Federal Register / Vol. 80, No. 226 / Tuesday, November 24, 2015 / Rules and Regulations 73103 

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-116- 

AMOC-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 

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. 

(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 http://www.regulations.

gov/#!documentDetail;D=FAA-2015-0251- 

0003. 

(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. 

(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 http://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: http://www.archives.

gov/federal-register/cfr/ibr-locations.html. 

Issued in Renton, Washington, on 

November 9, 2015. 

Michael Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[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 

[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 

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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. 

SUMMARY: 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. 

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: http://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: http://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 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

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: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 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. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

AquaBounty Technologies, 

Inc., Two Clock Tower Pl., 

suite 395, Maynard, MA 

01754 ................................ 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. 

■ 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. 

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