[Federal Register Volume 90, Number 83 (Thursday, May 1, 2025)]
[Notices]
[Pages 18682-18685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-07592]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0349]
Agency Information Collection Activities; Proposed Collection;
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 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 of FDA's Foreign Supplier Verification
Programs (FSVP) for Importers of Food for Humans and Animals.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 30, 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 June 30, 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:
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-0349 for '' Foreign Supplier Verification Programs (FSVP)
for Importers of Food for Humans and Animals.'' 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
[[Page 18683]]
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,
[email protected].
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.
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 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 Sec. 1.509(a). ``Recognition
of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier
Verification Program Regulation Guidance for Industry'' (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 Sec. 1.509(a).
Respondents to the information collection are persons who import
food into the United States.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden1 2
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Number of Total
21 CFR section Number of responses per annual Average burden per Total
respondents respondent responses response hours
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Exemption for Food for 36,360 40 1,454,400 0.083 (5 minutes)......... 120,715
research; Sec. 1.501(c).
DUNS number for filing with 56,800 157 8,917,600 0.02 (1.2 minutes)........ 178,352
CBP; Sec. Sec. 1.509(c),
1.511(c), 1.512(b)(2).
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[[Page 18684]]
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 Number of Total
Activity; 21 CFR section record records per annual Average burden per Total
keepers 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).
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 37,082 1.25...................... 46,353
Written assurances; Sec. 11,701 8.72 102,038 0.5 (30 minutes).......... 51,019
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 .............. .............. 4,984,036 .......................... 1,917,174
Recordkeeping Itemized
Above.
Written assurances for food 11,701 2.88 33,664 2.25...................... 75,744
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 2.8 141,084 2.25...................... 317,439
associated with very
small importer/certain
small foreign supplier;
Sec. 1.512(b)(3).
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Total................... .............. .............. .......... .......................... 2,370,579
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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.
[[Page 18685]]
Dated: April 24, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-07592 Filed 4-30-25; 8:45 am]
BILLING CODE 4164-01-P