Notice2022-01796
Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers
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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
January 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 on the information collection requirements associated with our Foreign Supplier Verification Programs for Food Importers.
Full Text
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<title>Federal Register, Volume 87 Issue 19 (Friday, January 28, 2022)</title>
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[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4607-4609]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01796]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-5225]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) 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 on the information collection
requirements associated with our Foreign Supplier Verification Programs
for Food Importers.
DATES: Submit either electronic or written comments on the collection
of information by March 29, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 29, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 29, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2017-D-5225 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Foreign Supplier Verification
Programs for Food Importers.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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
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CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#356567746641545353755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="732321322007121515331517125d1b1b005d141c05">[email protected]</span></a>.
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 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), 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 21 CFR 1.501 set forth the
applicability of requirements for FSVP, while regulations in sections
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 section 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. 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>.
We estimate the burden for the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
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.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of
Information collection activity; 21 CFR Number of records per Total annual Average burden per recordkeeping Total hours
section 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: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01796 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P
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