[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Rules and Regulations]
[Pages 34777-34779]
[FR Doc No: 2022-12364]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2021-N-0600]

Medical Devices; Cardiovascular Devices; Classification of the
Intravascular Bleed Monitor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the intravascular bleed monitor into class II (special controls). The
special controls that apply to the device type are identified in this
order and will be part of the codified language for the intravascular
bleed monitor's classification. We are taking this action because we
have determined that classifying the device into class II (special
controls) will provide a reasonable assurance of safety and
effectiveness of the device. We believe this action will also enhance
patients' access to beneficial innovative devices.

DATES: This order is effective June 8, 2022. The classification was
applicable on March 1, 2019.

FOR FURTHER INFORMATION CONTACT: LT Stephen Browning, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 2106, Silver Spring, MD 20993-0002,
240-402-5241, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the intravascular bleed monitor as
class II (special controls), which we have determined will provide a
reasonable assurance of safety and effectiveness. In addition, we
believe this action will enhance patients' access to beneficial
innovation, in part by placing the device into a lower device class
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate device by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    On April 23, 2018, Saranas, Inc. submitted a request for De Novo
classification of the Early Bird Bleed Monitoring System. FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for

its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on March 1, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
870.1345.\1\ We have named the generic type of device intravascular
bleed monitor, and it is identified as a probe, catheter, or catheter
introducer that measures changes in bioimpedance and uses an algorithm
to detect or monitor progression of potential internal bleeding
complications.
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    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

   Table 1--Intravascular Bleed Monitor Risks and Mitigation Measures
------------------------------------------------------------------------
           Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction..............  Biocompatibility evaluation.
Infection............................  Sterilization validation,
                                        Pyrogenicity testing, Shelf-life
                                        testing, and Labeling.
Blood loss, bleeding, hematoma.......  Human factors testing, Labeling,
                                        Animal performance testing, and
                                        Non-clinical performance
                                        testing.
Embolization (micro or macro) with     Human factors testing, Labeling,
 transient or permanent ischemia.       Animal performance testing, and
                                        Non-clinical performance
                                        testing.
Vascular trauma (i.e., dissection,     Human factors testing, Labeling,
 rupture, perforation, tear, etc.).     Animal performance testing, and
                                        Non-clinical performance
                                        testing.
Electrical shock.....................  Electrical safety testing.
Device failure due to interference     Electromagnetic compatibility
 with other devices.                    (EMC) testing, and Electrical
                                        safety testing.
Device failure due to software         Software verification,
 malfunction.                           validation, and hazard analysis.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. We encourage sponsors to consult
with us if they wish to use a non-animal testing method they believe is
suitable, adequate, validated, and feasible. We will consider if such
an alternative method could be assessed for equivalency to an animal
test method. This device is subject to premarket notification
requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR
part 870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for part 870 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  870.1345 to subpart B to read as follows:

Sec.  870.1345   Intravascular bleed monitor.

    (a) Identification. An intravascular bleed monitor is a probe,
catheter, or catheter introducer that measures changes in bioimpedance
and uses an algorithm to detect or monitor progression of potential
internal bleeding complications.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) In vivo animal performance testing must demonstrate that the
device performs as intended under anticipated conditions of use and
evaluate the following:
    (i) Device performance characteristics;
    (ii) Adverse effects, including gross necropsy and histopathology;
and
    (iii) Device usability, including device preparation, device
handling, and user interface.
    (2) Non-clinical performance testing data must demonstrate that the
device performs as intended under anticipated conditions of use. The
following

performance characteristics must be tested:
    (i) Tensile testing of joints and materials;
    (ii) Mechanical integrity testing;
    (iii) Friction testing;
    (iv) Flush testing;
    (v) Air leakage and liquid leakage testing;
    (vi) Latching and unlatching testing;
    (vii) Kink and bend testing;
    (viii) Insertion force testing;
    (ix) Torque testing;
    (x) Corrosion testing; and
    (xi) Dimensional tolerance testing.
    (3) Performance data must support the sterility and pyrogenicity of
the device components intended to be provided sterile.
    (4) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the identified shelf life.
    (5) The patient contacting components of the device must be
demonstrated to be biocompatible.
    (6) Software verification, validation, and hazard analysis must be
performed.
    (7) Performance data must demonstrate electromagnetic compatibility
(EMC), electrical safety, thermal safety, and mechanical safety.
    (8) Human factors performance evaluation must demonstrate that the
user can correctly use the device, based solely on reading the
directions for use.
    (9) Labeling must include:
    (i) Instructions for use;
    (ii) A shelf life and storage conditions;
    (iii) Compatible procedures;
    (iv) A sizing table; and
    (v) Quantification of blood detected.

    Dated: June 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12364 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 226 (Monday, November 27, 2023)]
[Notices]
[Page 82945]
[FR Doc No: 2023-26066]

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DEPARTMENT OF TRANSPORTATION

[DOT-OST-2023-0157]

Department of Transportation Advisory Committee on Human
Trafficking: Notice of Public Meeting

AGENCY: Office of the Secretary of Transportation, U.S. Department of
Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice announces an in-person meeting of the Department
of Transportation Advisory Committee on Human Trafficking.

DATES: The meeting will be held on December 13, 2023, from 10 a.m. to 4
p.m. EST.

ADDRESSES: The meeting will be held at the U.S. Department of
Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Any
person requiring accessibility accommodations should contact the
Official listed in the next section.

FOR FURTHER INFORMATION CONTACT:  Maha Alkhateeb, Office of
International Transportation and Trade, U.S. Department of
Transportation, at [email protected] or<PHONE_NUMBER>. Also visit
the ACHT website at https://www.transportation.gov/stophumantrafficking/acht.

SUPPLEMENTARY INFORMATION:

I. Background

    ACHT was re-chartered on July 29, 2022, using the Department's
authorities under the Bipartisan Infrastructure Law (BIL) (Pub. L. 117-
58). The ACHT was initially established as mandated by Sec. 5(a) of the
2018 Combating Human Trafficking in Commercial Vehicles Act (Pub. L.
115-99). Sec. 23020 of the BIL requires the Secretary of
Transportation, acting through the ACHT and in coordination with the
Attorney General, to submit a triennial counter-trafficking report with
recommendations for countering human trafficking, an assessment of best
practices by transportation stakeholders, and human trafficking
violations involving commercial motor vehicles.

II. Agenda

    At the December 13, 2023 meeting, the agenda will cover the
following topics:

 Welcome and Introductions
 Survivor Remarks
 Subcommittee Updates
 Public Participation

    A final agenda that includes a virtual participation link will be
posted on the ACHT internet website at https://www.transportation.gov/stophumantrafficking/acht at least one week in advance of the meeting.

III. Public Participation

    The hybrid meeting will be open to the public in-person and
virtually. Members of the public who wish to attend are asked to
register, including name, title, affiliation, and whether they plan to
attend in-person or virtually, to [email protected] by December 5,
2023. Individuals requesting accessibility accommodations, such as sign
language, interpretation, or other ancillary aids, may do so via email
at: [email protected] by December 5, 2023.
    There will be 30 minutes allotted for oral comments from members of
the public joining the meeting. To accommodate as many speakers as
possible, the time for public comments may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, the Office of the Secretary
may conduct a lottery to determine the speakers. Speakers are requested
to submit a written copy of their prepared remarks by 5 p.m. EST on
December 5, 2023, for inclusion in the meeting records and for
circulation to ACHT members. Written comments timely submitted from
those participants not selected to speak will be accepted and
considered as part of the meeting record.
    Persons who wish to submit written comments for consideration by
ACHT during the meeting must submit them no later than 5 p.m. EST on
December 5, 2023, to ensure transmission to ACHT prior to the meeting.
Comments received after that date and time will be distributed to the
members but may not be reviewed prior to the meeting.
    Copies of the meeting minutes will be available on the ACHT
internet website at https://www.transportation.gov/stophumantrafficking/acht.

    Issued in Washington, DC, on November 17, 2023.
Carol Annette Petsonk,
Assistant Secretary, Aviation and International Affairs, U.S.
Department of Transportation.
[FR Doc. 2023-26066 Filed 11-24-23; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register: November 24, 2006 (Volume 71, Number 226)]
[Notices]
[Page 67946-67948]
[DOCID:fr24no06-128]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54769; File No. SR-FICC-2006-10]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change To Amend the Rules of Its
Mortgage-Backed Securities Division Regarding Membership Requirements
for Unregistered Investment Pools

 November 16, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on June 9, 2006, the Fixed
Income Clearing Corporation (``FICC'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change that is
described in Items I, II, and III below, which items have been prepared
primarily by FICC. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested parties.
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    \1\ 15 U.S.C. 78s(b)(1).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FICC is proposing to amend the rules of the Mortgage-Backed
Securities Division (``MBSD'') regarding the membership requirements of
``Unregistered Investment Pools.'' \2\
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    \2\ As noted below, the term ``Unregistered Investment Pool''
would be a newly-defined term in the MBSD's Rules.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FICC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\3\
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    \3\ The Commission has modified the text of the summaries
prepared by FICC.
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(A) Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    FICC is proposing to amend the rules of the MBSD regarding the
membership requirements of ``unregistered investment pools.''
Currently, unregistered investment pools have essentially the same
membership standards as other non-broker MBSD clearing members.\4\ The
size of the unregistered investment pool industry has grown, and
unregistered investment pools and their advisers have become
significant participants in the industry. FICC believes it is necessary
to reexamine its treatment of participants that are unregistered
investment pools and to enhance the clearing membership standards
applicable to these entities.
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    \4\ Currently, a clearing applicant or participant that is an
unregistered investment pool and whose financial statements are
prepared in accordance with U.S. generally accepted accounting
principles (``GAAP'') must satisfy a minimum financial requirement
of $10 million in net assets. In this filing, FICC is making a
technical change to replace the term ``net asset value'' with the
term ``net assets'' to more accurately state the financial
requirement.
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    FICC is proposing to adopt a definition for Unregistered Investment
Pool, which will identify the entities that would become subject to the
proposed enhanced membership requirements for such entities. Under the
proposed rule, an Unregistered Investment Pool is an entity that holds
a pool of securities and/or other assets

that meets the following criteria: (i) It is not registered as an
investment company under the Investment Company Act of 1940, (ii) it
does not register its securities offerings under the Securities Act of
1933, and (iii) it has an investment advisor that is registered with
the Commission under the Investment Advisers Act of 1940, or if the
investment adviser is not registered, the entity has as lock-up period
of two (2) years or greater.
    Under the proposed rule change, entities that meet the definition
of Unregistered Investment Pool will be eligible to apply to become
MBSD clearing participants only if they meet the new membership
criteria set forth below.\5\ The MBSD's current participants that meet
the definition of Unregistered Investment Pool will have one year from
the date of approval of this rule filing in which to conform to the new
minimum financial and qualitative rating requirements.
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    \5\ It is important to note that entities that meet the MBSD's
definition of Unregistered Investment Pool will be treated as such
by the MBSD regardless of whether the entity considers itself to be
an unregistered investment pool.
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    The new membership requirements for Unregistered Investment Pools
are as follows:
    (1) SEC Registration: As stated above, the investment advisor of
the Unregistered Investment Pool must: (i) Be registered with the
Commission under the Investment Advisers Act of 1940 or (ii) if it is
not registered with the Commission, the Unregistered Investment Pool
that the investment adviser advises must have an initial lock-up period
of two (2) years or greater.
    (2) Minimum Net Assets: The Unregistered Investment Pool will be
required to have and maintain net assets of $250 million or greater.\6\
If the Unregistered Investment Pool does not meet the $250 million net
asset requirement, but the Unregistered Investment Pool has net assets
of at least $50 million \7\ or greater, then the Unregistered
Investment Pool will be eligible for MBSD clearing membership if its
investment advisor has assets under management of at least $1.5 billion
and advises an existing MBSD clearing participant.
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    \6\ The $250 million net asset requirement is the requirement
that will be applicable to Unregistered Investment Pools whose
financial statements are prepared in accordance with U.S. GAAP.
Those Unregistered Investment Pools whose financial statements are
prepared using other types of GAAP will be subject to the higher
minimum requirements as determined by Article III, Rule 1, Section 2
of the MBSD's Rules.
    \7\ The $50 million net asset requirement is the requirement
that will be applicable to Unregistered Investment Pools whose
financial statements are prepared in accordance with U.S. GAAP.
Those Unregistered Investment Pools whose financial statements are
prepared using other types of GAAP will be subject to the higher
minimum requirements as determined by Article III, Rule 1, Section 2
of the MBSD's Rules.
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    (3) Qualitative Rating: The MBSD will require an Unregistered
Investment Pool to obtain a minimum required rating of ``above
average'' as a result of an FICC internal qualitative assessment. FICC
believes it is important to consider qualitative factors in order to
assess both Unregistered Investment Pool applicants and members.
    Specifically, staff in the MBSD's Risk Division will determine a
qualitative rating for each Unregistered Investment Pool applicant.
Risk staff will review qualitative ratings of Unregistered Investment
Pool members on an annual basis. The assessment will include
consideration of factors deemed relevant by the Risk Division,
including management, capital, strategy and risk profile, and internal
controls.\8\ The assessment will assess the strengths and weaknesses of
these factors and will assign a qualitative rating to the Unregistered
Investment Pool. In order to qualify for membership, Unregistered
Investment Pools must meet a qualitative rating of at least ``above
average'' as determined by the Risk Division's staff.
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    \8\ Because responsibility for these factors with respect to a
particular Unregistered Investment Pool may fall at the level of the
Unregistered Investment Pool or at the level of the investment
advisor or other third party service provider, or in some
combination of these, Risk staff will perform the assessment for
each factor at the level or levels deemed appropriate.
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    FICC believes that the proposed change is consistent with Section
17A of the Act \9\ and the rules and regulations thereunder applicable
to FICC because it enhances certain membership requirements and as
such, assures the safeguarding of securities and funds which are in the
custody or control of FICC or for which it is responsible.
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    \9\ 15 U.S.C. 78q-1.
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(B) Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

(C) Self-Regulatory Organization's Statement on Comments on the
Proposed Rule Change Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not yet
been solicited or received. FICC will notify the Commission of any
written comments received by FICC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within thirty-five days of the date of publication of this notice
in the Federal Register or within such longer period: (i) As the
Commission may designate up to ninety days of such date if it finds
such longer period to be appropriate and publishes its reasons for so
finding; or (ii) as to which the self-regulatory organization consents,
the Commission will:
    (A) By order approve such proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
) or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-FICC-2006-10 in the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FICC-2006-10. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549. Copies of such filings also

will be available for inspection and copying at the principal office of
FICC and on FICC's Web site, http://www.ficc.com. All comments received will

be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-FICC-2006-10 and should be submitted on
or before December 15, 2006.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-19850 Filed 11-22-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Rules and Regulations]
[Pages 11820-11821]
[FR Doc No: 2017-03542]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-3835; Airspace Docket No. 14-ASW-13]
RIN 2120-AA66

Amendment of Air Traffic Service (ATS) Routes; Southwest Oklahoma

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action modifies 3 VHF Omnidirectional Range (VOR) Federal
airways (V-140, V-272, and V-440) in the vicinity of Sayre, OK. The FAA
is taking this action due to the scheduled decommissioning of the
Sayre, OK, VOR/Tactical Air Navigation (VORTAC) facility that provides
navigation guidance for a portion of the airways listed. This action
enhances the enroute structure within the National Airspace System.

DATES: Effective date 0901 UTC, April 27, 2017. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA, Order 7400.11 and publication of conforming
amendments.

ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace Policy Group,
Office of Airspace Services, 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 would amend the route structure as required to preserve the safe
and efficient flow of air traffic in the vicinity of Sayre, OK.

History

    On October 20, 2015, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) (80 FR 63473), Docket No. FAA-
2015-3835, to amend VOR Federal airways V-140, V-272, and V-440 due to
the scheduled decommissioning of the Sayre VORTAC. Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal. One comment was received.

Discussion of Comments

    The comment received was in regard to navigation aid signal
reception coverage along the proposed realigned airway segments being
sufficient enough for navigation. The commenter noted that low altitude
VORs, like the Sayre and Burns Flat, OK, VORTAC facilities were only
certified to 40 nautical miles (NM). He also stated that the distance
of V-440 between the Sayre and Panhandle, TX, VORTACs was 102 NM and
had already stretched the approved reception of the two VORs from 80 NM
to 102 NM. The commenter offered that moving airway operations from the
Sayre VORTAC to the Burns Flat VORTAC would only increase the reception
distance further and possibly cause loss of navigation reception while
on the airway. He recommended the FAA test the reception along the new
proposed airway and confirm the airway

amendment would have sufficient navigation reception.
    In response to the comment received, the FAA accomplished an
extended service volume (ESV) analysis of the VORTACs supporting all
the proposed amendments and determined that the navigation aid signal
reception along the proposed VOR Federal airway route segments fell
within historical signal reception coverages for the area. FAA flight
check evaluation of the amended route segments confirmed there is
satisfactory navigation aid signal coverage along the new routes.
    VOR Federal airways are published in paragraph 6010 of FAA Order
7400.11A dated August 3, 2016, and effective September 15, 2016, which
is incorporated by reference in 14 CFR 71.1. The VOR Federal airways
listed in this document will be subsequently published in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    The FAA is amending Title 14, Code of Federal Regulations (14 CFR)
part 71 to modify three VOR Federal airways (V-140, V-272, and V-440)
in the vicinity of Sayre, OK, due to the scheduled decommissioning of
the Sayre VORTAC. The route modifications are outlined below.
    V-140: V-140 extends from the Panhandle VORTAC to the Casanova, VA,
VORTAC. The route segment between the Panhandle and Kingfisher, OK,
VORTACs is amended to proceed over the Burns Flat VORTAC.
    V-272: V-272 extends from the Dalhart, TX, VORTAC to the Fort
Smith, AR, VORTAC. The route segment between the Borger and Will Rogers
VORTACs is amended to proceed over the Burns Flat VORTAC.
    V-440: V-440 extends from the Panhandle VORTAC to the Will Rogers
VORTAC. The route segment between the BRISC and CARFF fixes is amended
to proceed over the Burns Flat VORTAC. Additionally, the intersecting
NAVAID radial information used to describe the BRISC fix is updated
using the Panhandle VORTAC 070[deg](T) and Burns Flat VORTAC
288[deg](T) radials and the intersecting NAVAID radial information used
to describe the CARFF fix is updated using the Burns Flat VORTAC
103[deg](T) and Will Rogers VORTAC 248[deg](T) radials.
    All radials in the regulatory text route descriptions below are
stated in True degrees.

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 of modifying three VOR
Federal airways near Sayre, OK qualifies for categorical exclusion
under the National Environmental Policy Act (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 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). Therefore, this
action is not expected to cause any potentially significant
environmental impacts. Also in accordance with FAA Order 1050.1F,
paragraph 5-2 regarding Extraordinary Circumstances, this action has
been reviewed for factors and circumstances in which a normally
categorically excluded action may have a significant environmental
impact requiring further analysis, and it is determined that no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

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 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 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways

* * * * *

V-140 [Amended]

From Panhandle, TX; Burns Flat, OK; Kingfisher, OK; INT Kingfisher
072[deg] and Tulsa, OK, 261[deg] radials; Tulsa; Razorback, AR;
Harrison, AR; Walnut Ridge, AR; Dyersburg, TN; Nashville, TN;
Livingston, TN; London, KY; Hazard, KY; Bluefield, WV; INT Bluefield
071[deg] and Montebello, VA, 250[deg] radials; Montebello; to
Casanova, VA.
* * * * *

V-272 [Amended]

From Dalhart, TX; Borger, TX; Burns Flat, OK; Will Rogers, OK; INT
Will Rogers 113[deg] and McAlester, OK, 286[deg] radials; McAlester;
to Fort Smith, AR.
* * * * *

V-440 [Amended]

From Panhandle, TX; INT Panhandle 070[deg] and Burns Flat, OK,
288[deg] radials; Burns Flat; INT Burns Flat 103[deg] and Will
Rogers, OK, 248[deg] radials; to Will Rogers.
* * * * *

    Issued in Washington, DC, on February 16, 2017.
Leslie M. Swann,
Acting Manager, Airspace Policy Group.
[FR Doc. 2017-03542 Filed 2-24-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)]
[Rules and Regulations]
[Pages 26597-26598]
[FR Doc No: 2018-12303]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[Docket No. EPA-R02-OAR-2018-0197; FRL-9978-07--Region 2]

Adequacy Status of Motor Vehicle Emissions Budgets for the New
York Portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT,
2008 8-Hour Ozone Nonattainment Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of adequacy.

-----------------------------------------------------------------------

SUMMARY: In this document, the Environmental Protection Agency (``EPA''
or ``Agency'') is notifying the public that the Agency has found that
the 2017 motor vehicle emissions budgets (``budgets'') for volatile
organic compounds (``VOCs'') and nitrogen oxides (``NOX'')
submitted by the New York State Department of Environmental
Conservation for the 2008 national ambient air quality standard
(``NAAQS'') for ozone are adequate for transportation conformity
purposes for the New York portions of the New York-Northern New Jersey-
Long Island, NY-NJ-CT 8-hour ozone nonattainment area. The
transportation conformity rule requires that the EPA

conduct a public process and make an affirmative decision on the
adequacy of these budgets before they can be used by metropolitan
planning organizations in conformity determinations. As a result of
this finding, upon the effective date of this notification of adequacy,
the New York Metropolitan Transportation Council must use these budgets
in future transportation conformity determinations. The budgets are
contained in New York's November 10, 2017, state implementation plan
submittal for the 2008 ozone NAAQS and are associated with the
reasonable further progress milestone demonstration.

DATES: This finding is effective June 25, 2018.

FOR FURTHER INFORMATION CONTACT: Hannah Greenberg, Environmental
Protection Agency Region 2, Air Programs Branch, 290 Broadway, 25th
Floor, New York, New York 10007-1866;<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we,''
``us,'' or ``our'' is used, we mean the EPA.
    This document is simply an announcement of a finding that we have
already made. EPA Region 2 sent a letter to the New York State
Department of Environmental Conservation on April 19, 2018, stating
that the 2017 motor vehicle emissions budgets (``budgets'') in the
submitted state implementation plan (``SIP'') for the 2008 national
ambient air quality standard for ozone for the New York portions of the
New York-Northern New Jersey-Long Island 8-hour ozone nonattainment
area are adequate for transportation conformity purposes. These budgets
are associated with the SIP's reasonable further progress milestone
demonstration and must apply to future transportation conformity
determinations conducted by the New York Metropolitan Transportation
Council (``NYMTC'').
    On November 10, 2017, the New York State Department of
Environmental Conservation submitted a SIP revision for the New York
portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT, 2008
8-hour ozone nonattainment area. This revision to the SIP included 2017
summer day volatile organic compound (``VOC'') and nitrogen oxides
(``NOX'') motor vehicle emissions budgets associated with
the SIP's reasonable further progress demonstration. We announced
availability of the plan and related budgets on the EPA's
transportation conformity website on December 6, 2017, requesting
comments by January 5, 2018. We received no comments in response to the
adequacy review posting.
    This finding will also be available at the EPA's conformity
website: https://www.epa.gov/state-and-local-transportation/conformity-adequacy-review-region-2.
    The motor vehicle emissions budgets are provided in Table 1 below.

         Table 1--2017 Motor Vehicle Emissions Budgets for NYMTC
                             [Tons per year]
------------------------------------------------------------------------
                        Year                             VOC       NOX
------------------------------------------------------------------------
2017................................................    65.69    117.21
------------------------------------------------------------------------

    Transportation conformity is required by Clean Air Act section
176(c). The EPA's conformity rule requires that long-range
transportation plans, transportation improvement programs, and
transportation projects conform to a state's air quality SIP and
establishes the criteria and procedures for determining whether or not
they conform. Conformity to a SIP means that transportation activities
will not produce new air quality violations, worsen existing
violations, or delay timely attainment of the NAAQS.
    The criteria the EPA uses to determine whether a SIP's motor
vehicle emission budgets are adequate for conformity purposes are
outlined in 40 CFR 93.118(e)(4). We have further described our process
for determining the adequacy of submitted SIP budgets in 40 CFR
93.118(f), and we followed this rule in making our adequacy
determination. Please note that an adequacy review is separate from the
EPA's completeness review and should not be used to prejudge the EPA's
ultimate action on the SIP. Even if we find a budget adequate, the SIP
could later be disapproved.
    Pursuant to 40 CFR 93.104(e), within 2 years of the effective date
of this document, NYMTC and the U.S. Department of Transportation will
need to demonstrate conformity to the new budgets. For demonstrating
conformity to the budgets in this plan, the on-road motor vehicle
emissions from implementation of the long-range transportation plan
should be projected consistently with the budgets in this plan.

    Authority:  42 U.S.C. 7401-7671 q.

    Dated: April 30, 2018.
Peter D. Lopez,
Regional Administrator, Region 2.
[FR Doc. 2018-12303 Filed 6-7-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Page 28541]
[FR Doc No: 2023-09488]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Staff Attendance at North American Electric Reliability
Corporation Meetings

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission and/or Commission staff may attend the
following meetings:

North American Electric Reliability Corporation Project 2022-04 EMT
Modeling SAR Drafting Team Meeting
    May 1, 2023 [bond] 3:00 p.m.-5:00 p.m. Eastern
North American Electric Reliability Corporation System Planning Impacts
from DERs Working Group (SPIDERWG) Meeting
    May 2, 2023 [bond] 1:00 p.m.-5:00 p.m. Eastern
    May 3, 2023 [bond] 1:00 p.m.-5:00 p.m. Eastern
North American Electric Reliability Corporation Member Representatives
Committee Meeting
    May 10, 2023 [bond] 4:00 p.m.-6:00 p.m. Eastern
North American Electric Reliability Corporation Board of Trustees
Meeting
    May 11, 2023 [bond] 10:00 a.m.-12:00 p.m. Mountain

    Further information regarding these meetings may be found at:
http://www.nerc.com/Pages/Calendar.aspx.
    The discussions at the meetings, which are open to the public, may
address matters at issue in the following Commission proceedings:

Docket Nos....................  RD22-4-000.......  Registration of
                                RD22-4-001.......   Inverter-Based
                                                    Resources.
                                RD23-1-000.......  Cold Weather
                                RD23-1-001.......   Reliability
                                                    Standards.

    For further information, please contact Leigh Anne Faugust (202)
502-6396 or [email protected].

    Dated: April 28, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-09488 Filed 5-3-23; 8:45 am]
BILLING CODE 6717-01-P