[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Notices]
[Pages 6152-6154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0143]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Foreign Supplier 
Verification Programs for Food Importers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
28, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0752. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Foreign Supplier Verification Programs (FSVP) for Food Importers

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 understanding the regulatory 
requirements, we have developed Agency guidance, which is available at: 
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.
    In the Federal Register of October 22, 2018 (83 FR 53271), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden for the information collection as follows:

[[Page 6153]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                  Number of
              21 CFR section(s)                   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, 1.511, 1.512.
                                              ----------------------------------------------------------------------------------------------------------
    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(s)                    recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.......................................         928,292
     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).
    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).
    Document hazard controls; 1.507(a)(1)....          11,701            3.17          37,092  1.25.....................................          46,365
    Written assurances; 1.507(a)(2), (a)(3),           11,701            8.72         102,038  0.50 (30 minutes)........................          51,019
     and (a)(4).
    Disclosures that accompany assurances;            102,038               1         102,038  0.50 (30 minutes)........................          51,019
     1.507(a)(2), (a)(3), and (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),              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            50,450             2.8         141,260  2.25.....................................         317,835
     small importer/certain small foreign
     supplier 1.512(b)(3).
                                              ----------------------------------------------------------------------------------------------------------

[[Page 6154]]

 
        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: February 21, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03282 Filed 2-25-19; 8:45 am]
BILLING CODE 4164-01-P