90 FR 143 pgs. 35695-35697 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Type: NOTICEVolume: 90Number: 143Pages: 35695 - 35697
Pages: 35695, 35696, 35697Docket number: [Docket No. FDA-2025-N-0349]
FR document: [FR Doc. 2025-14228 Filed 7-28-25; 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-0349]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
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 August 28, 2025.
ADDRESSES:
[top] 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 OMB control number for this information collection is 0910-0752. Also include
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 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.
Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals-21 CFR Part 1; Subpart L
OMB Control Number 0910-0752-Extension
This information collection helps support implementation of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a), which requires persons who import food into the United States to perform risk-based foreign supplier verification activities as set forth in part 1, subpart L (21 CFR part 1, subpart L) (Foreign Supplier Verification Programs for Food Importers). The regulatory requirements are intended to verify that food imported into the United States is as safe as food produced and sold within the United States. Specifically, regulations in §?1.501 set forth the applicability of requirements for FSVP, while regulations in §§?1.502 through 1.508, prescribe specific activities for developing, maintaining, and following an FSVP; as well as for evaluating compliance and for identifying and correcting hazards. Finally, regulations in §?1.509 identify required data elements applicable to food products offered for importation into the United States, while regulations in §?1.510 govern required records, providing that records be made available to FDA upon request and that records be maintained electronically.
The information collection covers activities attendant to statutory and regulatory requirements applicable to establishing and maintaining FSVP records, including recordkeeping pertaining to the hazard controls set forth in the regulations. We have also established and maintain a web page regarding the FSVP program at https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp, including relevant resources.
The regulations also include requirements pertaining to reporting to Customs and Border Protection (CBP) for subsequent transfer to FDA. The reporting requirements to CBP specify that the information must be provided electronically. The FSVP Importer Portal for FSVP Records Submission allows for importers to upload and submit records electronically, after receiving a written request from FDA. The portal may be found https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download. FDA has issued guidance for industry relating to the Unique Facility Identifier (UFI) requirement for FSVP importers found in §?1.509(a). "Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Program Regulation Guidance for Industry" (March 2017) (see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recognition-acceptable-unique-facility-identifier-ufi-foreign-supplier ) indicates that the Dun & Bradstreet (D&B) Data Universal Number System (DUNS) would be an acceptable UFI for FSVP importers to submit in compliance with §?1.509(a).
Respondents to the information collection are persons who import food into the United States.
In the Federal Register of May 1, 2025 (90 FR 18682), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
| 21 CFR section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| Exemption for Food for research; §?1.501(c) | 36,360 | 40 | 1,454,400 | 0.083 (5 minutes) | 120,715 |
| DUNS number for filing with CBP; §§?1.509(c), 1.511(c), 1.512(b)(2) | 56,800 | 157 | 8,917,600 | 0.02 (1.2 minutes) | 178,352 |
| Total | 299,067 | ||||
| 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. | |||||
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| Activity; 21 CFR section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| Controls for Low Acid Canned Food; §?1.502(b) | 2,443 | 4 | 9,772 | 1 | 9,772 |
| FSVP Recordkeeping including hazard determination, written procedures, reevaluation; audits; and corrective actions | |||||
| Determine and document hazards; §?1.504(a) | 11,701 | 1 | 11,701 | 3.5 | 40,954 |
| Review hazard analysis; §?1.504(d) | 11,701 | 7 | 81,907 | 0.33 (20 minutes) | 27,029 |
| Evaluation of food and foreign supplier; §§?1.505(a)(2), 1.511(c)(1) | 11,701 | 1 | 11,701 | 4 | 46,804 |
| Approval of suppliers; §§?1.505(b), 1.512(c)(1)(iii) | 8,191 | 1 | 8,191 | 12 | 98,292 |
| Reevaluation of food and foreign supplier; §§?1.505(c), 1.512(c)(1)(ii)(A) | 11,701 | 365 | 4,270,865 | 0.25 (15 minutes) | 1,067,716 |
| Confirm or change requirements of foreign supplier verification activity; §§?1.505(c), 1.512(c)(1)(ii)(A) | 2,340 | 1 | 2,340 | 2 | 4,680 |
| Review of other entities assessments; §§?1.505(d), 1.512(c)(1)(iii) | 3,510 | 1 | 3,510 | 1.2 | 4,212 |
| Written procedures for use of approved foreign suppliers; §§?1.506(a)(1), 1.511(c)(2), 1.512(c)(3)(i) | 11,701 | 1 | 11,701 | 8 | 93,608 |
| Review of written procedures; §§?1.506(a)(2), 1.511(c)(2)(ii), 1.512(c)(3)(ii) | 11,701 | 1 | 11,701 | 1 | 11,701 |
| Written procedures for conducting verification activities; §§?1.506(b), 1.511(c)(3) | 11,701 | 1 | 11,701 | 2 | 23,402 |
| Determination and documentation of appropriate supplier verification activities; §§?1.506(d)(1)-(2) 1.511(c)(5)(i) | 11,701 | 4 | 46,804 | 3.25 | 152,113 |
| Review of appropriate supplier verification activities determined by another entity; §§?1.506(d)(3) 1.511(c)(5)(iii) | 11,701 | 2 | 23,402 | 0.33 (20 minutes) | 7,723 |
| Conduct/review audits; §?1.506(e)(1)(i), 1.511(c)(6)(i)(A) | 11,701 | 2 | 23,402 | 3 | 70,206 |
| Conduct periodic sampling/testing; §§?1.506(e)(1)(ii), 1.511(c)(6)(i)(B) | 11,701 | 2 | 23,402 | 1 | 23,402 |
| Review records; §§?1.506(e)(1)(iii), 1.511(c)(6)(i)(C) | 11,701 | 2 | 23,402 | 1.6 | 37,443 |
| Document your review of supplier verification activity records; §§?1.506(e)(3), 1.511(c)(6)(iii) | 11,701 | 6 | 70,206 | 0.25 (15 minutes) | 17,552 |
| §?1.507(a)(1) | 11,701 | 3.17 | 37,092 | 1.25 | 46,365 |
| Written assurances; §§?1.507(a)(2), 1.507(a)(3), and 1.507(a)(4) | 11,701 | 8.72 | 102,033 | 0.5 (30 minutes) | 51,017 |
| Disclosures that accompany assurances; §§?1.507(a)(2), 1.507(a)(3), and 1.507(a)(4) | 102,038 | 1 | 102,038 | 0.5 (30 minutes) | 51,019 |
| Document assurances from customers; §?1.507(c) | 36,522 | 2.8 | 102,262 | 0.25 (15 minutes) | 25,566 |
| Document corrective actions; §§?1.508(a) and 1.512(b)(4) | 2,340 | 1 | 2,340 | 2 | 4,680 |
| Investigate and determine FSVP adequacy; §§?1.508(b), 1.511(c)(1) | 2,340 | 1 | 2,340 | 5 | 11,700 |
| Subtotal for FSVP Recordkeeping Itemized Above | 1,917,184 | ||||
| Written assurances for food produced under dietary supplement CGMPs; §?1.511(b) | 11,701 | 2.88 | 33,699 | 2.25 | 75,823 |
| Document very small importer/certain small foreign supplier status; §?1.512(b)(1) | 50,450 | 1 | 50,450 | 1 | 50,450 |
| Written assurances associated with very small importer/certain small foreign supplier; §?1.512(b)(3) | 50,450 | 2.8 | 141,260 | 2.25 | 317,835 |
| Overall Total | 2,371,064 | ||||
| 1 ?Totals may not sum due to rounding. | |||||
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to the currently approved burden estimate. However, a miscalculation in the burden estimate was identified during a review of the prior renewal and has been corrected.
Dated: July 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-14228 Filed 7-28-25; 8:45 am]
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