Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers, 4607-4609 [2022-01796]
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Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
access by user authentication controls,
intrusion detection, and firewalls.
Routine system security scans are run to
detect web and architecture
vulnerabilities.
• Physical Safeguards: The facility
housing OCC information systems is a
secure data center and can only be
accessed by authorized infrastructure
staff from HHS and NIH. The facility
maintains fire suppression and
detection devices/systems (e.g.,
sprinkler systems, handheld fire
extinguishers, fixed fire hoses, and/or
smoke detectors) that are activated in
the event of a fire. Servers and other
computer equipment used to process
identifiable data are located in secured
areas and use physical access devices
(e.g., keys, locks, combinations, and
card readers) and/or security guards to
control entries into the facility.
RECORD ACCESS PROCEDURES:
An individual seeking access to
records about him or her in this system
of records must submit a written request
to the System Manager/Policy
Coordinating Official at the address
specified in the ‘‘System Manager’’
section above. The requester must verify
his or her identity by providing either
a notarization of the request or a written
certification that the requester is who or
she claims to be and understands that
the knowing and willful request for
access to a record pertaining to an
individual from an agency under false
pretenses is a criminal offense under the
Privacy Act, subject to a fine of up to
five thousand dollars. Requesters may
also ask for an accounting of disclosures
that have been made of their records, if
any.
jspears on DSK121TN23PROD with NOTICES1
CONTESTING RECORD PROCEDURES:
An individual seeking to amend a
record about him or her in this system
of records must submit a written request
to the System Manager indicated above,
verify his or her identity in the same
manner as is required for an access
request, and reasonably identify the
record and specify the information
being contested, the corrective action
sought, and the reasons for requesting
the correction, along with any
supporting documentation. The right to
contest records is limited to information
that is incomplete, incorrect, untimely,
or irrelevant.
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains records
about him or her must submit a written
request to the System Manager indicated
above, and must verify his or her
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
identity in the same manner as is
required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
80 FR 17893 (Apr. 2, 2015), 83 FR
6591 (Feb. 14, 2018).
[FR Doc. 2022–01771 Filed 1–27–22; 8:45 am]
BILLING CODE 4184–81–P
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.
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 https://www.regulations.gov
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.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
4607
• 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–
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 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
E:\FR\FM\28JAN1.SGM
28JAN1
4608
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
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
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-201509-18/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, PRAStaff@
fda.hhs.gov.
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 riskbased 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-safetymodernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programsfsvp-importers-food-humans-andanimals.
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 https://www.access.fda.gov/,
and a user guide is available at https://
www.fda.gov/media/148312/download.
We estimate the burden for the
information collection as follows:
jspears on DSK121TN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Exemption for food for research; 1.501(c) ...............
Identifier for filing with U.S. Customs and Border
Protection; 1.509.
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
PO 00000
Number of
responses per
respondent
36,360
56,800
Frm 00057
Fmt 4703
40
157
Sfmt 4703
Total annual
responses
1,454,400
8,917,600
E:\FR\FM\28JAN1.SGM
Average
burden per
response
0.083 (5 minutes) ......
0.02 (1.2 minutes) .....
28JAN1
Total hours
120,715
178,352
Federal Register / Vol. 87, No. 19 / Friday, January 28, 2022 / Notices
4609
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section
Total ..................................................................
1 There
Number of
respondents
Number of
responses per
respondent
........................
........................
Average
burden per
response
Total annual
responses
10,372,000
....................................
Total hours
299,067
are no capital costs or operating and maintenance costs associated with the information collection.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
Information collection activity; 21 CFR section
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
Controls for low-acid canned foods; 1.502(b) .........
Hazard determinations, controls, and audits; 1.504,
1.506, 1.511.
Written assurances for food produced under dietary supplement current good manufacturing
practices; 1.511.
Document very small importer/certain small foreign
supplier status; 1.512(b)(1).
Written assurances associated with very small importer/certain small foreign supplier; 1.512(b)(3).
2,443
56,800
4
87.74
9,772
4,984,036
1 ................................
0.38 (23 minutes) ......
9,772
1,917,174
11,701
2.88
33,664
2.25 ...........................
75,744
50,450
1
50,450
1 ................................
50,450
50,450
2.79
141,084
2.25 ...........................
317,439
Total ..................................................................
........................
........................
5,219,006
....................................
2,370,579
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
have been rounded to the nearest one hundredth.
2 Figures
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0370]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Export of Medical
Devices; Foreign Letters of Approval
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:03 Jan 27, 2022
Jkt 256001
solicits comments on reporting
requirements for firms that intend to
export certain unapproved medical
devices.
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 https://www.regulations.gov
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:
• 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
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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–
2013–N–0370 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Export of
Medical Devices; Foreign Letters of
Approval.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
E:\FR\FM\28JAN1.SGM
28JAN1
]]>Agencies
[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4607-4609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01796]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
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-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 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
[[Page 4608]]
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 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 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: 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 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 https://www.access.fda.gov/, and a user guide is available at https://www.fda.gov/media/148312/download.
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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[[Page 4609]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
