[Federal Register Volume 88, Number 91 (Thursday, May 11, 2023)]
[Notices]
[Pages 30315-30316]
[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,<PHONE_NUMBER>.
     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,<PHONE_NUMBER>.

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,<PHONE_NUMBER>,
[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

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
                                 -------------------------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
Quality Assurance Program (QAP)                5               1               5             160             800
 preparation....................
QAP maintenance and updates.....               6               1               6              16              96
                                 -------------------------------------------------------------------------------
    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]
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[Federal Register Volume 87, Number 233 (Tuesday, December 6, 2022)]
[Rules and Regulations]
[Pages 74505-74507]
[FR Doc No: 2022-26458]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1472; Airspace Docket No. 22-AWA-8]
RIN 2120-AA66

Amendment of Class C Airspace; Manchester, NH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Manchester, NH Class C airspace
description to update the Manchester Airport name and airport reference
point (ARP) geographic coordinates to match the FAA's National Airspace
System Resources (NASR) database information. This action also updates
the Nashua Airport name. Additionally, references to the Manchester, NH
(MHT), VHF Omnidirectional Range/Distance Measuring Equipment (VOR/DME)
and Boire Field Airport and their geographical coordinates are added to
the Class C description header. This action does not change the
boundaries, altitudes, or operating requirements of the Class C
airspace area.

DATES: Effective date 0901 UTC, February 23, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it updates the information in the Manchester, NH Class C
airspace description.

History

    During a recent review of the Manchester, NH Class C airspace
description, the FAA identified the need to update the name and ARP
geographic coordinates for the Manchester Airport, and to update the
name of the Nashua Airport, NH. This action also makes administrative
edits to the airspace description header to add the geographic
coordinates for the Boire Field Airport and the Manchester, NH (MHT),
VOR/DME, because these facilities are used in the Class C description.
There are no changes to the boundaries, altitudes, or air traffic
control services resulting from this action.
    Class C airspace areas are published in paragraph 4000 of FAA Order
7400.11G, dated August 19, 2022, and effective September 15, 2022,
which is incorporated by reference in 14 CFR 71.1. The Class C airspace
listed in this document will be published subsequently in FAA Order JO
7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11G, Airspace Designations and
Reporting Points, dated August 19, 2022, and effective September 15,
2022. FAA Order 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11G lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by amending the Manchester, NH
Class C airspace description as published in FAA Order 7400.11G,
Airspace Designations and Reporting Points. The ``Manchester Airport''
name is changed to ``Manchester Boston Regional Airport'', to match the
Airport Master Record database, and the ARP geographic coordinates are
updated from ``lat. 42[deg]56'00'' N, long. 71[deg]26'16'' W'' to
``lat. 42[deg]55'58'' N, long. 71[deg]45'39'' W.'' The ARP geographic
coordinates update is made to match the FAA's National Airspace System
Resource database information. The ``Nashua Airport'' name in the Class
description is updated to ``Boire Field Airport'' to match the Airport
Master Records database. Additionally, administrative edits are made to
the Class C airspace description header by adding the Boire Field
Airport and the Manchester VOR/DME and their geographical coordinates,
which are used in the airspace description.
    This action consists of administrative changes only and does not
affect the boundaries, altitudes, or operating requirements of the
airspace. Therefore, notice and public procedure under 5 U.S.C. 553(b)
is unnecessary.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action making administrative edits
to the Manchester, NH, Class C airspace description qualifies for
categorical exclusion under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points). As such, this action is not expected to result in any
potentially significant environmental impacts. In accordance with FAA
Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the
FAA has reviewed this action for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis. Accordingly, the FAA
has determined that no extraordinary circumstances exist that warrant
preparation of an environmental assessment or environmental impact
study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p.389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, effective September 15, 2022, is amended as follows:

Paragraph 4000 Class C Airspace.

* * * * *

ANE NH C Manchester, NH [Amended]

Manchester Boston Regional Airport, NH
    (Lat. 42[deg]55'58'' N, long. 71[deg]45'39'' W)
Boire Field Airport, Nashua, NH
    (Lat. 42[deg]46'57'' N, long. 71[deg]30'51'' W)
Manchester, NH VOR/DME
    (Lat. 42[deg]52'07'' N, long. 71[deg]22'10'' W)

    That airspace extending upward from the surface to and including
4,300 feet MSL

within a 5-mile radius of the Manchester Boston Regional Airport;
including that airspace extending upward from 2,500 feet MSL to and
including 4,300 feet MSL within a 10-mile radius of the airport;
including that airspace from 1,500 feet MSL between a 5-mile radius
and 10-mile radius south of the airport from Interstate 93 clockwise
to the eastern edge of the 5-mile radius of Boire Field Airport;
including that airspace from 2,000 feet MSL between a 5-mile radius
and 10-mile radius north of the airport from the Manchester, NH VOR/
DME 315[deg] radial clockwise to Interstate 93.

    Issued in Washington, DC, on November 30, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-26458 Filed 12-5-22; 8:45 am]
BILLING CODE 4910-13-P