[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66039-66040]
[FR Doc No: 2016-23106]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2610]

A List of Biomarkers Used as Outcomes in Development of FDA-
Approved New Molecular Entities and New Biological Therapeutics
(October 2007 to December 2015); Establishment of a Public Docket;
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice
entitled ``A List of Biomarkers Used as Outcomes in Development of FDA-
Approved New Molecular Entities and New Biological Therapeutics
(October 2007 to December 2015); Establishment of a Public Docket''
that appeared in the Federal Register of September 19, 2016 (81 FR
64177). The document announced the establishment of a docket to receive
suggestions, recommendations, and comments from interested parties
(such as academic researchers, regulated industries, consortia, and
patient groups) on a list of biomarkers that were used as outcomes to
develop FDA-approved new molecular entities (NMEs) and New Biological
Therapeutics from October 2007 to December 2015. The document was
published without an active Web link. This document corrects that
error.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver
Spring MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, September
19, 2016, in FR Doc. 2016-22470, on page 64178 the following correction
is made:
    On page 64178, in the second column, in the last sentence of the
first paragraph under Section I, Background, ``Biomarkers Used as
Outcomes in Development of FDA-Approved Therapeutics (October 2007 to
December 2015)'' is corrected to read ``http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm483052.htm''.

    Dated: September 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23106 Filed 9-23-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 98 (Tuesday, May 21, 2013)]
[Rules and Regulations]
[Pages 29615-29616]
[FR Doc No: 2013-11969]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0081; Airspace Docket No. 12-AEA-5]
RIN 2120-AA66

Establishment of Area Navigation (RNAV) Routes; Washington, DC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes five new RNAV routes in support of the
Washington, DC, Optimization of Airspace and Procedures in a Metroplex
project. The routes increase National Airspace System (NAS) efficiency
and allow easier transition into the high altitude structure for
departures from the Washington, DC Metropolitan area airports.

DATES: Effective date 0901 UTC, August 22, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy and ATC
Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published in the Federal Register a notice of proposed
rulemaking (NPRM) to establish three high altitude RNAV routes,
designated Q-68, Q-72 and Q-80; and two low altitude RNAV routes,
designated T-291 and T-295, in the Washington, DC area (78 FR 10562,
February 14, 2013). Interested parties were invited to participate in
this rulemaking effort by submitting written comments on the proposal.
One comment was received and the commenter expressed support for the
proposal.

The Rule

    The FAA is amending Title 14, Code of Federal Regulations (14 CFR)
part 71 by establishing three high altitude RNAV routes, designated Q-
68, Q-72 and Q-80; and two low altitude RNAV routes, designated T-291
and T-295, in the Washington, DC area. The new Q-routes facilitate the
divergence of aircraft departures from the Washington, DC, Metropolitan
area airports, produce shorter routings and allow easier transition
into the high altitude route structure. The Q-routes are one-way routes
going westward and serve primarily as feeders and alternate dispersion
routes for aircraft departing the DC Metro area to the west. The new T-
routes reduce ATC complexity and provide shorter routes of flight in
some cases.
    The following routes are established. Q-68 extends between the
Charleston, WV, VHF omnidirectional range tactical air navigation
(VORTAC) aid and the OTTTO, VA, waypoint (WP). Q-72 extends between the
HACKS, WV, intersection and the RAMAY, VA, WP. It provides an alternate
route for jet route J-149 via a direct routing to the HACKS
intersection, thus reducing miles flown for RNAV-equipped aircraft. Q-
80 extends between the FAREV, KY, WP and the OTTTO, VA, WP to serve
aircraft headed to the southwest.
    T-291 extends between the LOUIE, MD, navigation fix and the
Harrisburg, PA, VORTAC. T-295 extends between the LOUIE fix and the
Lancaster, PA, VORTAC. T-291 and T-295 have a maximum assigned altitude
(MAA) of 11,000 feet MSL. The new T-routes provide more efficient and
predictable routing for aircraft utilizing airports near Harrisburg,
PA, and the airports south of Patuxent River, MD, that normally fly VOR
Federal airways V-31, V-33, V-93 and V-499 near the area. The T-routes
also enhance segregation of those aircraft utilizing those airways from
the DC Metro arrivals coming from the northeast and from the DC Metro
departures headed eastbound.
    The above routes increase NAS efficiency and advance the use of
NextGen technology.
    High altitude RNAV routes are published in paragraph 2006, and low
altitude RNAV routes are published in paragraph 6011, respectively, of
FAA Order 7400.9W dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The RNAV
routes listed in this document would be subsequently published in the
Order. The RNAV routes listed in this document will be published
subsequently in the Order.
    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.
Therefore, this regulation: (1) is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that only affects air traffic
procedures and air navigation, it is certified that this rule, when
promulgated, does not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes RNAV routes to enhance the safe and efficient flow of
traffic in the Washington, DC Metropolitan area.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

    Authority:  49 U.S.C. 106(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 7400.9W,

Airspace Designations and Reporting Points, dated August 8, 2012, and
effective September 15, 2012, is amended as follows:

Paragraph 2006 United States Area Navigation Routes

* * * * *

Q68 Charleston, WV (HVQ) to OTTTO, VA [New]

Charleston, WV (HVQ)          VORTAC              (Lat. 38[deg]20'59'' N., long. 081[deg]46'12'' W.)
TOMCA,WV                      WP                  (Lat. 38[deg]34'42'' N., long. 080[deg]36'41'' W.)
RONZZ, WV                     WP                  (Lat. 38[deg]33'16'' N., long. 080[deg]07'57'' W.)
HHOLZ, WV                     WP                  (Lat. 38[deg]38'02'' N., long. 079[deg]41'33'' W.)
HAMME, WV                     WP                  (Lat. 38[deg]42'30'' N., long. 079[deg]14'39'' W.)
CAPOE, VA                     WP                  (Lat. 38[deg]51'13'' N., long. 078[deg]22'27'' W.)
OTTTO, VA                     WP                  (Lat. 38[deg]51'16'' N., long. 078[deg]12'20'' W.)

Q72 HACKS, WV to RAMAY, VA [New]

HACKS, WV                     FIX                 (Lat. 39[deg]07'46'' N., long. 081[deg]05'35'' W.)
GEQUE. WV                     WP                  (Lat. 39[deg]05'19'' N., long. 080[deg]17'58'' W.)
BENSH, WV                     WP                  (Lat. 39[deg]01'10'' N., long. 079[deg]10'29'' W.)
RAMAY, VA                     WP                  (Lat. 38[deg]57'39'' N., long. 078[deg]12'59'' W.)

Q80 FAREV, KY to OTTTO, VA [New]

FAREV, KY                     WP                  (Lat. 37[deg]12'28'' N., long. 085[deg]07'21'' W.)
JEDER, KY                     WP                  (Lat. 37[deg]19'31'' N., long. 084[deg]45'14'' W.)
ENGRA, KY                     WP                  (Lat. 37[deg]29'02'' N., long. 084[deg]15'02'' W.)
DEWAK, KY                     WP                  (Lat. 37[deg]46'38'' N., long. 083[deg]14'58'' W.)
CEGMA, KY                     WP                  (Lat. 37[deg]54'00'' N., long. 082[deg]50'32'' W.)
JONEN, KY                     WP                  (Lat. 37[deg]59'09'' N., long. 082[deg]32'46'' W.)
BULVE, WV                     WP                  (Lat. 38[deg]13'20'' N., long. 081[deg]42'43'' W.)
WISTA, WV                     WP                  (Lat. 38[deg]17'01'' N., long. 081[deg]27'47'' W.)
LEVII, WV                     WP                  (Lat. 38[deg]22'20'' N., long. 081[deg]05'52'' W.)
RONZZ, WV                     WP                  (Lat. 38[deg]33'16'' N., long. 080[deg]07'57'' W.)
HHOLZ, WV                     WP                  (Lat. 38[deg]38'02'' N., long. 079[deg]41'33'' W.)
HAMME, WV                     WP                  (Lat. 38[deg]42'30'' N., long. 079[deg]14'39'' W.)
CAPOE, VA                     WP                  (Lat. 38[deg]51'13'' N., long. 078[deg]22'27'' W.)
OTTTO, VA                     WP                  (Lat. 38[deg]51'16'' N., long. 078[deg]12'20'' W.)

Paragraph 6011 United States Area Navigation Routes

* * * * *

T-291 LOUIE, MD to Harrisburg (HAR), PA [New]

LOUIE, MD                     Fix                 (Lat. 38[deg]36'44'' N., long. 076[deg]18'04'' W.)
MORTY, MD                     WP                  (Lat. 39[deg]19'51'' N., long. 076[deg]24'41'' W.)
Harrisburg, PA (HAR)          VORTAC              (Lat. 40[deg]18'08'' N., long. 077[deg]04'10'' W.)

T-295 LOUIE, MD to Lancaster (LRP), PA [New]

 LOUIE, MD                    Fix                 (Lat. 38[deg]36'44'' N., long. 076[deg]18'04'' W.)
MORTY, MD                     WP                  (Lat. 39[deg]19'51'' N., long. 076[deg]24'41'' W.)
Lancaster, PA (LRP)           VORTAC              (Lat. 40[deg]07'12'' N., long. 076[deg]17'29'' W.)

    Issued In Washington, DC, on May 14, 2013.
Gary A. Norek,
Manager, Airspace Policy and ATC Procedures Group.
[FR Doc. 2013-11969 Filed 5-20-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 69 (Thursday, April 10, 2014)]
[Proposed Rules]
[Pages 19846-19848]
[FR Doc No: 2014-08071]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0193; Directorate Identifier 2013-NM-234-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A318, A319, A320, and A321 series airplanes. This
proposed AD was prompted by a report of a crack found in the fuselage
during a fatigue test campaign. This proposed AD would require
repetitive rototest inspections for cracking; corrective actions if
necessary; and modification of the torsion box, which would terminate
the repetitive inspections. We are proposing this AD to prevent
cracking in the side box beam flange of the fuselage, which could
affect the structural integrity of the airplane.

DATES: We must receive comments on this proposed AD by May 27, 2014.

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 W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0193; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed 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: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0193;
Directorate Identifier 2013-NM-234-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on 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 proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2013-0261, dated October 28, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    During the full scale fatigue test campaign of the A320 family
type design, a crack was reported in the fuselage side box beam
flange at frame (FR) 43 level, both sides.
    This condition, if not detected and corrected, could affect the
structural integrity of the aeroplane.
    For the reason describe above, this [EASA] AD requires
repetitive inspections of the fuselage side box beam flange at FR43,
and, depending on findings, corrective action(s) [repair]. This
[EASA] AD also requires a modification, which constitutes
terminating action for the repetitive inspections.

    The modification includes related investigative and corrective
actions. The related investigative actions include a rotoprobe
inspection of the holes for cracks, and a high frequency eddy current
(HFEC) inspection for cracks. The corrective action includes repair.
You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No. FAA-
2014-0193.

Relevant Service Information

    Airbus has issued Service Bulletin A320-53-1251, Revision 01, dated
October 18, 2013, and Service Bulletin A320-53-1258, dated October 18,
2012. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed 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 proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Repair Approvals

    In many FAA transport ADs, when the service information specifies
to contact the manufacturer for further instructions if certain
discrepancies are found, we typically include in the AD a requirement
to accomplish the action using a method approved by either the FAA or
the State of Design Authority (or its delegated agent).
    We have recently been notified that certain laws in other countries
do not allow such delegation of authority, but some countries do
recognize design approval organizations. In addition, we have become
aware that some U.S. operators have used repair instructions that were
previously approved by a State of Design Authority or a Design Approval
Holder (DAH) as a method of compliance with this provision in FAA ADs.
Frequently, in these cases, the previously approved repair instructions
come from the airplane structural repair manual or the DAH repair
approval statements that were not specifically developed to address the
unsafe condition corrected by the AD. Using repair instructions that
were not specifically approved for a particular AD creates the
potential for doing repairs that were not developed to address the
unsafe condition identified by the MCAI AD, the FAA AD, or the
applicable service information, which could result in the unsafe
condition not being fully corrected.
    To prevent the use of repairs that were not specifically developed
to correct the unsafe condition, certain requirements of this proposed
AD would require that the repair approval specifically refer to the FAA
AD. This change is intended to clarify the method of compliance and to
provide operators with better visibility of repairs that are
specifically developed and approved to correct the unsafe condition. In
addition, we use the phrase ``its delegated agent, or the DAH with
State of Design Authority design organization approval, as applicable''
in this proposed AD to refer to a DAH authorized to approve certain
required repairs for this proposed AD.

Costs of Compliance

    We estimate that this proposed AD affects 851 airplanes of U.S.
registry.
    We also estimate that it would take about 178 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour. Required parts would cost
about $31,334 per product. Based on these figures, we estimate the cost
of this proposed AD on U.S. operators to be $39,540,864, or $46,464 per
product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

Airbus: Docket No. FAA-2014-0193; Directorate Identifier 2013-NM-
234-AD.

(a) Comments Due Date

    We must receive comments by May 27, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A318-111, -112, -121, and -122
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -
133 airplanes; Model A320-111, -211, -212, -214, -231, -232, and -
233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -
231, and -232 airplanes; certificated in any category; all
manufacturer serial numbers on which Airbus modification 21202 has
been embodied in production, except those on which modification
152569 has been embodied in production.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by a report of a crack found in the side
box beam flange of the fuselage at the frame (FR) 43 level during a
fatigue test campaign. We are issuing this AD to prevent cracking in
the side box beam flange of the fuselage, which could affect the
structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Inspection

    At the time specified in paragraph (g)(1) or (g)(2) of this AD,
whichever occurs later: Do a rototest inspection for cracking of the
beam flange of the stiffener 15 side box on the left- and right-hand
sides in the FR43 area, in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A320-53-1258, dated October
18, 2012. Repeat the inspection thereafter at intervals not to
exceed 7,500 flight cycles or 15, 000 flight hours, whichever occurs
first.
    (1) Before exceeding 24,000 flight cycles or 48,000 flight
hours, whichever occurs first since the airplane's first flight.
    (2) Within 3,000 flight cycles or 6,000 flight hours, whichever
occurs first after the effective date of this AD.

(h) Corrective Action

    If any crack is found during any inspection required by
paragraph (g) of this AD: Before further flight, repair using a
method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; or European Aviation Safety
Agency (EASA) (or its delegated agent, or the Design Approval Holder
(DAH) with EASA design organization approval). For a repair method
to be approved, the repair approval must specifically refer to this
AD.

(i) Modification

    Before exceeding 48,000 flight cycles or 96,000 flight hours,
whichever occurs first since the airplane's first flight: Modify the
fittings on the left- and right-hand sides of the torsion box,
including doing all applicable related investigative and corrective
actions, in accordance with the Accomplishment Instructions of
Airbus Service Bulletin A320-53-1251, Revision 01, dated October 18,
2013; except where Airbus Service Bulletin A320-53-1251, Revision
01, dated October 18, 2013, specifies to contact Airbus for repair,
before further flight, repair using a method approved by the
Manager, International Branch, ANM-116, Transport Airplane
Directorate, FAA; or European Aviation Safety Agency (EASA) (or its
delegated agent, or the Design Approval Holder (DAH) with EASA
design organization approval). For a repair method to be approved,
the repair approval must specifically refer to this AD.

(j) Terminating Action

    Modification of the airplane as required by paragraph (i) of
this AD constitutes terminating action for the repetitive
inspections required by paragraph (g) of this AD.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(i) of this AD, if those actions were performed before the effective
date of this AD using Airbus Service Bulletin A320-53-1251, November
16, 2012, which is not incorporated by reference in this AD.

(l) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch, send it to ATTN: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM 116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone (425) 227
1405; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, 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, use these actions if they
are FAA-approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the DAH with a State of Design Authority's
design organization approval, as applicable). For a repair method to
be approved, the repair approval must specifically refer to this AD.
You are required to ensure the product is airworthy before it is
returned to service.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2013-0261, dated October 28,
2013, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2014-0193.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on April 1, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-08071 Filed 4-9-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20781]
[DOCID:fr17ap08-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-0161; Airspace Docket No. 07-ASO-25]

Establishment of Class E Airspace; New Albany, MS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; confirmation of effective date.

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

SUMMARY: This action confirms the effective date of a direct final rule
published in the Federal Register (73 FR 5434) that establishes a Class
E airspace area to support Area Navigation (RNAV) Global Positioning
System (GPS) Standard Instrument Approach Procedures (IAPs) that serve
the New Albany-Union County Airport, New Albany, MS.

DATES: Effective 0901 UTC, April 10, 2008. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Daryl Daniels, Airspace Specialist,
System Support, AJO2-E2B.12, FAA Eastern Service Center, 1701 Columbia
Ave., College Park, GA 30337; telephone<PHONE_NUMBER>; fax (404) 305-
5572.

SUPPLEMENTARY INFORMATION:

Confirmation of Effective Date

    The FAA published this direct final rule with a request for
comments in the Federal Register on January 30, 2008 (73 FR 5434),
Docket No. FAA-2007-0161; Airspace Docket No. 07-ASO-25. The FAA uses
the direct final rulemaking procedure for a non controversial rule
where the FAA believes that there will be no adverse public comment.
This direct final rule advised the public that no adverse comments were
anticipated, and that unless a written adverse comment, or a written
notice of intent to submit such an adverse comment, were received
within the comment period, the regulation would become effective on
April 10, 2008. No adverse comments were received, and thus this notice
confirms that effective date.

    Issued in College Park, GA on April 2, 2008.
Barry A. Knight,
Acting Manager, System Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. E8-8063 Filed 4-16-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: October 7, 2008 (Volume 73, Number 195)]
[Proposed Rules]
[Page 58513-58514]
[DOCID:fr07oc08-26]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0985; Airspace Docket No. 08-ASW-18]

Proposed Establishment of Class E Airspace; Edinburg, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This action proposes to establish Class E airspace at South
Texas International Airport, Edinburg, TX. Controlled airspace is
necessary to accommodate Standard Instrument Approach Procedures (SIAP)
at South Texas International Airport, Edinburg, TX. The FAA is taking
this action to enhance the safety and management of Instrument Flight
Rules (IFR) aircraft operations at South Texas International Airport.

DATES: Comments must be received on or before November 21, 2008.

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 20590-0001. You
must identify the docket number FAA-2008-0985/Airspace Docket No. 08-
ASW-18, at the beginning of your comments. You may also submit comments
on 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 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The Docket Office
(telephone 1-800-647-5527), is on the ground floor of the building at
the above address.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone: (817)
222-5582.

SUPPLEMENTARY INFORMATION:

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. Commenters 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-2008-0985/
Airspace Docket No. 08-ASW-18.'' The postcard will be date/time stamped
and returned to the commenter.

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 or the Superintendent of Document's Web page at http://
www.access.gpo.gov/nara.
    Additionally, any person may obtain a copy of this notice by
submitting a request to the Federal Aviation Administration (FAA),
Office of Air Traffic Airspace Management, ATA-400, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>.
Communications must identify both docket numbers for this notice.
Persons interested in being placed on a mailing list for future NPRMs
should contact the FAA's Office of Rulemaking<PHONE_NUMBER>, to
request a copy of Advisory Circular No.

11-2A, Notice of Proposed Rulemaking Distribution System, which
describes the application procedure.

The Proposal

    This action proposes to amend Title 14, Code of Federal Regulations
(14 CFR), Part 71 by establishing Class E airspace for SIAP IFR
operations at South Texas International Airport, Edinburg, TX. The area
would be depicted on appropriate aeronautical charts.
    Class E airspace areas are published in Paragraph 6005 of FAA Order
7400.9R, dated August 15, 2007, and effective September 15, 2007, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designation listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under 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, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the U.S.
Code. Subtitle 1, 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 establish controlled
airspace at South Texas International Airport, Edinburg, TX.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

The Proposed Amendment

    In consideration of the foregoing, 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;
AIRWAYS; ROUTES; AND REPORTING POINTS

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9R, Airspace Designations and
Reporting Points, dated August 15, 2007, and effective September 15,
2007, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700' or
more above the surface of the earth.

* * * * *

ASW TX E5 Edinburg, TX [New]

South Texas International Airport, TX
    (Lat. 26[deg]26'30'' N., long. 98[deg]07'20'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of South Texas International Airport.
* * * * *

    Issued in Fort Worth, TX on September 26, 2008.
Donald R. Smith,
Manager, Operations Support Group, ATO Central Service Center.
 [FR Doc. E8-23768 Filed 10-6-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Notices]
[Page 113]
[DOCID:fr03ja06-73]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Declaration of Intention and Soliciting Comments,
Protests, and/or Motions to Intervene

December 22, 2005.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI06-1-000.
    c. Date Filed: November 23, 2005.
    d. Applicant: Ice House Partners, Inc.
    e. Name of Project: Ice House Project.
    f. Location: The proposed Ice House Project will be located on the
Nashua River, tributary to Merrimack River, in the city of Ayer,
Middlesex County, Massachusetts.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Ms. Lisa Dowd, Ice House Partners, Inc., 323
West Main Street, Ayer, MA 01432; telephone:<PHONE_NUMBER>, fax: (978)
772-3441.
    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments, protests, and/or motions: December
30, 2005.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and/or
interventions may be filed electronically via the Internet in lieu of
paper. Any questions, please contact the Secretary's Office. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov. Please include the docket number (DI06-1-

000) on any comments, protests, and/or motions filed.
    k. Description of Project: The proposed run-of-river Ice House
Project would include: (1) An existing 300-foot-long, 12-foot-high log
and plank dam with a concrete cap; (2) an impoundment of 965 acre-feet;
(3) two electrically operated steel sluice gates; (4) a 45-foot-long,
25-foot-wide powerhouse containing two Canadian Hydro Components, 1.2
meter-wide-propeller-type open flume vertical turbines, each with a
capacity of 135-kW; (5) a 300-foot-long transmission line; and (6)
appurtenant facilities. The power would be used to power the Grady
Research x-ray manufacturing facility. The proposed project will be
connected to an interstate grid, and will not occupy any tribal or
federal lands.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the web at http://www.ferc.gov using the

``eLibrary'' link, select ``Docket'' and follow the
instructions. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or TTY,

contact<PHONE_NUMBER>.
    m. Mailing List: Individuals desiring to be included on the
Commission's mailing list should so indicate by writing to the
Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-8164 Filed 12-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Notices]
[Pages 20137-20138]
[FR Doc No: 2019-09414]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2973]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Obtaining Information
for Evaluating Nominated Bulk Drug Substances for Use in Compounding
Drug Products Under Section 503B of the Federal Food, Drug, and
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 7,
2019.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Obtaining Information for Evaluating Nominated Bulk Drug
Substances for Use in Compounding Drug Products Under Section 503B of
the Federal Food, Drug, and Cosmetic Act.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Clinical Use of Bulk Drug Substances Nominated for Use in Compounding
by Outsourcing Facilities OMB Control Number 0910--NEW

    This information collection supports Agency-sponsored research.
Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 353b) requires FDA to develop a list of bulk drug substances
that may be used in compounding under that section (503B bulks list).
Section 503B defines compounding to include the combining, admixing,
mixing, diluting, pooling, reconstituting, or otherwise altering of a
drug or bulk drug substance to create a drug. Compounded drugs are not
FDA-approved. If the conditions under section 503B are met, drug
products compounded by entities known as outsourcing facilities are
exempt from the following requirements of the FD&C Act: requirements
for FDA approval of drugs in section 505 of the FD&C Act (21 U.S.C.
355), labeling with adequate directions for use under section 502(f)(1)
of the FD&C Act (21 U.S.C. 352(f)(1)), and drug supply chain security
requirements under section 582 (21 U.S.C. 360eee-1). One of the
conditions that must be met for a drug product compounded by an
outsourcing facility to qualify for these exemptions is that the
outsourcing facility may not compound a drug using a bulk drug
substance unless (1) the bulk drug substance appears on a list
established by the Secretary identifying bulk drug substances for which
there is a clinical need (``bulks list''); or (2) the substance appears
on the drug shortage list in effect under section 506E of the FD&C Act
(21 U.S.C. 356e) at the time of compounding, distribution, and
dispensing.
    Many bulk drug substances have been nominated by the public for use
in compounding by outsourcing facilities with adequate supporting
information for FDA to evaluate them. The substances were nominated to
treat a variety of conditions. To inform our evaluation of bulk drug
substances for inclusion on the 503B bulks list, we have entered into a
research study with the University of Maryland (UMD) Center of
Excellence in Regulatory Science and Innovation (CERSI) and the Johns
Hopkins University (JHU) CERSI.
    FDA intends to use a two-part analysis in evaluating substances
nominated for placement on the 503B bulks list to determine whether
there is a clinical need. The collaboration with CERSI-UMD and CERSI-
JHU pertains to part 2 of the analysis, which applies to bulk drug
substances that are not components of FDA-approved drug products, as
well as certain bulk drug substances that are components of FDA-
approved drug products that have gone through part 1 and warrant
further evaluation under part 2 of the analysis. One of the factors
that FDA considers under part 2 is ``current and historical use of the
substance in compounded drug products, including information about the
medical condition(s) that the substance has been used to treat and any
references in peer-reviewed medical literature.''
    Researchers may use surveys, interviews, focus groups, and other

information collect tools, as appropriate, to obtain information
concerning the use of compounded product(s) from medical experts,
outsourcing facilities, and other stakeholders. Within this context,
the following questions may be posed:
    1. What are the health condition(s) that the compounded drug is
currently and has been historically used to treat? What is the patient
population for which the compound drug has been used to treat?
    2. What are the characteristics of the compounded drug(s) using the
bulk drug substance (e.g., dosage form, strength, route of
administration)?
    3. Is the compounded drug considered standard therapy by healthcare
practitioners, or is it recommended in clinical practice guidelines? If
so, under what circumstances?
    4. Does an approved drug exist for the health condition that the
compounded drug product is used to treat? If so, what are the
circumstances under which a compounded drug product using the bulk drug
substance would be used in lieu of the approved drug product?
    5. What is the historical use of the compounded drug to treat the
health conditions identified, including the number of years during
which the compounded drug has been prescribed for each use, and any
change regarding its use over time?
    6. To what extent do practitioners prescribe the compounded drug to
treat each health condition identified? How many such prescriptions
and/or orders have been written in the past 5 years? Have there been
any notable changes in the number of prescriptions and/or orders
written over this time?
    7. How widespread is the use of the compounded drug product,
including use in other countries?
    8. Do practitioners order the compounded drug to maintain on hand
before a patient presents with a need for the drug (``office stock''),
or do practitioners typically write prescriptions for a patient after
the patient presents with a need for the compounded drug? If the
former, why (e.g., emergency situations, convenience)?
    In the Federal Register of September 17, 2018 (83 FR 46957), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received, and FDA determined
that this comment was applicable to a different docket published in the
Federal Register, and not relevant to this proposed collection of
mation.
    We estimate the burden of the collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
UMD-CERSI Expert Focus Groups                150              10           1,500               2           3,000
 and Interviews.................
UMD-CERSI Expert Questionnaire..             750              10           7,500           * 0.5           3,750
JHU-CERSI Parent Questionnaire..           1,000               1           1,000           * 0.5             500
                                 -------------------------------------------------------------------------------
    Total.......................           7,250
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
* 30 minutes.

    We base our estimate of the average burden per response on review
activities familiar to the Agency. Since issuing the 60-day notice, FDA
determined an additional burden estimate related to completion of
questionnaires. We welcome additional comments regarding this estimate.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09414 Filed 5-7-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 131 (Tuesday, July 11, 2023)]
[Rules and Regulations]
[Pages 44040-44042]
[FR Doc No: 2023-14584]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0437; Project Identifier MCAI-2022-01358-E;
Amendment 39-22480; AD 2023-12-21]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2021-26-
13, which applied to all Rolls-Royce Deutschland Ltd & Co KG (RRD)
Model Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2,
Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-
J2, Trent 1000-K2, and Trent 1000-L2 engines. AD 2021-26-13 required
revision of the engine Time Limits Manual (TLM) life limits of certain
critical rotating parts and direct accumulation counting (DAC) data
files. Since the FAA issued AD 2021-26-13, RRD has revised the TLM with
more restrictive airworthiness limitations, including updated life
limits for certain critical parts and updated DAC data files. This AD
was prompted by the manufacturer revising the engine TLM life limits of
certain critical rotating parts, updating the DAC data files, and
updating certain maintenance tasks. This AD requires revising the
existing approved maintenance or inspection program, as applicable, to
incorporate more restrictive airworthiness limitations, as specified in
a European Union Aviation Safety Agency (EASA) AD, which is
incorporated by reference (IBR). The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective August 15, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 15,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0437; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, the mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; phone:
+49 221 8999 000; email: [email protected]; website: easa.europa.eu.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the
AD docket at regulations.gov under Docket No. FAA-2023-0437.

FOR FURTHER INFORMATION CONTACT: Sungmo Cho, Aviation Safety Engineer,
FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (781)
238-7241; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2021-26-13, Amendment 39-21872 (86 FR
72840, December 23, 2021), (``AD 2021-26-13''). AD 2021-26-13 applied
to all RRD Model Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent
1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2,
Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 engines. AD 2021-26-13
required operators to update the airworthiness limitations section
(ALS) of their approved maintenance and inspection program by
incorporating the latest revision of the engine TLM life limits of
certain critical rotating parts and updating DAC data files for each
affected model engine. The FAA issued AD 2021-26-13 to prevent the
failure of critical rotating parts.
    The NPRM published in the Federal Register on March 23, 2023 (88 FR
17426). The NPRM was prompted by EASA AD 2022-0210, dated October 17,
2022 (referred to after this as ``the MCAI''), issued by EASA, which is
the Technical Agent for the Member States of the European Union. The
MCAI states the manufacturer published a revised TLM introducing new or
more restrictive tasks and limitations. These new or more restrictive
tasks and limitations include updating declared lives of certain
critical parts and updating DAC data files.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0437.
    In the NPRM, the FAA proposed to require revising the existing
approved maintenance or inspection program, as applicable, to
incorporate more restrictive airworthiness limitations, as specified in
EASA AD 2022-0210. The FAA is issuing this AD to address the unsafe
condition on these products.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from one commenter, The Boeing Company
(Boeing). Boeing supported the NPRM without change.

Conclusion

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA reviewed the relevant data,
considered the comment received, and determined that air safety
requires adopting this AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these products. Except for
minor editorial changes, this AD is adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed EASA AD 2022-0210. EASA AD 2022-0210 specifies
instructions for accomplishing the actions specified in the applicable
TLM, including performing maintenance tasks, replacing life-limited
parts, and revising the existing approved maintenance or inspection
program, as applicable, by incorporating the limitations, tasks, and
associated thresholds and intervals described in the TLM.
    This material is reasonably available because the interested
parties have access to it through their normal course

of business or by the means identified in ADDRESSES.

Differences Between This AD and the MCAI

    Where paragraph (3) of EASA AD 2022-0210 specifies revising the
approved Aircraft Maintenance Programme within 12 months after the
effective date of EASA AD 2022-0210, this AD requires revising the ALS
of the existing approved maintenance or inspection program, as
applicable, within 90 days after the effective date of this AD.

Costs of Compliance

    The FAA estimates that this AD affects 32 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Revise the continuous airworthiness   1 work-hours x $85 per               $0              $85           $2,720
 maintenance program.                  hour = $85.
----------------------------------------------------------------------------------------------------------------

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.
    The FAA is 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

    The FAA has 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

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:
0
a. Removing Airworthiness Directive 2021-26-13, Amendment 39-21872 (86
FR 72840, December 23, 2021); and
0
b. Adding the following new airworthiness directive:

2023-12-21 Rolls-Royce Deutschland Ltd & Co KG: Amendment 39-22480;
Docket No. FAA-2023-0437; Project Identifier MCAI-2022-01358-E.

(a) Effective Date

    This airworthiness directive (AD) is effective August 15, 2023.

(b) Affected ADs

    This AD replaces AD 2021-26-13, Amendment 39-21872 (86 FR 72840,
December 23, 2021).

(c) Applicability

    This AD applies to Rolls-Royce Deutschland Ltd & Co KG Model
Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent
1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2,
Trent 1000-K2, and Trent 1000-L2 engines, all serial numbers.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7200, Engine
(Turbine/Turboprop).

(e) Unsafe Condition

    This AD was prompted by the manufacturer revising the engine
Time Limits Manual life limits of certain critical rotating parts,
updating the direct accumulation counting data files, and updating
certain maintenance tasks. The FAA is issuing this AD to prevent the
failure of critical rotating parts. The unsafe condition, if not
addressed, could result in failure of one or more engines, loss of
thrust control, and loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Except as specified in paragraph (h) of this AD: Perform all
required actions within the compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0210, dated October 17, 2022 (EASA AD 2022-0210).

(h) Exceptions to EASA AD 2022-0210

    (1) Where EASA AD 2022-0210 defines the AMP as the approved
Aircraft Maintenance Programme on the basis of which the operator or
the owner ensures the continuing airworthiness of each operated
engine, this AD defines the AMP as the Aircraft Maintenance Program
on the basis of which the operator or the owner ensures the
continuing airworthiness of each operated airplane.
    (2) Where EASA AD 2022-0210 refers to its effective date, this
AD requires using the effective date of this AD.
    (3) This AD does not require compliance with paragraph (1) of
EASA AD 2022-0210.
    (4) This AD does not require compliance with paragraph (2) of
EASA AD 2022-0210.
    (5) Where paragraph (3) of EASA AD 2022-0210 specifies revising
the approved AMP within 12 months after the effective date of EASA
AD 2022-0210, this AD requires revising the existing approved
maintenance or inspection program, as applicable, and airworthiness
limitations section within 90 days after the effective date of this
AD.
    (6) This AD does not adopt the ``Remarks'' paragraph of EASA AD
2022-0210.

(i) Provisions for Alternative Actions and Intervals

    After performing the actions required by paragraph (g) of this
AD, no alternative actions and associated thresholds and intervals,
including life limits, are allowed unless they are approved as
specified in the provisions of the ``Ref. Publications'' section of
EASA AD 2022-0210.

(j) Alternative Methods of Compliance (AMOCs)

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or responsible Flight
Standards Office, as appropriate. If sending information directly to
the manager of the certification office, send it to the attention of
the person identified in paragraph (k) of this AD and email to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.

(k) Additional Information

    For more information about this AD, contact Sungmo Cho, Aviation
Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; phone:<PHONE_NUMBER>; email: [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Union Aviation Safety Agency AD 2022-0210, dated
October 17, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0210, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; phone: +49 221 8999 000; email:
[email protected]; website: easa.europa.eu. This EASA AD may be
found in the AD docket at regulations.gov under Docket No. FAA-2023-
0437.
    (4) You may view this service information at the at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this 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, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 28, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-14584 Filed 7-10-23; 8:45 am]
BILLING CODE 4910-13-P