80_FR_50052 80 FR 49893 - Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Electronic Flight Control System: Control Surface Position Awareness

80 FR 49893 - Special Conditions: Gulfstream Aerospace Corporation Model GVII-G500 Airplanes; Electronic Flight Control System: Control Surface Position Awareness

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

Page Range49893-49895
FR Document2015-20296

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.

Federal Register, Volume 80 Issue 159 (Tuesday, August 18, 2015)
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Rules and Regulations]
[Pages 49893-49895]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20296]


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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

[[Page 49894]]

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, fly-by-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 flight-control 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 control-
surface movement to accomplish, possibly encroaching on a control-
surface 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 back-driven during autopilot system operation.
    These special conditions for control-surface 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 Sec.  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 Sec.  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 Sec.  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 Sec.  11.38, and they become part of the type certification basis 
under Sec.  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 flight-control 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 control-surface 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.

[[Page 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 Sec. Sec.  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



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

                                             Type Certification Basis                                Administrator considers necessary to                    Operation of the high-speed limiter
                                                Under the provisions of 14 CFR 21.17,                establish a level of safety equivalent to             during all routine and descent
                                             Bombardier Inc. must show that the                      that established by the existing                      procedure flight must not impede
                                             Model BD–700–2A12 and BD–700–                           airworthiness standards.                              normal attainment of speeds up to high-
                                             2A13 airplanes meet the applicable                                                                            speed warning.
                                                                                                     Applicability
                                             provisions of part 25 as amended by                                                                              Issued in Renton, Washington, on August
                                             Amendments 25–1 through 25–129.                           As discussed above, these special                   7, 2015.
                                                If the Administrator finds that the                  conditions are applicable to the                      Michael Kaszycki,
                                             applicable airworthiness regulations                    Bombardier Model BD–700–2A12 and
                                                                                                                                                           Acting Manager, Transport Airplane
                                             (i.e., 14 CFR part 25) do not contain                   BD–700–2A13 airplanes. Should                         Directorate, Aircraft Certification Service.
                                             adequate or appropriate safety standards                Bombardier Inc. apply at a later date for
                                                                                                                                                           [FR Doc. 2015–20299 Filed 8–17–15; 8:45 am]
                                             for the Model BD–700–2A12 and BD–                       a change to the type certificate to
                                                                                                                                                           BILLING CODE 4910–13–P
                                             700–2A13 airplanes because of a novel                   include another model incorporating the
                                             or unusual design feature, special                      same novel or unusual design feature,
                                             conditions are prescribed under the                     these special conditions would apply to               DEPARTMENT OF TRANSPORTATION
                                             provisions of § 21.16.                                  that model as well.
                                                Special conditions are initially                     Conclusion                                            Federal Aviation Administration
                                             applicable to the model for which they
                                             are issued. Should the type certificate                   This action affects only certain novel              14 CFR Part 25
                                             for that model be amended later to                      or unusual design features on
                                                                                                     Bombardier Model BD–700–2A12 and                      [Docket No. FAA–2015–0311; Special
                                             include any other model that
                                                                                                     BD–700–2A13 airplanes. It is not a rule               Conditions No. 25–592–SC]
                                             incorporates the same novel or unusual
                                             design feature, these special conditions                of general applicability.                             Special Conditions: Gulfstream
                                             would also apply to the other model                       The substance of these special                      Aerospace Corporation Model GVII–
                                             under § 21.101.                                         conditions has been subjected to the                  G500 Airplanes; Electronic Flight
                                                In addition to the applicable                        notice and comment period in several                  Control System: Control Surface
                                             airworthiness regulations and special                   prior instances and has been derived                  Position Awareness
                                             conditions, the Model BD–700–2A12                       without substantive change from those
                                             and BD–700–2A13 airplanes must                          previously issued. It is unlikely that                AGENCY:  Federal Aviation
                                             comply with the fuel-vent and exhaust-                  prior public comment would result in a                Administration (FAA), DOT.
                                             emission requirements of 14 CFR part                    significant change from the substance                 ACTION: Final special conditions, request
                                             34, and the noise-certification                         contained herein. Therefore, because a                for comments.
                                             requirements of 14 CFR part 36; and the                 delay would significantly affect the
                                             FAA must issue a finding of regulatory                  certification of the airplane, the FAA                SUMMARY:   These special conditions are
                                             adequacy under § 611 of Public Law 92–                  has determined that prior public notice               issued for Gulfstream Model GVII–G500
                                             574, the ‘‘Noise Control Act of 1972.’’                 and comment are unnecessary and                       airplanes. These airplanes have a novel
                                                The FAA issues special conditions, as                impracticable, and good cause exists for              or unusual design feature associated
                                             defined in 14 CFR 11.19, in accordance                  adopting these special conditions upon                with control-surface awareness
                                             with § 11.38, and they become part of                   publication in the Federal Register. The              provided by the electronic flight-control
                                             the type-certification basis under                      FAA is requesting comments to allow                   system. The applicable airworthiness
                                             § 21.17(a)(2).                                          interested persons to submit views that               regulations do not contain adequate or
                                             Novel or Unusual Design Features                        may not have been submitted in                        appropriate safety standards for this
                                                                                                     response to the prior opportunities for               design feature. These special conditions
                                               The Bombardier Model BD–700–2A12                      comment described above.                              contain the additional safety standards
                                             and BD–700–2A13 airplanes will                                                                                that the Administrator considers
                                             incorporate the following novel or                      List of Subjects in 14 CFR Part 25                    necessary to establish a level of safety
                                             unusual design feature:                                   Aircraft, Aviation safety, Reporting                equivalent to that established by the
                                               An electronic flight-control system                   and recordkeeping requirements.                       existing airworthiness standards.
                                             that contains fly-by-wire control laws,
                                                                                                       The authority citation for these                    DATES: This action is effective on
                                             including envelope protections, for
                                                                                                     special conditions is as follows:                     Gulfstream on August 18, 2015. We
                                             high-speed protection functions.
                                                                                                       Authority: 49 U.S.C. 106(g), 40113, 44701,          must receive your comments by October
                                             Current part 25 requirements do not
                                                                                                     44702, 44704.                                         2, 2015.
                                             contain appropriate standards for high-
                                             speed protection systems.                                                                                     ADDRESSES: Send comments identified
                                                                                                     The Special Conditions                                by docket number FAA–2015–0311
                                             Discussion                                                Accordingly, pursuant to the                        using any of the following methods:
                                               Model BD–700–2A12 and BD–700–                         authority delegated to me by the                         • Federal eRegulations Portal: Go to
                                             2A13 airplanes are equipped with a                      Administrator, the following special                  http://www.regulations.gov/ and follow
                                             high-speed protection system, which,                    conditions are issued as part of the type             the online instructions for sending your
                                             when the system detects airspeed                        certification basis for Bombardier Model              comments electronically.
                                             exceeding a small tolerance above VMO/                  BD–700–2A12 and BD–700–2A13                              • Mail: Send comments to Docket
                                             MMO, employs a high-speed limiter to                    airplanes. The requirements of § 25.253               Operations, M–30, U.S. Department of
                                                                                                     (high-speed characteristics), and its                 Transportation (DOT), 1200 New Jersey
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                                             automatically deploy multifunction
                                             spoilers (MFS) as speed brakes. The                     related policy, are applicable to the                 Avenue SE., Room W12–140, West
                                             MFS retract automatically when the                      Model BD–700–2A12 and BD–700–                         Building Ground Floor, Washington, DC
                                             system detects that airspeed is                         2A13 airplanes, and are not affected by               20590–0001.
                                             sufficiently reduced.                                   these special conditions.                                • Hand Delivery or Courier: Take
                                               These special conditions contain the                    In addition to § 25.143, the following              comments to Docket Operations in
                                             additional safety standards that the                    requirement applies:                                  Room W12–140 of the West Building


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                                             49894             Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations

                                             Ground Floor at 1200 New Jersey                         Whitney turbofan engines. Avionics will               exemptions, or later amended sections
                                             Avenue SE., Washington, DC, between 9                   include four primary display units and                of the applicable part that are not
                                             a.m. and 5 p.m., Monday through                         multiple touchscreen controllers. The                 relevant to these special conditions.
                                             Friday, except Federal holidays.                        flight-control system is a three-axis, fly-              If the Administrator finds that the
                                                • Fax: Fax comments to Docket                        by-wire system controlled through                     applicable airworthiness regulations
                                             Operations at 202–493–2251.                             active control/coupled side sticks.                   (i.e., 14 CFR part 25) do not contain
                                                Privacy: The FAA will post all                          The Model GVII–G500 airplane will                  adequate or appropriate safety standards
                                             comments it receives, without change,                   have a wingspan of approximately 87 ft.               for the Model GVII–G500 airplane
                                             to http://www.regulations.gov/,                         and a length of just over 91 ft. Maximum              because of a novel or unusual design
                                             including any personal information the                  takeoff weight will be approximately                  feature, special conditions are
                                             commenter provides. Using the search                    76,850 lbs and maximum takeoff thrust                 prescribed under § 21.16.
                                             function of the docket Web site, anyone                 will be approximately 15,135 lbs.                        Special conditions are initially
                                             can find and read the electronic form of                Maximum range will be approximately                   applicable to the model for which they
                                             all comments received into any FAA                      5,000 nm and maximum operating                        are issued. Should the type certificate
                                             docket, including the name of the                       altitude will be 51,000 ft.                           for that model be amended later to
                                             individual sending the comment (or                         In airplanes with electronic flight-               include any other model that
                                             signing the comment for an association,                 control systems, a direct                             incorporates the same or similar novel
                                             business, labor union, etc.). DOT’s                     correspondence between pilot-control                  or unusual design feature, these special
                                             complete Privacy Act Statement can be                   position and the associated airplane
                                                                                                                                                           conditions would also apply to the other
                                             found in the Federal Register published                 control-surface position is not always
                                                                                                                                                           model under § 21.101.
                                             on April 11, 2000 (65 FR 19477–19478),                  apparent. Under certain circumstances,
                                                                                                     a commanded maneuver that may not                        In addition to the applicable
                                             as well as at http://DocketsInfo.dot                                                                          airworthiness regulations and special
                                             .gov/.                                                  involve a large flightcrew-control input
                                                                                                     may nevertheless require a large control-             conditions, the Gulfstream Model GVII–
                                                Docket: Background documents or                                                                            G500 airplane must comply with the
                                             comments received may be read at                        surface movement to accomplish,
                                                                                                     possibly encroaching on a control-                    fuel-vent and exhaust-emission
                                             http://www.regulations.gov/ at any time.                                                                      requirements of 14 CFR part 34, and the
                                             Follow the online instructions for                      surface or actuation-system limit
                                                                                                     without the flightcrew’s knowledge.                   noise-certification requirements of 14
                                             accessing the docket or go to Docket                                                                          CFR part 36; and the FAA must issue a
                                             Operations in Room W12–140 of the                       This situation can arise in both piloted
                                                                                                     (i.e., manual) and autopilot flight, and              finding of regulatory adequacy under
                                             West Building Ground Floor at 1200                                                                            § 611 of Public Law 92–574, the ‘‘Noise
                                             New Jersey Avenue SE., Washington,                      may be further intensified on airplanes
                                                                                                     where the pilot controls are not back-                Control Act of 1972.’’
                                             DC, between 9 a.m. and 5 p.m., Monday                                                                            The FAA issues special conditions, as
                                             through Friday, except Federal holidays.                driven during autopilot system
                                                                                                     operation.                                            defined in 14 CFR 11.19, under § 11.38,
                                             FOR FURTHER INFORMATION CONTACT: Joe                       These special conditions for control-              and they become part of the type
                                             Jacobsen, FAA, Airplane and Flightcrew                  surface awareness, applicable to                      certification basis under § 21.17(a)(2).
                                             Interface Branch, ANM–111, Transport                    Gulfstream Model GVII–G500 airplanes,
                                             Airplane Directorate, Aircraft                                                                                Novel or Unusual Design Features
                                                                                                     require suitable flight-control-position
                                             Certification Service, 1601 Lind Avenue                 annunciation and control-system mode                    The Gulfstream Model GVII–G500
                                             SW., Renton, Washington 98057–3356;                     of operation to be provided to the                    airplane incorporates the following
                                             telephone (425) 227–2011; facsimile                     flightcrew when a flight condition exists             novel or unusual design features:
                                             (425) 227–1320.                                         in which nearly full surface authority                Electronic flight-control system
                                             SUPPLEMENTARY INFORMATION: The FAA                      (not crew-commanded) is being utilized.               providing control-surface awareness to
                                             has determined that notice of, and                      Suitability of such a display must take               the flightcrew.
                                             opportunity for prior public comment                    into account that some pilot-demanded                 Discussion
                                             on, these special conditions is                         maneuvers (e.g., rapid roll) are
                                             impracticable because these procedures                  necessarily associated with intended                     Gulfstream Aerospace Corporation is
                                             would significantly delay issuance of                   full performance, which may saturate                  intending to utilize an electronic flight-
                                             the design approval and thus delivery of                the surface. Therefore, simple alerting               control system (including side-stick
                                             the affected airplanes.                                 systems, which would function in both                 controllers for pitch and roll control) in
                                                In addition, the substance of these                  intended or unexpected control-limiting               their new Model GVII–G500 airplane.
                                             special conditions has been subject to                  situations, must be properly balanced                 With an electronic flight-control system
                                             the public comment process in several                   between needed crew awareness and                     and no direct coupling from the
                                             prior instances with no substantive                     nuisance features. A monitoring system                flightdeck controller to the control
                                             comments received. The FAA therefore                    that might compare airplane motion,                   surface, the pilot may not be aware of
                                             finds that good cause exists for making                 surface deflection, and pilot side-stick              the actual surface position utilized to
                                             these special conditions effective upon                 controller (SSC) demand, could be                     fulfill the requested demand. Some
                                             publication in the Federal Register.                    useful for elimination of nuisance                    unusual flight conditions, arising from
                                                                                                     alerting.                                             atmospheric conditions, airplane
                                             Background                                                                                                    malfunctions, or engine failures, may
                                               On March 29, 2012, Gulfstream                         Type Certification Basis                              result in full or nearly full control-
                                             applied for a type certificate for their                  Under Title 14, Code of Federal                     surface deflection. Unless the flightcrew
                                             new Model GVII–G500 airplane. This                                                                            is made aware of excessive deflection or
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                                                                                                     Regulations (14 CFR) 21.17, Gulfstream
                                             airplane is a large-cabin business jet                  must show that the Model GVII–G500                    impending control-surface limiting,
                                             capable of accommodating up to 19                       airplane meets the applicable provisions              piloted or auto-flight system control of
                                             passengers. It will incorporate a low,                  of 14 CFR part 25, as amended by                      the airplane might be inadvertently
                                             swept-wing design with winglets and a                   Amendments 25–1 through 25–137.                       continued in such a manner as to cause
                                             T-tail. The powerplant will consist of                    In addition, the certification basis                loss of airplane control, or other unsafe
                                             two aft-fuselage mounted Pratt &                        includes certain special conditions,                  stability or performance characteristics.


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                                                               Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Rules and Regulations                                          49895

                                               These special conditions contain the                  DEPARTMENT OF HEALTH AND                                 Section 513(f)(2) of the FD&C Act, as
                                             additional safety standards that the                    HUMAN SERVICES                                        amended by section 607 of the Food and
                                             Administrator considers necessary to                                                                          Drug Administration Safety and
                                             establish a level of safety equivalent to               Food and Drug Administration                          Innovation Act (Pub. L. 112–144),
                                             that established by the existing                                                                              provides two procedures by which a
                                             airworthiness standards.                                21 CFR Part 870                                       person may request FDA to classify a
                                                                                                     [Docket No. FDA–2015–N–2723]                          device under the criteria set forth in
                                             Applicability                                                                                                 section 513(a)(1). Under the first
                                                                                                     Medical Devices; Cardiovascular                       procedure, the person submits a
                                               As discussed above, these special                                                                           premarket notification under section
                                                                                                     Devices; Classification of the
                                             conditions apply to Gulfstream Model                                                                          510(k) of the FD&C Act for a device that
                                                                                                     Esophageal Thermal Regulation
                                             GVII–G500 airplanes. Should                                                                                   has not previously been classified and,
                                                                                                     Device
                                             Gulfstream apply later for a change to                                                                        within 30 days of receiving an order
                                             the type certificate to include another                 AGENCY:    Food and Drug Administration,              classifying the device into class III
                                             model incorporating the same or similar                 HHS.                                                  under section 513(f)(1), the person
                                             novel or unusual design feature, these                  ACTION:   Final order.                                requests a classification under section
                                             special conditions would apply to that                                                                        513(f)(2) of the FD&C Act. Under the
                                                                                                     SUMMARY:   The Food and Drug
                                             model as well.                                                                                                second procedure, rather than first
                                                                                                     Administration (FDA) is classifying the
                                                                                                                                                           submitting a premarket notification
                                             Conclusion                                              esophageal thermal regulation device
                                                                                                                                                           under section 510(k) of the FD&C Act
                                                                                                     into class II (special controls). The
                                                This action affects only certain novel                                                                     and then a request for classification
                                                                                                     special controls that will apply to the
                                             or unusual design features on                                                                                 under the first procedure, the person
                                                                                                     device are identified in this order and
                                             Gulfstream Model GVII–G500 airplanes.                                                                         determines that there is no legally
                                                                                                     will be part of the codified language for
                                                                                                                                                           marketed device upon which to base a
                                             It is not a rule of general applicability.              the esophageal thermal regulation
                                                                                                                                                           determination of substantial
                                                                                                     device’s classification. The Agency is
                                             List of Subjects in 14 CFR Part 25                                                                            equivalence and requests a classification
                                                                                                     classifying the device into class II
                                                                                                                                                           under section 513(f)(2) of the FD&C Act.
                                               Aircraft, Aviation safety, Reporting                  (special controls) in order to provide a
                                                                                                                                                           If the person submits a request to
                                             and recordkeeping requirements.                         reasonable assurance of safety and
                                                                                                                                                           classify the device under this second
                                                                                                     effectiveness of the device.
                                               The authority citation for these                                                                            procedure, FDA may decline to
                                                                                                     DATES: This order is effective August 18,
                                             special conditions is as follows:                                                                             undertake the classification request if
                                                                                                     2015. The classification was applicable               FDA identifies a legally marketed device
                                               Authority: 49 U.S.C. 106(g), 40113, 44701,            on June 23, 2015.                                     that could provide a reasonable basis for
                                             44702, 44704.                                           FOR FURTHER INFORMATION CONTACT:                      review of substantial equivalence with
                                                                                                     Lydia Glaw, Center for Devices and                    the device or if FDA determines that the
                                             The Special Conditions                                  Radiological Health, Food and Drug                    device submitted is not of ‘‘low-
                                                Accordingly, pursuant to the                         Administration, 10903 New Hampshire                   moderate risk’’ or that general controls
                                                                                                     Ave., Bldg. 66, Rm. 1102, Silver Spring,              would be inadequate to control the risks
                                             authority delegated to me by the
                                                                                                     MD 20993–0002, 301–796–1456,                          and special controls to mitigate the risks
                                             Administrator, the following special
                                                                                                     Lydia.glaw@fda.hhs.gov.                               cannot be developed.
                                             conditions are issued as part of the type
                                                                                                     SUPPLEMENTARY INFORMATION:                               In response to a request to classify a
                                             certification basis for Gulfstream Model
                                                                                                     I. Background                                         device under either procedure provided
                                             GVII–G500 airplanes.
                                                                                                                                                           by section 513(f)(2) of the FD&C Act,
                                                In addition to the requirements of                      In accordance with section 513(f)(1) of            FDA will classify the device by written
                                             §§ 25.143, 25.671, 25.672, and 25.1322,                 the Federal Food, Drug, and Cosmetic                  order within 120 days. This
                                             when a flight condition exists where,                   Act (the FD&C Act) (21 U.S.C.                         classification will be the initial
                                             without being commanded by the crew,                    360c(f)(1)), devices that were not in                 classification of the device. On May 8,
                                             control surfaces are coming so close to                 commercial distribution before May 28,                2014, Advanced Cooling Therapy, LLC,
                                             their limits that return to the normal                  1976 (the date of enactment of the                    submitted a request for classification of
                                             flight envelope, or continuation of safe                Medical Device Amendments of 1976),                   the Esophageal Cooling Device under
                                             flight, or both, requires a specific crew               generally referred to as postamendments               section 513(f)(2) of the FD&C Act. The
                                             action, a suitable flight-control-position              devices, are classified automatically by              manufacturer recommended that the
                                                                                                     statute into class III without any FDA                device be classified into class II (Ref. 1).
                                             annunciation must be provided to the
                                                                                                     rulemaking process. These devices                        In accordance with section 513(f)(2) of
                                             crew, unless other existing indications
                                                                                                     remain in class III and require                       the FD&C Act, FDA reviewed the
                                             are found adequate or sufficient to                     premarket approval, unless and until                  request in order to classify the device
                                             prompt that action.                                     the device is classified or reclassified              under the criteria for classification set
                                               Note: The term ‘‘suitable’’ indicates an              into class I or II, or FDA issues an order            forth in section 513(a)(1). FDA classifies
                                             appropriate balance between necessary                   finding the device to be substantially                devices into class II if general controls
                                             operation and nuisance factors.                         equivalent, in accordance with section                by themselves are insufficient to
                                                                                                     513(i) of the FD&C Act, to a predicate                provide reasonable assurance of safety
                                                Issued in Renton, Washington, on August              device that does not require premarket                and effectiveness, but there is sufficient
                                             7, 2015.                                                approval. The Agency determines
rmajette on DSK7SPTVN1PROD with RULES




                                                                                                                                                           information to establish special controls
                                             Michael Kaszycki,                                       whether new devices are substantially                 to provide reasonable assurance of the
                                             Acting Manager, Transport Airplane                      equivalent to predicate devices by                    safety and effectiveness of the device for
                                             Directorate, Aircraft Certification Service.            means of premarket notification                       its intended use. After review of the
                                             [FR Doc. 2015–20296 Filed 8–17–15; 8:45 am]             procedures in section 510(k) of the                   information submitted in the request,
                                             BILLING CODE 4910–13–P                                  FD&C Act (21 U.S.C. 360(k)) and part                  FDA determined that the device could
                                                                                                     807 (21 CFR part 807) of the regulations.             be classified into class II with the


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Document Created: 2015-12-15 12:05:14
Document Modified: 2015-12-15 12:05:14
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal special conditions, request for comments.
DatesThis action is effective on Gulfstream on August 18, 2015. We must receive your comments by October 2, 2015.
ContactJoe 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.
FR Citation80 FR 49893 
CFR AssociatedAircraft; Aviation Safety and Reporting and Recordkeeping Requirements

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