90 FR 125 pgs. 29025-29027 - Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
Type: NOTICEVolume: 90Number: 125Pages: 29025 - 29027
Pages: 29025, 29026, 29027Docket number: [Docket No. FDA-2025-N-0339]
FR document: [FR Doc. 2025-12308 Filed 7-1-25; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0339]
Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration
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, 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 collections of information applicable to mitigation strategies to protect food against intentional adulteration.
DATES:
Either electronic or written comments on the collection of information must be submitted by September 2, 2025.
ADDRESSES:
[top] You may submit comments as follows. Please note that late,
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-2025-N-0339 for "Agency Information Collection Activities; Proposed Collection; Comment Request; Mitigation Strategies To Protect Food Against Intentional Adulteration." 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.
Mitigation Strategies To Protect Food Against Intentional Adulteration-21 CFR Part 21
OMB Control Number 0910-0812-Extension
This information collection helps support the implementation of statutory and regulatory requirements intended to ensure the safety of food. Section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g) governs the assessment and evaluation of hazard analyses and risk-based preventive controls intended to provide assurances that food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342). Similarly, section 419 of the FD&C Act (21 U.S.C. 350h) establishes standards for produce safety, and section 420 of the FD&C Act (21 U.S.C. 350i) requires the mitigation against intentional adulteration of high-risk foods (exempting farms except for farms that produce milk).
[top] Agency regulations in part 121 (21 CFR part 121) establish requirements applicable to owners, operators, or agents in charge of domestic or foreign food facilities that manufacture/process, pack, or hold food for consumption in the United States. The regulations, require the preparation, retention and
To help facilitate the submission to FDA of required information and reduce burden on respondents, we have developed resources, including an "FDA Food Defense Plan Builder," (version 2.0) available at https://www.fda.gov/food/food-defense/food-defense-tools-educational-materials. Other resources made available to respondents include two draft guidance documents entitled "Mitigation Strategies To Protect Food Against Intentional Adulteration: Draft Guidance for Industry" (84 FR 8103, March 6, 2019), and "Supplemental Draft Guidance for Industry: Mitigation Strategies To Protect Food Against Intentional Adulteration" (85 FR 8599, February 14, 2020), which are available at https://www.fda.gov/food/food-defense . The guidance documents are intended to assist respondents in developing and implementing requisite elements of a food defense plan. All Agency guidance documents are issued in accordance with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time. Finally, we developed the small entity compliance guide entitled "Mitigation Strategies To Protect Food Against Intentional Adulteration" (82 FR 40484, August 25, 2017), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-mitigation-strategies-protect-food-against-intentional-adulteration .
Description of Respondents: The respondents to this information collection are manufacturers, processors, packers, and holders of retail food products marketed in the United States.
We estimate the burden of the collection of information as follows:
| Information collection activity; 21 CFR section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Exemption requests for very small businesses; §?121.5 | 18,080 | 1 | 18,080 | 0.5 (30 minutes) | 9,040 |
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
| Activity; 21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| Food Defense Plan; §?121.126 | 3,247 | 1 | 3,247 | 23 | 74,681 |
| Actionable Process Steps; §?121.130 | 9,759 | 1 | 9,759 | 20 | 195,180 |
| Mitigation Strategies; §?121.135(b) | 9,759 | 1 | 9,759 | 20 | 195,180 |
| Monitoring, Corrective Actions, Verification; §§?121.140(a), 121.145(a)(1), and 121.150(b) | 9,759 | 1 | 9,759 | 175 | 1,707,825 |
| Training; §?121.4 | 367,203 | 1 | 367,203 | 0.67 (40 minutes) | 246,026 |
| Records; §§?121.305 and 121.310 | 9,759 | 1 | 9,759 | 10 | 97,590 |
| Total | 2,516,482 | ||||
| 1 ?There are no capital costs or operating and maintenance costs associated with this collection of information. | |||||
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Dated: June 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12308 Filed 7-1-25; 8:45 am]
BILLING CODE 4164-01-P