Notice2023-20226
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 180 (Tuesday, September 19, 2023)</title>
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[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64440-64441]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2286]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary National
Retail Food Regulatory Program Standards
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by October 19, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: 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,
<a href="/cdn-cgi/l/email-protection#a4f4f6e5f7d0c5c2c2e4c2c0c58accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="a2f2f0e3f1d6c3c4c4e2c4c6c38ccacad18cc5cdd4">[email protected]</span></a>.
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--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 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 <a href="https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-august-2022">https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-august-2022</a> 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
<a href="https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-august-2022">https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-august-2022</a>.
Finally, we are revising the information collection to include
additional Agency resources. We have created a dedicated emailbox at
<a href="/cdn-cgi/l/email-protection#2153445540484d474e4e4551534e55444255484e4f5544404c614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="1f6d7a6b7e76737970707b6f6d706b7a7c6b7670716b7a7e725f797b7e3177776c31787069">[email protected]</span></a> to receive requests for program
documentation and have developed the following instruments to support
the standardization of food safety inspection officer candidates:
<bullet> 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.
<bullet> 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.''
<bullet> Proposed Form FDA 5019, ``Standardized Food Safety
Inspection Officer Nomination Form,'' allows FDA to collect
qualification information from food safety inspection officer
candidates.
In the Federal Register of August 30, 2023 (88 FR 42372) FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 64441]]
Table 1--Estimated Annual Reporting Burden \1\
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Voluntary national retail Number of
program standards (August Number of responses per Total annual Average burden per Total hours
2022) respondents respondent responses response
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Program self-assessments for 500 1 500 92.3.............. 46,150
element Nos. 1 through 8.
Program element No. 9; risk 500 1 500 333............... 166,500
factor study and
intervention strategy.
Program Verification audit.. 500 1 500 46.15............. 23,075
Program records; associated 500 1 500 94.29............. 47,145
documentation/maintenance
of worksheets, assessments,
associated program tools.
FDA Form 3958; VNRFP 500 1 500 0.1 (6 minutes)... 50
National Registry Report.
Requests for program 500 3 1,500 0.1 (6 minutes)... 150
documentation (dedicated
email).
Proposed Form FDA 5017; 10 1 10 0.35 (21 minutes). 3.5
Waiver of Annual
Maintenance Requirement.
Proposed Form FDA 5018; Food 130 1 130 0.35 (21 minutes). 43
Safety Inspection Officer
Annual Maintenance.
Proposed Form FDA 5019; Food 14 1 14 0.35 (21 minutes). 5
Safety Inspection Officer
Nomination.
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Total................... .............. .............. 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: September 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20226 Filed 9-18-23; 8:45 am]
BILLING CODE 4164-01-P
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