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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-2275]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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, 
                        *PRAStaff@fda.hhs.gov.*


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 
                    ( print 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
Respondent
Number of recordkeepers
Number of records per recordkeeper
Total annual records
Average
                             burden per 
                             recordkeeping
Total hoursState or Territorial Governments; Maintenance of data records consistent with the PRPS
48
11
528
85.36
45,0721
                         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