Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Food Importers, 53271-53273 [2018-22953]
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
appeared in the Federal Register). FDA
will announce additional modifications
and revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often if necessary.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
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recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
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should contain, at a minimum, the
following information available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123739.htm.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22977 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0143]
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 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 on the information
collection requirements associated with
our Foreign Supplier Verification
Programs (FSVP) for Food Importers.
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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18:12 Oct 19, 2018
Jkt 247001
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before December 21,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 2018.
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–
2011–N–0143 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
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
53271
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.
• 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
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
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. 3501–3520), 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
E:\FR\FM\22OCN1.SGM
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53272
Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
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
OMB Control Number 0910–0752—
Extension
This information collection supports
FDA regulations at 21 CFR part 1,
subpart L—Foreign Supplier
Verification Programs for Food
Importers, as well as associated
guidance. As amended by the FDA Food
Safety Modernization Act (FSMA) (Pub.
L. 111–353), the Federal Food, Drug,
and Cosmetic Act (FD&C Act) enables
the Agency to better protect the public
health by helping to ensure the safety
and security of the food supply. The
regulations are intended to help ensure
that food imported into the United
States is produced in compliance with
specific processes and procedures,
including reasonably appropriate riskbased preventive controls. The
regulations establish that importers of
foods must develop, maintain, and
follow an FSVP that provides adequate
assurances that 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 the
requirements we have developed
Agency guidance, which is available at:
https://www.fda.gov/Food/Guidance
Regulation/FSMA/ucm253380.htm.
We estimate the burden of the
information collection is as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Exemption for food for research 1.501(c) ...................
DUNS number for filing with U.S. Customs and Border Protection 1.509(c), 1.511(c), 1.512(b)(2).
36,360
56,800
40
157
1,454,400
8,917,600
0.083 (5 minutes) ...
0.02 (1.2 minutes) ..
120,715
178,352
Total ......................................................................
........................
........................
........................
................................
299,067
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
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Information collection activity; 21 CFR section
Number of
recordkeepers
Controls for low-acid canned foods; 1.502(b) .............
FSVP Recordkeeping, including hazard determination, written procedures, reevaluation; audits; and
corrective actions:
Determine and document hazards; 1.504(a) .......
Review hazard analysis; 1.504(d) ........................
Evaluation of food and foreign supplier;
1.505(a)(2), 1.511(c)(1).
Approval of suppliers; 1.505(b), 1.512(c)(1)(iii) ...
Reevaluation of food and foreign supplier;
1.505(c), 1.512(c)(1)(ii)(A).
Confirm or change requirements of foreign supplier
verification
activity;
1.505(c),
1.512(c)(1)(ii)(A).
Review of other entities assessments; 1.505(d),
1.512(c)(1)(iii).
Written procedures for use of approved foreign
suppliers;
1.506(a)(1),
1.511(c)(2),
1.512(c)(3)(i).
Review of written procedures; 1.506(a)(2),
1.511(c)(2)(ii), 1.512(c)(3)(ii).
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Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
2,443
4
9,772
1 .............................
9,772
11,701
11,701
11,701
1
7
1
11,701
81,907
11,701
3.5 ..........................
0.33 (20 minutes) ...
4 .............................
40,954
27,029
46,804
8,191
11,701
1
365
8,191
4,270,865
12 ...........................
0.25 (15 minutes) ...
98,292
1,067,716
2,340
1
2,340
2 .............................
4,680
3,510
1
3,510
1.2 ..........................
4,212
11,701
1
11,701
8 .............................
93,608
11,701
1
11,701
1 .............................
11,701
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Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices
53273
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Information collection activity; 21 CFR section
Number of
recordkeepers
Written procedures for conducting verification activities; 1.506(b), 1.511(c)(3).
Determination and documentation of appropriate
supplier verification activities; 1.506(d)(1)–(2),
1.511(c)(5)(i).
Review of appropriate supplier verification activities determined by another entity; 1.506(d)(3),
1.511(c)(5)(iii).
Conduct/review
audits;
1.506(e)(1)(i),
1.511(c)(4)(ii)(A).
Conduct
periodic
sampling/testing;
1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C)
Document your review of supplier verification activity records; 1.506(e)(3), 1.511(c)(4)(iii).
1.507(a)(1) ............................................................
Written assurances; 1.507(a)(2), 1.507(a)(3), and
1.507(a)(4).
Disclosures
that
accompany
assurances;
1.507(a)(2), 1.507(a)(3), and 1.507(a)(4).
Document assurances from customers; 1.507(c)
Document corrective actions; 1.508(a) and
1.512(b)(4).
Investigate and determine FSVP adequacy;
1.508(b), 1.511(c)(1).
Average
burden per
recordkeeping
Total annual
records
Total hours
11,701
1
11,701
2 .............................
23,402
11,701
4
46,804
3.25 ........................
152,113
11,701
2
23,402
0.33 (20 minutes) ...
7,723
11,701
2
23,402
3 .............................
70,206
11,701
2
23,402
1 .............................
23,402
11,701
11,701
2
6
23,402
70,206
1.6 ..........................
0.25 (15 minutes) ..
37,443
17,552
11,701
11,701
3.17
8.72
37,092
102,038
1.25 ........................
0.50 (30 minutes) ...
46,365
51,019
102,038
1
102,038
0.50 (30 minutes) ...
51,019
36,522
2,340
2.8
1
102,262
2,340
0.25 (15 minutes) ..
2 .............................
25,566
4,680
2,340
1
2,340
5 .............................
11,700
Subtotal for FSVP Recordkeeping Itemized
Above.
........................
........................
4,984,046
................................
1,917,186
Written assurances for food produced under dietary supplement current good manufacturing
practices; 1.511(b).
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).
11,701
2.88
33,699
2.25 ........................
75,823
50,450
1
50,450
1 .............................
50,450
50,450
2.8
141,260
2.25 ........................
317,835
........................
........................
........................
................................
2,361,294
Total ......................................................................
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
We are retaining the currently
approved burden estimates. The FSVP
requirements became effective May 30,
2017, and we continue to evaluate
associated burden.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22953 Filed 10–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
Determination of Regulatory Review
Period for Purposes of Patent
Extension; BESPONSA
Food and Drug Administration,
HHS.
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18:12 Oct 19, 2018
Jkt 247001
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for BESPONSA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 21, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
DATES:
[Docket Nos. FDA–2018–E–0675, FDA–
2018–E–0678, and FDA–2018–E–0689]
AGENCY:
ACTION:
PO 00000
Frm 00068
Fmt 4703
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during the regulatory review period by
April 22, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 December 21,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 21, 2018.
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
E:\FR\FM\22OCN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53271-53273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22953]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0143]
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 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 on the information collection requirements
associated with our Foreign Supplier Verification Programs (FSVP) for
Food Importers.
DATES: Submit either electronic or written comments on the collection
of information by December 21, 2018.
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 December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 2018. 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-2011-N-0143 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.
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 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.gpo.gov/fdsys/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.
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. 3501-3520), 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
[[Page 53272]]
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
OMB Control Number 0910-0752--Extension
This information collection supports FDA regulations at 21 CFR part
1, subpart L--Foreign Supplier Verification Programs for Food
Importers, as well as associated guidance. As amended by the FDA Food
Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food,
Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect
the public health by helping to ensure the safety and security of the
food supply. The regulations are intended to help ensure that food
imported into the United States is produced in compliance with specific
processes and procedures, including reasonably appropriate risk-based
preventive controls. The regulations establish that importers of foods
must develop, maintain, and follow an FSVP that provides adequate
assurances that 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 the requirements we have developed
Agency guidance, which is available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.
We estimate the burden of the information collection is as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food for research 1.501(c)..... 36,360 40 1,454,400 0.083 (5 minutes)........................ 120,715
DUNS number for filing with U.S. Customs and 56,800 157 8,917,600 0.02 (1.2 minutes)....................... 178,352
Border Protection 1.509(c), 1.511(c),
1.512(b)(2).
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Total.................................... .............. .............. .............. ......................................... 299,067
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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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
FSVP Recordkeeping, including hazard
determination, written procedures,
reevaluation; audits; and corrective
actions:
Determine and document hazards; 1.504(a). 11,701 1 11,701 3.5...................................... 40,954
Review hazard analysis; 1.504(d)......... 11,701 7 81,907 0.33 (20 minutes)........................ 27,029
Evaluation of food and foreign supplier; 11,701 1 11,701 4........................................ 46,804
1.505(a)(2), 1.511(c)(1).
Approval of suppliers; 1.505(b), 8,191 1 8,191 12....................................... 98,292
1.512(c)(1)(iii).
Reevaluation of food and foreign 11,701 365 4,270,865 0.25 (15 minutes)........................ 1,067,716
supplier; 1.505(c), 1.512(c)(1)(ii)(A).
Confirm or change requirements of foreign 2,340 1 2,340 2........................................ 4,680
supplier verification activity;
1.505(c), 1.512(c)(1)(ii)(A).
Review of other entities assessments; 3,510 1 3,510 1.2...................................... 4,212
1.505(d), 1.512(c)(1)(iii).
Written procedures for use of approved 11,701 1 11,701 8........................................ 93,608
foreign suppliers; 1.506(a)(1),
1.511(c)(2), 1.512(c)(3)(i).
Review of written procedures; 11,701 1 11,701 1........................................ 11,701
1.506(a)(2), 1.511(c)(2)(ii),
1.512(c)(3)(ii).
[[Page 53273]]
Written procedures for conducting 11,701 1 11,701 2........................................ 23,402
verification activities; 1.506(b),
1.511(c)(3).
Determination and documentation of 11,701 4 46,804 3.25..................................... 152,113
appropriate supplier verification
activities; 1.506(d)(1)-(2),
1.511(c)(5)(i).
Review of appropriate supplier 11,701 2 23,402 0.33 (20 minutes)........................ 7,723
verification activities determined by
another entity; 1.506(d)(3),
1.511(c)(5)(iii).
Conduct/review audits; 1.506(e)(1)(i), 11,701 2 23,402 3........................................ 70,206
1.511(c)(4)(ii)(A).
Conduct periodic sampling/testing; 11,701 2 23,402 1........................................ 23,402
1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
Review records; 1.506(e)(1)(iii), 11,701 2 23,402 1.6...................................... 37,443
1.511(c)(4)(ii)(C).
Document your review of supplier 11,701 6 70,206 0.25 (15 minutes)........................ 17,552
verification activity records;
1.506(e)(3), 1.511(c)(4)(iii).
1.507(a)(1).............................. 11,701 3.17 37,092 1.25..................................... 46,365
Written assurances; 1.507(a)(2), 11,701 8.72 102,038 0.50 (30 minutes)........................ 51,019
1.507(a)(3), and 1.507(a)(4).
Disclosures that accompany assurances; 102,038 1 102,038 0.50 (30 minutes)........................ 51,019
1.507(a)(2), 1.507(a)(3), and
1.507(a)(4).
Document assurances from customers; 36,522 2.8 102,262 0.25 (15 minutes)........................ 25,566
1.507(c).
Document corrective actions; 1.508(a) and 2,340 1 2,340 2........................................ 4,680
1.512(b)(4).
Investigate and determine FSVP adequacy; 2,340 1 2,340 5........................................ 11,700
1.508(b), 1.511(c)(1).
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Subtotal for FSVP Recordkeeping .............. .............. 4,984,046 ......................................... 1,917,186
Itemized Above.
==========================================================================================================
Written assurances for food produced 11,701 2.88 33,699 2.25..................................... 75,823
under dietary supplement current good
manufacturing practices; 1.511(b).
Document very small importer/certain 50,450 1 50,450 1........................................ 50,450
small foreign supplier status;
1.512(b)(1).
Written assurances associated with very small 50,450 2.8 141,260 2.25..................................... 317,835
importer/certain small foreign supplier
1.512(b)(3).
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Total.................................... .............. .............. .............. ......................................... 2,361,294
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\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
We are retaining the currently approved burden estimates. The FSVP
requirements became effective May 30, 2017, and we continue to evaluate
associated burden.
Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22953 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P
