80 FR 18084 - IFR Altitudes; Miscellaneous Amendments
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration Federal Register Volume 80, Issue 64 (April 3, 2015)
Federal Aviation Administration
Federal Register Volume 80, Issue 64 (April 3, 2015)
| Page Range | 18084-18087 | |
| FR Document | 2015-07505 |
[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)] [Rules and Regulations] [Pages 18084-18087] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07505] ----------------------------------------------------------------------- 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 [[Page 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. 0 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. 0 2. Part 95 is amended to read as follows: Sec. Sec. 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 ---------------------------------------------------------------------------------------------------------------- Sec. 95.4000 High Altitude RNAV Routes Sec. 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 ------------------------------------------------------------------------ Sec. 95.6001 Victor Routes--U.S. Sec. 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 2100 VORTAC. * 5000--MRA Fighting Tiger, LA VORTAC........ Picayune, MS VOR/DME.... 2000 ------------------------------------------------------------------------ Sec. 95.6071 VOR Federal Airway V71 is Amended to Read in Part ------------------------------------------------------------------------ Fighting Tiger, LA VORTAC........ Wrack, LA FIX........... 2200 ------------------------------------------------------------------------ Sec. 95.6114 VOR Federal Airway V114 is Amended to Read in Part ------------------------------------------------------------------------ * Mikle, LA FIX.................. Fighting Tiger, LA 2000 VORTAC. * 3000--MRA Fighting Tiger, LA VORTAC........ Veils, LA FIX........... 2800 Veils, LA FIX.................... Reserve, LA VOR/DME..... 2000 ------------------------------------------------------------------------ Sec. 95.6133 VOR Federal Airway V133 is Amended to Read in Part ------------------------------------------------------------------------ * Ladin, MI FIX.................. Traverse City, MI VOR/ ** 5000 DME. * 5000--MRA ** 2800--MOCA ------------------------------------------------------------------------ Sec. 95.6145 VOR Federal Airway V145 is Amended to Read in Part ------------------------------------------------------------------------ Utica, NY VORTAC................. Weepy, NY FIX........... * 3400 [[Page 18086]] * 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 ------------------------------------------------------------------------ Sec. 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 2100 VORTAC. * 5000--MRA Fighting Tiger, LA VORTAC........ McComb, MS VORTAC....... 2300 ------------------------------------------------------------------------ Sec. 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 ------------------------------------------------------------------------ Sec. 95.6511 VOR Federal Airway V511 is Amended to Read in Part ------------------------------------------------------------------------ Lakeland, FL VORTAC.............. Hallr, FL FIX........... * 4000 * 2300--MOCA ------------------------------------------------------------------------ Sec. 95.6559 VOR Federal Airway V559 is Amended to Read in Part ------------------------------------------------------------------------ Lafayette, LA VORTAC............. Fighting Tiger, LA 2100 VORTAC. ------------------------------------------------------------------------ Sec. 95.6566 VOR Federal Airway V566 is Amended to Read in Part ------------------------------------------------------------------------ Veils, LA FIX.................... Reserve, LA VOR/DME..... 2000 ------------------------------------------------------------------------ Sec. 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 ---------------------------------------------------------------------------------------------------------------- Sec. 95.7001 Jet Routes Sec. 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 ---------------------------------------------------------------------------------------------------------------- Sec. 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 ---------------------------------------------------------------------------------------------------------------- Sec. 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 ---------------------------------------------------------------------------------------------------------------- Sec. 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
![18084 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Rules and Regulations
(1) Is not a ‘‘significant regulatory LK55386, LK86483, or LK86503, that exceeds DEPARTMENT OF TRANSPORTATION
action’’ under Executive Order 12866, 11,000 flight cycles since new.
(2) Is not a ‘‘significant rule’’ under (2) If you cannot determine the Federal Aviation Administration
the DOT Regulatory Policies and accumulated flight cycles, remove any LPT
Procedures (44 FR 11034, February 26, stage 3 turbine blade, P/N LK55386, 14 CFR Part 95
1979), LK86483, or LK86503, within 200 flight
[Docket No. 31012; Amdt. No. 519]
(3) Will not affect intrastate aviation cycles after the effective date of this AD.
in Alaska to the extent that it justifies (3) After the effective date of this AD, do
IFR Altitudes; Miscellaneous
making a regulatory distinction, and not install any LPT stage 3 turbine blade, P/
Amendments
(4) Will not have a significant N LK55386, LK86483, or LK86503, on any
economic impact, positive or negative, engine if the blade has accumulated 11,000 AGENCY: Federal Aviation
on a substantial number of small entities or more flight cycles since new. Administration (FAA), DOT.
under the criteria of the Regulatory (f) Alternative Methods of Compliance ACTION: Final rule.
Flexibility Act. (AMOCs)
SUMMARY: This amendment adopts
List of Subjects in 14 CFR Part 39 The Manager, Engine Certification Office, miscellaneous amendments to the
Air transportation, Aircraft, Aviation FAA, may approve AMOCs for this AD. Use required IFR (instrument flight rules)
safety, Incorporation by reference, the procedures found in 14 CFR 39.19 to altitudes and changeover points for
Safety. make your request. You may email your certain Federal airways, jet routes, or
request to: ANE-AD-AMOC@faa.gov.
Adoption of the Amendment direct routes for which a minimum or
(g) Related Information maximum en route authorized IFR
Accordingly, under the authority altitude is prescribed. This regulatory
delegated to me by the Administrator, (1) For more information about this AD,
contact Kenneth Steeves, Aerospace action is needed because of changes
the FAA amends 14 CFR part 39 as occurring in the National Airspace
follows: Engineer, Engine Certification Office, FAA,
Engine & Propeller Directorate, 12 New System. These changes are designed to
PART 39—AIRWORTHINESS England Executive Park, Burlington, MA provide for the safe and efficient use of
DIRECTIVES 01803; phone: 781–238–7765; fax: 781–238– the navigable airspace under instrument
7199; email: kenneth.steeves@faa.gov. conditions in the affected areas.
■ 1. The authority citation for part 39 (2) Refer to MCAI European Aviation DATES: Effective Date: 0901 UTC, April
continues to read as follows: Safety Agency AD 2014–0210, dated 30, 2015.
Authority: 49 U.S.C. 106(g), 40113, 44701. September 19, 2014, for more information. FOR FURTHER INFORMATION CONTACT:
You may examine the MCAI in the AD Harry Hodges, Flight Procedure
§ 39.13 [Amended] docket on the Internet at http:// Standards Branch (AMCAFS–420),
www.regulations.gov/ Flight Technologies and Programs
■ 2. The FAA amends § 39.13 by adding
#!documentDetail;D=FAA-2014-0904-0002. Division, Flight Standards Service,
the following new airworthiness
(3) RR Alert Non-Modification Service Federal Aviation Administration, Mike
directive (AD):
Bulletin No. RB.211–72–AH790, Revision 1, Monroney Aeronautical Center, 6500
2015–07–01 Rolls-Royce plc: Amendment dated November 5, 2014, which is not
39–18129; Docket No. FAA–2014–0904; South MacArthur Blvd. Oklahoma City,
incorporated by reference in this AD, can be OK 73169 (Mail Address: P.O. Box
Directorate Identifier 2014–NE–14–AD.
obtained from Rolls-Royce plc, using the
25082 Oklahoma City, OK 73125)
(a) Effective Date contact information in paragraph (g)(4) of this
telephone: (405) 954–4164.
This AD becomes effective May 8, 2015. AD.
(4) For service information identified in SUPPLEMENTARY INFORMATION: This
(b) Affected ADs this AD, contact Rolls-Royce plc, Corporate amendment to part 95 of the Federal
None. Communications, P.O. Box 31, Derby, Aviation Regulations (14 CFR part 95)
England, DE24 8BJ; phone: 011–44–1332– amends, suspends, or revokes IFR
(c) Applicability
242424; fax: 011–44–1332–249936; email: altitudes governing the operation of all
This AD applies to all Rolls-Royce plc (RR) aircraft in flight over a specified route
RB211–524B–02, RB211–524B–B–02, http://www.rolls-royce.com/contact/civil_
team.jsp; Internet: https:// or any portion of that route, as well as
RB211–524B2–19, RB211–524B2–B–19,
RB211–524B3–02, RB211–524C2–19, and www.aeromanager.com. the changeover points (COPs) for
RB211–524C2–B–19 turbofan engines with (5) You may view this service information Federal airways, jet routes, or direct
low-pressure turbine (LPT) stage 3 turbine at the FAA, Engine & Propeller Directorate, routes as prescribed in part 95.
blade, part number (P/N) LK55386, LK86483, 12 New England Executive Park, Burlington,
or LK86503, installed.
The Rule
MA. For information on the availability of
(d) Reason this material at the FAA, call 781–238–7125. The specified IFR altitudes, when
used in conjunction with the prescribed
This AD was prompted by reports of LPT (h) Material Incorporated by Reference changeover points for those routes,
stage 3 turbine blade failure, release of
blades, and subsequent in-flight shutdown.
None. ensure navigation aid coverage that is
We are issuing this AD to prevent failure of Issued in Burlington, Massachusetts, on adequate for safe flight operations and
LPT stage 3 turbine blades and subsequent March 26, 2015. free of frequency interference. The
release of blade debris, which could lead to reasons and circumstances that create
Colleen M. D’Alessandro,
asabaliauskas on DSK5VPTVN1PROD with RULES
failure of one or more engines, loss of thrust the need for this amendment involve
control, and damage to the airplane. Assistant Directorate Manager, Engine & matters of flight safety and operational
Propeller Directorate, Aircraft Certification efficiency in the National Airspace
(e) Actions and Compliance Service.
Comply with this AD within the
System, are related to published
[FR Doc. 2015–07492 Filed 4–2–15; 8:45 am] aeronautical charts that are essential to
compliance times specified, unless already
done. BILLING CODE 4910–13–P the user, and provide for the safe and
(1) Remove from service before further efficient use of the navigable airspace.
flight any LPT stage 3 turbine blade, P/N In addition, those various reasons or
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circumstances require making this ‘‘significant regulatory action’’ under Administrator, part 95 of the Federal
amendment effective before the next Executive Order 12866; (2) is not a Aviation Regulations (14 CFR part 95) is
scheduled charting and publication date ‘‘significant rule’’ under DOT amended as follows effective at 0901
of the flight information to assure its Regulatory Policies and Procedures (44 UTC, April 30, 2015.
timely availability to the user. The FR 11034; February 26, 1979); and (3)
effective date of this amendment reflects does not warrant preparation of a ■ 1. The authority citation for part 95
those considerations. In view of the regulatory evaluation as the anticipated continues to read as follows:
close and immediate relationship impact is so minimal. For the same Authority: 49 U.S.C. 106(g), 40103, 40106,
between these regulatory changes and reason, the FAA certifies that this 40113, 40114, 40120, 44502, 44514, 44719,
safety in air commerce, I find that notice amendment will not have a significant 44721.
and public procedure before adopting economic impact on a substantial
this amendment are impracticable and number of small entities under the ■ 2. Part 95 is amended to read as
contrary to the public interest and that criteria of the Regulatory Flexibility Act. follows:
good cause exists for making the List of Subjects in 14 CFR Part 95
amendment effective in less than 30 §§ 95.4000, 95.4024, 95.6001, 95.6070,
days. Airspace, Navigation (air). 95.6071, 95.6114, 95.6133, 95.6145, 95.6194,
95.6420, 95.6438, 95.6511, 95.6559, 95.6566,
Issued in Washington, DC on March 27,
Conclusion 2015. 95.7001, 95.7002, 95.7138, 95.7590, 95.8003
The FAA has determined that this [AMENDED]
John Duncan,
regulation only involves an established Director, Flight Standards Service.
body of technical regulations for which
frequent and routine amendments are Adoption of the Amendment
necessary to keep them operationally Accordingly, pursuant to the
current. It, therefore—(1) is not a authority delegated to me by the
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
asabaliauskas on DSK5VPTVN1PROD with RULES
§ 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 Cov-
erage.
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
asabaliauskas on DSK5VPTVN1PROD with RULES
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 which applicants must submit this provision for purposes of accuracy
HUMAN SERVICES information related to applications or and consistency when referring to
products regulated by CBER or from products regulated by CBER or CDER.
Food and Drug Administration which the public can request • In § 203.37(e), the CBER unit and
information. Where appropriate, CBER address for submitting information in
21 CFR Parts 1, 26, 99, 201, 203, 206, Web addresses for obtaining or notifications and reports involving
207, 310, 312, 314, 600, 601, 606, 607, submitting forms and other information human prescription biological products
610, 660, 680, 801, 807, 812, 814, 822, are added or updated, and outdated regulated by CBER are updated to the
and 1271 addresses are removed. In certain
CBER Document Control Center on the
instances, mail previously addressed to
[Docket No. FDA–2015–N–0011] White Oak campus. Several other minor
specific CBER offices should now be
changes in terminology also are made to
Food and Drug Administration addressed to the CBER Document
this provision for purposes of accuracy
Regulations; Change of Addresses; Control Center.
The technical amendments, reflected and consistency when referring to
Technical Amendment products regulated by CBER or CDER.
in the regulatory text of this final rule,
AGENCY: Food and Drug Administration, are as follows: • In § 203.70(b)(2), the CBER unit and
HHS. • In § 1.101(d)(2)(i), the CBER unit address to apply for a reward when
Final rule; technical
ACTION: and address for submitting notifications providing information leading to a
amendment. regarding CBER-regulated products criminal proceeding or conviction
exported under section 802 of the related to the sale, purchase, or trade of
SUMMARY: The Food and Drug Federal Food, Drug, and Cosmetic Act a drug sample are updated to the CBER
Administration (FDA) is amending its (21 U.S.C. 382) are updated to the CBER Document Control Center on the White
regulations to update address Document Control Center on the White Oak campus.
information for the Center for Biologics Oak campus.
Evaluation and Research (CBER) as a • In Appendix E to subpart A of part • In § 206.7(b)(1)(i), the CBER unit
result of the recent relocation of CBER 26, the contact information provided for and address for requesting an exemption
offices and laboratories to the FDA CBER, including its address, telephone, from imprinting requirements involving
White Oak campus in Silver Spring, and fax numbers to be used in the two- human drug products in solid oral
MD, as well as make other related way alert system established in dosage form are updated to the CBER
technical revisions. These changes are accordance with the 1998 ‘‘Agreement Document Control Center on the White
being made to ensure the accuracy of on Mutual Recognition Between the Oak campus.
the Agency’s regulations. United States of America and the • In § 207.7(a), the CBER unit and
DATES: This rule is effective April 3, European Community,’’ is updated to address for submitting blood
2015. reflect CBER’s move to the White Oak establishment registration and product
campus. listing information are updated to the
FOR FURTHER INFORMATION CONTACT: John • In § 99.201(c)(1), the CBER unit and CBER Document Control Center on the
Reilly, Center for Biologics Evaluation address to send a submission and White Oak campus.
and Research, Food and Drug certification statement, or to send an
Administration, 10903 New Hampshire • In § 310.503(f)(3), the CBER unit
application for exemption relating to the
Ave., Bldg. 71, Rm. 7301, Silver Spring, and address for submitting an
dissemination of information on an
MD 20993–0002, 240–402–7911. investigational new drug (IND)
unapproved/new use regarding a
SUPPLEMENTARY INFORMATION: FDA is application or an application for a
biological product or device is updated
amending its regulations in parts 1, 26, biologics license under section 351 of
to the CBER Document Control Center
99, 201, 203, 206, 207, 310, 312, 314, the Public Health Service Act with
on the White Oak campus.
600, 601, 606, 607, 610, 660, 680, 801, • In § 201.25(d)(2), the CBER unit and regard to certain radioactive drugs
807, 812, 814, 822, and 1271 (21 CFR address for submitting a request for considered biologics are updated to the
parts 1, 26, 99, 201, 203, 206, 207, 310, exemption from the bar code label CBER Document Control Center on the
312, 314, 600, 601, 606, 607, 610, 660, requirement for biological products White Oak campus.
680, 801, 807, 812, 814, 822, and 1271) regulated by CBER are updated to the • In § 312.140(a)(3), the address for
to reflect the following changes: (1) The CBER Document Control Center on the submitting an IND application involving
relocation of CBER offices and White Oak campus. Several other minor biological products regulated by CBER
laboratories from various Rockville and changes are made to this provision for is updated to the White Oak campus.
Bethesda, MD, locations to the FDA purposes of clarity and correctness in • In § 312.145(b), the CBER unit and
White Oak campus in Silver Spring, referring to products regulated by CBER address from which to request a list of
MD; (2) the change of address of CBER’s or CDER. CBER guidances are updated to the
Document Control Center; (3) updating • In § 201.58, the CBER unit and Office of Communication, Outreach and
the names of certain CBER address for submitting a request for Development and the White Oak
organizational units referenced in the waiver from certain labeling campus.
regulations; (4) revising certain cross- requirements are updated to the CBER
references to be more specific and Document Control Center on the White • In § 312.310(d)(1), the CBER local
thereby facilitate locating the Oak campus. telephone number for requesting
asabaliauskas on DSK5VPTVN1PROD with RULES
appropriate mailing addresses for • In § 203.12, the CBER unit and emergency expanded access use of
submissions, requests, and other address for submitting an appeal from investigational biological drug products
correspondence relating to biological an adverse decision relating to the regulated by CBER is updated.
products regulated by CBER and the reimportation of biological products • In § 314.440(b), the CBER addresses
Center for Drug Evaluation and Research regulated by CBER are updated to the for submitting new drug applications
(CDER); and (5) making other minor CBER Document Control Center on the and other correspondence involving
changes to ensure accuracy. The White Oak campus. Several other minor certain drug products used in the
updated addresses include locations to changes in terminology also are made to collection, processing, or storage of
VerDate Sep<11>2014 18:25 Apr 02, 2015 Jkt 235001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\03APR1.SGM 03APR1](https://thefederalregister.org/doc/80_FR_18148/page/4.svg)
Document Created: 2015-12-18 15:29:17
Document Modified: 2015-12-18 15:29:17
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| 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 | |
| FR Citation | 80 FR 18084 | |
| CFR Associated | Airspace and Navigation (air) |
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