69666 Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Rules and Regulations 

5http://rgl.faa.gov/Regulatory_and_Guidance_

Library/rgAdvisoryCircular.nsf/0/E35FBC0060

E2159186257BBE00719FB3?OpenDocument&

Highlight=ac%2020–115b. 

6http://rgl.faa.gov/Regulatory_and_Guidance_

Library/rgAdvisoryCircular.nsf/0/6D4AE0BF

1BDE3579862570360055D119?Open

Document&Highlight=ac%2020–152. 

Lithium battery installations on the 

Model A36 airplanes must be designed 

and installed as follows: 

a. Safe cell temperatures and 

pressures must be maintained during 

any probable charging or discharging 

condition, or during any failure of the 

charging or battery monitoring system 

not shown to be extremely remote. The 

lithium battery installation must be 

designed to preclude explosion or fire in 

the event of those failures. 

b. Lithium batteries must be designed 

to preclude the occurrence of selfsustaining, uncontrolled increases in 

temperature or pressure. 

c. No explosive or toxic gasses 

emitted by any lithium battery in 

normal operation or as the result of any 

failure of the battery charging or 

monitoring system, or battery 

installation not shown to be extremely 

remote, may accumulate in hazardous 

quantities within the airplane. 

d. Lithium batteries that contain 

flammable fluids must comply with the 

flammable fluid fire protection 

requirements of 14 CFR 23.863(a) 

through (d). 

e. No corrosive fluids or gases that 

may escape from any lithium battery 

may damage airplane structure or 

essential equipment. 

f. Each lithium battery installation 

must have provisions to prevent any 

hazardous effect on structure or 

essential systems that may be caused by 

the maximum amount of heat the 

battery can generate during a short 

circuit of the battery or of its individual 

cells. 

g. Lithium battery installations must 

have— 

(1) A system to control the charging 

rate of the battery automatically to 

prevent battery overheating or 

overcharging, or 

(2) A battery temperature sensing and 

over-temperature warning system with a 

means for automatically disconnecting 

the battery from its charging source in 

the event of an over-temperature 

condition or, 

(3) A battery failure sensing and 

warning system with a means for 

automatically disconnecting the battery 

from its charging source in the event of 

battery failure. 

h. Any lithium battery installation 

functionally required for safe operation 

of the airplane, must incorporate a 

monitoring and warning feature that 

will provide an indication to the 

appropriate flight crewmembers, 

whenever the capacity and state of 

charge of the batteries have fallen below 

levels considered acceptable for 

dispatch of the airplane. 

i. The ICAW must contain 

recommended manufacturer’s 

maintenance and inspection 

requirements to ensure that batteries, 

including single cells, meet a 

functionally safe level essential to the 

aircraft’s continued airworthiness. 

(1) The ICAW must contain operating 

instructions and equipment limitations 

in an installation maintenance manual. 

(2) The ICAW must contain 

installation procedures and limitations 

in a maintenance manual, sufficient to 

ensure that cells or batteries, when 

installed according to the installation 

procedures, still meet safety functional 

levels essential to the aircraft’s 

continued airworthiness. The 

limitations must identify any unique 

aspects of the installation. 

(3) The ICAW must contain corrective 

maintenance procedures to check 

battery capacity at manufacturer’s 

recommended inspection intervals. 

(4) The ICAW must contain scheduled 

servicing information to replace 

batteries at manufacturer’s 

recommended replacement time. 

(5) The ICAW must contain 

maintenance and inspection 

requirements how to check visually for 

battery and charger degradation. 

j. Batteries in a rotating stock (spares) 

that have degraded charge retention 

capability or other damage due to 

prolonged storage must be checked at 

manufacturer’s recommended 

inspection intervals. 

k. If the lithium battery application 

contains software and/or complex 

hardware, in accordance with AC 20– 

115 5 and AC 20–152,6 they should be 

developed to the standards of DO–178 

for software and DO–254 for complex 

hardware. 

Compliance with the requirements of 

this Special Condition must be shown 

by test or analysis, with the concurrence 

of the New York Aircraft Certification 

Office. 

Issued in Kansas City, Missouri on 

September 28, 2016. 

William Schinstock, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–24343 Filed 10–6–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2016–3986; Directorate 

Identifier 2015–NM–147–AD; Amendment 

39–18661; AD 2016–19–12] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for certain 

The Boeing Company Model 747–400, 

747–400D, and 747–400F series 

airplanes. This AD was prompted by a 

determination that a certain fastener 

type in the fuel tank walls has 

insufficient bond to the structure, and 

an electrical wiring short could cause 

arcing to occur at the ends of fasteners 

in the fuel tanks. This AD requires the 

installation of new clamps and 

polytetrafluoroethylene (TFE) sleeves on 

the wire bundles of the front spars and 

rear spars of the wings. This AD also 

requires inspecting the existing TFE 

sleeves under the wire bundle clamps 

for correct installation, and replacement 

if necessary. We are issuing this AD to 

prevent potential ignition sources in the 

fuel tank in the event of a lightning 

strike or high-powered short circuit, and 

consequent fire or explosion. 

DATES: This AD is effective November 

14, 2016. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of November 14, 2016. 

ADDRESSES: For service information 

identified in this final rule, contact 

Boeing Commercial Airplanes, 

Attention: Data & Services Management, 

P.O. Box 3707, MC 2H–65, Seattle, WA 

98124–2207; telephone: 206–544–5000, 

extension 1; fax: 206–766–5680; 

Internet: https:// 

www.myboeingfleet.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. It is also available 

on the Internet at http:// 

www.regulations.gov by searching for 

and locating Docket No. FAA–2016– 

3986. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

mstockstill on DSK3G9T082PROD with RULES

Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Rules and Regulations 69667 

www.regulations.gov by searching for 

and locating Docket No. FAA–2016– 

3986; 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 

Docket 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: 

Tung Tran, Aerospace Engineer, 

Propulsion Branch, ANM–140S, FAA, 

Seattle Aircraft Certification Office 

(ACO), 1601 Lind Avenue SW., Renton, 

WA 98057–3356; phone: 425–917–6505; 

fax: 425–917–6590; email: 

Tung.Tran@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 The Boeing Company 

Model 747–400, 747–400D, and 747– 

400F series airplanes. The NPRM 

published in the Federal Register on 

March 1, 2016 (81 FR 10537) (‘‘the 

NPRM’’). The NPRM was prompted by 

a determination that a certain fastener 

type in the fuel tank walls has 

insufficient bond to the structure, and 

an electrical wiring short could cause 

arcing to occur at the ends of fasteners 

in the fuel tanks. The NPRM proposed 

to require the installation of new clamps 

and TFE sleeves on the wire bundles of 

the front spars and rear spars of the 

wings. The NPRM also proposed to 

require inspecting the existing TFE 

sleeves under the wire bundle clamps 

for correct installation, and replacement 

if necessary. We are issuing this AD to 

prevent potential ignition sources in the 

fuel tank in the event of a lightning 

strike or high-powered short circuit, and 

consequent fire or explosion. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. The 

following presents the comments 

received on the NPRM and the FAA’s 

response to each comment. 

Support for the NPRM 

Boeing supported the content of the 

NPRM. United Airlines had no objection 

to the NPRM. 

Conclusion 

We reviewed the relevant data, 

considered the comments received, and 

determined that air safety and the 

public interest require adopting this AD 

as proposed, except for minor editorial 

changes. We have determined that these 

minor changes: 

• Are consistent with the intent that 

was proposed in the NPRM for 

correcting the unsafe condition; and 

• Do not add any additional burden 

upon the public than was already 

proposed in the NPRM. 

Related Service Information Under 1 

CFR Part 51 

We reviewed Boeing Special 

Attention Service Bulletin 747–28– 

2324, Revision 1, dated July 27, 2015. 

The service information describes 

procedures for installing new clamps 

and TFE sleeves on the wire bundles of 

the front spars and rear spars of the 

wings. The service information also 

describes procedures for inspecting TFE 

sleeves under the wire bundle clamps 

that were installed using the procedures 

specified in Boeing Special Attention 

Service Bulletin 747–28–2324, dated 

November 3, 2014, for correct 

installation, and replacing them if 

necessary. 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. 

Costs of Compliance 

We estimate that this AD affects 135 

airplanes of U.S. registry. 

We estimate the following costs to 

comply with this AD: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per product Cost on U.S. operators 

Installation of wire bundle 

clamps.

Up to 7 work-hours × $85 per hour = $595 ......... $138 Up to $733 ............ Up to $98,955. 

Inspection .............................. Up to 5 work-hours × $85 per hour = $425 ......... 0 Up to $425 ............ Up to $57,375. 

We have received no definitive data 

that enables us to provide cost estimates 

for the on-condition actions specified in 

this AD. 

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, 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, 

mstockstill on DSK3G9T082PROD with RULES

69668 Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Rules and Regulations 

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. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2016–19–12 The Boeing Company: 

Amendment 39–18661; Docket No. 

FAA–2016–3986; Directorate Identifier 

2015–NM–147–AD. 

(a) Effective Date 

This AD is effective November 14, 2016. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 747–400, 747–400D, and 747–400F 

series airplanes, certificated in any category, 

as identified in Boeing Special Attention 

Service Bulletin 747–28–2324, Revision 1, 

dated July 27, 2015. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 28, Fuel. 

(e) Unsafe Condition 

This AD was prompted by a determination 

that a certain fastener type in the fuel tank 

walls has insufficient bond to the structure, 

and an electrical wiring short could cause 

arcing to occur at the ends of fasteners in the 

fuel tanks. We are issuing this AD to prevent 

potential ignition sources in the fuel tank in 

the event of a lightning strike or highpowered short circuit, and consequent fire or 

explosion. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Installation/Inspection 

Within 60 months after the effective date 

of this AD, do the actions specified in 

paragraph (g)(1) or (g)(2) of this AD, as 

applicable. 

(1) For airplanes on which the 

modification specified in Boeing Special 

Attention Service Bulletin 747–28–2324, 

dated November 3, 2014, has not been done 

as of the effective date of this AD: Install new 

clamps and polytetrafluoroethylene (TFE) 

sleeves on the wire bundles of the front spars 

and rear spars of the wings, in accordance 

with the Accomplishment Instructions of 

Boeing Special Attention Service Bulletin 

747–28–2324, Revision 1, dated July 27, 

2015. 

(2) For airplanes on which the 

modification specified in Boeing Special 

Attention Service Bulletin 747–28–2324, 

dated November 3, 2014, has been done as 

of the effective date of this AD: Do a detailed 

inspection of the TFE sleeves under the wire 

bundle clamps for correct installation, and 

replace the sleeves if not correctly installed, 

in accordance with the Accomplishment 

Instructions of Boeing Special Attention 

Service Bulletin 747–28–2324, Revision 1, 

dated July 27, 2015. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO), 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 manager of the ACO, send it to the 

attention of the person identified in 

paragraph (i) of this AD. Information may be 

emailed to: 9-ANM-Seattle-ACO-AMOCRequests@faa.gov. 

(2) 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. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair, 

alteration, or modification required by this 

AD if it is approved by the Boeing 

Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Seattle 

ACO, to make those findings. For a repair 

method to be approved, the repair method, 

modification deviation, or alteration 

deviation must meet the certification basis of 

the airplane, and the approval must 

specifically refer to this AD. 

(i) Related Information 

For more information about this AD, 

contact Tung Tran, Aerospace Engineer, 

Propulsion Branch, ANM–140S, FAA, Seattle 

Aircraft Certification Office (ACO), 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

phone: 425–917–6505; fax: 425–917–6590; 

email: Tung.Tran@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. 

(i) Boeing Special Attention Service 

Bulletin 747–28–2324, Revision 1, dated July 

27, 2015. 

(ii) Reserved. 

(3) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P. O. Box 3707, MC 2H–65, 

Seattle, WA 98124–2207; telephone: 206– 

544–5000, extension 1; fax: 206–766–5680; 

Internet: https://www.myboeingfleet.com. 

(4) 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. 

(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/ibrlocations.html. 

Issued in Renton, Washington, on 

September 13, 2016. 

Michael Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2016–22707 Filed 10–6–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 216 

[Docket No. FDA–1999–N–0194 (Formerly 

99N–4490)] 

RIN 0910–AH08 

Additions and Modifications to the List 

of Drug Products That Have Been 

Withdrawn or Removed From the 

Market for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

amending its regulations to revise the 

list of drug products that have been 

withdrawn or removed from the market 

because the drug products or 

components of such drug products have 

been found to be unsafe or not effective. 

Drugs appearing on this list may not be 

compounded under the exemptions 

provided by sections 503A and 503B of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). Specifically, the 

rule adds 24 entries to this list of drug 

products, modifies the description of 

one entry on this list, and revises the 

list’s title and introductory language. 

These revisions are necessary because 

information has come to the Agency’s 

attention since March 8, 1999, when 

FDA published the original list as a final 

rule. 

DATES: This rule is effective November 

7, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Edisa Gozun, Center for Drug Evaluation 

and Research (HFD–310), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 5199, 

Silver Spring, MD 20993–0002, 301– 

796–3110. 

mstockstill on DSK3G9T082PROD with RULES