        Email Exchanges and Meeting Invitations on Contingency Measures

The attached documents include email exchanges and meeting invitations between EPA and Colorado regarding the topic of contingency measures.

 Email from Abby Fulton, EPA (Feb. 1, 2021) (forwarding Sierra Club decision). Attachment:
 CAA Court Decision (2015 Ozone SRR) Email 020212021.pdf

 Email from Abby Fulton (May 6, 2021 (subject "Follow Up on Contingency Measure Percent Reduction Requirements and Control Measures Triggered Upon Failure to Attain"). Attachment:
 Follow Up on Contingency Measure Percent Reduction Email 05062021.pdf

 Email from Abby Fulton, with others in thread (Feb. 1, 2021) (subject "RE: EPA/APCD/RAQC Coordination") (agreeing to discuss Sierra Club as pertaining to contingency measures with CDPHE). Attachment:
 RE_ EPA_APCD_RAQC Coordination Email 02012021.pdf

 Email from Abby Fulton, with others in thread (June 8, 2021) (subject "RE: Contingency Measures Follow_Up and Meeting Request"): Attachment:
 RE_ Contingency Measures Follow_Up and Meeting Request Email 06082021.pdf

 Meeting invitation, subject "Contingency Measures Follow-Up" (July 20, 2021). Attachment:
 Contingency Measures Follow-Up.pdf

 Meeting invitation, subject "EPA/APCD/RACQ coordination" (March 15, 2023) (with agenda item including "update contingency measures"). Attachment:
 Updated invitation with note_ EPA_APCD_RACQ coordination @ Wed Mar 15, 202.pdf

 Email from Abby Fulton (March 17, 2023) (forwarding new draft guidance on approaches to meeting contingency measures requirements while complying with CAA as courts have interpreted it). Attachment:
 Contingency Measures Guidance Release and Additional Updates Email 03172023.pdf

This document was created on October 21, 2023, for posting to the "Supporting & Related Material" section of docket EPA-R08-OAR-2023-0272.


[Federal Register Volume 84, Number 53 (Tuesday, March 19, 2019)]
[Notices]
[Pages 10056-10057]
[FR Doc No: 2019-05049]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2814-025]

Great Falls Hydroelectric Company; Notice of Application Tendered
for Filing With The Commission and Soliciting Additional Study Requests
and Establishing Procedural Schedule for Relicensing and a Deadline for
Submission of Final Amendments

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2814-025.
    c. Date Filed: February 28, 2019.
    d. Applicant: Great Falls Hydroelectric Company and the City of
Paterson, New Jersey, as co-licensees.
    e. Name of Project: Great Falls Hydroelectric Project.
    f. Location: On the Passaic River, near the City of Paterson,
Passaic County, New Jersey. The project does not occupy federal land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825 (r).
    h. Applicant Contact: Mr. Robert Gates, Senior Vice President of
Operations, Eagle Creek Renewable Energy, 65 Madison Avenue, Suite 500,
Morristown, NJ 07960;<PHONE_NUMBER><EMAIL_ADDRESS>and/or Ben-David Seligman, 2nd Assistant Corp. Counsel, City of
Paterson, 155 Market Street, Paterson, NJ;<PHONE_NUMBER>; email_
<EMAIL_ADDRESS>    i. FERC Contact: Christopher Millard at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: April 29, 2019.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202)
502-8659 (TTY). In lieu of electronic filing, please send a paper copy
to: Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Washington, DC 20426. The first page of any filing should include
docket number P-2814-025.
    m. This application is not ready for environmental analysis at this
time.
    n. The existing project works consist of: (1) The Society for the
Establishment of Useful Manufactures dam, an overflow granite stone
gravity structure about 315 feet long, with a maximum height of 15 feet
and having a crest elevation of 114.6 feet mean sea level (msl); (2) a
reservoir with a surface area of 202 acres and a storage capacity of
1,415 acre-feet at elevation 114.6 feet msl; (3) a forebay inlet
structure; (4) a headgate control structure containing three trashracks
and three steel gates; (5) three penstocks, each 8.5 feet in diameter
and approximately 55 feet long; (6) a powerhouse containing three
turbine-generator units with a total rated capacity of 10.95 megawatts;
(7) a 37-foot-long 4.16-kilovolt (kV) underground transmission line
connecting the powerhouse to a 4.16/26.4-kV step-up transformer which
in turn is connected to a 26.4-kV

transmission grid via an approximately 30-foot-long 26.4-kV underground
transmission line; (8) and appurtenant facilities.
    The Great Falls Project is operated in a run-of-river mode. For the
period 2010 through 2018, the average annual generation at the Great
Falls Project was 17,484 megawatt-hours.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural schedule and final amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate.

Issue Deficiency Letter (if necessary)..  April 2019.
Request Additional Information..........  April 2019.
Issue Acceptance Letter.................  July 2019.
Issue Scoping Document 1 for comments...  August 2019.
Request Additional Information (if        October 2019.
 necessary).
Issue Scoping Document 2................  November 2019.
Issue notice of ready for environmental   November 2019.
 analysis.
Commission issues EA....................  May 2020.
Comments on EA..........................  June 2020.

    q. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: March 11, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-05049 Filed 3-18-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Rules and Regulations]
[Pages 64382-64384]
[FR Doc No: 2022-22724]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0554; FRL-9187-02-R4]

Air Plan Approval; North Carolina; Miscellaneous Emission Control
Standards Rule Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is finalizing the
approval of changes to the North Carolina State Implementation Plan
(SIP), submitted by the State of North Carolina through the North
Carolina Department of Environmental Quality (NCDEQ), Division of Air
Quality (DAQ), through a letter dated April 13, 2021. This SIP revision
includes changes to a subset of NCDEQ's regulations regarding emission
control standards. EPA is approving these changes pursuant to the Clean
Air Act (CAA or Act).

DATES: This rule is effective November 25, 2022.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2021-0554. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sarah LaRocca, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, Region 4, U.S. Environmental Protection Agency, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. The telephone number is
(404) 562-8994. Ms. LaRocca can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    EPA is approving certain changes to North Carolina's SIP that were
provided to EPA by NCDEQ via a letter dated April 13, 2021, and are
related to North Carolina's 15A North Carolina Administrative Code
(NCAC) Subchapter 02D, Section .0500,

Emission Control Standards.\1\ Specifically, EPA is approving changes
to 15A NCAC 02D Sections .0516, Sulfur Dioxide Emissions from
Combustion Sources, which include minor grammatical edits and remove
references to outdated State-only rules; .0517, Emissions from Plants
Producing Sulfuric Acid, which include minor typographical edits;
.0519, Control of Nitrogen Dioxide and Nitrogen Oxides Emission, which
correct typographical errors and incorrect references, and are
clarifying in natures; and .0533, Stack Height, which include minor
grammatical and formatting changes that do not alter the meaning of the
provision.\2\ \3\
---------------------------------------------------------------------------

    \1\ EPA notes that the April 13, 2021, submittal was received by
EPA on April 14, 2021.
    \2\ EPA received several revisions to the North Carolina SIP
through the same April 13, 2021, cover letter. This rulemaking only
addresses the revisions identified within this notice. EPA may act
on the remaining revisions, including certain 02D Section .0500
rules not considered in this action, through separate rulemakings.
    \3\ On February 22, 2022, and July 6, 2022, North Carolina
submitted letters to EPA withdrawing the changes to Rule 15A NCAC
02D .0532 and .0527, respectively, from EPA's consideration. For
this reason, EPA will not act on these changes to Rule .0532 or
.0527. Both letters can be found in the docket for this action.
---------------------------------------------------------------------------

    Through a notice of proposed rulemaking (NPRM), published on August
15, 2022, EPA proposed to approve the changes to North Carolina's SIP-
approved Rule .0516, Sulfur Dioxide Emissions from Combustion Sources;
.0517, Emissions from Plants Producing Sulfuric Acid; .0519, Control of
Nitrogen Dioxide and Nitrogen Oxides Emissions; and .0533, Stack
Height, as submitted by NCDEQ on April 13, 2021. See 87 FR 50028.
Additional details on North Carolina's April 13, 2021, SIP revision, as
well as EPA's analysis of these changes, can be found in the August 15,
2022, NPRM. Comments on the August 15, 2022, NPRM were due on or before
September 14, 2022. No comments were received on the August 15, 2022,
NPRM, so EPA is now finalizing the approval of the changes as proposed.

II. Incorporation by Reference

    In this document, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, and as discussed in Section I of this preamble, EPA is finalizing
the incorporation by reference of 15A NCAC Subchapter 02D, Rules .0516,
Sulfur Dioxide Emissions from Combustion Sources; .0517, Emissions from
Plants Producing Sulfuric Acid; .0519, Control of Nitrogen Dioxide and
Nitrogen Oxides Emissions; and .0533, Stack Height, all state effective
on November 1, 2020. EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 4 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the SIP, have been incorporated by reference by EPA into
that plan, are fully federally enforceable under sections 110 and 113
of the CAA as of the effective date of the final rulemaking of EPA's
approval, and will be incorporated by reference in the next update to
the SIP compilation.\4\
---------------------------------------------------------------------------

    \4\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

III. Final Action

    As described in the August 15, 2022, NPRM, EPA is approving the
April 13, 2021, SIP revision to incorporate various changes to a subset
of North Carolina's emission control standards provisions into the SIP.
Specifically, EPA is approving changes to 15A NCAC 02D Rules .0516,
Sulfur Dioxide Emissions from Combustion Sources; .0517, Emissions from
Plants Producing Sulfuric Acid; .0519, Control of Nitrogen Dioxide and
Nitrogen Oxides Emissions; and .0533, Stack Height.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those imposed by state law. For that
reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by December 27, 2022. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and

shall not postpone the effectiveness of such rule or action. This
action may not be challenged later in proceedings to enforce its
requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate
matter, Sulfur oxides, Volatile organic compounds.

    Dated: October 14, 2022.
Daniel Blackman,
Regional Administrator, Region 4.

    For the reasons stated in the preamble, EPA amends 40 CFR part 52
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart II--North Carolina

0
2. In Sec.  52.1770(c)(1), amend the table under ``Subchapter 2D Air
Pollution Control Requirements,'' ``Section .0500 Emission Control
Standards,'' by removing the entries for ``Section .0516,'' ``Section
.0517,'' ``Section .0519,'' and ``Section .0533'' and adding in their
places entries for ``Rule .0516,'' ``Rule .0517,'' ``Rule .0519,'' and
``Rule .0533'' to read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (c) * * *
    (1) EPA Approved North Carolina Regulations

----------------------------------------------------------------------------------------------------------------
                                                               State
         State citation                Title/subject      effective date     EPA approval date      Explanation
----------------------------------------------------------------------------------------------------------------
                                Subchapter 2D Air Pollution Control Requirements
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                    Section .0500 Emission Control Standards
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Rule .0516......................  Sulfur Dioxide               11/1/2020  10/25/2022, [Insert
                                   Emissions from                          citation of
                                   Combustion Sources.                     publication].
Rule .0517......................  Emissions from Plants        11/1/2020  10/25/2022, [Insert
                                   Producing Sulfuric                      citation of
                                   Acid.                                   publication].
Rule .0519......................  Control of Nitrogen          11/1/2020  10/25/2022, [Insert
                                   Dioxide and Nitrogen                    citation of
                                   Oxides Emissions.                       publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Rule .0533......................  Stack Height..........       11/1/2020  10/25/2022, [Insert
                                                                           citation of
                                                                           publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-22724 Filed 10-24-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 751-753]
[FR Doc No: 2022-28604]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-3239]

Medical Devices; Orthopedic Devices; Classification of the
Implantable Post-Surgical Kinematic Measurement Knee Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA, Agency or we) is
classifying the implantable post-surgical kinematic measurement knee
device 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 implantable post-surgical kinematic
measurement knee device'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 January 5, 2023. The classification was
applicable on August 27, 2021.

FOR FURTHER INFORMATION CONTACT: Patrick Macatangga, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1567, Silver Spring, MD 20993-0002, 301-
796-4369, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the implantable post-surgical
kinematic measurement knee device 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 (see 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 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. 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 section 513(f)(2)(B)(i) of the FD&C
Act). 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 section 513(i) of the FD&C Act,
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On October 19, 2020, FDA received Canary Medical, Inc.'s request
for De Novo classification of the Canary Tibial Extension with Canary
Health Implanted Reporting Processor (CHIRP) 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 August 27, 2021, 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
888.3600.\1\ We have named the generic type of device implantable post-
surgical kinematic measurement knee device, and it is identified as a
device that provides objective kinematic data after total knee
arthroplasty surgery. The kinematic data provided by the device are
used as an adjunct to other physiological parameter measurement tools
utilized during the course of patient monitoring and treatment post
surgery.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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--Implantable Post-Surgical Kinematic Measurement Knee Device
                      Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Tissue injury, thermal injury, or        Thermal safety testing,
 electric shock due to device failure     Electrical safety testing,
 including:                               Battery safety testing, and
 Loss of hermeticity.             Non-clinical performance
 Battery failure.                 testing.
Loosening/migration due to device        Non-clinical performance
 failure at the bone/implant interface.   testing, and Labeling.
Inaccurate, unreliable, and              Non-clinical performance
 irreproducible kinematic data leading    testing.
 to improper post-surgical patient
 management.
Interference with imaging modalities...  Non-clinical performance
                                          testing, and Magnetic
                                          resonance compatibility
                                          testing.
Data access failure and delayed access   Software verification,
 to kinematic data due to:                validation, and hazard
 Software failure.                analysis, Electromagnetic
 Interference with other          compatibility testing, Human
 devices.                                 factors testing, and Labeling.
 Use error.
Infection..............................  Sterilization validation,
                                          Reprocessing validation,
                                          Biocompatibility evaluation,
                                          and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
------------------------------------------------------------------------

    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. 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. 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 21 CFR part 860, subpart D, regarding De Novo
classification 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 parts 801, regarding labeling, have been

approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

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

0
2. Add Sec.  888.3600 to subpart D to read as follows:

Sec.  888.3600  Implantable post-surgical kinematic measurement knee
device.

    (a) Identification. An implantable post-surgical kinematic
measurement knee device is a device that provides objective kinematic
data after total knee arthroplasty surgery. The kinematic data provided
by the device are used as an adjunct to other physiological parameter
measurement tools utilized during the course of patient monitoring and
treatment post surgery.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use. The
following tests must be conducted:
    (i) Mechanical testing must evaluate the mechanical function
(mechanical fatigue, static mechanical strength) and durability of the
implant.
    (ii) Simulated use testing must evaluate the ability of the device
to be sized, inserted, and sufficiently secured to any compatible
components.
    (iii) Testing must demonstrate the accuracy, reliability, and
reproducibility of kinematic measurements.
    (iv) Testing must demonstrate diagnostic and therapeutic ultrasound
conditions for safe use.
    (v) Testing must demonstrate that the device performs as intended
under anticipated conditions of use demonstrating the following
performance characteristics, if applicable:
    (A) Magnetic pulse output testing;
    (B) Magnetic and electrical field testing; and
    (C) Testing of the safety features built into the device.
    (vi) Testing must demonstrate hermeticity of any electronic
component enclosures.
    (2) Performance testing must evaluate the compatibility of the
device in a magnetic resonance (MR) environment.
    (3) Human factors testing must demonstrate that the intended
user(s) can correctly use the device for its intended use, including
for implantation and post-procedure data access.
    (4) Performance data must demonstrate the sterility of the device
implant and patient-contacting components.
    (5) Performance data must validate the reprocessing instructions
for the reusable components of the device.
    (6) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (7) Design characteristics of the device, including engineering
schematics, must ensure that the geometry and material composition are
consistent with the intended use.
    (8) Performance testing must demonstrate the electromagnetic
compatibility/interference, (EMC/EMI), electrical safety, thermal
safety, battery safety, and wireless performance of the device.
    (9) Software verification, validation, and hazard analysis must be
performed.
    (10) The labeling must include the following:
    (i) A shelf life;
    (ii) Physician and patient instructions for use, including images
that demonstrate how to interact with the device;
    (iii) Detailed instruction of the surgical technique;
    (iv) Hardware and software requirements for interacting with the
device;
    (v) A clear description of the technological features of the device
including identification of the device materials, compatible
components, and the principles of operation;
    (vi) Identification of magnetic resonance (MR) compatibility
status;
    (vii) Validated methods and instructions for reprocessing of any
reusable components; and
    (viii) A statement regarding the limitations of the clinical
significance of the kinematic data.

    Dated: December 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28604 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 47047-47048]
[FR Doc No: 2013-17940]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2013-0265]

Proposed Policy for Discontinuance of Certain Instrument Approach
Procedures

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed policy and request for comment.

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

SUMMARY: As, new technology facilitates the introduction of area
navigation (RNAV) instrument approach procedures over the past decade,
the number of procedures available in the National Airspace System has
nearly doubled. The complexity and cost to the Federal Aviation
Administration (FAA) of maintaining the existing ground based
navigational infrastructure while expanding the new RNAV capability is
not sustainable. The FAA is considering the cancellation of certain
Non-directional Beacon (NDB) and Very High Frequency (VHF)
Omnidirectional Radio Range (VOR) instrument approach procedures (IAP)
at airports that have multiple instrument approach procedures. The FAA
proposes specific criteria to guide the identification and selection of
appropriate NDB and VOR instrument approach procedures that can be
considered for cancellation. The VOR IAPs associated with this
cancellation initiative would be selected from the criteria outlined
below. This Notice is not a part of the FAA's VOR minimum operating
network (MON) initiative.

DATES: Comments must be received on or before October 1, 2013.

ADDRESSES: Send comments identified by docket number 2013-0265 using
any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
     Privacy: The FAA will post all comments it receives,
without change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA dockets, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
     Docket: Background documents or comments received may be
read at http://www.regulations.gov at any time. Follow the online
instructions for accessing the docket or Docket Operations in Room W12-
140 of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. This proposal is subject to change after
review of public comments.

FOR FURTHER INFORMATION CONTACT: For questions concerning this action,
contact Mr. Larry Strout, Aeronautical Navigational Products, Terminal
Products Group, Central Products Team Manager, Air Traffic
Organization, AJV-353, Federal Aviation Administration, 6500 S.
MacArthur BLVD, Oklahoma City, OK 73169; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Authority

    Title 49 of the United States Code, section 40103, vests the
Administrator with broad authority to regulate the safe and efficient
use of the navigable airspace. The Administrator is authorized to issue
rules and regulations to govern the flight, navigation, protection, and
identification of aircraft for the protection of persons and property
on the ground, and for the efficient use of the navigable airspace (49
U.S.C. 40103(b)). The Administrator also is authorized under Sec.
44701(a)(5) to promote safe flight of civil aircraft in air commerce by
prescribing regulations and minimum standards for other practices,
methods, and procedures necessary for safety in air commerce and
national security.

Background

    The FAA is continuing to expand the availability and capability of
area navigation (RNAV) to improve safety and efficiency within the
National Airspace System (NAS). A major enhancement is the introduction
of Wide Area Augmentation System (WAAS) capable RNAV instrument
approach procedures that provide for near-precision vertical guidance.
    As a result of new RNAV instrument approach procedures, the number
of instrument approach procedures available to the public has nearly
doubled over the past decade and will continue to grow with the
public's demand for new WAAS procedures. The complexity and cost of
maintaining existing ground-based navigational infrastructure while
expanding new RNAV capability is exceeding the FAA's current staffing
and budget allocations and projections over the next five years. To
meet the public's demand for WAAS capable RNAV procedures, the FAA must
manage the growth in the number of instrument approach procedures and
finds that certain redundant ground-based procedures can be eliminated
without affecting safety or access to airports.
    To help identify viable strategies for cancellation of ground-based
procedures, the FAA awarded a grant to the Flight Safety Foundation. In
conducting its research, the Flight Safety Foundation held meetings
with FAA and Department of Defense (DOD) personnel and key industry
interest groups. Outreach conducted by the Foundation identified that
most NDB procedures are no longer desired, except in support of certain
DOD operations and flight schools. The Flight Safety Foundation also
found user support for cancelling some VOR procedures when multiple
IAPs are available. Results of the Flight Safety Foundation study were
published in the report titled ``A Recommended Process: Safely Reducing
Redundant or Underutilized Instrument Approach Procedures.'' The report
is available for review at: https://www.faa.gov/air_traffic/flight_info/aeronav/procedures/reports/media/FAA_Grant_Flight_Safety_Foundation_Inc-2010G023.pdf.
    By this notice, the FAA seeks comments on proposed criteria that
would facilitate the FAA's determination of which procedures can be
considered for cancellation. After reviewing the comments submitted to
this notice, the FAA will use the criteria for selection of potential
NDB and VOR procedures for cancellation. Once the criteria are
established and the FAA

considers IAPs for cancellation, the FAA will publish a list of
potential IAPs in the Federal Register for notice and comment.
Submitted comments will be reviewed and addressed in the final list of
subject IAPs published in the Federal Register. The criteria proposed
in this notice does not affect any NAS navigational back-up plans and
is not a part of the FAA's VOR minimum operating network (MON)
initiative.

Proposed Policy

    The NDB and VOR IAPs recommended for cancellation would be selected
at airports using the following criteria. It must be noted that all
airports that have existing RNAV and ground-based IAPs would maintain
at least one RNAV and one ground-based IAP.
    Airports that would be considered for NDB or VOR IAP cancellation:

-- All airports with an NDB IAP.
--All airports with a VOR/DME RNAV IAP, unless it is the only IAP at
the airport.
--All airports with two or more ground-based IAPs and an RNAV IAP.
--All airports with multiple, redundant ground-based IAPs (e.g., three
VOR procedures).

    Additional consideration would be given to the following factors in
determining the list of potential candidates for cancellation:

--Prevailing wind runways.
--Prevailing runway alignment during adverse weather operations.
--If an airport has a published ILS IAP and additional ground-based
IAPs, cancel the procedure to the same runway as the ILS.
--For airports with multiple VOR and NDB IAP's, retain the IAP with the
lowest minimums (if minimums are within 20 feet of each other retain
the procedure that allows optimum use by all customers (i.e. VOR and
VOR/DME retain VOR because there are no equipage limitations).

    Airports that would not be considered for NDB or VOR IAP
cancellations:

--Airport with only RNAV/RNPs IAPs published.
--Airport with only one ground-based procedure.
--Airports will not be considered if cancellation would result in
removing all IAPs from the airport.

    Lastly, the FAA is not considering the following types of
procedures for cancellation:

PBN Procedures (RNAV or RNP).
ILS procedures.
Localizer procedures.
TACAN procedures.
Standard Instrument Arrivals (STARs).
Standard Instrument Departures (SIDs).

Comments Invited

    The FAA invites interested parties to submit written comments,
data, or views. The agency also invites comments relating to the
economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments or, if comments are filed
electronically, commenters should submit only one time.
    The FAA will file in the docket all comments it receives. Before
acting on this proposal, the FAA will consider all comments it receives
on or before the closing date for comments. The FAA will consider
comments filed after the comment period has closed if it is possible to
do so without incurring expense or delay. The agency may change this
proposal in light of the comments it receives.
    Proprietary or Confidential Business Information: Commenters should
not file proprietary or confidential business information in the
docket. Such information must be sent or delivered directly to the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this document, and marked as proprietary or confidential. If submitting
information on a disk or CD-ROM, mark the outside of the disk or CD-
ROM, and identify electronically within the disk or CD-ROM the specific
information that is proprietary or confidential.
    Under 14 CFR 11.35(b), the FAA is aware of proprietary information
filed with a comment, the agency does not place it in the docket. It is
held in a separate file to which the public does not have access and
the FAA places a note in the docket that it has received it. If the FAA
receives a request to examine or copy this information, it treats it as
any other request under the Freedom of Information Act (5 U.S.C. 552).
The FAA processes such a request under Department of Transportation
procedures found in 49 CFR part 7.

    Issued in Washington, DC, on July 19, 2013.
Abigail Smith,
Aeronautical Navigation Products, Director.
[FR Doc. 2013-17940 Filed 8-1-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Proposed Rules]
[Pages 70649-70650]
[FR Doc No: 2016-24625]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-9173; Airspace Docket No. 16-AAL-2]

Proposed Amendment of Class E Airspace, Barter Island, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify Class E airspace at Barter
Island LRRS Airport, Barter Island, AK because the North Slope Borough
is relocating the airport. The FAA found modification of this airspace
and adjustment of the airport's geographic coordinates necessary for
the safety and management of Instrument Flight Rules (IFR) operations
at the airport.

DATES: Comments must be received on or before November 28, 2016.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2016-9173; Airspace Docket No. 16-AAL-2, at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    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:<PHONE_NUMBER>.
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: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

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
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 Class E airspace at Barter Island LRRS Airport,
Barter Island, AK.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2016-9173/
Airspace Docket No. 16-AAL-2.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at  http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA
98057.

Availability and Summary of Documents Proposed for Incorporation by
Reference

    This document proposes to amend 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 Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at Barter Island LRRS Airport,
Barter Island, AK. The North Slope Borough is relocating the airport
approximately 2 miles southwest to address oceanic erosion issues at
this remote location. The airspace would be modified to a 6.4-mile
radius of the airport. Modification of the airspace is necessary for
the safety and management of IFR operations at the airport.
Additionally, the airport's geographic coordinates would be updated to
lat. 70[deg]06'47'' N., long. 143[deg]39'13'' W.
    Class E airspace designations are published in paragraph 6005 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 Class E
airspace designations listed in this document will be published
subsequently in the Order.

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, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
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 will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 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 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016, and
effective September 15, 2016, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AAL AK E5 Barter Island, AK [Modified]

Barter Island LRRS Airport, AK
    (Lat. 70[deg]06'47'' N., long. 143[deg]39'13'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Barter Island LRRS Airport, and that
airspace extending upward from 1,200 feet above the surface within a
83-mile radius of Barter Island LRRS Airport, excluding that
airspace east of 141[deg] west longitude and excluding that airspace
that extends beyond 12 miles of the shoreline.

    Issued in Seattle, Washington, on October 3, 2016.
Richard Roberts,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2016-24625 Filed 10-12-16; 8:45 am]
 BILLING CODE 4910-13-P