4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-2275]
Agency Information Collection Activities; Proposed Collection; Comment Request;
Produce 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 and to allow
60 days for public comment in response to the notice. This notice solicits comments on
collections of information associated with our Produce Regulatory Program Standards (PRPS).
DATES: Either electronic or written comments on the collection of information must be
submitted by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
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 [INSERT DATE 60 DAYS
AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. 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-2024-N-2275

for “Agency Information Collection Activities; Proposed Collection; Comment Request; Produce
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://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, PRAStaff@fda.hhs.gov.
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 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.
Produce Regulatory Program Standards
OMB Control Number--0910-NEW
This information collection helps establish and implement FDA’s “Produce Regulatory
Program Standards.” Section 1012 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
399c) authorizes FDA to administer training and education programs for employees of State,
local, Territorial, and Tribal food safety authorities relating to regulatory programs. Also, under
section 205 of the FDA Safety Modernization Act (codified in 21 U.S.C. 2224), FDA, together
with the Centers for Disease Control and Prevention is directed to enhance foodborne illness
surveillance to improve the collection, analysis, reporting, and usefulness of data on foodborne
illnesses. As part of this effort, we have initiated programs that include developing and

instituting regulatory standards intended to reduce the risk of foodborne illness through
coordinated efforts with our strategic partners. Regulatory program standards establish a
uniform foundation for the design and management of State, local, Tribal, and Territorial
programs that have the responsibility for regulating human and animal food. Partnering with
other regulatory officials also helps maximize limited resources in administering FDA
regulations pertaining to the manufacturing/processing, packing, or holding of food for
consumption in the United States.
The PRPS are the result of external collaboration and coordination with the Association of
Food and Drug Officials (AFDO), the National Association of State Departments of Agriculture
(NASDA), and state produce regulatory programs. FDA, NASDA, AFDO, and states worked
collaboratively to develop the content of the PRPS. A copy of the standards and accompanying
worksheets and forms is available in the Federal Register docket for this notice. We recommend

that State and Territorial produce safety regulatory programs use these program standards as the
framework to design and manage their produce safety regulatory programs. The states that
assisted in the development of PRPS were representative of the 43 State and Territorial programs
regulatory programs enrolled currently conducting produce safety inspections via funding from a
cooperative agreement grant, “The FDA’s Cooperative Agreement Program for States and
Territories to Implement a National Produce Safety Program, PAR-21-174,” (this program also
includes 4 programs which do not conduct inspections). For more information on this
cooperative agreement, we invite you to visit our website at: https://www.fda.gov/federal-statelocal-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safetyimplementation-cooperative-agreement-program.
The PRPS identifies and includes resource and training material for the following
standards: regulatory foundations; training; inspection; product-specific illnesses, outbreaks and
hazard response; compliance and enforcement; industry and community relations; program
assessments; and product sampling and testing. We recommend using the worksheets and forms

contained in the standards, however, alternate forms that are equivalent may be used. The
educational worksheets and resource materials include recordkeeping and reporting activities that
help FDA verify participation and successful completion of the respective requirements. In the
first year of enrollment, information is used to conduct a baseline self-assessment to determine
whether the materials meet the elements of each standard. In subsequent years, we use the
information to conduct a comprehensive review and evaluate program effectiveness and
participation. We modify the program standards based on the ongoing assessments as well as
comments and informal feedback obtained from participants.
Description of Respondents: Respondents are State Departments of Agriculture or Health
regulatory officials who enroll in the PRPS (State or Territorial governments). Currently we
estimate 43 respondents to the information collection based on expected participation.
We estimate the burden of this collection of information as follows:
Table 1--Estimated Annual Recordkeeping Burden1
Information Collection Activity

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden per
Response

Total Hours

State or Territorial Governments;
Development and reporting of data
43
11
473
88
consistent with PRPS
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

To demonstrate conformance with the standards prior to and after enrollment in the grant
program, State and Territorial governments participating in the PRPS (respondents) will submit
comprehensive program assessments and evaluations to their technical advisors at FDA using a
dedicated email. The information required for these submissions is outlined in the provided
worksheets. Additionally, the PRPS requires ongoing documentation to verify conformance.
We estimate, based on the implementation of other standards programs and informal consultation
with the affected State and Territorial governments, that the information collection activities will
average 968 hours annually for each of the 43 participants, for a total of 41,624 hours.
Dated: June 25, 2024.

41,624

Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-14329 Filed: 6/27/2024 8:45 am; Publication Date: 6/28/2024]