10328 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 

The electronic-system network 

architecture for the Model 767–2C series 

airplane introduces potential security 

risks and vulnerabilities not addressed 

in current regulations and airplane-level 

or system-level safety-assessment 

methods. 

This network architecture allows 

connection to previously isolated data 

networks connected to systems that 

perform functions required for the safe 

operation of the airplane. This data 

network and design integration may 

result in security vulnerabilities from 

intentional or unintentional internalconnection corruption of data and 

systems critical to the safety and 

maintenance of the airplane. 

Discussion 

The Boeing Model 767–2C series 

airplane design introduces the potential 

for unauthorized persons to access, from 

internal connection, airplane-control 

domain and operator-informationservices domain in the passengerservices domain. The Model 767–2C 

design further introduces the potential 

for security vulnerabilities related to the 

introduction of viruses, worms, user 

mistakes, and intentional sabotage of 

airplane networks, systems, and 

databases. As such, these special 

conditions address these vulnerabilities. 

The digital systems architecture for 

the Boeing Model 767–2C series 

airplanes is composed of several 

connected networks. This network 

architecture is used for a diverse set of 

functions, including: 

1. Flight-safety related control and 

navigation systems, 

2. operator business and 

administrative support, and 

3. passenger entertainment. 

The existing regulations and guidance 

material did not anticipate this type of 

system architecture or electronic access 

to airplane systems. Furthermore, 

regulations, and current system safetyassessment policy and techniques, do 

not address potential security 

vulnerabilities, which could be caused 

by unauthorized access to airplane data 

buses and servers. These special 

conditions are meant to ensure that 

security, integrity, and availability of 

airplane systems are not compromised 

by certain wired or wireless electronic 

connections between airplane data 

busses and networks. 

Special conditions have been applied 

on past airplane programs to require 

consideration of related security 

vulnerabilities. These special conditions 

are similar to those previously applied, 

except that the scope has been adjusted 

to be consistent with those features 

unique to the Model 767–2C series 

airplane. 

Applicability 

As discussed above, these special 

conditions apply to Boeing Model 767– 

2C series airplanes. Should Boeing 

apply later for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well. 

Conclusion 

This action affects only certain novel 

or unusual design features on one model 

series of airplane. 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 typecertification basis for Boeing Model 

767–2C series airplanes. 

1. The applicant must ensure that the 

design provides isolation from, or 

airplane electronic-system security 

protection against, access by 

unauthorized sources internal to the 

airplane. The design must prevent 

inadvertent and malicious changes to, 

and all adverse impacts upon, airplane 

equipment, systems, networks, or other 

assets required for safe flight and 

operations. 

2. The applicant must establish 

appropriate procedures to allow the 

operator to ensure that continued 

airworthiness of the airplane is 

maintained, including all post-typecertification modifications that may 

have an impact on the approved 

electronic-system security safeguards. 

Issued in Renton, Washington, on February 

19, 2015. 

John J. Piccola, Jr., 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–03969 Filed 2–25–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 25 

[Docket No. FAA–2014–0711; Special 

Conditions No. 25–575–SC] 

Special Conditions: Boeing Model 767– 

2C Series Airplanes; Airplane 

Electronic-System Security Protection 

From Unauthorized External Access 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final special conditions; request 

for comments. 

SUMMARY: These special conditions are 

issued for Boeing Model 767–2C series 

airplanes. These airplanes, as modified 

by The Boeing Company, will have a 

novel or unusual design feature 

associated with airplane electronicsystem security protection or isolation 

from unauthorized external access. 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 The 

Boeing Company on February 26, 2015. 

We must receive your comments by 

April 13, 2015. 

ADDRESSES: Send comments identified 

by docket number FAA–2014–0711 

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 


rmajette on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 10329 

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 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: 

Varun Khanna, FAA, Airplane and 

Flightcrew Interface Branch, ANM–111, 

Transport Airplane Directorate, Aircraft 

Certification Service, 1601 Lind Avenue 

SW., Renton, Washington 98057–3356; 

telephone (425) 227–1298; 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 airplane. 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. 

Comments Invited 

We invite 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. 

We will consider all comments we 

receive on or before the closing date for 

comments. We may change these special 

conditions based on the comments we 

receive. 

Background 

On January 18, 2010, Boeing applied 

for an amendment to Type Certificate 

No. A1NM to include a new Model 767– 

2CX series airplane, a derivative of the 

767–200, which later was renamed 767– 

2C. Later, Boeing requested, and the 

FAA approved, an extension to the date 

of application for FAA amended type 

certification to December 22, 2010. 

The Model 767–2C is a freighter 

airplane equipped with Pratt & Whitney 

PW4062 engines. This freighter has a 

maximum takeoff weight of 415,000 

pounds and can be configured to carry 

up to 11 supernumeraries (see 

Exemption No. 10691). 

Type-Certification Basis 

The regulations listed in the type 

certificate are commonly referred to as 

the ‘‘original type-certification basis.’’ 

The regulations to be listed in A1NM 

are as follows: 

Under the provisions of Title 14, Code 

of Federal Regulations (14 CFR) 21.101, 

Boeing must show that the Boeing 

Model 767–2C series airplane meets the 

applicable provisions of part 25, as 

amended by Amendments 25–1 through 

25–130, and 14 CFR 25.1316 at 

Amendment 25–134, except for earlier 

amendments as agreed upon by the 

FAA. These regulations will be listed in 

Type Certificate No. A1NM after typecertification approval of the 767–2C. 

14 CFR part 26 as amended by 

Amendments 26–1 through 26–6, and 

any later amendments in existence at 

the time of certification per 14 CFR 26.5. 

For any future part 26 Amendments, the 

holder of this type certificate must 

demonstrate compliance with the 

applicable sections. 

14 CFR part 34 as amended by 

Amendments 34–1 through 34–5A, and 

any later amendments in existence at 

the time of certification. 

14 CFR part 36 as amended by 

Amendments 36–1 through 36–29, and 

any later amendments in existence at 

the time of certification. 

The certification basis also 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 767–2C series 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 novel or unusual 

design feature, or should any other 

model already included on the same 

type certificate be modified to 

incorporate 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 767–2C series 

airplane must comply with the fuel-vent 

and exhaust-emission requirements of 

14 CFR part 34, and the noisecertification requirements of 14 CFR 

part 36. 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 typecertification basis under § 21.101. 

Novel or Unusual Design Feature 

The Boeing Model 767–2C series 

airplane will incorporate the following 

novel or unusual design feature: 

The electronic-system network 

architecture for the Model 767–2C series 

airplane introduces potential security 

risks and vulnerabilities not addressed 

in current regulations and airplane-level 

or system-level safety-assessment 

methods. This network architecture 

allows connection to airplane electronic 

systems and networks, and access from 

airplane external sources (e.g., operator 

networks, wireless devices, Internet 

connectivity, service-provider satellite 

communications, electronic flight bags, 

etc.), to the previously isolated airplane 

electronic assets. Airplane electronic 

assets include electronic equipment and 

systems, instruments, networks, servers, 

software and electronic components, 

field-loadable software and hardware 

applications, and databases. 

Discussion 

The Boeing Model 767–2C series 

airplane design introduces the potential 

for unauthorized persons to access 

airplane-control domain and operatorinformation-services domain in the 

passenger-services domain. The 767–2C 

design further introduces the potential 

for security vulnerabilities related to the 

introduction of viruses, worms, user 

mistakes, and intentional sabotage of 

airplane networks, systems, and 


rmajette on DSK2VPTVN1PROD with RULES
10330 Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Rules and Regulations 

databases. As such, these special 

conditions address these vulnerabilities. 

The digital systems architecture for 

the Boeing Model 767–2C series 

airplanes is composed of several 

connected networks. This network 

architecture is used for a diverse set of 

functions providing data connectivity 

between systems, including: 

1. Airplane control, communication, 

display, monitoring and navigation 

systems, 

2. operator business and 

administrative support systems, 

3. passenger entertainment systems, 

and 

4. access by systems external to the 

airplane. 

The Model 767–2C series airplane 

electronic-system network architecture 

allows connection to airplane electronic 

systems and networks, and access from 

airplane external sources (e.g., operator 

networks, wireless devices, Internet 

connectivity, service-provider satellite 

communications, electronic flight bags, 

etc.) to the previously isolated airplane 

electronic assets. 

This design may result in networksecurity vulnerabilities from intentional 

or unintentional corruption of data and 

systems required for the safety, 

operations, and maintenance of the 

airplane. The existing regulations and 

guidance material did not anticipate this 

type of system architecture, or external 

wired and wireless electronic access to 

airplane electronic systems. 

Furthermore, regulations, and current 

system safety-assessment policy and 

techniques, do not address potential 

security vulnerabilities, which could be 

caused by unauthorized access to 

airplane electronic systems and 

networks. 

Special conditions have been applied 

on past airplane programs to require 

consideration of related security 

vulnerabilities. These special conditions 

are similar to those previously applied, 

except that the scope has been adjusted 

to be consistent with those features 

unique to the Model 767–2C series 

airplane. 

Applicability 

As discussed above, these special 

conditions apply to Boeing Model 767– 

2C series airplanes. Should Boeing 

apply later for a change to the type 

certificate to include another model 

incorporating the same novel or unusual 

design feature, the special conditions 

would apply to that model as well. 

Conclusion 

This action affects only certain novel 

or unusual design features on one model 

series of airplane. 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 typecertification basis for Boeing Model 

767–2C series airplanes. 

1. The applicant must ensure airplane 

electronic-system security protection 

from access by unauthorized sources 

external to the airplane, including those 

possibly caused by maintenance 

activity. 

2. The applicant must ensure that 

electronic-system security threats are 

identified and assessed, and that 

effective electronic-system security 

protection strategies are implemented to 

protect the airplane from all adverse 

impacts on safety, functionality, and 

continued airworthiness. 

3. The applicant must establish 

appropriate procedures to allow the 

operator to ensure that continued 

airworthiness of the airplane is 

maintained, including all post typecertification modifications that may 

have an impact on the approved 

electronic-system security safeguards. 

Issued in Renton, Washington, on February 

19, 2015. 

John J. Piccola, Jr., 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–03970 Filed 2–25–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 884 

[Docket No. FDA–2014–M–1957] 

Medical Devices; Obstetrical and 

Gynecological Devices; Classification 

of the Assisted Reproduction Embryo 

Image Assessment System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

Assisted Reproduction Embryo Image 

Assessment System 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 Assisted Reproduction 

Embryo Image Assessment System 

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 February 

26, 2015. The classification was 

applicable June 6, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Michael Bailey, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G120, Silver Spring, 

MD 20993–0002, 301–796–6530. 

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), 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. 


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