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[Federal Register Volume 89, Number 219 (Wednesday, November 13, 2024)]
[Notices]
[Pages 89648-89649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26209]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2275]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Produce 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 December 13, 2024.

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 title of this 
information collection is Produce Regulatory Program Standards. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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.

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

[[Page 89649]]

administering FDA regulations pertaining to the manufacturing/
processing, packing, or holding of food for consumption in the United 
States.
    The Produce Regulatory Program Standards (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-state-local-tribal-and-territorial-officials/grants-and-cooperative-agreements/fda-state-produce-safety-implementation-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.
    In the Federal Register of June 28, 2024 (89 FR 54009), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that did not 
pertain to the information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                             Respondent                                 Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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State or Territorial Governments; Maintenance of data records                    48               11              528            85.36           45,072
 consistent with the PRPS..........................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: October 30, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26209 Filed 11-12-24; 8:45 am]
BILLING CODE 4164-01-P
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