[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Notices]
[Pages 85638-85639]
[FR Doc No: 2023-27013]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-E-0791]

Determination of Regulatory Review Period for Purposes of Patent
Extension; VILTEPSO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for VILTEPSO and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by February 6, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 5, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 6, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-E-0791 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; VILTEPSO.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this

information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with Sec.  10.20 (21 CFR 10.20) and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, VILTEPSO
(viltolarsen), which is indicated for the treatment of Duchenne
muscular dystrophy (DMD) in patients who have a confirmed mutation of
the DMD gene that is amenable to exon 53 skipping. This indication is
approved under accelerated approval based on an increase in dystrophin
production in skeletal muscle observed in patients treated with
VILTEPSO. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
trial. Subsequent to this approval, the USPTO received a patent term
restoration application for VILTEPSO (U.S. Patent No. 9,079,934) from
Nippon Shinyaku Co., LTD. and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated August 24, 2022, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of VILTEPSO represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
VILTEPSO is 1,573 days. Of this time, 1,255 days occurred during the
testing phase of the regulatory review period, while 318 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
April 24, 2016. The applicant claims March 24, 2016, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was April 24, 2016,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: September 30,
2019. The applicant claims February 1, 2019, as the date the new drug
application (NDA) for VILTEPSO (NDA 212154) was initially submitted.
However, FDA records indicate that on September 30, 2019, NDA 212154 (a
complete application) was submitted.
    3. The date the application was approved: August 12, 2020. FDA has
verified the applicant's claim that NDA 212154 was approved on August
12, 2020.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,077 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27013 Filed 12-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 31 (Tuesday, February 15, 2011)]
[Rules and Regulations]
[Pages 8612-8615]
[FR Doc No: 2011-3067]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0039; Directorate Identifier 2010-NM-184-AD;
Amendment 39-16605; AD 2011-04-05]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A340-200, -300, -500, and
-600 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI (European Aviation Safety Agency AD 2009-
0192) describes the unsafe condition as:

    Performing some quality tests on material, Airbus found that
some 300M steel forgings used to manufacture certain landing gear
components were below specification limits. Adapted airworthiness
limitations were introduced in Airbus A340 Airworthiness Limitations
Section (ALS) Part 1 ``Safe Life Airworthiness Limitation Items (SL
ALI)'' for different source route codes.
* * * * *
    This [EASA] AD introduces more restrictive life limitations for
several landing gear components.
    The MCAI (EASA AD 2010-0131) describes the unsafe condition as:
* * * * *
    The revision 04 of Airbus A330 and A340 ALS Part 1 introduces
more restrictive maintenance requirements and/or airworthiness
limitations as specified in Airbus A330 and A340 ALS Part 1 revision
04.

The unsafe condition is failure of certain life-limited parts, which
could result in reduced structural integrity of the airplane. This AD
requires actions that are intended to address the unsafe condition
described in the MCAI.

DATES: This AD becomes effective March 2, 2011.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of March 2,
2011.
    We must receive comments on this AD by April 1, 2011.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor,

Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the aviation
authority for the Member States of the European Community, has issued
EASA Airworthiness Directives 2010-0131, dated June 28, 2010 and EASA
AD 2009-0192, dated August 28, 2009 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI (EASA AD 2009-0192) states:

    Performing some quality tests on material, Airbus found that
some 300M steel forgings used to manufacture certain landing gear
components were below specification limits. Adapted airworthiness
limitations were introduced in Airbus A340 Airworthiness Limitations
Section (ALS) Part 1 ``Safe Life Airworthiness Limitation Items (SL
ALI)'' for different source route codes.
    A new source route (S3) has since been investigated and has led
to another set of adapted airworthiness limitations for affected
main fittings.
    In addition, further tests based on a new method for damage load
selection led to the limitation changes for A340-500/-600 centre
landing gear main fitting part number (P/N) 50-1105236-01 and P/N
1105296-00.
    This [EASA] AD introduces more restrictive life limitations for
several landing gear components.
    The MCAI (EASA AD 2010-0131) describes the unsafe condition as:
    The airworthiness limitations are currently distributed in the
Airbus A330 and A340 Airworthiness Limitations Section (ALS).
    The airworthiness limitations applicable to the Safe Life
Airworthiness Limitation Items (SL ALI) are given in Airbus A330 and
A340 ALS Part 1, which are approved by the European Aviation Safety
Agency (EASA).
    The revision 04 of Airbus A330 and A340 ALS Part 1 introduces
more restrictive maintenance requirements and/or airworthiness
limitations as specified in Airbus A330 and A340 ALS Part 1 revision
04.
    This new [EASA] AD supersedes EASA AD 2007-0300, EASA AD 2008-
0152 and EASA AD 2009-0191 and requires the implementation of the
new or more restrictive maintenance requirements and/or
airworthiness limitations as specified in Airbus A330 and A340 ALS
Part 1 revision 04.

The unsafe condition is failure of certain life-limited parts, which
could result in reduced structural integrity of the airplane. You may
obtain further information by examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued A340 ALS Part 1, Safe Life Airworthiness
Limitation Items Revision 05, dated July 29, 2010. This document
provides for mandatory replacement times, structural inspection
intervals, and related structural inspection procedures or other
procedures (e.g., modifications). The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

Other Relevant Rulemaking

    On April 20, 2006, we issued AD 2006-09-07, Amendment 39-14577 (71
FR 25919, May 3, 2006), for all Airbus Model A330-200 and -300, and
A340-200 and -300 series airplanes, and A340-541 and -642 airplanes.
That AD requires operators to revise the Airworthiness Limitations
section of the Instructions for Continued Airworthiness to incorporate
new information. That information includes, for all affected airplanes,
decreased life limit values for certain components; and for Model A330-
200 and -300 series airplanes, new inspections, compliance times, and
new repetitive intervals to detect fatigue cracking, accidental damage,
or corrosion in certain structures. That AD results from a revision to
section 9-1 of the Airbus A330 and A340 maintenance planning documents
(MPDs) for life limits/monitored parts, and section 9-2 of the Airbus
A330 MPD for airworthiness limitations items. Accomplishing the
revision in paragraph (g) of this AD eliminates the need for the
revision required by paragraph (f)(2) of AD 2006-09-07 for Model A340
airplanes.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.
    There are no products of this type currently registered in the
United States. However, this rule is necessary to ensure that the
described unsafe condition is addressed if any of these products are
placed on the U.S. Register in the future.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the AD.

FAA's Determination of the Effective Date

    Since there are currently no domestic operators of this product,
notice and opportunity for public comment before issuing this AD are
unnecessary.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2011-0039; Directorate
Identifier 2010-NM-184-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2011-04-05 Airbus: Amendment 39-16605. Docket No. FAA-2011-0039;
Directorate Identifier 2010-NM-184-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March 2,
2011.

Affected ADs

    (b) This AD affects AD 2006-09-07, Amendment 39-14577.

Applicability

    (c) This AD applies to Airbus Model A340-211, -212, and -213
airplanes; A340-311, -312, and -313 airplanes; A340-541 airplanes;
and A340-642 airplanes; certificated in any category; all
manufacturer serial numbers.

    Note 1:  This AD requires revisions to certain operator
maintenance documents to include new inspections. Compliance with
these inspections is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the
areas addressed by these inspections, the operator may not be able
to accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (j)(1) of this AD. The request should include a
description of changes to the required inspections that will ensure
the continued operational safety of the airplane.

Subject

    (d) Air Transport Association (ATA) of America Code 05.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
(European Aviation Safety Agency (EASA) AD 2009-0192) states:

    Performing some quality tests on material, Airbus found that
some 300M steel forgings used to manufacture certain landing gear
components were below specification limits. Adapted airworthiness
limitations were introduced in Airbus A340 Airworthiness Limitations
Section (ALS) Part 1 ``Safe Life Airworthiness Limitation Items (SL
ALI)'' for different source route codes.
* * * * *
    This [EASA] AD introduces more restrictive life limitations for
several landing gear components.
    The MCAI (EASA AD 2010-0131) describes the unsafe condition as:
* * * * *
    The revision 04 of Airbus A330 and A340 ALS Part 1 introduces
more restrictive maintenance requirements and/or airworthiness
limitations as specified in Airbus A330 and A340 ALS Part 1 revision
04.

The unsafe condition is failure of certain life-limited parts, which
could result in reduced structural integrity of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Revise the Maintenance Program

    (g) Within 3 months after the effective date of this AD: Revise
the maintenance program by incorporating Airbus A340 ALS Part 1--
Safe Life Airworthiness Limitation Items (SL ALI), Revision 05,
dated July 29, 2010. At the times specified in the Airbus A340 ALS
Part 1--SL ALI, Revision 05, dated July 29, 2010, comply with all
applicable maintenance requirements and associated airworthiness
limitations specified in Airbus A340 ALS, Part 1--SL ALI, Revision
05, dated July 29, 2010.

Alternative Intervals or Limits

    (h) Except as provided by paragraph (j)(1) of this AD, after
accomplishing the actions specified in paragraph (g) of this AD, no
alternative to the replacements, replacement intervals, or
limitations specified in paragraph (g) of this AD may be used.

Method of Compliance With Paragraph (f)(2) of AD 2006-09-07

    (i) Doing the revision required by paragraph (g) of this AD
terminates the requirements of paragraph (f)(2) of AD 2006-09-07 for
that Model A340 airplane only.

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows: Although the MCAI specifies a compliance time of ``from
the effective date of this AD'' for revising the maintenance program
to incorporate Airbus A340 ALS Part 1--Safe Life Airworthiness
Limitation Items, Revision 05, dated July 29, 2010; this AD requires
the action be done within 3 months after the effective date of this
AD.

Other FAA AD Provisions

    (j) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN:
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector, or lacking a
principal inspector, the manager of the local flight standards
district office/certificate holding district office. The AMOC
approval letter must specifically reference this AD.

    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (k) Refer to MCAI EASA Airworthiness Directive 2010-0131, dated
June 28, 2010, and 2009-0192, dated August 28, 2009; and Airbus A340
ALS Part 1--Safe Life Airworthiness Limitation Items, Revision 05,
dated July 29, 2010; for related information.

Material Incorporated by Reference

    (l) You must use the service information contained in Airbus
A340 Airworthiness Limitations Section, Part 1--Safe Life
Airworthiness Limitations Items, Revision 05, dated July 29, 2010;
to do the actions required by this AD, unless the AD specifies
otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on February 3, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-3067 Filed 2-14-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Rules and Regulations]
[Pages 50199-50203]
[FR Doc No: 2015-20501]

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

40 CFR Parts 51, 52, 70, and 71

[EPA-HQ-OAR-2015-0414; FRL-9932-11-OAR]

Prevention of Significant Deterioration and Title V Permitting
for Greenhouse Gases: Removal of Certain Vacated Elements

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is amending its
Prevention of Significant Deterioration (PSD) and title V regulations
to remove from the Code of Federal Regulations portions of those
regulations that were initially promulgated in 2010 and that the Court
of Appeals for the District of Columbia Circuit (D.C. Circuit)
specifically identified as vacated in the April 10, 2015, amended
judgment, Coalition for Responsible Regulation v. EPA. This action is
exempt from notice-and-comment rulemaking because it is ministerial in
nature.

DATES: This rule is effective on August 19, 2015.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2015-0414. All documents in the docket are
listed on the www.regulations.gov Web site. Publicly available docket
materials are available either electronically through
www.regulations.gov or in hard copy at the EPA Docket Center, Room
3334, EPA William Jefferson Clinton West Building, Room 3334, 1301
Constitution Avenue NW., Washington, DC 20004. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744 and the telephone number for the Office of Air and
Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Questions concerning this final rule
should be addressed to Mrs. Jessica Monta[ntilde]ez, U.S. Environmental
Protection Agency, Office of Air Quality Planning and Standards, Air
Quality Planning Division, (C504-03), Research Triangle Park, NC 27711,
telephone number<PHONE_NUMBER>, email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information in this section of the
preamble is organized as follows:

I. Does this action apply to me?
II. Background and Rationale for This Action
III. Final Action
IV. Implementation
V. Environmental Justice Considerations
VI. Statutory and Executive Order Reviews
VII. Judicial Review

I. Does this action apply to me?

    Entities potentially affected by this final action include new and
modified stationary sources in all industry groups. To determine
whether your facility would be affected by this action, you should
carefully examine the applicability criteria in Sec. Sec.  51.166 and
52.21 of title 40 of the Code of Federal Regulations (CFR). Entities
potentially affected by this final action also include state, local and
tribal governments that are authorized to implement the PSD program
through an EPA-approved State Implementation Plan (SIP) or Tribal
Implementation Plan (TIP) or that have been authorized to implement the
PSD program through a delegation of the federal PSD regulations.

II. Background and Rationale for This Action

    Part C of title I of the Clean Air Act (CAA or the Act) contains
the requirements for a component of the major New Source Review (NSR)
program known as the PSD program. This program sets forth procedures
for the preconstruction review and permitting of new and modified
stationary sources of air pollution locating in areas meeting the
National Ambient Air Quality Standards (NAAQS) (``attainment'' areas)
and areas for which there is insufficient information to classify an
area as either attainment or nonattainment (``unclassifiable'' areas).
The applicability of PSD to a particular source must be determined in
advance of construction of a new source or major modification of an
existing source and is pollutant-specific. Once a source is determined
to be subject to PSD, among other requirements, the source must
demonstrate that it will not cause or contribute to a violation of any
NAAQS or PSD increment,\1\ and that it will use the Best Available
Control Technology (BACT).\2\ The EPA regulations for the PSD program
are contained in 40 CFR 51.166 (applicable to air agencies that issue
permits under EPA-approved SIPs) and 40 CFR 52.21 (the federal PSD
program applicable to permits issued by the EPA or air agencies that
have received delegation to implement the federal PSD program).
---------------------------------------------------------------------------

    \1\ CAA section 165(a)(3).
    \2\ CAA section 165(a)(4).
---------------------------------------------------------------------------

    Title V of the CAA, on the other hand, requires all major
stationary sources of air pollution and certain other sources to apply
for a title V operating permit that includes emission limitations and
other conditions as necessary to assure compliance with applicable
requirements of the CAA.\3\ The title V operating permit program is a
vehicle for ensuring that air quality control requirements are
appropriately applied to facility emission units and for assuring
compliance with such requirements. The title V program does not
generally impose new substantive air quality control requirements, but
does require permits to contain adequate monitoring, recordkeeping,
reporting and other requirements to assure sources' compliance. The
title V program is implemented through regulations contained in 40 CFR
part 70 (for programs implemented by state or local agencies and
tribes) and 40 CFR part 71 (for programs generally implemented by the
EPA).
---------------------------------------------------------------------------

    \3\ CAA sections 502(a) and 504(a).
---------------------------------------------------------------------------

    On June 3, 2010, the EPA published a final rule, known as the
Tailoring Rule, which phased in permitting requirements for greenhouse
gas (GHG) emissions from stationary sources under the CAA PSD and title
V permitting programs (75 FR 31514). Under its interpretation of the
CAA at the time, the EPA believed the Tailoring Rule was necessary to
avoid a sudden and unmanageable increase in the number of sources that
would be required to obtain PSD and title V permits under the CAA
because the sources emitted or had the potential to emit GHGs above the
applicable major source and major modification thresholds. In Step 1 of
the Tailoring Rule, which began on January 2, 2011, the EPA limited
application of PSD and title V requirements to sources only if they
were subject to PSD or title V ``anyway'' due to their emissions of
non-GHG pollutants. These sources are referred to as ``anyway
sources.'' In Step 2 of the Tailoring Rule, which began on July 1,
2011, the EPA applied the PSD and title V permitting requirements under
the CAA to sources that were classified as major, and, thus, required
to obtain a permit, based solely on their GHG emissions or potential to
emit GHGs, and to modifications of otherwise major sources that
required a PSD permit because they increased only GHG emissions above
the level in the EPA regulations.
    On June 23, 2014, the U.S. Supreme Court issued a decision in
Utility Air Regulatory Group (UARG) v. EPA, 134 S. Ct. 2427, addressing
the application of stationary source permitting requirements to GHGs.
The U.S. Supreme Court held that the EPA may not treat GHGs as an air
pollutant for the

specific purpose of determining whether a source is a major source (or
a modification thereof) and thus required to obtain a PSD or title V
permit. However, the U.S. Supreme Court also said that the EPA could
continue to require that PSD permits, otherwise required based on
emissions of pollutants other than GHGs pollutants, contain limitations
on GHG emissions based on the application of GHG BACT. That is, with
respect to PSD, the ruling effectively upheld PSD permitting
requirements for GHG emissions under Step 1 of the Tailoring Rule for
``anyway sources,'' and invalidated PSD permitting requirements for
Step 2 sources.
    Because the Supreme Court decision affirmed in part and reversed in
part an earlier decision of the D.C. Circuit in Coalition for
Responsible Regulation v. EPA, 684 F.3d 102 (D.C. Cir. 2012), on April
10, 2015, the D.C. Circuit issued an Amended Judgment (Nos. 09-1322,
10-073, 10-1092 and 10-1167), which reflects the UARG v. EPA Supreme
Court decision. The D.C. Circuit simultaneously issued its mandate,
which means that the Coalition Amended Judgment became final and
effective upon issuance.
    In the Coalition Amended Judgment, the D.C. Circuit ordered that
the EPA regulations under review (including 40 CFR 51.166(b)(48)(v) and
40 CFR 52.21(b)(49)(v)) be vacated to the extent they require a
stationary source to obtain a PSD permit if GHGs are the only pollutant
(i) that the source emits or has the potential to emit above the
applicable major source thresholds, or (ii) for which there is a
significant emissions increase from a modification. The D.C. Circuit
also ordered that the regulations under review be vacated to the extent
they require (i) a stationary source to obtain a title V permit solely
because the source emits or has the potential to emit GHGs above the
applicable major source thresholds and (ii) the EPA to consider further
phasing-in the GHG permitting requirements at lower GHG emission
thresholds (in particular 40 CFR 52.22 and 40 CFR 70.12, 71.13).
    Consistent with the Coalition Amended Judgment, this action removes
from the PSD regulations certain regulatory provisions that require a
stationary source to obtain a PSD permit solely on the basis of the
source's GHG emissions and the regulations that require the EPA to
consider further phasing-in GHG permitting requirements into the PSD
and title V permitting programs at lower GHG emissions thresholds. The
EPA intends to further revise the PSD and title V regulations to fully
implement the Coalition Amended Judgment in a separate rulemaking. This
future rulemaking will include revisions to additional definitions in
the PSD regulations. It will also include further revising the title V
regulations to remove portions of the title V regulations that were
vacated in the Coalition Amended Judgment case--those that require a
stationary source to obtain a title V permit solely because the source
emits or has the potential to emit GHGs above the applicable major
source thresholds. Those additional revisions to the PSD and title V
regulations, although necessary to implement the Coalition Amended
Judgment, are not purely ministerial in nature and will be addressed in
this separate notice-and-comment rulemaking, which would give the
public an opportunity to comment on how the EPA proposes to address
those portions of the Coalition Amended Judgment.

III. Final Action

    This final action removes from the CFR several provisions of the
PSD and title V permitting regulations that were originally promulgated
as part of the Tailoring Rule and that the D.C. Circuit specifically
identified as vacated in the Coalition Amended Judgment. Because the
D.C. Circuit specifically identified the Tailoring Rule Step 2 PSD
permitting requirements in 40 CFR 51.166(b)(48)(v) and 40 CFR
52.21(b)(49)(v) and the regulations that require the EPA to consider
further phasing-in the GHG permitting requirements at lower GHG
emission thresholds in 40 CFR 52.22, 70.12, and 71.13 as vacated, the
EPA is taking the ministerial action of removing these provisions from
the CFR.
    Furthermore, and since the D.C. Circuit's Coalition Amended
Judgment further ordered ``the EPA to take steps to rescind and/or
revise the applicable provisions of the CFR as expeditiously as
practicable'' to reflect its vacatur of certain provisions from the
Tailoring Rule, this rulemaking addresses only those provisions
specifically identified in the Coalition Amended Judgment that can be
removed from the CFR without the need for any further changes. In a
subsequent notice-and-comment rulemaking, the EPA will need to make
additional changes to its PSD and title V permitting regulations in
order to fully implement the Coalition Amended Judgment.
    The EPA is taking this action as a final rule without providing an
opportunity for public comment or a public hearing because the EPA
finds that the Administrative Procedure Act (APA) good cause exemption
applies here. In general, the APA requires that general notice of
proposed rulemaking shall be published in the Federal Register. Such
notice must provide an opportunity for public participation in the
rulemaking process. However, the APA also provides a way for an agency
to directly issue a final rulemaking in certain specific instances.
This may occur, in particular, when an agency for good cause finds (and
incorporates the finding and a brief statement of reasons in the rule
issued) that notice and public procedure thereon are impracticable,
unnecessary, or contrary to the public interest. See 5 U.S.C.
553(b)(3)(B). The EPA has determined that it is not necessary to
provide a public hearing or an opportunity for public comment on this
action because the removal of the affected PSD and title V Tailoring
Rule provisions from the CFR is a necessary ministerial act. The D.C.
Circuit specifically identified as vacated the PSD and title V
regulations this rule removes, and ordered that the EPA take steps to
rescind and/or revise the applicable provisions of the CFR as
expeditiously as practicable. The EPA no longer has the authority to
require any source to obtain a PSD or title V permit based solely on
the source having GHG emissions above applicable thresholds. Thus, EPA
may not implement the vacated provisions at 40 CFR 51.166(b)(48)(v) and
52.21(b)(49)(v) that applied PSD to this population of sources.
Further, the EPA is no longer required to take the actions specified in
the vacated regulations at 40 CFR 52.22, 70.12, and 71.13 to consider
further phasing in GHG PSD and title V permitting requirements at lower
GHG emissions thresholds. Therefore, removing the affected regulatory
text simply implements the decision of the Supreme Court and D.C.
Circuit and it would serve no useful purpose to provide an opportunity
for public comment or a public hearing on this issue.
    In addition, notice-and-comment would be contrary to the public
interest because it would unnecessarily delay the removal from the CFR
of the Tailoring Rule Step 2 PSD permitting provisions that the Supreme
Court held were invalid and the regulations that require the EPA to
consider further phasing-in the GHG permitting requirements for lower
GHG emissions thresholds in 40 CFR 52.22, 70.12, and 71.13 that the
D.C. Circuit's Coalition Amended Judgment specifically identified as
vacated. Such delay could result in confusion on the part of the

regulated industry and state, local and tribal air agencies about how
the D.C. Circuit's decision affects the PSD and title V regulations as
well as PSD permitting. Promulgation of this rule soon after the D.C.
Circuit decision serves to clarify that sources are no longer required
to obtain PSD permits under the preconstruction permitting regulations
associated with Step 2 of the Tailoring Rule and that the EPA will not
be required under 40 CFR 52.22, 70.12, and 71.13 to take further steps
to consider further phasing in PSD and title V permitting requirements
at lower GHG emissions thresholds. Given the substantial costs to the
owner/operator of projects associated with delays and uncertainty, it
is in the public interest for the EPA to amend the CFR without delay.
Furthermore, and as stated previously, the D.C. Circuit's Coalition
Amended Judgment ordered the EPA to take steps to undertake these
revisions as expeditiously as practicable.
    For these reasons, the EPA finds good cause to issue a final
rulemaking pursuant to section 553 of the APA, 5 U.S.C. 553(b)(3)(B).
The requirements of CAA section 307(d), including the requirement for
public comment and hearing on proposed rulemakings, do not apply to
this action because 5 U.S.C. 553(b)(3)(B) applies. In addition, this
rule relieves a restriction on construction of some stationary sources
and therefore is not subject to the requirement for a 30-day delay in
effective date. 5 U.S.C. 553(d)(1). Moreover, the agency finds that the
problems outlined above regarding the effects of delaying issuance of
the rule also provide good cause for not delaying its effective date. 5
U.S.C. 553(d)(3). Accordingly, the requirement for a delay in effective
date does not apply and the rule will take effect upon publication in
the Federal Register. 5 U.S.C. 553(d).

IV. Implementation

    The D.C. Circuit's vacatur of the Tailoring Rule Step 2 PSD
permitting requirements in 40 CFR 51.166(b)(48)(v) and 40 CFR
52.21(b)(49)(v) and the provisions that required further action to
consider phasing-in GHG permitting requirements into the PSD and title
V programs at lower GHG emission thresholds at 40 CFR 52.22, 70.12, and
71.13 means that these provisions can no longer be relied upon by the
EPA, permit applicants or permitting authorities as a basis for issuing
PSD permits. Further, this means that the EPA will not be required to
take the actions specified in the regulations at 40 CFR 52.22, 70.12,
and 71.13 to consider further phasing in GHG PSD and title V permitting
requirements at lower GHG emissions thresholds.
    Permit reviewing authorities with EPA-approved SIPs containing any
or all of the affected provisions previously allowed by 40 CFR
51.166(b)(48)(v) may request to remove their corresponding Tailoring
Rule Step 2 provisions as soon as feasible, which may be in conjunction
with the next otherwise planned SIP revision. Permit reviewing
authorities also have the option to retain the Tailoring Rule Step 2
permitting requirements solely as a requirement of state law, but these
requirements will not be approved as part of their federally-
enforceable SIP. As we explained in a memorandum issued by the agency
on July 24, 2014, titled, ``Next Steps and Preliminary Views on the
Application of Clean Air Act Permitting Programs to Greenhouse Gases
Following the Supreme Court's Decision in UARG v. EPA'' (Preliminary
Views Memo),\4\ we again note that the ``[EPA does] not read the [U.S.]
Supreme Court decision to preclude states from retaining permitting
requirements for sources of GHG emissions that apply independently
under state law even where those requirements are no longer required
under federal law.''
---------------------------------------------------------------------------

    \4\ http://epa.gov/nsr/documents/20140724memo.pdf.
---------------------------------------------------------------------------

    With regard to PSD Step 2 permits already issued, the Preliminary
Views Memo explained that the EPA ``will no longer require PSD . . .
permits for Step 2 sources'' (Preliminary Views Memo at 2) and that the
EPA expected ``to provide additional views in the future with respect
to Step 2 sources that had already obtained a PSD permit . . .''
(Preliminary Views Memo at 4). The EPA provided additional views
regarding EPA-issued Step 2 PSD permits \5\ when it issued two
memoranda on December 19, 2014. In the first memorandum issued by the
Office of Air and Radiation (OAR) and titled, ``Next Steps for
Addressing EPA-Issued Step 2 Prevention of Significant Deterioration
Greenhouse Gas Permits and Associated Requirements'' (OAR Next Steps
Memo),\6\ the EPA explained that it intended to complete a rulemaking
``authorizing the rescission of Step 2 PSD permits.'' In the second
memorandum, which was issued by the Office of Enforcement and
Compliance Assurance (OECA) and titled, ``No Action Assurance Regarding
EPA-Issued Step 2 Prevention of Significant Deterioration Permits and
Related Title V Requirements Following Utility Air Regulatory Group v.
Environmental Protection Agency'' (OECA No Action Assurance Memo),\7\
OECA issued a narrowly tailored No Action Assurance for sources with
EPA-issued Step 2 PSD permits. The OECA No Action Assurance Memo
establishes that the EPA will exercise its enforcement discretion not
to pursue enforcement of the terms and conditions relating to GHGs in a
source's EPA-issued Step 2 PSD permit, and for related GHG terms and
conditions that are contained in the source's title V permit, if any,
until 11:59 p.m. EDT, September 30, 2016. The No Action Assurance
ceases to apply to a source once its EPA-issued Step 2 PSD permit is
rescinded, and, if applicable, its title V permit is accordingly
revised, whichever is later.
---------------------------------------------------------------------------

    \5\ For purposes of this rule, the phrases ``EPA-issued PSD
permits that were issued under Step 2 of the Tailoring Rule'' and
``EPA-issued Step 2 PSD permits'' are intended to have the same
meaning. The use of the term ``EPA-issued'' in both phrases includes
PSD permits issued by the EPA as well as permits issued by state or
local reviewing authorities exercising federal law authority
delegated by an EPA Regional Office under 40 CFR 52.21(u).
    \6\ http://www.epa.gov/nsr/ghgdocs/Step2PermitRescissionMemoFinal_12-19-14.pdf.
    \7\ http://epa.gov/nsr/ghgdocs/OECANoActionAssuranceMemo_December192014.pdf.
---------------------------------------------------------------------------

    Consistent with the plan described in the OAR Next Steps Memo, the
EPA completed the rulemaking that allows for rescission of Step 2
permits. ``Prevention of Significant Deterioration Permitting for
Greenhouse Gases: Providing Option for Rescission of EPA-Issued
Tailoring Rule Step 2 Prevention of Significant Deterioration Permits''
(80 FR 26183; May 7, 2015). This rule provides a mechanism for the EPA
and delegated reviewing authorities to rescind EPA-issued Step 2 PSD
permits in response to requests from applicants who can demonstrate
that they are eligible for permit rescission and as further discussed
in that rule. EPA received no comments on this rule, and it is now in
effect. Sources with questions on PSD permitting obligations arising
from Step 2 PSD permits issued by state, local or tribal permitting
authorities under permitting programs approved into the state or tribal
implementation plans should review the governing statutory provisions
and the provisions in the applicable state or tribal implementation
plans to determine how to address these Step 2 permits and consult with
the EPA, states and tribes, as necessary.
    In the case of sources that trigger PSD based on emissions of
pollutants other than GHG (``anyway sources''), the PSD BACT
requirement continues to apply to GHG emissions from such sources. This
rulemaking does not change Sec. Sec.  51.166(j), 51.166(b)(48)(iv),
52.21(j),

or 52.21(b)(48)(iv) of EPA's regulations, which remain in effect. Under
these provisions, the BACT requirement applies to GHG emissions from
``anyway sources'' when a new source emits or has the potential to emit
75,000 tons per year (tpy) or more of GHG on a carbon dioxide
equivalent (``CO2e'') basis. When an anyway source is
modified, under these provisions, the BACT requirement applies to GHGs
if (1) the modification is otherwise subject to PSD for a pollutant
other than GHG; and (2) the modification results in a GHG emissions
increase and a net GHG emission increase equal to or greater than
75,000 tpy or more on a CO2e basis and greater than zero on
a mass basis.
    With respect to title V, the D.C. Circuit's Amended Judgment in
Coalition means that the provisions at 40 CFR 70.12 and 71.13
addressing further consideration of phasing-in of title V permitting
program requirements at lower GHG emission thresholds are no longer in
effect. The obligations that they contain for the EPA to further study
and take further action to consider regulating GHGs at lower GHG
emissions thresholds under the title V program no longer exist.

V. Environmental Justice Considerations

    This action removes sections and paragraphs of the PSD and title V
GHG Tailoring Rule regulations that the D.C. Circuit specifically
identified as vacated in the Coalition Amended Judgment. In accordance
with the changes made by this action, permit applicants are no longer
required to request PSD permits if GHGs are the only pollutant (i) that
the source emits or has the potential to emit above the major source
thresholds, or (ii) for which there is a significant emissions increase
and a significant net emissions increase from a modification. In
addition, the EPA will not be required to take the actions specified in
the regulations at 40 CFR 52.22, 70.12, and 71.13 to consider further
phasing in GHG PSD and title V permitting requirements at lower GHG
emissions thresholds. Therefore, this action itself does not compel any
specific permit action that will affect the fair treatment and
meaningful involvement of all people. Rather, it makes clear that a
portion of the Coalition Amended Judgment is efficiently implemented
and permit applicants are no longer required to submit PSD permit
applications if GHGs are the only pollutant that the sources emits
above the applicable major source thresholds.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations and has assigned OMB
control number 2060-0003. To the extent this rule has any substantive
effect, it relieves regulatory burdens by removing regulations that
purport to require permit applicants to request PSD permits if GHGs are
the only pollutant emitted by the new source or modification to an
existing source above the applicable major source thresholds and
regulations that required the EPA to consider further phasing-in the
GHG permitting requirements at lower GHG emission thresholds. This
action is taken in light of the D.C. Circuit's Coalition Amended
Judgment that vacated those regulations.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden or otherwise has a positive economic effect on the small
entities subject to the rule. To the extent this rule has any
substantive effect, it relieves regulatory burdens by removing
regulations that purport to require permit applicants to request PSD
permits if GHGs are the only pollutant emitted by the new source or
modification to an existing source above the applicable major source
thresholds and regulations that required the EPA to consider further
phasing-in the GHG permitting requirements at lower GHG emission
thresholds. This action is taken in light of the D.C. Circuit's
Coalition Amended Judgment that vacated those regulations. We have
therefore concluded that this action will relieve regulatory burden for
all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175. Although the Tribal Air Rule (76 FR 38748, July
1, 2011) under the CAA gives tribes the opportunity to request and be
granted delegation of the federal PSD program found at 40 CFR 52.21 to
issue PSD permits, there are no tribal agencies currently implementing
the federal PSD permitting program. As a result, the removal of the PSD
provisions that the D.C. Circuit vacated will not affect any tribal
reviewing authorities and any tribally-owned sources with EPA-issued
Step 2 PSD permits have the discretion to request the EPA to rescind
their permit. In addition, the D.C. Circuit vacatur of the requirements
for the EPA to consider further phasing in GHG permitting requirements
into the PSD and title V programs at lower GHG emission thresholds
provides relief to tribally-owned sources that could have been subject
to GHG permitting regulations at lower GHG emission thresholds if the
EPA would have taken steps to apply GHG permitting requirements to such
sources at such thresholds. Thus, Executive Order 13175 does not apply
to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045

because it does not concern an environmental health risk or safety
risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed
by this action will not have potential disproportionately high and
adverse human health or environmental effects on minority, low-income
or indigenous populations. The results of this evaluation are contained
in the section V titled, ``Environmental Justice Considerations'' for
this action.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice-and-comment rulemaking procedures are
impracticable, unnecessary or contrary to the public interest (5 U.S.C.
808(2)). The EPA has made a good cause finding for this rule as
discussed in the Final Action section of this rulemaking, including the
basis for that finding.

L. Determination Under Section 307(d)

    Pursuant to CAA section 307(d)(1)(V), the Administrator determines
that this action is subject to provisions of section 307(d). Section
307(d) establishes procedural requirements specific to rulemaking under
the CAA. Section 307(d)(1)(V) provides that the provisions of section
307(d) apply to ``such other actions as the Administrator may
determine.''

VII. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the U.S. Court of Appeals for the D.C.
Circuit within 60 days from August 19, 2015. 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) of the CAA).

List of Subjects

40 CFR Parts 51 and 52

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by reference, Intergovernmental
relations, Lead, National ambient air quality standards, New source
review, Nitrogen dioxide, Ozone, Particulate matter, Preconstruction
permitting, Prevention of significant deterioration, Reviewing
authorities, Sulfur oxides, Tailoring rule, Volatile organic compounds.

40 CFR Parts 70 and 71

    Environmental protection, Air pollution control, Carbon monoxide,
Greenhouse gases, Intergovernmental relations, Lead, National ambient
air quality standards, Nitrogen dioxide, Operating permits, Ozone,
Particulate matter, Permitting authorities, Sulfur oxides, Tailoring
rule, Title V, Volatile organic compounds.

    Dated: August 12, 2015.
Gina McCarthy,
Administrator.

    For the reasons stated in the preamble, title 40, Chapter I of the
Code of Federal Regulations is amended as follows:

PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS

0
1. The authority citation for part 51 continues to read as follows:

    Authority:  23 U.S.C. 101; 42 U.S.C. 7401-7671q.

Subpart I--Review of New Sources and Modifications

Sec.  51.166  [Amended]

0
2. Section 51.166 is amended by removing paragraph (b)(48)(v).

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart A--General Provisions

Sec.  52.21  [Amended]

0
4. Section 52.21 is amended by removing paragraph (b)(49)(v).

Sec.  52.22  [Removed]

0
5. Section 52.22 is removed.

PART 70--STATE OPERATING PERMIT PROGRAMS

0
6. The authority citation for part 70 continues to read as follows:

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

Sec.  70.12  [Removed]

0
7. Section 70.12 is removed.

PART 71--FEDERAL OPERATING PERMIT PROGRAMS

0
8. The authority citation for part 71 continues to read as follows:

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

Sec.  71.13  [Removed]

0
9. Section 71.13 is removed.
[FR Doc. 2015-20501 Filed 8-18-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Proposed Rules]
[Pages 57806-57808]
[FR Doc No: 2020-20235]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0800; Airspace Docket No. 20-ANM-43]
RIN 2120-AA66

Proposed Revocation of Class D and Amendment of Class E Airspace;
Gillette, WY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to remove the Class D airspace and modify
the following: Class E surface area, the Class E airspace as an
extension to the surface area and the Class E airspace extending upward
from 700 feet AGL at Gillette-County Airport, Gillette, WY. In
addition, this proposal would remove the VOR/DME from the legal
description and replace the outdated term Airport Facility/Directory
with the term Chart Supplement.
    After being informed that the Airport Traffic Control Tower at
Gillette-County Airport is closed permanently, the FAA found it
necessary to amend the existing airspace for the safety and management
of Instrument Flight Rules (IFR) operations at this airport.

DATES: Comments must be received on or before November 2, 2020.

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-2020-0800; Airspace Docket No. 20-ANM-43, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11E, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://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
7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S. 216th Street, Des Moines, WA 98198; 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 remove the Class D and modify the Class E airspace at
Gillette-County Airport, Gillette, WY to support IFR operations at the
airport.

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-2020-0800;
Airspace Docket No. 20-ANM-43''. 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 https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://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, 2200 S. 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E 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 14 CFR part 71 to remove the
Class D airspace and modify the following: Class E surface area, the
Class E airspace as an extension to the Class E surface area and the
Class E airspace extending upward from 700 feet AGL at Gillette-
Campbell County Airport, Gillette, WY.
    The FAA was informed that the Airport Traffic Control Tower at
Gillette-Campbell County Airport is closed, which is a basic
qualification for the establishment of Class D airspace. As a result,
the FAA is proposing to remove the Class D airspace and modify the
Class E Surface Airspace at the airport. The Class E surface airspace
would be expanded from 4.3 miles to 5 miles to ensure departures are
contained in the surface area until reaching 700 feet AGL.
    The Class E airspace extending upward from the surface as an
extension to the Class E surface area would be expanded to 3.4 miles
each side of the 170[deg] bearing from 3 miles to 12 miles (formerly
12.2 miles) south of the airport. This adjustment would protect
aircraft as they descend through 1,000 feet AGL, while using the RNAV
and ILS approaches to runway 34.
    The Class E airspace extending upward from 700 feet would be
modified to within 4 miles each side of the 170[deg] and 350[deg]
bearings (reduced from 6.1 miles east and 8.3 miles west) and extend 14
miles south (reduced from 15.3 miles) and 11 miles north (reduced from
16.1miles). The additional airspace is no longer needed to protect
departing aircraft to 1,200 feet and arrivals as they descend through
1,500 feet AGL. This proposal would remove the Class E airspace
extending upward from 1,200 feet as it is redundant with the Denver E6
airspace and no longer needed.
    In addition, the legal descriptions for the Class E airspace
extending upward from the surface as an extension to the Class E
surface area and the Class E airspace extending upward from 700 feet
would be rewritten to eliminate the use of the VOR/DME as a reference
point. The VOR/DME is no longer needed to adequately describe the
airspace.
    The use of the term Airport Facility/Directory would be replaced
with Chart Supplement and the geographical coordinates updated to match
the FAA database.
    Class E airspace designations are published in paragraph 5000,
6002, 6004, 6005 of FAA Order 7400.11E, dated July 21, 2020, and
effective September 15, 2020, 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. FAA Order 7400.11,
Airspace Designations and Reporting Points, is published yearly and
effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, 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 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ANM WY D Gillette, WY [Remove]

Gillette-Campbell County Airport, WY
    (Lat. 44[deg]20'56'' N, long. 105[deg]32'22'' W)

Paragraph 6002. Class E Airspace Designated as Surface Areas.

* * * * *

ANM WY E2 Gillette, WY [Amended]

Gillette-Campbell County Airport, WY
    (Lat. 44[deg]20'56'' N, long. 105[deg]32'22'' W)

    That airspace extending upward from the surface to and including
6,900 feet MSL within a 5-mile radius of the Gillette-Campbell
County Airport. This Class E airspace is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

ANM WY E4 Gillette, WY [Amended]

Gillette-Campbell County Airport, WY
    (Lat. 44[deg]20'56'' N, long. 105[deg]32'22'' W)

    That airspace extending upward from the surface within 3.4 miles
each side of the Gillette County Airport 170[deg] bearing extending
from the 5-mile radius of Gillette-Campbell County Airport to 12
miles south of the airport.

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

* * * * *

ANM WY E5 Gillette, WY [Amended]

Gillette-Campbell County Airport, WY
    (Lat. 44[deg]20'56'' N, long. 105[deg]32'22'' W)

    That airspace extending upward from 700 feet above the surface
of the earth within 4 miles each side of the 170[deg] bearing
extending from the 5-mile radius to 14 miles south of the airport,
and that airspace 4 miles each side of the 350[deg] bearing
extending from the 5-mile radius to 11 miles north of the airport.

    Issued in Seattle, Washington, on September 8, 2020.
Byron Chew,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2020-20235 Filed 9-15-20; 8:45 am]
BILLING CODE 4910-13-P