Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
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 a...
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
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:
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,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed
( printed 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
www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2024
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
www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/voluntary-national-retail-food-regulatory-program-standards-november-2024.
We have created a dedicated email at
retailfoodprotectionstaff@fda.hhs.gov
to receive requests for program documentation and the following instruments to support the standardization of food safety inspection officer candidates:
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.
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.”
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
Voluntary National Retail Program Standards
(November 2024)
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Program self-assessments for element Nos. 1 through 8
500
1
500
92.3
46,150
Program element No. 9; risk factor study and intervention strategy
500
1
500
333
166,500
Program Verification audit
500
1
500
46.15
23,075
Program records; associated documentation/maintenance of worksheets, assessments, associated program tools
500
1
500
94.29
47,145
FDA Form 3958; VNRFP National Registry Report
500
1
500
0.1 (6 minutes)
50
Requests for program documentation (dedicated email)
500
3
1,500
0.1 (6 minutes)
150
Proposed Form FDA 5017; Waiver of Annual Maintenance Requirement
10
1
10
0.35 (21 minutes)
4
Proposed Form FDA 5018; Retail Food Safety Inspection Officer Annual Maintenance
130
1
130
0.35 (21 minutes)
43
Proposed Form FDA 5019; Retail Food Safety Inspection Officer Nomination
14
1
14
0.35 (21 minutes)
5
( printed page 65223)
Total
4,154
283, 122
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.
Use this for formal legal and research references to the published document.
91 FR 65221
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards,” thefederalregister.org (October 14, 2026), https://thefederalregister.org/documents/2026-20981/agency-information-collection-activities-submission-for-office-of-management-and-budget-review-comment-request-voluntary.