensive strategic approach to
help ensure the safety and security of
the food supply at the retail level.
Respondents to the information
collection are State, local, territorial,
and tribal governments.
The Retail Program Standards were
revised most recently in August 2022
and include the following elements: (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. These elements are
enumerated and discussed on our
website at https://www.fda.gov/food/
voluntary-national-retail-foodregulatory-program-standards/
voluntary-national-retail-foodregulatory-program-standards-august-
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42373
2022 along with worksheets and
assessments that allow FDA to
determine conformance with the Retail
Program Standards. State, local,
territorial, tribal, and Federal regulatory
agencies that participate in the
voluntary program are required to report
information demonstrating that a
program self-assessment, a risk factor
study of the regulated industry, and an
independent outside audit (verification
audit) have been completed. The
information also includes Form FDA
3958, ‘‘Voluntary National Retail Food
Regulatory Program Standards FDA
National Registry Report,’’ which may
be completed electronically at https://
www.fda.gov/food/voluntary-nationalretail-food-regulatory-programstandards/voluntary-national-retailfood-regulatory-program-standardsaugust-2022.
Finally, we are revising the
information collection to include
additional Agency resources. We have
created a dedicated emailbox at
retailfoodprotectionteam@fda.hhs.gov to
receive requests for program
documentation and have developed the
following instruments to support the
standardization of food safety
inspection officer candidates:
• Proposed Form FDA 5017,
‘‘Standardized Retail Food Safety
Inspection Officer Waiver of Annual
Maintenance Requirement Form,’’
pertains to requests for waivers from
maintenance requirements, referenced
in section 3–403 of the ‘‘FDA
Procedures for Standardization of Retail
Food Safety Inspection Officers.’’ FDA
uses the information submitted on Form
FDA 5017 to determine a food safety
inspection officer’s eligibility for restandardization.
• Proposed Form FDA 5018,
‘‘Standardized Retail Food Safety
Inspection Officer Annual Maintenance
Form,’’ provides verification that a food
safety inspection officer has met
program standardization requirements
in accordance with section 3–403 of the
‘‘FDA Procedures for Standardization of
Retail Food Safety Inspection Officers.’’
• Proposed Form FDA 5019,
‘‘Standardized Food Safety Inspection
Officer Nomination Form,’’ allows FDA
to collect qualification information from
food safety inspection officer
candidates.
We estimate the burden of this
collection of information as follows:
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42374
Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Voluntary National Retail Program Standards
(August 2022)
Number of
respondents
Program self-assessments for element Nos. 1
through 8.
Program element No. 9; risk factor study and intervention strategy.
Program Verification audit ...........................................
Program records; associated documentation/maintenance of worksheets, assessments, associated
program tools.
FDA Form 3958; VNRFP National Registry Report ....
Requests for program documentation (dedicated
email).
Proposed Form FDA 5017; Waiver of Annual Maintenance Requirement.
Proposed Form FDA 5018; Food Safety Inspection
Officer Annual Maintenance.
Proposed Form FDA 5019; Food Safety Inspection
Officer Nomination.
1 There
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
500
1
500
92.3 ........................
46,150
500
1
500
333 .........................
166,500
500
500
1
1
500
500
46.15 ......................
94.29 ......................
23,075
47,145
500
500
1
3
500
1,500
0.1 (6 minutes) .......
0.1 (6 minutes) ......
50
150
10
1
10
0.35 (21 minutes) ..
3.5
130
1
130
0.35 (21 minutes) ..
43
14
1
14
0.35 (21 minutes) ...
5
........................
........................
4,154
................................
283,121.5
are no capital or operational and maintenance costs associated with this collection of information.
Our estimate of burden for the
associated program activities as
identified in table 1 is based on our
experience with the information
collection, along with other regulatory
standards programs we administer.
Upon reorganizing the collection to
reflect the cumulative activities, we
have accounted for burden that may be
attributable recordkeeping for risk-factor
studies and verification tasks that may
have been previously overlooked. The
burden we attribute to completing and
submitting FDA Form 3958, ‘‘Voluntary
National Retail Food Regulatory
Program Standards FDA National
Registry Report,’’ is exclusive of other
program records, which we account for
in row 4. We have also accounted for
burden we assume will be attendant to
the completion and submission of
newly developed Agency forms. As a
result of these changes and adjustments,
the information collection reflects an
increase of 235,776.5 hours and 1,654
responses annually.
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13930 Filed 6–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–1427; FDA–
2022–N–0863; FDA–2023–N–0187; FDA–
2013–N–1393; FDA–2022–D–0814; FDA–
2013–N–0796; FDA–2016–N–0736; and
FDA–2019–N–3065]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
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Title of collection
Hazard Analysis and Critical Control Point (HACCP) Procedures for the Safe and Sanitary Processing and Importing of Juice .....................................................................................................................................................
Monthly Monitoring Study ........................................................................................................................................
Premarket Approval of Medical Devices .................................................................................................................
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions ................................
Infant Formula Requirements ..................................................................................................................................
Testing Communications on Medical Devices and Radiation-Emitting Products ...................................................
Tracking Network for PETNet, LivestockNet, and SampleNet ................................................................................
Required Warnings for Cigarette Packages and Advertisements ...........................................................................
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0910–0466
0910–0914
0910–0231
0910–0233
0910–0256
0910–0678
0910–0680
0910–0877
Date approval
expires
4/30/2026
4/30/2026
5/31/2026
5/31/2026
5/31/2026
5/31/2026
5/31/2026
5/31/2026
]]>Agencies
[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42372-42374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13930]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2286]
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, Agency, 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 (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 information collection
associated with our Voluntary National Retail Food Regulatory Program
(VNRFRP) Standards.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 29, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 29, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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, 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2023-N-2286 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary National Retail Food
Regulatory Program Standards.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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 Dockets Management Staff. 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://
[[Page 42373]]
www.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Voluntary National Retail Food Regulatory Program Standards
OMB Control Number 0910-0621--Revision
This information collection helps support implementation of FDA's
Voluntary National Retail Food Regulatory Program Standards (the Retail
Program Standards). Regulatory Program Standards play a critical role
in an integrated food safety system and serve as the foundation for
mutual reliance between FDA and other regulatory agencies that work to
ensure food safety. The Retail Program Standards define what
constitutes a highly effective and responsive program for the
regulation of foodservice and retail food establishments. The Retail
Program Standards are intended to provide a foundation upon which
continuous improvements can be made with the ultimate goal to reduce
the occurrence of factors that cause and contribute to foodborne
illness. In support of this goal, FDA works cooperatively with our
State, local, Territorial, and Tribal partners using a risk-based
approach to leverage limited resources. We engage in education and
outreach efforts to facilitate collaboration with our partners in food
safety. The Retail Program Standards represent an important component
of a comprehensive strategic approach to help ensure the safety and
security of the food supply at the retail level. Respondents to the
information collection are State, local, territorial, and tribal
governments.
The Retail Program Standards were revised most recently in August
2022 and include the following elements: (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. These elements are enumerated and discussed on our website
at https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-august-2022 along with worksheets and assessments that allow
FDA to determine conformance with the Retail Program Standards. State,
local, territorial, tribal, and Federal regulatory agencies that
participate in the voluntary program are required to report information
demonstrating that a program self-assessment, a risk factor study of
the regulated industry, and an independent outside audit (verification
audit) have been completed. The information also includes Form FDA
3958, ``Voluntary National Retail Food Regulatory Program Standards FDA
National Registry Report,'' which may be completed electronically at
https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-august-2022.
Finally, we are revising the information collection to include
additional Agency resources. We have created a dedicated emailbox at
[email protected] to receive requests for program
documentation and have developed the following instruments to support
the standardization of food safety inspection officer candidates:
Proposed Form FDA 5017, ``Standardized Retail Food Safety
Inspection Officer Waiver of Annual Maintenance Requirement Form,''
pertains to requests for waivers from maintenance requirements,
referenced in section 3-403 of the ``FDA Procedures for Standardization
of Retail Food Safety Inspection Officers.'' FDA uses the information
submitted on Form FDA 5017 to determine a food safety inspection
officer's eligibility for re-standardization.
Proposed Form FDA 5018, ``Standardized Retail Food Safety
Inspection Officer Annual Maintenance Form,'' provides verification
that a food safety inspection officer has met program standardization
requirements in accordance with section 3-403 of the ``FDA Procedures
for Standardization of Retail Food Safety Inspection Officers.''
Proposed Form FDA 5019, ``Standardized Food Safety
Inspection Officer Nomination Form,'' allows FDA to collect
qualification information from food safety inspection officer
candidates.
We estimate the burden of this collection of information as
follows:
[[Page 42374]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Voluntary National Retail Program Standards Number of responses per Total annual Average burden per response Total hours
(August 2022) respondents respondent responses
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Program self-assessments for element Nos. 1 500 1 500 92.3..................................... 46,150
through 8.
Program element No. 9; risk factor study and 500 1 500 333...................................... 166,500
intervention strategy.
Program Verification audit................... 500 1 500 46.15.................................... 23,075
Program records; associated documentation/ 500 1 500 94.29.................................... 47,145
maintenance of worksheets, assessments,
associated program tools.
FDA Form 3958; VNRFP National Registry Report 500 1 500 0.1 (6 minutes).......................... 50
Requests for program documentation (dedicated 500 3 1,500 0.1 (6 minutes).......................... 150
email).
Proposed Form FDA 5017; Waiver of Annual 10 1 10 0.35 (21 minutes)........................ 3.5
Maintenance Requirement.
Proposed Form FDA 5018; Food Safety 130 1 130 0.35 (21 minutes)........................ 43
Inspection Officer Annual Maintenance.
Proposed Form FDA 5019; Food Safety 14 1 14 0.35 (21 minutes)........................ 5
Inspection Officer Nomination.
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.............. .............. 4,154 ......................................... 283,121.5
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\1\ There are no capital or operational and maintenance costs associated with this collection of information.
Our estimate of burden for the associated program activities as
identified in table 1 is based on our experience with the information
collection, along with other regulatory standards programs we
administer. Upon reorganizing the collection to reflect the cumulative
activities, we have accounted for burden that may be attributable
recordkeeping for risk-factor studies and verification tasks that may
have been previously overlooked. The burden we attribute to completing
and submitting FDA Form 3958, ``Voluntary National Retail Food
Regulatory Program Standards FDA National Registry Report,'' is
exclusive of other program records, which we account for in row 4. We
have also accounted for burden we assume will be attendant to the
completion and submission of newly developed Agency forms. As a result
of these changes and adjustments, the information collection reflects
an increase of 235,776.5 hours and 1,654 responses annually.
Dated: June 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13930 Filed 6-29-23; 8:45 am]
BILLING CODE 4164-01-P
