90 FR 114 pgs. 25309-25311 - Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
Type: NOTICEVolume: 90Number: 114Pages: 25309 - 25311
Pages: 25309, 25310, 25311Docket number: [Docket No. FDA-2025-N-0734]
FR document: [FR Doc. 2025-10891 Filed 6-13-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0734]
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) 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 the collection of information associated with our Manufactured Food Regulatory Program Standards (MFRPS).
DATES:
Either electronic or written comments on the collection of information must be submitted by August 15, 2025.
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 August 15, 2025. 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:
[top] • 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
• 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-2025-N-0734 for "Manufactured 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 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, 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.
Manufactured Food Regulatory Program Standards
OMB Control Number 0910-0601-Extension
This information collection helps implement FDA's "Manufactured Food 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 manufacturing/processing, packing, or holding of food for consumption in the United States.
[top] The MFRPS are the result of external collaboration and coordination with the Association of Food and Drug Officials (AFDO) and State manufactured food regulatory programs. FDA, AFDO, and states worked collaboratively to develop the content of the MFRPS. A copy of the standards and accompanying worksheets and forms is available in the Federal Register docket for this notice. We recommend that State manufactured food regulatory programs use these program standards as the framework to design and manage their manufactured food regulatory programs. The States that assisted in the development of MFRPS were representative of the 42
The regulatory program standards provide a uniform and consistent approach to manufactured food regulation in the United States. States may implement the program standards on a voluntary basis. The MFRPS is the framework that each participating State should use to design, manage, and improve its manufactured food regulatory program. The MFRPS provide for the following standards: (1) regulatory foundation; (2) training program; (3) inspection program; (4) inspection audit program; (5) food-related illness, outbreak and hazards response; (6) compliance and enforcement program; (7) industry and community relations; (8) program resources; (9) program assessment; and (10) laboratory support. For more information, including access to the program standards and appendices, visit our website at: https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/integrated-food-safety-system-ifss-programs-and-initiatives/regulatory-program-standards.
The MFPS includes appendices to help the State program assess and meet the program elements in the standard. State programs are not obligated to use the appendices provided with the standards. Other manual or automated forms, worksheets, and templates may be used if the pertinent data elements are present. Records and other documents specified in the standards must be current and fit for use by the State program and must be available to verify the implementation of each standard. As set forth in the standards, the State program is expected to develop or update a strategic improvement plan that aids the State program in achieving and maintaining conformance with the program elements of each standard and addresses any necessary corrective actions.
Description of Respondents: Respondents are State Departments of Agriculture or Health regulatory officials who enroll in the MFRPS. We estimate 42 respondents to the information collection based on current participation.
FDA estimates the burden of this collection of information as follows:
| Type of respondent; information collection activity | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| State Governments; Maintenance of data records consistent with the MFRPS | 42 | 11 | 462 | 88.09 | 40,698 |
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| 2 ?Totals may not sum due to rounding. | |||||
One State program is no longer participating in the MFRPS and two enrolled state agencies have been reorganized into one state agency since our last evaluation. We have consolidated our estimates from the previous request for renewal of this information collection to account for burden attributable to reporting tasks in the recordkeeping table. This consolidation of reporting and recordkeeping hours results in an increase in the average burden per recordkeeping. Due to the decrease in respondents, the total estimated burden for this collection has decreased by 1,938 hours.
Dated: June 9, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-10891 Filed 6-13-25; 8:45 am]
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