Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 8575 

Aviation Safety Agency Airworthiness 

Directive 2014–0164, dated July 11, 2014, for 

related information. This MCAI may be 

found in the AD docket on the Internet at 

http://www.regulations.gov by searching for 

and locating Docket No. FAA–2015–0243. 

(2) For service information identified in 

this AD, contact Airbus SAS, Airworthiness 

Office—EAW, 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. 

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. 

Issued in Renton, Washington, on February 

2, 2015. 

Dionne Palermo, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–02922 Filed 2–17–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–0086; Directorate 

Identifier 2014–NM–191–AD] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for all 

Airbus Model A310–203 airplanes. This 

proposed AD is intended to complete 

certain mandated programs intended to 

support the airplane reaching its limit of 

validity (LOV) of the engineering data 

that support the established structural 

maintenance program. This proposed 

AD was prompted by reports that side 

link clevis bolts of the front engine 

mount do not meet the Design Service 

Goal (DSG) requirements on airplanes 

equipped with General Electric 

Company CF6–80A3 engines. This 

proposed AD would require repetitive 

replacement of all side link clevis 

engine mount bolts. We are proposing 

this AD to prevent failure of the front 

engine mount, and consequent possible 

departure of the engine. 

DATES: We must receive comments on 

this proposed AD by April 6, 2015. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this proposed AD, contact Airbus SAS, 

Airworthiness Office—EAW, 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. You 

may view this referenced 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. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0086; or in person at the Docket 

Management Facility between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Operations 

office (telephone 800–647–5527) is in 

the ADDRESSES section. Comments will 

be available in the AD docket shortly 

after receipt. 

FOR FURTHER INFORMATION CONTACT: Dan 

Rodina, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue SW., Renton, 

Washington 98057–3356; telephone 

425–227–2125; fax 425–227–1149. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2015–0086; Directorate Identifier 

2014–NM–191–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD based on those comments. 

We will post all comments we 

receive, without change, to http://

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

As described in FAA Advisory 

Circular 120 104 (http://www.faa.gov/

documentLibrary/media/Advisory_

Circular/120-104.pdf), several programs 

have been developed to support 

initiatives that will ensure the 

continued airworthiness of aging 

airplane structure. The last element of 

those initiatives is the requirement to 

establish a LOV of the engineering data 

that support the structural maintenance 

program under 14 CFR 26.21. This 

proposed AD is the result of an 

assessment of the previously established 

programs by Airbus during the process 

of establishing the LOV for Airbus 

Model A310–203 airplanes. The actions 

specified in this proposed AD are 

necessary to complete certain programs 

to ensure the continued airworthiness of 

aging airplane structure and to support 

an airplane reaching its LOV. 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Union, has issued EASA Airworthiness 

Directive 2014–0191, dated August 29, 

2014 (referred to after this as the 

Mandatory Continuing Airworthiness 

Information, or ‘‘the MCAI’’), to correct 

an unsafe condition for all Airbus 

Model A310–203 airplanes. The MCAI 

states: 

During fatigue analysis performed in the 

scope of the Extended Service Goal, taking 

into account the certification loads and the 

new lift-off loads, Airbus determined that 

side link clevis engine mount bolts do not 

meet the Design Service Goal (DSG) 

requirements on aeroplanes equipped with 

CF6–80A3 engines. 

This condition, if not corrected, could lead 

to failure of the front engine mount, possibly 

resulting in-flight separation of the engine 

from the aeroplane. 

To address this potential unsafe condition, 

Airbus issued Service Bulletin (SB) A310– 

71–2038 to introduce a life limit on the side 

link clevis engine mount bolts. 

For the reason described above, this 

[EASA] AD requires implementation of the 

new life limit and replacement of all side 

link clevis engine mount bolts that have 

exceeded the new limit. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

8576 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 

You may examine the MCAI in the 

AD docket on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0086. 

Relevant Service Information Under 1 

CFR Part 51 

Airbus has issued Mandatory Service 

Bulletin A310–71–2038, including 

Appendices 01 and 02, dated April 8, 

2014. The service information describes 

procedures for replacement of all side 

link clevis bolts on the CF6–80A3 front 

engine mount and subsequent reidentification of the newly installed 

bolts with a cross (to differentiate them 

from the old ones). The actions 

described in this service information are 

intended to correct the unsafe condition 

identified in the MCAI. This service 

information is reasonably available; see 

ADDRESSES for ways to access this 

service information. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 

bilateral agreement with the State of 

Design Authority, we have been notified 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are proposing this 

AD because we evaluated all pertinent 

information and determined an unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

Costs of Compliance 

We estimate that this proposed AD 

affects 13 airplanes of U.S. registry. 

We also estimate that it would take 

about 142 work-hours per product to 

comply with the basic requirements of 

this proposed AD. The average labor 

rate is $85 per work-hour. Required 

parts would cost about $2,900 per 

product. Based on these figures, we 

estimate the cost of this proposed AD on 

U.S. operators to be $194,610, or 

$14,970 per product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect on the States, on 

the relationship between the national 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this proposed regulation: 

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; 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. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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): 

Airbus: Docket No. FAA–2015–0086; 

Directorate Identifier 2014–NM–191–AD. 

(a) Comments Due Date 

We must receive comments by April 6, 

2015. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Airbus Model A310– 

203 airplanes, certificated in any category, all 

manufacturer serial numbers. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 71, Powerplant. 

(e) Reason 

This AD was prompted by reports that side 

link clevis bolts of the front engine mount do 

not meet the Design Service Goal (DSG) 

requirements on airplanes equipped with 

General Electric Company CF6–80A3 

engines. We are issuing this AD to prevent 

failure of the front engine mount, and 

consequent possible departure of the engine. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Repetitive Bolt Replacement 

Within 18 months after the effective date 

of this AD, replace the side link clevis bolts, 

nuts, and bushings of the front engine mount 

on both engines, and re-identify the new 

installed bolts with a cross (to differentiate 

them from the old ones), in accordance with 

the Accomplishment Instructions of Airbus 

Mandatory Service Bulletin A310–71–2038, 

including Appendices 01 and 02, dated April 

8, 2014. Repeat the replacement thereafter at 

intervals not to exceed 29 years. 

(h) 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: 

Dan Rodina, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

telephone 425–227–2125; 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) 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 European Aviation Safety Agency 

(EASA); or Airbus’s EASA Design 

Organization Approval (DOA). If approved by 

the DOA, the approval must include the 

DOA-authorized signature. 

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Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Proposed Rules 8577 

(i) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) EASA 

Airworthiness Directive 2014–0191, dated 

August 29, 2014, for related information. 

This MCAI may be found in the AD docket 

on the Internet at http://www.regulations.gov 

by searching for and locating Docket No. 

FAA–2015–0086. 

(2) For service information identified in 

this AD, contact Airbus SAS, Airworthiness 

Office—EAW, 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. 

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. 

Issued in Renton, Washington, on January 

30, 2015. 

Jeffrey E. Duven, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2015–02683 Filed 2–17–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 314 and 601 

[Docket No. FDA–2013–N–0500] 

Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products; Public 

Meeting; Request for Comments; 

Reopening of the Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

1-day public meeting entitled 

‘‘Supplemental Applications Proposing 

Labeling Changes for Approved Drugs 

and Biological Products.’’ The purpose 

of the meeting is to provide a public 

forum for FDA to listen to comments on 

the proposed rule on ‘‘changes being 

effected’’ supplements that was 

published in the Federal Register of 

November 13, 2013, and alternatives 

offered to this proposed rule. FDA is 

also reopening the comment period for 

the proposed rule to receive 

submissions of additional written 

comments on the proposed rule as well 

as alternative proposals presented 

during the public meeting. 

DATES: Meeting. The public meeting will 

be held on March 27, 2015, from 8 a.m. 

to 5 p.m. Registration to attend the 

meeting must be received by March 20, 

2015. See the SUPPLEMENTARY

INFORMATION section for information on 

how to register for the meeting. 

Comments. The comment period for 

the proposed rule publilshed November 

13, 2013 (78 FR 67985), is reopened. 

Submit either electronic or written 

comments regarding proposed 

alternatives to the proposed rule by 

April 27, 2015. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave, Building 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

You may submit comments by any of 

the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–0500 for the proposed rule. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Molinaro, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, Rm. 

6218, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3601, FAX: 301–847–8440. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of November 

13, 2013 (78 FR 67985), FDA proposed 

regulations to revise and clarify 

procedures for application holders of an 

approved drug or biological product to 

change the product labeling to reflect 

certain types of newly acquired safetyrelated information in advance of FDA’s 

review of the change by submitting a 

changes being effected (CBE–0) 

supplement to FDA. The need to 

promptly communicate certain safetyrelated labeling changes based on newly 

acquired information is the basis for the 

‘‘changes being effected’’ exception to 

the general requirement for FDA 

approval of revised labeling prior to 

distribution. The proposed rule, if 

finalized, would enable abbreviated new 

drug application (ANDA) holders for 

generic drugs to update product labeling 

promptly to reflect certain types of 

newly acquired safety-related 

information, irrespective of whether the 

revised labeling differs from that of the 

corresponding reference listed drug 

(RLD or brand drug) upon submission of 

a CBE–0 supplement to FDA. FDA’s 

proposed revisions to its regulations to 

allow generic drug manufacturers to 

update product labeling through CBE–0 

supplements in the same manner as 

brand drug manufacturers are intended 

to improve communication of 

important, newly acquired drug safety 

information to health care professionals 

and the public. For further information 

about this and other proposed 

regulatory changes described in the 

proposed rule, see 78 FR 67985. 

FDA received numerous comments on 

the proposed rule from a diverse group 

of stakeholders, including comments 

proposing alternative approaches to 

communicating newly acquired safetyrelated information in a multisource 

environment. In November 2014, FDA 

received a request from two trade 

associations for a listening meeting with 

FDA to present an alternative to the 

proposed regulatory changes described 

in the proposed rule that they described 

as intended to meet shared public 

health goals regarding multisource 

drugs (see Ref. 1). In December 2014, an 

explanatory statement accompanying 

the Consolidated and Further 

Continuing Appropriations Act, 2015 

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