Notice2023-17150
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Qualified Importer Program
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 10, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 153 (Thursday, August 10, 2023)</title>
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[Federal Register Volume 88, Number 153 (Thursday, August 10, 2023)]
[Notices]
[Pages 54322-54323]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#07575546547366616147616366296f6f7429606871"><span class="__cf_email__" data-cfemail="c595978496b1a4a3a385a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
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 <a href="https://www.access.fda.gov">https://www.access.fda.gov</a>, 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fdas-voluntary-qualified-importer-program">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fdas-voluntary-qualified-importer-program</a>. 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
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