Agency Information Collection Activities; Proposed Collection; 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

June 30, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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.

Full Text

<html>
<head>
<title>Federal Register, Volume 88 Issue 125 (Friday, June 30, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Pages 42372-42374]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#affffdeefcdbcec9c9efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="a5f5f7e4f6d1c4c3c3e5c3c1c48bcdcdd68bc2cad3">[email&#160;protected]</span></a>.

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 <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#bfcddacbded6d3d9d0d0dbcfcdd0cbdadccbd6d0d1cbdaded2ffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="99ebfcedf8f0f5fff6f6fde9ebf6edfcfaedf0f6f7edfcf8f4d9fffdf8b7f1f1eab7fef6ef">[email&#160;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 re-standardization.
<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.
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

</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>

View on FederalRegister.gov →Plain-text source

Indexed from Federal Register on June 30, 2023.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.