[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