[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]


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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.

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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\
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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
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).
                                              ----------------------------------------------------------------------------------------------------------
    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).
                                              ----------------------------------------------------------------------------------------------------------
        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).
                                              ----------------------------------------------------------------------------------------------------------
    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