[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30315-30316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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.govinfo.gov/content/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, 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, 
[email protected].

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

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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 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 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 
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 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