[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64440-64441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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 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 
<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\
----------------------------------------------------------------------------------------------------------------
  Voluntary national retail                      Number of
  program standards (August      Number of     responses per   Total annual   Average burden per    Total hours
            2022)               respondents     respondent       responses         response
----------------------------------------------------------------------------------------------------------------
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.
                             -----------------------------------------------------------------------------------
    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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