Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations 55235 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–0277; Directorate 

Identifier 2015–NE–05–AD; Amendment 39– 

18262; AD 2015–18–04] 

RIN 2120–AA64 

Airworthiness Directives; CFM 

International S.A. Turbofan Engines 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for certain 

CFM International S.A. (CFM) CFM56– 

7B and CFM56–3 turbofan engines. This 

AD was prompted by a report of an 

uncommanded in-flight shutdown 

(IFSD) on a CFM CFM56–7B engine 

following rupture of the 73-tooth 

gearshaft located in the engine accessory 

gearbox (AGB). This AD requires AGB/ 

transfer gearbox (TGB) magnetic chip 

detector (MCD) inspection of the 

affected gearshafts until removal. We are 

issuing this AD to prevent failure of 

certain engine AGB gearshafts, which 

could lead to failure of one or more 

engines, loss of thrust control, and 

damage to the airplane. 

DATES: This AD is effective October 20, 

2015. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of October 20, 2015. 

ADDRESSES: For service information 

identified in this AD, contact CFM 

International Inc., Aviation Operations 

Center, 1 Neumann Way, M/D Room 

285, Cincinnati, OH 45125; phone: 877– 

432–3272; fax: 877–432–3329; email: 

aviation.fleetsupport@ge.com. 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. It is also available 

on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0277. 

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– 

0277; 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 AD, the regulatory 

evaluation, any comments received, and 

other information. The address for the 

Docket Office (phone: 800–647–5527) is 

Document Management Facility, U.S. 

Department of Transportation, Docket 

Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue SE., Washington, 

DC 20590. 

FOR FURTHER INFORMATION CONTACT: Kyle 

Gustafson, Aerospace Engineer, Engine 

Certification Office, FAA, Engine & 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: 781–238–7183; fax: 781–238– 

7199; email: kyle.gustafson@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 by adding an AD that would 

apply to certain CFM CFM56–7B series 

turbofan engines. The NPRM published 

in the Federal Register on May 1, 2015 

(80 FR 24856). The NPRM was 

prompted by a report of an 

uncommanded IFSD on a CFM CFM56– 

7B engine following rupture of the 73- 

tooth gearshaft located in the engine 

AGB. The NPRM proposed to require 

MCD inspection of the affected 

gearshafts until removal. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. The 

following presents the comments 

received on the NPRM (80 FR 24856, 

May 1, 2015) and the FAA’s response to 

each comment. 

Request To Add CFM56–3 Engines to 

Applicability 

CFM requested that we add CFM56– 

3 engines to this AD, as the CFM56–3 

engines share the same 73-tooth and 41- 

tooth gearshafts as the CFM56–7B 

engines. 

We agree. We revised the applicability 

of this AD by adding CFM56–3 engines. 

Request To Clarify Discussion of IFSDs 

CFM commented that the NPRM (80 

FR 24856, May 1, 2015) incorrectly 

indicated that multiple instances of 

uncommanded IFSDs occurred on 

CFM56–7B engines following rupture of 

the 73-tooth gearshaft when only one 

IFSD actually occurred. CFM requested 

that this AD be revised to reflect that 

only one IFSD occurred following 

rupture of the 73-tooth gearshaft. 

We agree. We revised the Summary, 

Discussion, and Unsafe Condition 

sections of this final rule to reflect the 

occurrence of one IFSD following 

rupture of the 73-tooth gearshaft in the 

CFM56–7B’s AGB. 

Request To Clarify Inspection 

Requirement 

CFM commented that the NPRM (80 

FR 24856, May 1, 2015) did not clearly 

specify that the MCD inspection is of 

the AGB/TGB. 

We agree. We revised the Summary 

and the Compliance sections of this 

final rule to reflect that the required 

inspection is an ‘‘AGB/TGB MCD 

inspection.’’ 

Request To Clarify Relevant Service 

Information 

CFM requested that we specify in the 

Relevant Service Information section of 

the NPRM (80 FR 24856, May 1, 2015) 

that the referenced service bulletins 

(SBs) describe the procedures for 

removal of the affected 73-tooth and 41- 

tooth gearshafts and also list the affected 

gearshafts by serial number (S/N). 

We disagree. This AD does not 

include a ‘‘Relevant Service 

Information’’ section. We are, however, 

incorporating this SB by reference and 

it is available on the Internet at http:// 

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0277. We did not change this AD. 

Request To Clarify Proposed AD 

Requirements 

CFM commented that the Proposed 

AD Requirements section should be 

revised to be consistent with the 

compliance and mandatory terminating 

action paragraphs in this AD. 

We disagree. This AD incorporates 

changes produced as a result of the 

comments received, as permitted by the 

Administrative Procedures Act (APA) 

(Pub. L. 79–404, 5 U.S.C. 551, et. seq.). 

To take the action the commenter 

suggests would be contrary to the APA. 

We did not change this AD. 

Request To Allow Use of Later 

Revisions to SBs 

CFM requested that we include a 

provision in this AD to allow for use of 

later revisions to CFM SB No. CFM56– 

7B S/B 72–0964, Revision 1, dated 

December 15, 2014, and SB No. CFM56– 

7B S/B 72–0965, dated December 16, 

2014. 

We disagree. We do not know the 

content of future revisions of SBs and, 

therefore, cannot approve them before 

publication. We did not change this AD. 

Request To Revise Description of 

Laboratory Analysis 

CFM requested we change the 

wording in the Compliance section of 

this AD from ‘‘particles lab analysis’’ to 

‘‘laboratory analysis.’’ 

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55236 Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations 

We agree. The term ‘‘laboratory 

analysis’’ is more accurate. We revised 

the term ‘‘particles lab analysis’’ to read 

‘‘laboratory analysis’’ in the Compliance 

section of this AD. 

Request To Include Serial Numbers of 

Affected Gearshafts 

CFM requested that we include the S/ 

Ns of the affected 73-tooth and 41-tooth 

gearshafts in this AD instead of 

referencing the SBs. CFM indicated that 

CFM56–3 operators may not have access 

to the CFM56–7B SBs. 

We disagree. Operators have access to 

CFM SB No. CFM56–7B S/B 72–0964, 

Revision 1, dated December 15, 2014, in 

the AD docket on the Internet at 

http://www.regulations.gov by searching 

for and locating Docket No. FAA–2015– 

0277, or by requesting the SB from CFM. 

We did not change this AD. 

Request To Limit Applicability by 

Engine Serial Number 

Sun Country Airlines requested that 

the Applicability of this AD be limited 

to CFM56–7B engines with engine S/Ns 

listed in Appendix A of CFM SB No. 

CFM56–7B S/B 72–0964 and CFM56–7B 

engines that have the 73-tooth gearshafts 

listed in Appendix B of CFM SB No. 

CFM56–7B S/B 72–0964 installed postproduction. Sun Country Airlines noted 

that the applicability of the NPRM (80 

FR 24856, May 1, 2015) could be 

misconstrued to mean to include all 

CFM56–7B engines unless it is proven 

that they do not have the affected 73- 

tooth or 41-toth gearshafts. 

We disagree. CFM identified the 

affected population of gearshafts by 

gearshaft S/N and by the engine S/N on 

which it was installed. However, an 

affected gearshaft may now be installed 

on an engine with an S/N not listed in 

Appendix A. To address the latter 

population, those engines with a 

gearshaft that has been installed on an 

unknown engine, we identified the 

affected population of 73-tooth and 41- 

tooth gearshafts by gearshaft part 

number and S/N. We did not change 

this AD. 

Request To Clarify That Applicability Is 

by Gearshaft Serial Number 

Delta Air Lines (Delta) requested that 

we clarify that the applicability of the 

AD is by gearshaft S/N rather than by 

engine S/N. 

We agree. We revised the 

Applicability paragraph of this AD to 

read: ‘‘This AD applies to all CFM 

International S.A. (CFM) CFM56–7B 

and CFM56–3 engines with a 73-tooth 

or 41-tooth gearshaft installed in the 

accessory gearbox (AGB), that has a 

gearshaft serial number in Appendix A 

or Appendix B of CFM Service Bulletin 

(SB) No. CFM56–7B S/B 72–0964, 

Revision 1, dated December 15, 2014.’’ 

Request To Verify Affected Gearshafts 

Have Been Removed From Service and 

Reduce the Scope of Applicability 

Delta requested that we verify which 

gearshafts have been removed from 

service per the proposed requirements 

of the NPRM (80 FR 24856, May 1, 

2015). Delta further asked that we 

reduce the applicability to only those 

affected gearshafts that remain in 

service. 

We disagree. This AD will ensure that 

all affected gearshafts are removed from 

service and that gearshafts already 

removed from service are not returned 

to service. We did not change this AD. 

Support for the NPRM 

The Boeing Company and an 

anonymous commenter expressed 

support for the NPRM (80 FR 24856, 

May 1, 2015) as proposed. 

Conclusion 

We reviewed the relevant data, 

considered the comments received, and 

determined that air safety and the 

public interest require adopting this AD 

with the changes described previously. 

We also determined that these 

changes will not increase the economic 

burden on any operator or increase the 

scope of this AD. 

Related Service Information Under 1 

CFR Part 51 

We reviewed CFM SB No. CFM56–7B 

S/B 72–0964, Revision 1, dated 

December 15, 2014. The service 

information describes procedures for 

removal of affected 73-tooth and 41- 

tooth gearshafts. This service 

information is reasonably available 

because the interested parties have 

access to it through their normal course 

of business or by the means identified 

in the ADDRESSES section of this AD. 

Costs of Compliance 

We estimate that this AD will affect 

about 67 engines installed on airplanes 

of U.S. registry. We also estimate that it 

will take about 1 hour per engine to do 

the inspection and 8 hours per engine 

to replace each affected gearshaft. We 

estimate thirty-six 73-tooth gearshafts 

and forty 41-tooth gearshafts will need 

replacement at a cost of $12,480 and 

$7,680 per part, respectively. The 

average labor rate is $85 per hour. Based 

on these figures, we estimate the cost of 

this AD on U.S. operators to be 

$813,855. 

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 

This AD will not have federalism 

implications under Executive Order 

13132. This AD will 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 that this AD: 

(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), 

(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. 

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Federal Register / Vol. 80, No. 178 / Tuesday, September 15, 2015 / Rules and Regulations 55237 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2015–18–04 CFM International S.A.: 

Amendment 39–18262; Docket No. 

FAA–2015–0277; Directorate Identifier 

2015–NE–05–AD. 

(a) Effective Date 

This AD is effective October 20, 2015. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to CFM International S.A. 

(CFM) CFM56–7B and CFM56–3 engines 

with a 73-tooth or 41-tooth gearshaft installed 

in the accessory gearbox (AGB), that has a 

gearshaft serial number in Appendix A or 

Appendix B of CFM Service Bulletin (SB) No. 

CFM56–7B S/B 72–0964, Revision 1, dated 

December 15, 2014. 

(d) Unsafe Condition 

This AD was prompted by a report of an 

uncommanded in-flight shutdown on a CFM 

CFM56–7B engine following rupture of the 

73-tooth gearshaft located in the engine AGB. 

We are issuing this AD to prevent failure of 

certain AGB gearshafts, which could lead to 

failure of one or more engines, loss of thrust 

control, and damage to the airplane. 

(e) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(1) Initial AGB/Transfer Gearbox (TGB)/

Magnetic Chip Detector (MCD) Inspection 

and Analysis 

(i) For affected 73-tooth gearshafts, perform 

an AGB/TGB MCD inspection within 250 

flight hours (FHs) since last inspection, 

within 25 FHs from the effective date of this 

AD, or when the gearshaft accumulates 3,000 

FHs since new, whichever comes later. 

(ii) For affected 41-tooth gearshafts, 

perform an AGB/TGB MCD inspection within 

250 FHs since last inspection, within 25 FHs 

from the effective date of this AD, or when 

the gearshaft accumulates 6,000 FHs since 

new, whichever comes later. 

(iii) If any magnetic particles, including 

fuzz, are seen, determine with laboratory 

analysis if the particles are 73-tooth or 41- 

tooth gearshaft material. 

(iv) If the particles are 73-tooth or 41-tooth 

gearshaft material, remove the affected 

gearshaft(s) within 75 FHs since the AGB/

TGB MCD inspection. 

(2) Repetitive AGB/TGB MCD Inspection and 

Analysis 

(i) For affected 73-tooth gearshafts, perform 

an AGB/TGB MCD inspection and laboratory 

analysis within every 500 FHs since the last 

AGB/TGB MCD inspection until affected 

gearshaft is removed. 

(ii) For affected 41-tooth gearshafts, 

perform an AGB/TGB MCD inspection and 

laboratory analysis within every 500 FHs 

since the last AGB/TGB MCD inspection 

until affected gearshaft is removed. 

(iii) If any magnetic particles, including 

fuzz, are seen, determine with laboratory 

analysis if the particles are 73-tooth or 41- 

tooth gearshaft material. 

(iv) If the particles are 73-tooth or 41-tooth 

gearshaft material, remove the affected 

gearshaft(s) within 75 FHs since the AGB/

TGB MCD inspection. 

(f) Mandatory Terminating Action 

(1) Remove the affected 73-tooth gearshaft 

prior to the gearshaft accumulating 6,000 FHs 

since new or within 50 FHs after the effective 

date of this AD, whichever comes later. 

(2) Remove the affected 41-tooth gearshaft 

prior to the gearshaft accumulating 9,000 FHs 

since new or within 50 FHs after the effective 

date of this AD, whichever comes later. 

(g) Installation Prohibition 

After the effective date of this AD, do not 

install an affected gearshaft into an AGB. 

(h) 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. 

(i) Related Information 

For more information about this AD, 

contact Kyle Gustafson, Aerospace Engineer, 

Engine Certification Office, FAA, Engine & 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: 781–238–7183; fax: 781–238–7199; 

email: kyle.gustafson@faa.gov. 

(j) 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 the AD specifies otherwise. 

(3) The following service information was 

approved for IBR on October 20, 2015. 

(i) CFM International Service Bulletin No. 

CFM56–7B S/B 72–0964, Revision 1, dated 

December 15, 2014. 

(ii) Reserved. 

(4) For CFM service information identified 

in this AD, contact CFM International Inc., 

Aviation Operations Center, 1 Neumann 

Way, M/D Room 285, Cincinnati, OH 45125; 

phone: 877–432–3272; fax: 877–432–3329; 

email: aviation.fleetsupport@ge.com. 

(5) You may view this service information 

at 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. 

(6) You may view this service information 

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 Burlington, Massachusetts, on 

August 28, 2015. 

Ann C. Mollica, 

Acting Directorate Manager, Engine & 

Propeller Directorate, Aircraft Certification 

Service. 

[FR Doc. 2015–22598 Filed 9–14–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2014–N–0504] 

RIN 0910–AH12 

Administrative Destruction of Certain 

Drugs Refused Admission to the 

United States 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

implementing its authority to destroy a 

drug valued at $2,500 or less (or such 

higher amount as the Secretary of the 

Treasury may set by regulation) that has 

been refused admission into the United 

States under the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act), by 

issuing a rule that provides to the owner 

or consignee notice and an opportunity 

to appear and introduce testimony to 

the Agency prior to destruction. This 

regulation is authorized by amendments 

made to the FD&C Act by the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA). 

Implementation of this authority will 

allow FDA to better protect the public 

health by providing an administrative 

process for the destruction of certain 

refused drugs, thus increasing the 

integrity of the drug supply chain. 

DATES: This rule is effective October 15, 

2015. 

FOR FURTHER INFORMATION CONTACT: Ann 

M. Metayer, Office of Regulatory Affairs, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

4338, Silver Spring, MD 20993–0002, 

301–796–3324, 

FDASIAImplementationORA@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

Purpose of the Regulatory Action 

Implementation of FDA’s 

administrative destruction authority 

will better protect the integrity of the 

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