### 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


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

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]**



### R EVISIONS TO 

### IFR ALTITUDES 

### & C HANGEOVER 

### 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


### 18086 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations

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**


### 18087 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations

**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 theregulations; (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