Document ID: FAA-2020-0519-0001
Agency: faa
Document Type: Proposed Rule
Title: Special Conditions: Aerospace Design and Compliance, LLC, Bombardier, Inc. Model CL-600-2B19 Airplane; Installation of a Therapeutic Oxygen System for Medical Use
Posted Date: 2020-06-16T04:00Z

[Federal Register Volume 85, Number 116 (Tuesday, June 16, 2020)]
[Proposed Rules]
[Pages 36351-36352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11437]

 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
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 

  Federal Register / Vol. 85, No. 116 / Tuesday, June 16, 2020 / 
Proposed Rules  

[[Page 36351]]

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2020-0519; Notice No. 25-20-06-SC]

Special Conditions: Aerospace Design and Compliance, LLC, 
Bombardier, Inc. Model CL-600-2B19 Airplane; Installation of a 
Therapeutic Oxygen System for Medical Use

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed special conditions.

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SUMMARY: This action proposes special conditions for the Bombardier 
Inc. (Bombardier) Model CL-600-2B19 airplane. This airplane, as 
modified by Aerospace Design and Compliance, LLC (Aerospace Design and 
Compliance), will have a novel or unusual design feature when compared 
to the state of technology envisioned in the airworthiness standards 
for transport category airplanes. The design feature is an installation 
of a therapeutic oxygen system for medical use. The applicable 
airworthiness regulations do not contain adequate or appropriate safety 
standards for this design feature. These proposed 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: Send comments on or before July 6, 2020.

ADDRESSES: Send comments identified by Docket No. FAA-2020-0519 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 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 website, 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).
    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: Robert Hettman, Propulsion & 
Mechanical Systems, AIR-672, Transport Standards Branch, Policy and 
Innovation Division, Aircraft Certification Service, Federal Aviation 
Administration, 2200 South 216th Street, Des Moines, Washington 98198; 
telephone and fax 206-231-3171; email Robert.Hettman@faa.gov.

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites interested people to take part in this rulemaking 
by sending written comments, data, or views. The most helpful comments 
reference a specific portion of the special conditions, explain the 
reason for any recommended change, and include supporting data.
    The FAA will consider all comments received by the closing date for 
comments. The FAA may change these special conditions based on the 
comments received.

Background

    On November 20, 2019, Aerospace Design and Compliance applied for a 
supplemental type certificate for the installation of a therapeutic 
oxygen system for medical use in the executive interiors of the 
Bombardier Model CL-600-2B19 airplane. The Model CL-600-2B19 airplane, 
which is currently approved under Type Certificate No. A21EA, is a 
twin-engine transport airplane with a maximum takeoff weight of 47,450 
lbs. The Model CL-600-2B19 airplane will have 55 seats approved for 
taxi, takeoff, and landing.

Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 
CFR) 21.101, Aerospace Design and Compliance must show that the 
Bombardier Model CL-600-2B19 airplane, as changed, continues to meet 
the applicable provisions of the regulations listed in Type Certificate 
No. A21EA, or the applicable regulations in effect on the date of 
application for the change, except for earlier amendments as agreed 
upon by the FAA.
    If the Administrator finds that the applicable airworthiness 
regulations (e.g., 14 CFR part 25) do not contain adequate or 
appropriate safety standards for the Bombardier Model CL-600-2B19 
airplane because of a novel or unusual design feature, special 
conditions are prescribed under the provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which 
they are issued. Should the applicant apply for a supplemental type 
certificate to modify any other model included on the same type 
certificate to incorporate the same 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 Bombardier Model CL-600-2B19 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.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in 
accordance with Sec.  11.38, and they become part of the type 
certification basis under Sec.  21.101.

[[Page 36352]]

Novel or Unusual Design Features

    The Bombardier Model CL-600-2B19 airplane will incorporate the 
following novel or unusual design features:
    A therapeutic oxygen system for medical use.
    As a part of the executive interior installation, the gaseous 
passenger oxygen system will be outfitted with a therapeutic oxygen 
system. The therapeutic oxygen system shares the same supply of oxygen 
with the existing passenger oxygen system and consists of multiple 
constant flow oxygen outlets located throughout the cabin. The 
flightcrew can turn the therapeutic oxygen system on and off from the 
flightdeck to allow use at any point during the flight, and to preserve 
a sufficient remaining oxygen reserve, in the event therapeutic oxygen 
is used for medical purposes, to accommodate the passengers in the 
event of an emergency oxygen situation.

Discussion

    No specific regulations address the design and installation of 
required passenger oxygen systems that share a supply source with an 
optional oxygen system used specifically for therapeutic applications. 
Therapeutic oxygen systems have been previously certified, and were 
generally considered an extension of the passenger oxygen system for 
the purpose of defining the applicable regulations. As a result, 
existing requirements, such as Sec. Sec.  25.1309, 25.1441(b) and (c), 
25.1451, and 25.1453, in the Bombardier Model CL-600-2B19 airplanes' 
certification basis applicable to this STC project, provide some design 
standards appropriate for oxygen system installations. In addition, 
Sec.  25.1445 includes standards for oxygen distribution systems when 
oxygen is supplied to flightcrew and passengers. If a common source of 
supply is used, Sec.  25.1445(a)(2) requires a means to separately 
reserve the minimum supply required by the flightcrew.
    Section 25.1445 is intended to protect the flightcrew by ensuring 
that an adequate supply of oxygen is available to complete a descent 
and landing following a loss of cabin pressure. When the regulation was 
written, the only passenger oxygen system designs were supplemental 
oxygen systems intended to protect passengers from hypoxia in the event 
of a decompression. Existing passenger oxygen systems did not include 
design features that would allow the flightcrew to control oxygen to 
passengers during flight. There are no similar requirements in Sec.  
25.1445 when oxygen is supplied from the same source to passengers for 
use during a decompression, and for discretionary or first-aid use any 
time during the flight. In the proposed design, the passenger and 
therapeutic oxygen systems use the same source of oxygen. The special 
conditions contain additional design requirements for the equipment 
involved in this dual therapeutic oxygen plus gaseous oxygen 
installation.
    Furthermore, the potential hazard that can exist when the oxygen 
content of an enclosed area becomes too high because of system leaks, 
malfunction, or damage from external sources, make it necessary to 
ensure that adequate safety standards are applied to the design and 
installation of the oxygen system in Bombardier Model CL-600-2B19 
airplanes. These potential hazards also necessitate development and 
application of appropriate additional design and installation 
standards.
    The proposed 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 CL-600-2B19 airplane as modified by Aerospace Design 
and Compliance. Should Aerospace Design and Compliance apply at a later 
date for a supplemental type certificate to modify any other model 
included on Type Certificate No. A21EA, to incorporate the same novel 
or unusual design feature, these special conditions would apply to that 
model as well.
    Certification of the Bombardier Model CL-600-2B19 airplane is 
currently scheduled for May 2020. The substance of these special 
conditions has been subject to the notice and public comment procedure 
in several prior instances with no public comments received. Therefore, 
because a delay would significantly affect the applicant's installation 
of the system and the certification of the airplane, the FAA is 
shortening the public comment period to 20 days.

Conclusion

    This action affects only a certain novel or unusual design feature 
on one model of airplane. It is not a rule of general applicability and 
affects only the applicant who applied to the FAA for approval of these 
features on the airplane.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping 
requirements.

Authority Citation

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the 
following special conditions as part of the type certification basis 
for Bombardier Model CL-600-2B19 airplanes, as modified by Aerospace 
Design and Compliance, LLC.
    The distribution system for the passenger therapeutic oxygen 
systems must be designed and installed to meet requirements as follows:
    1. When oxygen is supplied to passengers for both supplemental and 
therapeutic purposes, the distribution system must be designed for 
either--
    a. A source of supplemental oxygen for protection following a loss 
of cabin pressure, and a separate source for therapeutic purposes: or
    b. A common source of supply with means to separately reserve the 
minimum supply required by the passengers for supplemental use 
following a loss of cabin pressure.

    Issued in Des Moines, Washington, on May 21, 2020.
James E. Wilborn,
Acting Manager, Transport Standards Branch, Policy and Innovation 
Division, Aircraft Certification Service.
[FR Doc. 2020-11437 Filed 6-15-20; 8:45 am]
BILLING CODE 4910-13-P