[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
 Voluntary National Retail Program Standards      Number of     responses per   Total annual          Average burden per response           Total hours
                (August 2022)                    respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                              ----------------------------------------------------------------------------------------------------------
                                               ..............  ..............           4,154  .........................................       283,121.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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