Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations 49893 

Type Certification Basis 

Under the provisions of 14 CFR 21.17, 

Bombardier Inc. must show that the 

Model BD–700–2A12 and BD–700– 

2A13 airplanes meet the applicable 

provisions of part 25 as amended by 

Amendments 25–1 through 25–129. 

If the Administrator finds that the 

applicable airworthiness regulations 

(i.e., 14 CFR part 25) do not contain 

adequate or appropriate safety standards 

for the Model BD–700–2A12 and BD– 

700–2A13 airplanes because of a novel 

or unusual design feature, special 

conditions are prescribed under the 

provisions of § 21.16. 

Special conditions are initially 

applicable to the model for which they 

are issued. Should the type certificate 

for that model be amended later to 

include any other model that 

incorporates the same novel or unusual 

design feature, these special conditions 

would also apply to the other model 

under § 21.101. 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Model BD–700–2A12 

and BD–700–2A13 airplanes must 

comply with the fuel-vent and exhaustemission requirements of 14 CFR part 

34, and the noise-certification 

requirements of 14 CFR part 36; and the 

FAA must issue a finding of regulatory 

adequacy under § 611 of Public Law 92– 

574, the ‘‘Noise Control Act of 1972.’’ 

The FAA issues special conditions, as 

defined in 14 CFR 11.19, in accordance 

with § 11.38, and they become part of 

the type-certification basis under 

§ 21.17(a)(2). 

Novel or Unusual Design Features 

The Bombardier Model BD–700–2A12 

and BD–700–2A13 airplanes will 

incorporate the following novel or 

unusual design feature: 

An electronic flight-control system 

that contains fly-by-wire control laws, 

including envelope protections, for 

high-speed protection functions. 

Current part 25 requirements do not 

contain appropriate standards for highspeed protection systems. 

Discussion 

Model BD–700–2A12 and BD–700– 

2A13 airplanes are equipped with a 

high-speed protection system, which, 

when the system detects airspeed 

exceeding a small tolerance above VMO/ 

MMO, employs a high-speed limiter to 

automatically deploy multifunction 

spoilers (MFS) as speed brakes. The 

MFS retract automatically when the 

system detects that airspeed is 

sufficiently reduced. 

These special conditions contain the 

additional safety standards that the 

Administrator considers necessary to 

establish a level of safety equivalent to 

that established by the existing 

airworthiness standards. 

Applicability 

As discussed above, these special 

conditions are applicable to the 

Bombardier Model BD–700–2A12 and 

BD–700–2A13 airplanes. Should 

Bombardier Inc. apply at a later date for 

a change to the type certificate to 

include another model incorporating the 

same novel or unusual design feature, 

these special conditions would apply to 

that model as well. 

Conclusion 

This action affects only certain novel 

or unusual design features on 

Bombardier Model BD–700–2A12 and 

BD–700–2A13 airplanes. It is not a rule 

of general applicability. 

The substance of these special 

conditions has been subjected to the 

notice and comment period in several 

prior instances and has been derived 

without substantive change from those 

previously issued. It is unlikely that 

prior public comment would result in a 

significant change from the substance 

contained herein. Therefore, because a 

delay would significantly affect the 

certification of the airplane, the FAA 

has determined that prior public notice 

and comment are unnecessary and 

impracticable, and good cause exists for 

adopting these special conditions upon 

publication in the Federal Register. The 

FAA is requesting comments to allow 

interested persons to submit views that 

may not have been submitted in 

response to the prior opportunities for 

comment described above. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

The authority citation for these 

special conditions is as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701, 

44702, 44704. 

The Special Conditions 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the following special 

conditions are issued as part of the type 

certification basis for Bombardier Model 

BD–700–2A12 and BD–700–2A13 

airplanes. The requirements of § 25.253 

(high-speed characteristics), and its 

related policy, are applicable to the 

Model BD–700–2A12 and BD–700– 

2A13 airplanes, and are not affected by 

these special conditions. 

In addition to § 25.143, the following 

requirement applies: 

Operation of the high-speed limiter 

during all routine and descent 

procedure flight must not impede 

normal attainment of speeds up to highspeed warning. 

Issued in Renton, Washington, on August 

7, 2015. 

Michael Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–20299 Filed 8–17–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. FAA–2015–0311; Special 

Conditions No. 25–592–SC] 

Special Conditions: Gulfstream 

Aerospace Corporation Model GVII– 

G500 Airplanes; Electronic Flight 

Control System: Control Surface 

Position Awareness 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions, request 

for comments. 

SUMMARY: These special conditions are 

issued for Gulfstream Model GVII–G500 

airplanes. These airplanes have a novel 

or unusual design feature associated 

with control-surface awareness 

provided by the electronic flight-control 

system. The applicable airworthiness 

regulations do not contain adequate or 

appropriate safety standards for this 

design feature. These special conditions 

contain the additional safety standards 

that the Administrator considers 

necessary to establish a level of safety 

equivalent to that established by the 

existing airworthiness standards. 

DATES: This action is effective on 

Gulfstream on August 18, 2015. We 

must receive your comments by October 

2, 2015. 

ADDRESSES: Send comments identified 

by docket number FAA–2015–0311 

using any of the following methods: 

• Federal eRegulations Portal: Go to 

http://www.regulations.gov/ and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30, U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 


rmajette on DSK7SPTVN1PROD with RULES
49894 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: The FAA will post all 

comments it receives, without change, 

to http://www.regulations.gov/, 

including any personal information the 

commenter provides. Using the search 

function of the docket Web site, anyone 

can find and read the electronic form of 

all comments received into any FAA 

docket, including the name of the 

individual sending the comment (or 

signing the comment for an association, 

business, labor union, etc.). DOT’s 

complete Privacy Act Statement can be 

found in the Federal Register published 

on April 11, 2000 (65 FR 19477–19478), 

as well as at http://DocketsInfo.dot 

.gov/. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov/ at any time. 

Follow the online instructions for 

accessing the docket or go to Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: Joe 

Jacobsen, FAA, Airplane and Flightcrew 

Interface Branch, ANM–111, Transport 

Airplane Directorate, Aircraft 

Certification Service, 1601 Lind Avenue 

SW., Renton, Washington 98057–3356; 

telephone (425) 227–2011; facsimile 

(425) 227–1320. 

SUPPLEMENTARY INFORMATION: The FAA 

has determined that notice of, and 

opportunity for prior public comment 

on, these special conditions is 

impracticable because these procedures 

would significantly delay issuance of 

the design approval and thus delivery of 

the affected airplanes. 

In addition, the substance of these 

special conditions has been subject to 

the public comment process in several 

prior instances with no substantive 

comments received. The FAA therefore 

finds that good cause exists for making 

these special conditions effective upon 

publication in the Federal Register. 

Background 

On March 29, 2012, Gulfstream 

applied for a type certificate for their 

new Model GVII–G500 airplane. This 

airplane is a large-cabin business jet 

capable of accommodating up to 19 

passengers. It will incorporate a low, 

swept-wing design with winglets and a 

T-tail. The powerplant will consist of 

two aft-fuselage mounted Pratt & 

Whitney turbofan engines. Avionics will 

include four primary display units and 

multiple touchscreen controllers. The 

flight-control system is a three-axis, flyby-wire system controlled through 

active control/coupled side sticks. 

The Model GVII–G500 airplane will 

have a wingspan of approximately 87 ft. 

and a length of just over 91 ft. Maximum 

takeoff weight will be approximately 

76,850 lbs and maximum takeoff thrust 

will be approximately 15,135 lbs. 

Maximum range will be approximately 

5,000 nm and maximum operating 

altitude will be 51,000 ft. 

In airplanes with electronic flightcontrol systems, a direct 

correspondence between pilot-control 

position and the associated airplane 

control-surface position is not always 

apparent. Under certain circumstances, 

a commanded maneuver that may not 

involve a large flightcrew-control input 

may nevertheless require a large controlsurface movement to accomplish, 

possibly encroaching on a controlsurface or actuation-system limit 

without the flightcrew’s knowledge. 

This situation can arise in both piloted 

(i.e., manual) and autopilot flight, and 

may be further intensified on airplanes 

where the pilot controls are not backdriven during autopilot system 

operation. 

These special conditions for controlsurface awareness, applicable to 

Gulfstream Model GVII–G500 airplanes, 

require suitable flight-control-position 

annunciation and control-system mode 

of operation to be provided to the 

flightcrew when a flight condition exists 

in which nearly full surface authority 

(not crew-commanded) is being utilized. 

Suitability of such a display must take 

into account that some pilot-demanded 

maneuvers (e.g., rapid roll) are 

necessarily associated with intended 

full performance, which may saturate 

the surface. Therefore, simple alerting 

systems, which would function in both 

intended or unexpected control-limiting 

situations, must be properly balanced 

between needed crew awareness and 

nuisance features. A monitoring system 

that might compare airplane motion, 

surface deflection, and pilot side-stick 

controller (SSC) demand, could be 

useful for elimination of nuisance 

alerting. 

Type Certification Basis 

Under Title 14, Code of Federal 

Regulations (14 CFR) 21.17, Gulfstream 

must show that the Model GVII–G500 

airplane meets the applicable provisions 

of 14 CFR part 25, as amended by 

Amendments 25–1 through 25–137. 

In addition, the certification basis 

includes certain special conditions, 

exemptions, or later amended sections 

of the applicable part that are not 

relevant to these special conditions. 

If the Administrator finds that the 

applicable airworthiness regulations 

(i.e., 14 CFR part 25) do not contain 

adequate or appropriate safety standards 

for the Model GVII–G500 airplane 

because of a novel or unusual design 

feature, special conditions are 

prescribed under § 21.16. 

Special conditions are initially 

applicable to the model for which they 

are issued. Should the type certificate 

for that model be amended later to 

include any other model that 

incorporates the same or similar novel 

or unusual design feature, these special 

conditions would also apply to the other 

model under § 21.101. 

In addition to the applicable 

airworthiness regulations and special 

conditions, the Gulfstream Model GVII– 

G500 airplane must comply with the 

fuel-vent and exhaust-emission 

requirements of 14 CFR part 34, and the 

noise-certification requirements of 14 

CFR part 36; and the FAA must issue a 

finding of regulatory adequacy under 

§ 611 of Public Law 92–574, the ‘‘Noise 

Control Act of 1972.’’ 

The FAA issues special conditions, as 

defined in 14 CFR 11.19, under § 11.38, 

and they become part of the type 

certification basis under § 21.17(a)(2). 

Novel or Unusual Design Features 

The Gulfstream Model GVII–G500 

airplane incorporates the following 

novel or unusual design features: 

Electronic flight-control system 

providing control-surface awareness to 

the flightcrew. 

Discussion 

Gulfstream Aerospace Corporation is 

intending to utilize an electronic flightcontrol system (including side-stick 

controllers for pitch and roll control) in 

their new Model GVII–G500 airplane. 

With an electronic flight-control system 

and no direct coupling from the 

flightdeck controller to the control 

surface, the pilot may not be aware of 

the actual surface position utilized to 

fulfill the requested demand. Some 

unusual flight conditions, arising from 

atmospheric conditions, airplane 

malfunctions, or engine failures, may 

result in full or nearly full controlsurface deflection. Unless the flightcrew 

is made aware of excessive deflection or 

impending control-surface limiting, 

piloted or auto-flight system control of 

the airplane might be inadvertently 

continued in such a manner as to cause 

loss of airplane control, or other unsafe 

stability or performance characteristics. 


rmajette on DSK7SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations 49895 

These special conditions contain the 

additional safety standards that the 

Administrator considers necessary to 

establish a level of safety equivalent to 

that established by the existing 

airworthiness standards. 

Applicability 

As discussed above, these special 

conditions apply to Gulfstream Model 

GVII–G500 airplanes. Should 

Gulfstream apply later for a change to 

the type certificate to include another 

model incorporating the same or similar 

novel or unusual design feature, these 

special conditions would apply to that 

model as well. 

Conclusion 

This action affects only certain novel 

or unusual design features on 

Gulfstream Model GVII–G500 airplanes. 

It is not a rule of general applicability. 

List of Subjects in 14 CFR Part 25 

Aircraft, Aviation safety, Reporting 

and recordkeeping requirements. 

The authority citation for these 

special conditions is as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701, 

44702, 44704. 

The Special Conditions 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, the following special 

conditions are issued as part of the type 

certification basis for Gulfstream Model 

GVII–G500 airplanes. 

In addition to the requirements of 

§§ 25.143, 25.671, 25.672, and 25.1322, 

when a flight condition exists where, 

without being commanded by the crew, 

control surfaces are coming so close to 

their limits that return to the normal 

flight envelope, or continuation of safe 

flight, or both, requires a specific crew 

action, a suitable flight-control-position 

annunciation must be provided to the 

crew, unless other existing indications 

are found adequate or sufficient to 

prompt that action. 

Note: The term ‘‘suitable’’ indicates an 

appropriate balance between necessary 

operation and nuisance factors. 

Issued in Renton, Washington, on August 

7, 2015. 

Michael Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–20296 Filed 8–17–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2015–N–2723] 

Medical Devices; Cardiovascular 

Devices; Classification of the 

Esophageal Thermal Regulation 

Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

esophageal thermal regulation device 

into class II (special controls). The 

special controls that will apply to the 

device are identified in this order and 

will be part of the codified language for 

the esophageal thermal regulation 

device’s classification. The Agency is 

classifying the device into class II 

(special controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. 

DATES: This order is effective August 18, 

2015. The classification was applicable 

on June 23, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Lydia Glaw, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1102, Silver Spring, 

MD 20993–0002, 301–796–1456, 

Lydia.glaw@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(f)(1)), devices that were not in 

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

provides two procedures by which a 

person may request FDA to classify a 

device under the criteria set forth in 

section 513(a)(1). Under the first 

procedure, the person submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified and, 

within 30 days of receiving an order 

classifying the device into class III 

under section 513(f)(1), the person 

requests a classification under section 

513(f)(2) of the FD&C Act. Under the 

second procedure, rather than first 

submitting a premarket notification 

under section 510(k) of the FD&C Act 

and then a request for classification 

under the first procedure, the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence and requests a classification 

under section 513(f)(2) of the FD&C Act. 

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. On May 8, 

2014, Advanced Cooling Therapy, LLC, 

submitted a request for classification of 

the Esophageal Cooling Device under 

section 513(f)(2) of the FD&C Act. The 

manufacturer recommended that the 

device be classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1). FDA classifies 

devices into class II if general controls 

by themselves are insufficient to 

provide reasonable assurance of safety 

and effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the request, 

FDA determined that the device could 

be classified into class II with the 


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