18084 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 

(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 to the extent that it justifies 

making a regulatory distinction, 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. 

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 

■ 1. The authority citation for part 39 

continues to read as follows: 

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

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2015–07–01 Rolls-Royce plc: Amendment 

39–18129; Docket No. FAA–2014–0904; 

Directorate Identifier 2014–NE–14–AD. 

(a) Effective Date 

This AD becomes effective May 8, 2015. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all Rolls-Royce plc (RR) 

RB211–524B–02, RB211–524B–B–02, 

RB211–524B2–19, RB211–524B2–B–19, 

RB211–524B3–02, RB211–524C2–19, and 

RB211–524C2–B–19 turbofan engines with 

low-pressure turbine (LPT) stage 3 turbine 

blade, part number (P/N) LK55386, LK86483, 

or LK86503, installed. 

(d) Reason 

This AD was prompted by reports of LPT 

stage 3 turbine blade failure, release of 

blades, and subsequent in-flight shutdown. 

We are issuing this AD to prevent failure of 

LPT stage 3 turbine blades and subsequent 

release of blade debris, which could lead to 

failure of one or more engines, loss of thrust 

control, and damage to the airplane. 

(e) Actions and Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(1) Remove from service before further 

flight any LPT stage 3 turbine blade, P/N 

LK55386, LK86483, or LK86503, that exceeds 

11,000 flight cycles since new. 

(2) If you cannot determine the 

accumulated flight cycles, remove any LPT 

stage 3 turbine blade, P/N LK55386, 

LK86483, or LK86503, within 200 flight 

cycles after the effective date of this AD. 

(3) After the effective date of this AD, do 

not install any LPT stage 3 turbine blade, P/ 

N LK55386, LK86483, or LK86503, on any 

engine if the blade has accumulated 11,000 

or more flight cycles since new. 

(f) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

FAA, may approve AMOCs for this AD. Use 

the procedures found in 14 CFR 39.19 to 

make your request. You may email your 

request to: ANE-AD-AMOC@faa.gov. 

(g) Related Information 

(1) For more information about this AD, 

contact Kenneth Steeves, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine & Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; phone: 781–238–7765; fax: 781–238– 

7199; email: kenneth.steeves@faa.gov. 

(2) Refer to MCAI European Aviation 

Safety Agency AD 2014–0210, dated 

September 19, 2014, for more information. 

You may examine the MCAI in the AD 

docket on the Internet at http://

www.regulations.gov/

#!documentDetail;D=FAA-2014-0904-0002. 

(3) RR Alert Non-Modification Service 

Bulletin No. RB.211–72–AH790, Revision 1, 

dated November 5, 2014, which is not 

incorporated by reference in this AD, can be 

obtained from Rolls-Royce plc, using the 

contact information in paragraph (g)(4) of this 

AD. 

(4) For service information identified in 

this AD, contact Rolls-Royce plc, Corporate 

Communications, P.O. Box 31, Derby, 

England, DE24 8BJ; phone: 011–44–1332– 

242424; fax: 011–44–1332–249936; email: 

http://www.rolls-royce.com/contact/civil_

team.jsp; Internet: https://

www.aeromanager.com. 

(5) You may view this service information 

at the FAA, Engine & Propeller Directorate, 

12 New England Executive Park, Burlington, 

MA. For information on the availability of 

this material at the FAA, call 781–238–7125. 

(h) Material Incorporated by Reference 

None. 

Issued in Burlington, Massachusetts, on 

March 26, 2015. 

Colleen M. D’Alessandro, 

Assistant Directorate Manager, Engine & 

Propeller Directorate, Aircraft Certification 

Service. 

[FR Doc. 2015–07492 Filed 4–2–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 95 

[Docket No. 31012; Amdt. No. 519] 

IFR Altitudes; Miscellaneous 

Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This amendment adopts 

miscellaneous amendments to the 

required IFR (instrument flight rules) 

altitudes and changeover points for 

certain Federal airways, jet routes, or 

direct routes for which a minimum or 

maximum en route authorized IFR 

altitude is prescribed. This regulatory 

action is needed because of changes 

occurring in the National Airspace 

System. These changes are designed to 

provide for the safe and efficient use of 

the navigable airspace under instrument 

conditions in the affected areas. 

DATES: Effective Date: 0901 UTC, April 

30, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Harry Hodges, Flight Procedure 

Standards Branch (AMCAFS–420), 

Flight Technologies and Programs 

Division, Flight Standards Service, 

Federal Aviation Administration, Mike 

Monroney Aeronautical Center, 6500 

South MacArthur Blvd. Oklahoma City, 

OK 73169 (Mail Address: P.O. Box 

25082 Oklahoma City, OK 73125) 

telephone: (405) 954–4164. 

SUPPLEMENTARY INFORMATION: This 

amendment to part 95 of the Federal 

Aviation Regulations (14 CFR part 95) 

amends, suspends, or revokes IFR 

altitudes governing the operation of all 

aircraft in flight over a specified route 

or any portion of that route, as well as 

the changeover points (COPs) for 

Federal airways, jet routes, or direct 

routes as prescribed in part 95. 

The Rule 

The specified IFR altitudes, when 

used in conjunction with the prescribed 

changeover points for those routes, 

ensure navigation aid coverage that is 

adequate for safe flight operations and 

free of frequency interference. The 

reasons and circumstances that create 

the need for this amendment involve 

matters of flight safety and operational 

efficiency in the National Airspace 

System, are related to published 

aeronautical charts that are essential to 

the user, and provide for the safe and 

efficient use of the navigable airspace. 

In addition, those various reasons or 


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Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations 18085 

circumstances require making this 

amendment effective before the next 

scheduled charting and publication date 

of the flight information to assure its 

timely availability to the user. The 

effective date of this amendment reflects 

those considerations. In view of the 

close and immediate relationship 

between these regulatory changes and 

safety in air commerce, I find that notice 

and public procedure before adopting 

this amendment are impracticable and 

contrary to the public interest and that 

good cause exists for making the 

amendment effective in less than 30 

days. 

Conclusion 

The FAA has determined that this 

regulation only involves an established 

body of technical regulations for which 

frequent and routine amendments are 

necessary to keep them operationally 

current. It, therefore—(1) is not a 

‘‘significant regulatory action’’ under 

Executive Order 12866; (2) is not a 

‘‘significant rule’’ under 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. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 95 

Airspace, Navigation (air). 

Issued in Washington, DC on March 27, 

2015. 

John Duncan, 

Director, Flight Standards Service. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, part 95 of the Federal 

Aviation Regulations (14 CFR part 95) is 

amended as follows effective at 0901 

UTC, April 30, 2015. 

■ 1. The authority citation for part 95 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40113, 40114, 40120, 44502, 44514, 44719, 

44721. 

■ 2. Part 95 is amended to read as 

follows: 

§§ 95.4000, 95.4024, 95.6001, 95.6070, 

95.6071, 95.6114, 95.6133, 95.6145, 95.6194, 

95.6420, 95.6438, 95.6511, 95.6559, 95.6566, 

95.7001, 95.7002, 95.7138, 95.7590, 95.8003 

[AMENDED] 

REVISIONS TO IFR ALTITUDES & CHANGEOVER POINT

[Amendment 519 effective date April 30, 2015] 

From To MEA MAA 

§ 95.4000 High Altitude RNAV Routes 

§ 95.4024 RNAV Route Q24 is Amended to Read in Part 

Lake Charles, LA Vortac ................................................... Fighting Tiger, LA Vortac ................................................. * 20000 45000 

* 18000—GNSS MEA 

* DME/DME/IRU MEA 

Fighting Tiger, LA VORTAC ............................................. Irube, MS WP ................................................................... * 20000 45000 

* 18000—GNSS MEA 

* DME/DME/IRU MEA 

Irube, MS WP ................................................................... Paytn, AL FIX ................................................................... * 20000 45000 

* 18000—GNSS MEA 

* DME/DME/IRU MEA 

From To MEA 

§ 95.6001 Victor Routes—U.S. 

§ 95.6070 VOR Federal Airway V70 is Amended to Read in Part 

Lafayette, LA VORTAC ................................................................. * Rosey, LA FIX ........................................................................... 2100 

* 5000—MRA 

* Rosey, LA FIX ............................................................................. Fighting Tiger, LA VORTAC ........................................................ 2100 

* 5000—MRA 

Fighting Tiger, LA VORTAC ......................................................... Picayune, MS VOR/DME ............................................................. 2000 

§ 95.6071 VOR Federal Airway V71 is Amended to Read in Part 

Fighting Tiger, LA VORTAC ......................................................... Wrack, LA FIX ............................................................................. 2200 

§ 95.6114 VOR Federal Airway V114 is Amended to Read in Part 

* Mikle, LA FIX ............................................................................... Fighting Tiger, LA VORTAC ........................................................ 2000 

* 3000—MRA 

Fighting Tiger, LA VORTAC ......................................................... Veils, LA FIX ................................................................................ 2800 

Veils, LA FIX ................................................................................. Reserve, LA VOR/DME ............................................................... 2000 

§ 95.6133 VOR Federal Airway V133 is Amended to Read in Part 

* Ladin, MI FIX ............................................................................... Traverse City, MI VOR/DME ....................................................... ** 5000 

* 5000—MRA 

** 2800—MOCA 

§ 95.6145 VOR Federal Airway V145 is Amended to Read in Part 

Utica, NY VORTAC ....................................................................... Weepy, NY FIX ............................................................................ * 3400 


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From To MEA 

* 3000—MOCA 

Weepy, NY FIX ............................................................................. Floor, NY FIX ............................................................................... * 3000 

* 2200—MOCA 

Floor, NY FIX ................................................................................ Watertown, NY VORTAC ............................................................ * 3000 

* 2700—MOCA 

Watertown, NY VORTAC .............................................................. U.S. Canadian Border ................................................................. * 3000 

* 1800—MOCA 

§ 95.6194 VOR Federal Airway V194 is Amended to Read in Part 

Lafayette, LA VORTAC ................................................................. * Rosey, LA FIX ........................................................................... 2100 

* 5000—MRA 

* Rosey, LA FIX ............................................................................. Fighting Tiger, LA VORTAC ........................................................ 2100 

* 5000—MRA 

Fighting Tiger, LA VORTAC ......................................................... McComb, MS VORTAC ............................................................... 2300 

§ 95.6420 VOR Federal Airway V420 is Amended to Read in Part 

Traverse City, MI VOR/DME ......................................................... Gaylord, MI VOR/DME ................................................................ #3000 

#Traverse City R–062 Unusable Use Gaylord R–247 

§ 95.6511 VOR Federal Airway V511 is Amended to Read in Part 

Lakeland, FL VORTAC ................................................................. Hallr, FL FIX ................................................................................ * 4000 

* 2300—MOCA 

§ 95.6559 VOR Federal Airway V559 is Amended to Read in Part 

Lafayette, LA VORTAC ................................................................. Fighting Tiger, LA VORTAC ........................................................ 2100 

§ 95.6566 VOR Federal Airway V566 is Amended to Read in Part 

Veils, LA FIX ................................................................................. Reserve, LA VOR/DME ............................................................... 2000 

§ 95.6438 Alaska VOR Federal Airway V438 is Amended to Read in Part 

* Sures, AK FIX ............................................................................. Liber, AK FIX ............................................................................... #** 11000 

* 10000—MRA 

** 8900—MOCA 

#MEA is Established With a Gap in Navigation Signal Coverage. 

From To MEA MAA 

§ 95.7001 Jet Routes 

§ 95.7002 Jet Route J2 is Amended to Read in Part 

Lake Charles, LA VORTAC .............................................. Fighting Tiger, LA VORTAC ............................................ 18000 45000 

Fighting Tiger, LA VORTAC ............................................. Semmes, AL VORTAC .................................................... 18000 45000 

§ 95.7138 Jet Route J138 is Amended to Read in Part 

Lake Charles, LA VORTAC .............................................. Fighting Tiger, LA VORTAC ............................................ 18000 45000 

Fighting Tiger, LA VORTAC ............................................. Semmes, AL VORTAC .................................................... 18000 45000 

§ 95.7590 Jet Route J590 is Amended to Read in Part 

Lake Charles, LA VORTAC .............................................. Fighting Tiger, LA VORTAC ............................................ 18000 45000 

Fighting Tiger, LA VORTAC ............................................. Greene County, MS VORTAC ......................................... 18000 45000 

Airway segment Changeover points 

From To Distance From 

§ 95.8003 VOR Federal Airway Changeover Point 

V285 is Amended to Delete Changeover Point 

Manistee, MI VOR/DME ................................................... Traverse City, MI VOR/DME ............................................ 29 

Manistee 

[FR Doc. 2015–07505 Filed 4–2–15; 8:45 am] 

BILLING CODE 4910–13–P 


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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 26, 99, 201, 203, 206, 

207, 310, 312, 314, 600, 601, 606, 607, 

610, 660, 680, 801, 807, 812, 814, 822, 

and 1271 

[Docket No. FDA–2015–N–0011] 

Food and Drug Administration 

Regulations; Change of Addresses; 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to update address 

information for the Center for Biologics 

Evaluation and Research (CBER) as a 

result of the recent relocation of CBER 

offices and laboratories to the FDA 

White Oak campus in Silver Spring, 

MD, as well as make other related 

technical revisions. These changes are 

being made to ensure the accuracy of 

the Agency’s regulations. 

DATES: This rule is effective April 3, 

2015. 

FOR FURTHER INFORMATION CONTACT: John 

Reilly, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulations in parts 1, 26, 

99, 201, 203, 206, 207, 310, 312, 314, 

600, 601, 606, 607, 610, 660, 680, 801, 

807, 812, 814, 822, and 1271 (21 CFR 

parts 1, 26, 99, 201, 203, 206, 207, 310, 

312, 314, 600, 601, 606, 607, 610, 660, 

680, 801, 807, 812, 814, 822, and 1271) 

to reflect the following changes: (1) The 

relocation of CBER offices and 

laboratories from various Rockville and 

Bethesda, MD, locations to the FDA 

White Oak campus in Silver Spring, 

MD; (2) the change of address of CBER’s 

Document Control Center; (3) updating 

the names of certain CBER 

organizational units referenced in the 

regulations; (4) revising certain crossreferences to be more specific and 

thereby facilitate locating the 

appropriate mailing addresses for 

submissions, requests, and other 

correspondence relating to biological 

products regulated by CBER and the 

Center for Drug Evaluation and Research 

(CDER); and (5) making other minor 

changes to ensure accuracy. The 

updated addresses include locations to 

which applicants must submit 

information related to applications or 

products regulated by CBER or from 

which the public can request 

information. Where appropriate, CBER 

Web addresses for obtaining or 

submitting forms and other information 

are added or updated, and outdated 

addresses are removed. In certain 

instances, mail previously addressed to 

specific CBER offices should now be 

addressed to the CBER Document 

Control Center. 

The technical amendments, reflected 

in the regulatory text of this final rule, 

are as follows: 

• In § 1.101(d)(2)(i), the CBER unit 

and address for submitting notifications 

regarding CBER-regulated products 

exported under section 802 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 382) are updated to the CBER 

Document Control Center on the White 

Oak campus. 

• In Appendix E to subpart A of part 

26, the contact information provided for 

CBER, including its address, telephone, 

and fax numbers to be used in the twoway alert system established in 

accordance with the 1998 ‘‘Agreement 

on Mutual Recognition Between the 

United States of America and the 

European Community,’’ is updated to 

reflect CBER’s move to the White Oak 

campus. 

• In § 99.201(c)(1), the CBER unit and 

address to send a submission and 

certification statement, or to send an 

application for exemption relating to the 

dissemination of information on an 

unapproved/new use regarding a 

biological product or device is updated 

to the CBER Document Control Center 

on the White Oak campus. 

• In § 201.25(d)(2), the CBER unit and 

address for submitting a request for 

exemption from the bar code label 

requirement for biological products 

regulated by CBER are updated to the 

CBER Document Control Center on the 

White Oak campus. Several other minor 

changes are made to this provision for 

purposes of clarity and correctness in 

referring to products regulated by CBER 

or CDER. 

• In § 201.58, the CBER unit and 

address for submitting a request for 

waiver from certain labeling 

requirements are updated to the CBER 

Document Control Center on the White 

Oak campus. 

• In § 203.12, the CBER unit and 

address for submitting an appeal from 

an adverse decision relating to the 

reimportation of biological products 

regulated by CBER are updated to the 

CBER Document Control Center on the 

White Oak campus. Several other minor 

changes in terminology also are made to 

this provision for purposes of accuracy 

and consistency when referring to 

products regulated by CBER or CDER. 

• In § 203.37(e), the CBER unit and 

address for submitting information in 

notifications and reports involving 

human prescription biological products 

regulated by CBER are updated to the 

CBER Document Control Center on the 

White Oak campus. Several other minor 

changes in terminology also are made to 

this provision for purposes of accuracy 

and consistency when referring to 

products regulated by CBER or CDER. 

• In § 203.70(b)(2), the CBER unit and 

address to apply for a reward when 

providing information leading to a 

criminal proceeding or conviction 

related to the sale, purchase, or trade of 

a drug sample are updated to the CBER 

Document Control Center on the White 

Oak campus. 

• In § 206.7(b)(1)(i), the CBER unit 

and address for requesting an exemption 

from imprinting requirements involving 

human drug products in solid oral 

dosage form are updated to the CBER 

Document Control Center on the White 

Oak campus. 

• In § 207.7(a), the CBER unit and 

address for submitting blood 

establishment registration and product 

listing information are updated to the 

CBER Document Control Center on the 

White Oak campus. 

• In § 310.503(f)(3), the CBER unit 

and address for submitting an 

investigational new drug (IND) 

application or an application for a 

biologics license under section 351 of 

the Public Health Service Act with 

regard to certain radioactive drugs 

considered biologics are updated to the 

CBER Document Control Center on the 

White Oak campus. 

• In § 312.140(a)(3), the address for 

submitting an IND application involving 

biological products regulated by CBER 

is updated to the White Oak campus. 

• In § 312.145(b), the CBER unit and 

address from which to request a list of 

CBER guidances are updated to the 

Office of Communication, Outreach and 

Development and the White Oak 

campus. 

• In § 312.310(d)(1), the CBER local 

telephone number for requesting 

emergency expanded access use of 

investigational biological drug products 

regulated by CBER is updated. 

• In § 314.440(b), the CBER addresses 

for submitting new drug applications 

and other correspondence involving 

certain drug products used in the 

collection, processing, or storage of 


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