[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21126-21127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5225]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Foreign Supplier 
Verification Programs for Food Importers

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: Fax written comments on the collection of information by May 11, 
2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#e58a8c9784ba969087888c96968c8a8ba58a8887cb808a95cb828a93"><span class="__cf_email__" data-cfemail="4f20263d2e103c3a2d22263c3c2620210f20222d612a203f61282039">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0752. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-45, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#dd8d8f9c8ea9bcbbbb9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="a8f8fae9fbdcc9cecee8ceccc986c0c0db86cfc7de">[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 Food Importers--21 
CFR Part 1, Subpart L

OMB Control Number 0910-0752--Extension

    This information collection supports FDA regulations in 21 CFR part 
1, subpart L (21 CFR 1.500 through 1.514 (Sec. Sec.  1.500 through 
(Sec. Sec.  1.514)), which help to implement section 805 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a). Section 805 
authorizes the Agency's FSVP and establishes requirements applicable to 
imported food. Respondents to the information collection are importers, 
as defined in section 805(a)(1) of the FD&C Act. The regulations are 
intended to provide verification that imported food is produced in 
compliance with statutory requirements that include the implementation 
of appropriate risk-based preventive controls. The regulations also 
establish that importers of foods must develop, maintain, and follow an 
FSVP that provides adequate assurances a foreign supplier is producing 
the food in compliance with processes and procedures that provide at 
least the same level of public health protection as those required 
under section 418 of the FD&C Act (21 U.S.C. 350g) (regarding hazard 
analysis and risk-based preventive controls for certain foods) or 419 
(21 U.S.C. 350h) (regarding standards for produce safety), if either is 
applicable, and the implementing regulations, and is producing the food 
in compliance with sections 402 (21 U.S.C. 342) (regarding 
adulteration) and 403(w) (21 U.S.C. 343(w)) (if applicable) (regarding 
misbranding with respect to labeling for the presence of major food 
allergens) of the FD&C Act. The regulations also provide for certain 
exemptions. To assist respondents with understanding the requirements 
we have developed Agency guidance, available at: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
    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. On May 10, 2021, FDA launched the FSVP 
Importer Portal for FSVP Records Submission as a means for importers to 
upload FSVP records electronically and submit them to the Agency, after 
receiving a request for records from FDA. The portal may be found at 
https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download.
    In the Federal Register of January 28, 2022 (87 FR 4607), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
          Activity; 21 CFR section               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Exemption for food for research; 1.501(c)...          36,360              40       1,454,400  0.083 (5 minutes).........................         120,715
Identifier for filing with U.S. Customs and           56,800             157       8,917,600  0.02 (1.2 minutes)........................         178,352
 Border Protection; 1.509.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............      10,372,000  ..........................................         299,067
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.


[[Page 21127]]


                                                 Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                                 Number of
          Activity; 21 CFR section               Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls for low-acid canned foods; 1.502(b)           2,443               4           9,772  1.........................................           9,772
Hazard determinations, controls, and audits;          56,800           87.74       4,984,036  0.38 (23 minutes).........................       1,917,174
 1.504, 1.506, 1.511.
Written assurances for food produced under            11,701            2.88          33,664  2.25......................................          75,744
 dietary supplement current good
 manufacturing practices; 1.511.
Document very small importer/certain small            50,450               1          50,450  1.........................................          50,450
 foreign supplier status; 1.512(b)(1).
Written assurances associated with very               50,450            2.79         141,084  2.25......................................         317,439
 small importer/certain small foreign
 supplier; 1.512(b)(3).
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............       5,219,006  ..........................................       2,370,579
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
\2\ Figures have been rounded to the nearest one hundredth.

    Upon evaluation of the information collection, we are retaining the 
currently approved burden estimates.

    Dated: April 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-07617 Filed 4-8-22; 8:45 am]
BILLING CODE 4164-01-P


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