Notice2025-14228
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 143 (Tuesday, July 29, 2025)</title>
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[Federal Register Volume 90, Number 143 (Tuesday, July 29, 2025)]
[Notices]
[Pages 35695-35697]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14228]
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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.
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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 August 28, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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
[[Page 35696]]
the FDA docket number found in brackets in the heading of this
document.
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,
<a href="/cdn-cgi/l/email-protection#207072617354414646604644410e4848530e474f56"><span class="__cf_email__" data-cfemail="e6b6b4a7b592878080a6808287c88e8e95c8818990">[email protected]</span></a>.
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 Sec. 1.501 set forth the applicability of requirements
for FSVP, while regulations in Sec. Sec. 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 Sec. 1.509
identify required data elements applicable to food products offered for
importation into the United States, while regulations in Sec. 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 <a href="https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp">https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp</a>, 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 <a href="https://www.access.fda.gov/">https://www.access.fda.gov/</a>, and a user guide is available
at <a href="https://www.fda.gov/media/148312/download">https://www.fda.gov/media/148312/download</a>. FDA has issued guidance
for industry relating to the Unique Facility Identifier (UFI)
requirement for FSVP importers found in Sec. 1.509(a). ``Recognition
of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier
Verification Program Regulation Guidance for Industry'' (March 2017)
(see <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recognition-acceptable-unique-facility-identifier-ufi-foreign-supplier">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recognition-acceptable-unique-facility-identifier-ufi-foreign-supplier</a>) 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 Sec. 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:
Table 1--Estimated Annual Reporting Burden \1\ \2\
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Number of Total
21 CFR section Number of responses per annual Average burden per response Total
respondents respondent responses hours
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Exemption for Food for research; Sec. 1.501(c) 36,360 40 1,454,400 0.083 (5 minutes)............................ 120,715
DUNS number for filing with CBP; Sec. Sec. 56,800 157 8,917,600 0.02 (1.2 minutes)........................... 178,352
1.509(c), 1.511(c), 1.512(b)(2).
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Total....................................... ............... .............. .......... ............................................. 299,067
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\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.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Total
Activity; 21 CFR section Number of records per annual Average burden per Total
recordkeepers recordkeeper records recordkeeping hours
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Controls for Low Acid Canned 2,443 4 9,772 1......................... 9,772
Food; Sec. 1.502(b).
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FSVP Recordkeeping including hazard determination, written procedures, reevaluation; audits; and corrective
actions
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Determine and document 11,701 1 11,701 3.5....................... 40,954
hazards; Sec. 1.504(a).
Review hazard analysis; Sec. 11,701 7 81,907 0.33 (20 minutes)......... 27,029
1.504(d).
Evaluation of food and 11,701 1 11,701 4......................... 46,804
foreign supplier; Sec.
Sec. 1.505(a)(2),
1.511(c)(1).
Approval of suppliers; Sec. 8,191 1 8,191 12........................ 98,292
Sec. 1.505(b),
1.512(c)(1)(iii).
Reevaluation of food and 11,701 365 4,270,865 0.25 (15 minutes)......... 1,067,716
foreign supplier; Sec.
Sec. 1.505(c),
1.512(c)(1)(ii)(A).
Confirm or change 2,340 1 2,340 2......................... 4,680
requirements of foreign
supplier verification
activity; Sec. Sec.
1.505(c),
1.512(c)(1)(ii)(A).
Review of other entities 3,510 1 3,510 1.2....................... 4,212
assessments; Sec. Sec.
1.505(d), 1.512(c)(1)(iii).
Written procedures for use 11,701 1 11,701 8......................... 93,608
of approved foreign
suppliers; Sec. Sec.
1.506(a)(1), 1.511(c)(2),
1.512(c)(3)(i).
Review of written 11,701 1 11,701 1......................... 11,701
procedures; Sec. Sec.
1.506(a)(2),
1.511(c)(2)(ii),
1.512(c)(3)(ii).
Written procedures for 11,701 1 11,701 2......................... 23,402
conducting verification
activities; Sec. Sec.
1.506(b), 1.511(c)(3).
Determination and 11,701 4 46,804 3.25...................... 152,113
documentation of
appropriate supplier
verification activities;
Sec. Sec. 1.506(d)(1)-
(2) 1.511(c)(5)(i).
[[Page 35697]]
Review of appropriate 11,701 2 23,402 0.33 (20 minutes)......... 7,723
supplier verification
activities determined by
another entity; Sec. Sec.
1.506(d)(3)
1.511(c)(5)(iii).
Conduct/review audits; Sec. 11,701 2 23,402 3......................... 70,206
1.506(e)(1)(i),
1.511(c)(6)(i)(A).
Conduct periodic sampling/ 11,701 2 23,402 1......................... 23,402
testing; Sec. Sec.
1.506(e)(1)(ii),
1.511(c)(6)(i)(B).
Review records; Sec. Sec. 11,701 2 23,402 1.6....................... 37,443
1.506(e)(1)(iii),
1.511(c)(6)(i)(C).
Document your review of 11,701 6 70,206 0.25 (15 minutes)......... 17,552
supplier verification
activity records; Sec.
Sec. 1.506(e)(3),
1.511(c)(6)(iii).
Sec. 1.507(a)(1).......... 11,701 3.17 37,092 1.25...................... 46,365
Written assurances; Sec. 11,701 8.72 102,033 0.5 (30 minutes).......... 51,017
Sec. 1.507(a)(2),
1.507(a)(3), and
1.507(a)(4).
Disclosures that accompany 102,038 1 102,038 0.5 (30 minutes).......... 51,019
assurances; Sec. Sec.
1.507(a)(2), 1.507(a)(3),
and 1.507(a)(4).
Document assurances from 36,522 2.8 102,262 0.25 (15 minutes)......... 25,566
customers; Sec. 1.507(c).
Document corrective actions; 2,340 1 2,340 2......................... 4,680
Sec. Sec. 1.508(a) and
1.512(b)(4).
Investigate and determine 2,340 1 2,340 5......................... 11,700
FSVP adequacy; Sec. Sec.
1.508(b), 1.511(c)(1).
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Subtotal for FSVP .............. .............. .......... .......................... 1,917,184
Recordkeeping Itemized
Above.
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Written assurances for food 11,701 2.88 33,699 2.25...................... 75,823
produced under dietary
supplement CGMPs; Sec.
1.511(b).
Document very small importer/ 50,450 1 50,450 1......................... 50,450
certain small foreign
supplier status; Sec.
1.512(b)(1).
Written assurances 50,450 2.8 141,260 2.25...................... 317,835
associated with very small
importer/certain small
foreign supplier; Sec.
1.512(b)(3).
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Overall Total........... .............. .............. .......... .......................... 2,371,064
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\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]
BILLING CODE 4164-01-P
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