Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer Program

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Published

May 11, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) 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 information collection associated with FDA's Voluntary Qualified Importer Program.

Full Text

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<title>Federal Register, Volume 88 Issue 91 (Thursday, May 11, 2023)</title>
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[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30315-30316]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) 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 information collection
associated with FDA's Voluntary Qualified Importer Program.

DATES: Either electronic or written comments on the collection of
information must be submitted by July 10, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 10, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-N-1529 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Voluntary Qualified Importer
Program.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.

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#306062716344515656705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="b6e6e4f7e5c2d7d0d0f6d0d2d798dedec598d1d9c0">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 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

[[Page 30316]]

of automated collection techniques, when appropriate, and other forms
of information technology.

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 delays at the point of import entry. Importers
interested in applying can start their application 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 will publish in the Federal Register a
schedule of fees applicable to VQIP.
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, finalized March 2022), 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 part 10.115,
which provides for public comment at any time.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Reporting using FIS VQIP portal Number of responses per Total annual burden per Total hours
respondents respondent responses 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....................... .............. .............. 13 .............. 1040
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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
Consistent with Implementing Number of responses per Total annual burden per Total hours
Guidance respondents respondent responses response
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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....................... .............. .............. 11 .............. 896
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

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, however we invite comment in this regard.

Dated: May 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10053 Filed 5-10-23; 8:45 am]
BILLING CODE 4164-01-P

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