Notice2022-07617
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers
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
April 11, 2022
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 87 Issue 69 (Monday, April 11, 2022)</title>
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[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Notices]
[Pages 21126-21127]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals">https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals</a>.
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
<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>.
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.
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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
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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).
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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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