Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) 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 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Notices]
[Pages 65221-65223]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20981]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-7338]


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 or we) 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 November 13, 2026.

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: Christopher Colburn, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8758, 
<a href="/cdn-cgi/l/email-protection#2b7b796a785f4a4d4d6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="702022312304111616301614115e1818035e171f06">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed

[[Page 65222]]

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 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.
    The Retail Program Standards were revised most recently in November 
2024 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 <a href="https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2024">https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2024</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-november-2024">https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2024</a>.
    We have created a dedicated email at 
<a href="/cdn-cgi/l/email-protection#fa889f8e9b93969c95959e8a88958e9f998e939594898e9b9c9cba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="3d4f58495c54515b5252594d4f5249585e495452534e495c5b5b7d5b595c1355554e135a524b">[email&#160;protected]</span></a> to receive requests for program 
documentation and the following instruments to support the 
standardization of food safety inspection officer candidates:
    <bullet> Form FDA 5017, ``Standardized Retail Food Safety 
Inspection Officer Waiver of Annual Maintenance Requirement,'' 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 retail food safety inspection officer's 
eligibility for restandardization.
    <bullet> Form FDA 5018, ``Standardized Retail Food Safety 
Inspection Officer Annual Maintenance Form,'' provides verification 
that a retail 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> Form FDA 5019, ``Standardized Retail Food Safety 
Inspection Officer Nomination Form,'' allows FDA to collect 
qualification information from retail food safety inspection officer 
candidates.
    Description of Respondents: Respondents to the information 
collection are State, local, territorial, and tribal regulatory 
agencies.
    In the Federal Register of July 17, 2026 (91 FR 44857), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was generally 
favorable of the collection of information.
    We estimate the burden of this collection of information as 
follows:

                                                     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
               (November 2024)                  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                   500               1             500  0.1 (6 minutes)...........................              50
 Report.
Requests for program documentation                       500               3           1,500  0.1 (6 minutes)...........................             150
 (dedicated email).
Proposed Form FDA 5017; Waiver of Annual                  10               1              10  0.35 (21 minutes).........................               4
 Maintenance Requirement.
Proposed Form FDA 5018; Retail Food Safety               130               1             130  0.35 (21 minutes).........................              43
 Inspection Officer Annual Maintenance.
Proposed Form FDA 5019; Retail Food Safety                14               1              14  0.35 (21 minutes).........................               5
 Inspection Officer Nomination.
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    Total...................................  ..............  ..............           4,154  ..........................................        283, 122
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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. Based on a review of the information collection since our 
last request for OMB approval, we have made no adjustments to our 
burden estimate.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20981 Filed 10-13-26; 8:45 am]
BILLING CODE 4164-01-P


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