Establishment of Class E Airspace; Newberry, MI, 73103-73104 [2015-29704]
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Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations
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this AD. This service information is not
incorporated by reference in this AD.
(i) Airbus Service Bulletin A320–22–1427,
dated January 25, 2013.
(ii) Airbus Service Bulletin A320–22–1427,
Revision 01, dated July 30, 2013.
(iii) Airbus Service Bulletin A320–22–
1427, Revision 02, dated October 14, 2013.
(iv) Airbus Service Bulletin A320–22–
1427, Revision 03, dated November 8, 2013.
(v) Airbus Service Bulletin A320–22–1427,
Revision 04, dated February 11, 2014.
(vi) Airbus Service Bulletin A320–22–
1447, dated October 18, 2013.
(vii) Airbus Service Bulletin A320–22–
1447, Revision 01, dated September 18, 2014.
(viii) Airbus Service Bulletin A320–22–
1447, Revision 02, dated December 2, 2014.
(ix) Airbus Service Bulletin A320–22–
1461, dated October 31, 2013.
(x) Airbus Service Bulletin A320–22–1461,
Revision 01, dated February 25, 2014.
(xi) Airbus Service Bulletin A320–22–
1461, Revision 02, dated April 30, 2014.
(xii) Airbus Service Bulletin A320–22–
1461, Revision 03, dated July 17, 2014.
(xiii) Airbus Service Bulletin A320–22–
1461, Revision 04, dated September 15, 2014.
(xiv) Airbus Service Bulletin A320–22–
1461, Revision 05, dated November 13, 2014.
(xv) Airbus Service Bulletin A320–22–
1461, Revision 06, dated January 21, 2015.
(xvi) Airbus Service Bulletin A320–31–
1414, dated December 19, 2012.
(xvii) Airbus Service Bulletin A320–31–
1414, Revision 01, dated March 21, 2013.
(xviii) Airbus Service Bulletin A320–31–
1414, Revision 02, dated July 30, 2013.
(n) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, International
Branch, ANM–116, Transport Airplane
Directorate, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
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 425–227–1149.
Information may be emailed to: 9-ANM-116AMOC-REQUESTS@faa.gov. 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) Required for Compliance (RC): If any
service information contains procedures or
tests that are identified as RC, those
procedures and tests must be done to comply
with this AD; any procedures or tests that are
not identified as RC are recommended. Those
procedures and tests that are not identified
as RC may be deviated from using accepted
methods in accordance with the operator’s
maintenance or inspection program without
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obtaining approval of an AMOC, provided
the procedures and tests identified as RC can
be done and the airplane can be put back in
an airworthy condition. Any substitutions or
changes to procedures or tests identified as
RC require approval of an AMOC.
(3) Contacting the Manufacturer: For any
requirement in this AD to obtain corrective
actions from a manufacturer, the action must
be accomplished using a method approved
by the Manager, International Branch, ANM–
116, Transport Airplane Directorate, FAA; or
the EASA; or Airbus’s EASA DOA. If
approved by the DOA, the approval must
include the DOA-authorized signature.
Issued in Renton, Washington, on
November 9, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
(o) Related Information
(1) Refer to Mandatory Continuing
Airworthiness Information (MCAI) EASA
Airworthiness Directive 2014–0217R1, dated
February 26, 2015, for related information.
This MCAI may be found in the AD docket
on the Internet at https://www.regulations.
gov/#!documentDetail;D=FAA-2015-02510003.
(2) Service information identified in this
AD that is not incorporated by reference is
available at the addresses specified in
paragraphs (p)(3) and (p(4) of this AD.
[Docket No. FAA–2015–1869; Airspace
Docket No. 15–AGL–9]
(p) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) 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 this AD specifies otherwise.
(i) Airbus Service Bulletin A320–22–1375,
dated January 15, 2014.
(ii) Airbus Service Bulletin A320–22–1427,
Revision 05, including Appendix 01, dated
November 24, 2014.
(iii) Airbus Service Bulletin A320–22–
1447, Revision 03, dated April 21, 2015.
(iv) Airbus Service Bulletin A320–22–
1454, dated February 12, 2014.
(v) Airbus Service Bulletin A320–22–1461,
Revision 07, including Appendix 01, dated
March 23, 2015.
(vi) Airbus Service Bulletin A320–22–
1480, Revision 02, dated March 30, 2015.
(vii) Airbus Service Bulletin A320–22–
1502, dated November 14, 2014.
(viii) Airbus Service Bulletin A320–31–
1414, Revision 03, dated September 15, 2014.
(3) For service information identified in
this AD, contact Airbus, Airworthiness
Office—EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France;
telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email account.airworth-eas@
airbus.com; Internet https://www.airbus.com.
(4) 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 425–227–1221.
(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, call
202–741–6030, or go to: https://www.archives.
gov/federal-register/cfr/ibr-locations.html.
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[FR Doc. 2015–29702 Filed 11–23–15; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
Establishment of Class E Airspace;
Newberry, MI
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction.
AGENCY:
This action corrects an error
in the legal description of a final rule
published in the Federal Register of
September 24, 2015, that establishes
Class E airspace at the Newberry VHF
Omni-Directional Range/Distance
Measuring Equipment (VOR/DME),
Newberry, MI. The legal description
noted exclusionary language for Federal
airways and Canadian airspace not
required for this airspace.
DATES: Effective date: 0901 UTC,
December 10, 2015. The Director of the
Federal Register approves this
incorporation by reference action under
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: Raul
Garza, Jr., Central Service Center,
Operations Support Group, Federal
Aviation Administration, Southwest
Region, 10101 Hillwood Parkway., Fort
Worth, TX 76177; telephone 817–222–
5874.
SUPPLEMENTARY INFORMATION:
SUMMARY:
History
On September 24, 2015, a final rule
was published in the Federal Register
establishing Class E airspace at the
Newberry VOR/DME, Newberry, MI (80
FR 57522) Docket No. FAA–2015–1869.
Subsequent to publication, the FAA
found that the exclusionary language for
Federal airways and Canadian airspace
noted in the airspace description is not
required and, therefore, is removed.
Final Rule Correction
Accordingly, pursuant to the
authority delegated to me, in the
Federal Register of September 24, 2015,
(80 FR 57522) FR Doc. 2015–23987, on
E:\FR\FM\24NOR1.SGM
24NOR1
73104
Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations
page 57523, column 2, beginning on line
26, remove ‘‘, excluding that airspace
within Federal airways and within
Canadian airspace’’.
Issued in Fort Worth, TX, on November 10,
2015.
Robert W. Beck,
Manager, Operations Support Group, ATO
Central Service Center.
[FR Doc. 2015–29704 Filed 11–23–15; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 528
[Docket No. FDA–2015–N–0002]
New Animal Drugs in Genetically
Engineered Animals; opAFP–GHc2
Recombinant Deoxyribonucleic Acid
Construct
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, the Agency) is
amending the animal drug regulations to
reflect the approval of a new animal
drug application (NADA) filed by
AquaBounty Technologies, Inc. The
NADA provides for use of a
recombinant deoxyribonucleic acid
(rDNA) gene construct in a lineage of
genetically engineered Atlantic salmon.
DATES: This rule is effective November
24, 2015.
FOR FURTHER INFORMATION CONTACT:
Larisa Rudenko, Center for Veterinary
Medicine (HFV–2), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8247,
email: abig@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
AquaBounty Technologies, Inc., Two
Clock Tower Pl., suite 395, Maynard,
MA 01754 filed NADA 141–454 for an
opAFP–GHc2 rDNA construct at the alocus in the EO–1a lineage triploid,
hemizygous, all-female Atlantic salmon
(Salmo salar) known as
AQUADVANTAGE Salmon.
Significantly more of these Atlantic
salmon grow to at least 100 grams
within 2,700 Celsius degree-days than
their comparators. The NADA is
approved as of November 19, 2015, and
the regulations are amended in 21 CFR
part 528 to reflect the approval.
In addition, AquaBounty
Technologies, Inc., is not currently
listed in the animal drug regulations as
a sponsor of an approved application.
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
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23:14 Nov 23, 2015
Jkt 238001
Accordingly, 21 CFR 510.600(c) is being
amended to add entries for this firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
(FOI Summary) may be seen in the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday.
The Agency has carefully considered
the potential environmental impact of
this action and has concluded that the
action will not have a significant impact
on the human environment and that an
environmental impact statement is not
required. FDA’s finding of no significant
impact (FONSI) and the evidence
supporting that finding, contained in an
environmental assessment (EA), may be
seen in the Division of Dockets
Management (address in the previous
paragraph) between 9 a.m. and 4 p.m.,
Monday through Friday.
Persons with access to the Internet
may obtain the FOI Summary, EA, and
FONSI at the Center for Veterinary
Medicine FOIA Electronic Reading
Room: https://www.fda.gov/AboutFDA/
CentersOffices/OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Patent information may be
accessed in FDA’s publication,
Approved Animal Drug Products Online
(Green Book) at: https://www.fda.gov/
AnimalVeterinary/Products/Approved
AnimalDrugProducts/default.htm.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects
21 CFR Part 528
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 510 and 528 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
Frm 00018
Fmt 4700
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘AquaBounty Technologies,
Inc.’’ and in the table in paragraph
(c)(2), numerically add an entry for
‘‘086053’’ to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
Sfmt 4700
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
AquaBounty Technologies,
Inc., Two Clock Tower Pl.,
suite 395, Maynard, MA
01754 ................................
*
*
*
Drug labeler
code
*
*
086053
*
*
(2) * * *
Drug
labeler code
Firm name
and address
*
*
086053 .........
*
*
*
*
*
AquaBounty Technologies,
Inc., Two Clock Tower Pl.,
suite 395, Maynard, MA
01754 * * *
*
*
*
PART 528—NEW ANIMAL DRUGS IN
GENETICALLY ENGINEERED
ANIMALS
3. The authority citation for 21 CFR
part 528 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
PO 00000
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
4. Add § 528.1092 to read as follows:
§ 528.1092 opAFP–GHc2 recombinant
deoxyribonucleic acid construct.
(a) Specifications. A single copy of the
a-form of the opAFP–GHc2 recombinant
deoxyribonucleic acid (rDNA) construct
at the a-locus in the EO–1 a lineage of
triploid, hemizygous, all-female Atlantic
salmon (Salmo salar).
(b) Sponsor. See No. 086053 in
§ 510.600 of this chapter.
(c) Indications for use. Significantly
more of these Atlantic salmon grow to
at least 100 grams within 2,700 Celsius
degree-days than their comparators.
(d) Limitations. These Atlantic salmon
are produced as eyed-eggs and grownout only in physically-contained,
freshwater culture facilities specified in
an FDA-approved application.
E:\FR\FM\24NOR1.SGM
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Agencies
[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Rules and Regulations]
[Pages 73103-73104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29704]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2015-1869; Airspace Docket No. 15-AGL-9]
Establishment of Class E Airspace; Newberry, MI
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This action corrects an error in the legal description of a
final rule published in the Federal Register of September 24, 2015,
that establishes Class E airspace at the Newberry VHF Omni-Directional
Range/Distance Measuring Equipment (VOR/DME), Newberry, MI. The legal
description noted exclusionary language for Federal airways and
Canadian airspace not required for this airspace.
DATES: Effective date: 0901 UTC, December 10, 2015. The Director of the
Federal Register approves this incorporation by reference action under
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: Raul Garza, Jr., Central Service
Center, Operations Support Group, Federal Aviation Administration,
Southwest Region, 10101 Hillwood Parkway., Fort Worth, TX 76177;
telephone 817-222-5874.
SUPPLEMENTARY INFORMATION:
History
On September 24, 2015, a final rule was published in the Federal
Register establishing Class E airspace at the Newberry VOR/DME,
Newberry, MI (80 FR 57522) Docket No. FAA-2015-1869. Subsequent to
publication, the FAA found that the exclusionary language for Federal
airways and Canadian airspace noted in the airspace description is not
required and, therefore, is removed.
Final Rule Correction
Accordingly, pursuant to the authority delegated to me, in the
Federal Register of September 24, 2015, (80 FR 57522) FR Doc. 2015-
23987, on
[[Page 73104]]
page 57523, column 2, beginning on line 26, remove ``, excluding that
airspace within Federal airways and within Canadian airspace''.
Issued in Fort Worth, TX, on November 10, 2015.
Robert W. Beck,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-29704 Filed 11-23-15; 8:45 am]
BILLING CODE 4910-13-P