
[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54322-54323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1529]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Voluntary Qualified 
Importer Program

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: Submit written comments (including recommendations) on the 
collection of information by September 11, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0840. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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.

Voluntary Qualified Importer Program

OMB Control Number 0910-0840--Extension

    This information collection supports implementation of FDA's 
Voluntary Qualified Importer Program (VQIP), a voluntary fee-based 
program that provides expedited review and import entry of human and 
animal foods into the United States. Program participants may import 
products to the United States with greater speed and predictability, 
avoiding unexpected

[[Page 54323]]

delays at the point of import entry. Importers interested in applying 
can start their application (Form FDA 4041) by submitting a notice of 
intent to participate after setting up an account through the FDA 
Industry Systems (FIS) website at https://www.access.fda.gov, which 
includes a VQIP Portal User Guide. To participate, importers must meet 
eligibility criteria and pay a user fee that covers costs associated 
with FDA's administration of the program. Consistent with section 
743(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 379j-31(b)(1)), FDA annually publishes a schedule of fees 
applicable to VQIP in the Federal Register.
    Respondents to the information collection are persons that bring 
food, or cause food to be brought, from a foreign country into the 
customs territory of the United States (section 806 of the FD&C Act (21 
U.S.C. 384b)) as a VQIP importer. A VQIP importer can be located 
outside the United States. Persons who may be a VQIP importer include 
the manufacturer, owner, consignee, and importer of record of a food, 
provided that the importer can meet all the criteria for participation.
    To assist respondents with the information collection, we developed 
the guidance document entitled ``FDA's Voluntary Qualified Importer 
Program'' (issued November 2016, updated July 2023 to change the 
Paperwork Reduction Act burden statement address), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fdas-voluntary-qualified-importer-program. The 
guidance document is prepared in a question-and-answer format and 
discusses eligibility criteria; includes instruction for completing a 
VQIP application; explains conditions that may result in revocation of 
participation as well as criteria for reinstatement; and communicates 
benefits VQIP importers can expect to receive under the program. The 
guidance also discusses preparation of the ``Quality Assurance Program 
(QAP),'' a compilation of written policies and procedures used to 
ensure adequate control over the safety and security of foods being 
imported. The guidance document was developed and issued consistent 
with FDA good guidance practice regulations in 21 CFR 10.115, which 
provides for public comment at any time.
    In the Federal Register of May 11, 2023 (88 FR 30315), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
Reporting using FIS VQIP portal/     Number of     responses per   Total annual   Average burden    Total hours
          form FDA 4041             respondents     respondent       responses     per response
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Initial VQIP application........               5               1               5             180             900
Application Renewals--subsequent               6               1               6              20             120
 year...........................
Requests for reinstatement......               2               1               2              10              20
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    Total.......................  ..............  ..............  ..............  ..............           1,040
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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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    VQIP participant records                         Number of                    Average burden
  consistent with implementing       Number of      records per    Total annual         per         Total hours
            guidance               recordkeepers   recordkeeper       records      recordkeeping
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Quality Assurance Program (QAP)                5               1               5             160             800
 preparation....................
QAP maintenance and updates.....               6               1               6              16              96
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    Total.......................  ..............  ..............  ..............  ..............             896
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects an 
overall adjustment decrease of 1,844 hours and a corresponding decrease 
of 18 responses. Since our last request for OMB approval of the 
information collection, we have adjusted our estimate of the number of 
respondents based on actual participation in the program. We assume the 
average burden required for the respective reporting and recordkeeping 
activities for both initial and continued participation in the program 
remain constant.

    Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17150 Filed 8-9-23; 8:45 am]
BILLING CODE 4164-01-P


