Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 65621 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 91 

[Docket No.: FAA–2014–0225; Amdt. No. 

91–331B] 

RIN 2120–AK78 

Extension of the Prohibition Against 

Certain Flights in the Simferopol 

(UKFV) and Dnipropetrovsk (UKDV) 

Flight Information Regions (FIRs) 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: This action extends the 

prohibition against certain flight 

operations in the Simferopol (UKFV) 

and Dnipropetrovsk (UKDV) flight 

information regions (FIRs) by all United 

States (U.S.) air carriers; U.S. 

commercial operators; persons 

exercising the privileges of a U.S. 

airman certificate, except when such 

persons are operating a U.S.-registered 

aircraft for a foreign air carrier; and 

operators of U.S.-registered civil aircraft, 

except when such operators are foreign 

air carriers. This action also revises the 

FAA approval process for proposed 

operations authorized by other U.S. 

Government departments, agencies, and 

instrumentalities to clarify the FAA’s 

expectations regarding requests for 

approval and revises the approval 

conditions and information about 

requests for exemptions to reflect the 

termination of statutory authorization 

for the FAA’s premium war risk 

insurance program. This action also 

makes minor non-substantive 

corrections to the wording of the rule. 

The FAA finds this action to be 

necessary to address a continuing 

hazard to persons and aircraft engaged 

in such flight operations. 

DATES: This final rule is effective on 

October 22, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Michael Filippell, Air Transportation 

Division, AFS–220, Flight Standards 

Service, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone: 202–267–8166; email: 

michael.e.filippell@faa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

This action continues the prohibition 

on flight operations in the UKFV and 

UKDV FIRs by all U.S. air carriers; U.S. 

commercial operators; persons 

exercising the privileges of a U.S. 

airman certificate, except when such 

persons are operating a U.S.-registered 

aircraft for a foreign air carrier; and 

operators of U.S.-registered civil aircraft, 

except when such operators are foreign 

air carriers. This action also revises the 

FAA approval process for proposed 

operations authorized by other U.S. 

Government departments, agencies, and 

instrumentalities to clarify the FAA’s 

expectations regarding requests for 

approval and revises the approval 

conditions and information about 

requests for exemptions to reflect the 

termination of statutory authorization 

for the FAA’s premium war risk 

insurance program. This action also 

makes minor non-substantive 

corrections to the wording of the rule. 

The FAA finds this action necessary to 

address a continuing hazard to persons 

and aircraft engaged in such flight 

operations. 

II. Good Cause for Immediate Adoption 

Section 553(b)(3)(B) of title 5, U.S. 

Code, authorizes agencies to dispense 

with notice and comment procedures 

for rules when the agency for ‘‘good 

cause’’ finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ In this instance, 

the FAA finds that notice and public 

comment to this immediately adopted 

final rule, as well as any delay in the 

effective date of this rule, are contrary 

to the public interest due to the 

immediate need to address the hazard to 

U.S. civil aviation that continues to 

exist in the UKFV and UKDV FIRs, as 

described in the Background section of 

this rule. 

III. Authority for This Rulemaking 

The FAA is responsible for the safety 

of flight in the U.S. and for the safety 

of U.S. civil operators, U.S.-registered 

civil aircraft, and U.S.-certificated 

airmen throughout the world. The 

FAA’s authority to issue rules on 

aviation safety is found in title 49, U.S. 

Code. Subtitle I, section 106(f), 

describes the authority of the FAA 

Administrator. Section 40101(d)(1) 

provides that the Administrator shall 

consider in the public interest, among 

other matters, assigning, maintaining, 

and enhancing safety and security as the 

highest priorities in air commerce. 

Section 40105(b)(1)(A) requires the 

Administrator to exercise his authority 

consistently with the obligations of the 

U.S. Government under international 

agreements. 

This rulemaking is promulgated 

under the authority described in 

Subtitle VII, Part A, subpart III, section 

44701, General requirements. Under 

that section, the FAA is charged broadly 

with promoting safe flight of civil 

aircraft in air commerce by prescribing, 

among other things, regulations and 

minimum standards for practices, 

methods, and procedures that the 

Administrator finds necessary for safety 

in air commerce and national security. 

This regulation is within the scope of 

that authority because it continues to 

prohibit the persons subject to 

paragraph (a) of SFAR No. 113, 

§ 91.1607, from conducting flight 

operations in the UKFV and UKDV FIRs 

due to the hazard to the safety of such 

persons’ flight operations, as described 

in the Background section of this rule. 

IV. Background 

On April 25, 2014, the FAA published 

SFAR No. 113, § 91.1607, which 

prohibited flight operations in a portion 

of the UKFV FIR by all U.S. air carriers; 

U.S. commercial operators; persons 

exercising the privileges of a U.S. 

airman certificate, except when such 

persons were operating a U.S.-registered 

aircraft for a foreign air carrier; and 

operators of U.S.-registered civil aircraft, 

except when such operators were 

foreign air carriers (79 FR 22862). At 

that time, the FAA viewed the 

possibility of civil aircraft receiving 

confusing and conflicting air traffic 

control instructions from both 

Ukrainian and Russian air traffic service 

providers when operating in the portion 

of the Simferopol (UKFV) FIR covered 

by SFAR No. 113, § 91.1607, as an 

unsafe condition that presented a 

potential hazard to U.S. civil flight 

operations in the disputed airspace. 

Because political and military tensions 

between Ukraine and the Russian 

Federation remained high, the FAA was 

also concerned that compliance with air 

traffic control instructions issued by the 

authorities of one country could result 

in a civil aircraft being misidentified as 

a threat and intercepted or otherwise 

engaged by air defense forces of the 

other country. The FAA continues to 

have these concerns. 

On July 18, 2014 (UTC), the FAA 

expanded its flight prohibition through 

the issuance of Notice to Airmen 

(NOTAM) FDC 4/2182, due to ongoing 

safety concerns regarding U.S. civil 

flight operations in the entire UKFV and 

UKDV FIRs. The FAA determined that 

the ongoing conflict in the region posed 

a significant threat to U.S. civil aviation 

operations in these FIRs. In addition to 

a series of attacks on fixed-wing and 

rotary-wing Ukrainian military aircraft 

flying at lower altitudes, a Ukrainian 

An-26 flying at 21,000 feet southeast of 

Luhansk was shot down on July 14, 

2014, and a Malaysia Airlines Boeing 

777 was shot down on July 17, 2014, 


tkelley on DSK3SPTVN1PROD with RULES
65622 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 

while flying over Ukraine at 33,000 feet 

just west of the Russian border. Two 

hundred ninety eight passengers and 

crew perished. The use of weapons 

capable of targeting and shooting down 

aircraft flying on civil air routes at 

cruising altitudes posed a significantly 

dangerous threat to civil aircraft flying 

in the UKFV and UKDV FIRs. The FAA 

published a final rule incorporating the 

expanded flight prohibition into SFAR 

No. 113, § 91.1607, on December 29, 

2014 (79 FR 77857). 

The FAA has continued to evaluate 

the situation in the UKFV and UKDV 

FIRs and has determined there is a 

continuing significant flight safety 

hazard to U.S. civil aviation from the 

ongoing risk of skirmishes in the area. 

There is also a potential for larger-scale 

fighting in eastern Ukraine involving 

pro-Russian separatists, which could 

result in civil aircraft being 

misidentified as a threat and then 

intercepted or otherwise engaged, as 

demonstrated by the shoot down of 

Malaysia Airlines Flight 17 on July 17, 

2014. Pro-Russian separatists have 

access to a variety of anti-aircraft 

weapons, to include man-portable air 

defense systems (MANPADS) and 

possibly more advanced surface-to-airmissiles (SAMs) that have the capability 

to engage aircraft at higher altitudes. 

Separatists have demonstrated their 

ability to use these anti-aircraft weapons 

by successfully shooting down a 

number of aircraft during the course of 

the fighting in eastern Ukraine in 2014. 

There is also continuing concern over 

the hazard to U.S. civil aviation from 

possible conflicting air traffic control 

instructions from Ukrainian and 

Russian air traffic service providers due 

to a dispute over responsibility for 

providing air navigation services in 

portions of the Simferopol (UKFV) FIR. 

In addition, there have been reported 

incidents of purposeful interference, 

including GPS jamming, in the UKFV 

and UKDV FIRs. 

Due to the previously described 

continuing hazards to U.S. civil aviation 

operations, the FAA is extending the 

expiration date of SFAR No. 113, 

§ 91.1607, to continue the prohibition 

on flight operations in the UKFV and 

UKDV FIRs by all U.S. air carriers; U.S. 

commercial operators; persons 

exercising the privileges of a U.S. 

airman certificate, except when such 

persons are operating a U.S.-registered 

aircraft for a foreign air carrier; and 

operators of U.S.-registered civil aircraft, 

except when such operators are foreign 

air carriers. This rule extends the 

expiration date of SFAR No. 113, 

§ 91.1607, from October 27, 2015, to 

October 27, 2016. 

The FAA will continue to actively 

evaluate the area to determine to what 

extent U.S. civil aviation may be able to 

safely operate therein. Adjustments to 

this SFAR may be appropriate if the risk 

to aviation safety and security changes. 

The FAA may amend or rescind this 

SFAR as necessary prior to its 

expiration date. 

Additionally, the FAA is revising its 

approval process for proposed 

operations authorized by other U.S. 

Government departments, agencies, and 

instrumentalities to clarify the FAA’s 

expectations regarding requests for 

approval. The FAA is also revising the 

approval conditions that will apply to 

operations authorized by other U.S. 

Government departments, agencies, and 

instrumentalities and approved by the 

FAA, and the information about 

requests for exemption, to reflect the 

termination of statutory authorization 

for the FAA premium war risk 

insurance program. Section 102 of 

Division L of the Consolidated and 

Further Continuing Appropriations Act, 

2015, Public Law 113–235, December 

16, 2014, inter alia, amended 49 U.S.C. 

44302(f) and 44310(a) to specify the 

termination dates in those sections as 

December 11, 2014. The effect was to 

terminate coverage under FAA’s 

premium war risk insurance program as 

of December 11, 2014. This action also 

makes minor non-substantive 

corrections to the wording of the rule. 

Because the circumstances described 

herein warrant immediate action by the 

FAA, I find that notice and public 

comment under 5 U.S.C. 553(b)(3)(B) are 

impracticable and contrary to the public 

interest. Further, I find that good cause 

exists under 5 U.S.C. 553(d) for making 

this rule effective immediately upon 

issuance. I also find that this action is 

fully consistent with the obligations 

under 49 U.S.C. 40105 to ensure that I 

exercise my duties consistently with the 

obligations of the United States under 

international agreements. 

V. Revised Approval Process Based on 

a Request From a Department, Agency, 

or Instrumentality of the United States 

Government 

If a department, agency, or 

instrumentality of the U.S. Government 

determines that it has a critical need to 

engage any person covered under SFAR 

No. 113, § 91.1607, including a U.S. air 

carrier or a U.S. commercial operator, to 

conduct a charter to transport civilian or 

military passengers or cargo or other 

operations in either or both of the UKFV 

and UKDV FIRs, that department, 

agency, or instrumentality may request 

that the FAA approve persons covered 

under SFAR No. 113, § 91.1607, to 

conduct such operations. An approval 

request must be made directly by the 

requesting department, agency, or 

instrumentality of the U.S. Government 

to the FAA’s Associate Administrator 

for Aviation Safety (AVS–1) in a letter 

signed by an appropriate senior official 

of the requesting department, agency, or 

instrumentality. Requests for approval 

submitted to the FAA by anyone other 

than the requesting department, agency, 

or instrumentality will not be accepted 

and will not be processed. In addition, 

the senior official signing the letter 

requesting FAA approval on behalf of 

the requesting department, agency, or 

instrumentality must be sufficiently 

highly placed within his or her 

organization to demonstrate that the 

senior leadership of the requesting 

department, agency, or instrumentality 

supports the request for approval and is 

committed to taking all necessary steps 

to minimize operational risks to the 

proposed flights. The senior official 

must also be in a position to: (1) Attest 

to the accuracy of all representations 

made to the FAA in the request for 

approval and (2) ensure that any 

support from the requesting U.S. 

government department, agency, or 

instrumentality described in the request 

for approval is in fact brought to bear 

and is maintained over time. Unless 

exigent circumstances exist, requests for 

approval must be submitted to the FAA 

not less than 30 calendar days before the 

date on which the requesting 

department, agency, or instrumentality 

wishes the proposed operations, if 

approved by the FAA, to commence. 

The letter must be sent by the 

requesting department, agency, or 

instrumentality to the Associate 

Administrator for Aviation Safety 

(AVS–1), Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591. 

Electronic submissions are acceptable, 

and the requesting entity may request 

that the FAA notify it electronically as 

to whether the approval request is 

granted. If a requestor wishes to make 

an electronic submission to the FAA, 

the requestor should contact the Air 

Transportation Division, Flight 

Standards Service, at (202) 267–8166 to 

obtain the appropriate email address. A 

single letter may request approval from 

the FAA for multiple persons covered 

under SFAR No. 113, § 91.1607, and/or 

for multiple flight operations. To the 

extent known, the letter must identify 

the person(s) expected to be covered 

under the SFAR on whose behalf the 

U.S. Government department, agency, or 

instrumentality is seeking FAA 

approval, and it must describe— 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 65623 

• The proposed operation(s), 

including the nature of the mission 

being supported; 

• The service to be provided by the 

person(s) covered by the SFAR; 

• To the extent known, the specific 

locations in either or both of the 

Simferopol (UKFV) and Dnipropetrovsk 

(UKDV) FIRs where the proposed 

operation(s) will be conducted, 

including, but not limited to, the flight 

path and altitude of the aircraft while it 

is operating in either or both of the 

Simferopol (UKFV) and Dnipropetrovsk 

(UKDV) FIRs and the airports, airfields 

and/or landing zones at which the 

aircraft will take-off and land; and 

• The method by which the 

department, agency, or instrumentality 

will provide, or how the operator will 

otherwise obtain, current threat 

information and an explanation of how 

the operator will integrate this 

information into all phases of its 

proposed operations (e.g., pre-mission 

planning and briefing, in-flight, and 

post-flight). 

The request for approval must also 

include a list of operators with whom 

the U.S. Government department, 

agency, or instrumentality requesting 

FAA approval has a current contract(s), 

grant(s), or cooperative agreement(s) (or 

with whom its prime contractor has a 

subcontract(s)) for specific flight 

operations in either or both of the UKFV 

and UKDV FIRs. Additional operators 

may be identified to the FAA at any 

time after the FAA approval is issued. 

However, all additional operators must 

be identified to, and obtain an 

Operations Specification (OpSpec) or 

Letter of Authorization (LOA), as 

appropriate, from, the FAA, for 

operations in either or both of the UKFV 

and UKDV FIRs before such operators 

commence such operations. The revised 

approval conditions discussed below 

will apply to any such additional 

operators. Updated lists should be sent 

to the email address to be obtained from 

the Air Transportation Division by 

calling (202) 267–8166. 

If an approval request includes 

classified information, requestors may 

contact Aviation Safety Inspector 

Michael Filippell for instructions on 

submitting it to the FAA. His contact 

information is listed in the ‘‘For Further 

Information Contact’’ section of this 

final rule. 

FAA approval of an operation under 

SFAR No. 113, § 91.1607, does not 

relieve persons subject to this SFAR of 

their responsibility to comply with all 

applicable FAA rules and regulations. 

Operators of civil aircraft must also 

comply with the conditions of their 

certificate, OpSpecs, and LOAs, as 

applicable. Operators must further 

comply with all rules and regulations of 

other U.S. Government departments and 

agencies that may apply to the proposed 

operation, including, but not limited to, 

the Transportation Security Regulations 

issued by the Transportation Security 

Administration, Department of 

Homeland Security. 

Revised Approval Conditions 

If the FAA approves the request, the 

FAA’s Aviation Safety Organization 

(AVS) will send an approval letter to the 

requesting department, agency, or 

instrumentality informing it that the 

FAA’s approval is subject to all of the 

following conditions: 

(1) The approval will stipulate those 

procedures and conditions that limit, to 

the greatest degree possible, the risk to 

the operator, while still allowing the 

operator to achieve its operational 

objectives. 

(2) Before any approval takes effect, 

the operator must submit to the FAA: 

(a) A written release of the U.S. 

Government from all damages, claims, 

and liabilities, including without 

limitation legal fees and expenses; and 

(b) The operator’s agreement to 

indemnify the U.S. Government with 

respect to any and all third-party 

damages, claims, and liabilities, 

including without limitation legal fees 

and expenses, relating to any event 

arising from or related to the approved 

operations in either or both of the UKFV 

and UKDV FIRs. 

(3) Other conditions that the FAA 

may specify, including those that may 

be imposed in OpSpecs or LOAs, as 

applicable. 

The release and agreement to 

indemnify do not preclude an operator 

from raising a claim under an applicable 

non-premium war risk insurance policy 

issued by the FAA under chapter 443 of 

title 49, United States Code. 

If the proposed operation or 

operations are approved, the FAA will 

issue an OpSpec or an LOA, as 

applicable, to the operator authorizing 

the operation or operations, and will 

notify the department, agency, or 

instrumentality that requested the 

FAA’s approval of any additional 

conditions beyond those contained in 

the approval letter. The requesting 

department, agency, or instrumentality 

must have a contract, grant, or 

cooperative agreement (or its prime 

contractor must have a subcontract) 

with the person(s) described in 

paragraph (a) of this SFAR No. 113, 

§ 91.1607, on whose behalf the 

department, agency, or instrumentality 

requests FAA approval. 

VI. Requests for Exemption 

Any operations not conducted under 

an approval issued by the FAA through 

the approval process set forth 

previously must be conducted under an 

exemption from SFAR No. 113, 

§ 91.1607. A request by any person 

covered under SFAR No. 113, § 91.1607, 

for an exemption must comply with 14 

CFR part 11, and will require 

exceptional circumstances beyond those 

contemplated by the approval process 

set forth previously. In addition to the 

information required by 14 CFR 11.81, 

at a minimum, the requestor must 

describe in its submission to the FAA— 

• The proposed operation(s), 

including the nature of the operation; 

• The service to be provided by the 

person(s) covered by the SFAR; 

• The specific locations in either or 

both of the Simferopol (UKFV) and 

Dnipropetrovsk (UKDV) FIRs where the 

proposed operation(s) will be 

conducted, including, but not limited 

to, the flight path and altitude of the 

aircraft while it is operating in the 

UKFV and/or UKDV FIRs and the 

airports, airfields and/or landing zones 

at which the aircraft will take-off and 

land); and 

• The method by which the operator 

will obtain current threat information 

and an explanation of how the operator 

will integrate this information into all 

phases of its proposed operations (e.g., 

the pre-mission planning and briefing, 

in-flight, and post-flight phases). 

Additionally, the release and 

agreement to indemnify, as referred to 

previously, will be required as a 

condition of any exemption that may be 

issued under SFAR No. 113, § 91.1607. 

The FAA recognizes that operations 

that may be affected by SFAR No. 113, 

§ 91.1607, may be planned for the 

governments of other countries with the 

support of the U.S. Government. While 

these operations will not be permitted 

through the approval process, the FAA 

will process exemption requests for 

such operations on an expedited basis 

and prior to any private exemption 

requests. 

VII. Regulatory Notices and Analyses 

A. Regulatory Evaluation 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Orders 12866 and 13563 

direct that each Federal agency shall 

propose or adopt a regulation only upon 

a reasoned determination that the 

benefits of the intended regulation 

justify its costs. Second, the Regulatory 

Flexibility Act of 1980 (Pub. L. 96–354), 

as codified in 5 U.S.C. 603 et seq., 

requires agencies to analyze the 


tkelley on DSK3SPTVN1PROD with RULES
65624 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 

economic impact of regulatory changes 

on small entities. Third, the Trade 

Agreements Act (Pub. L. 96–39), as 

amended, 19 U.S.C. Chapter 13, 

prohibits agencies from setting 

standards that create unnecessary 

obstacles to the foreign commerce of the 

United States. In developing U.S. 

standards, the Trade Agreements Act 

requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), as codified in 2 U.S.C. Chapter 

25, requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this final rule. 

In conducting these analyses, FAA 

has determined this final rule has 

benefits that justify its costs. This rule 

is a significant regulatory action as 

defined in section 3(f) of Executive 

Order 12866, as it raises novel policy 

issues contemplated under that 

Executive Order; further, this rule is 

‘‘significant’’ as defined in DOT’s 

Regulatory Policies and Procedures. 

This rule will not have a significant 

economic impact on a substantial 

number of small entities. This rule will 

not create unnecessary obstacles to the 

foreign commerce of the United States. 

This rule will not impose an unfunded 

mandate on State, local, or tribal 

governments, or on the private sector by 

exceeding the threshold identified 

above. 

Department of Transportation (DOT) 

Order 2100.5 prescribes policies and 

procedures for simplification, analysis, 

and review of regulations. If the 

expected cost impact is so minimal that 

a proposed or final rule does not 

warrant a full evaluation, this order 

permits a statement to that effect and 

the basis for it to be included in the 

preamble if a full regulatory evaluation 

of the costs and benefits is not prepared. 

Such a determination has been made for 

this final rule. The reasoning for this 

determination follows. 

This rule extends the existing 

prohibition against U.S. civil flight 

operations in the UKFV and UKDV 

FIRs. As we noted in the most recent 

previous amendment to SFAR No. 113, 

§ 91.1607 (79 FR 77860, December 29, 

2014), almost all U.S. operators already 

had voluntarily ceased their operations 

in these FIRs prior to the issuance of the 

FAA NOTAM on July 18, 2014 (UTC), 

prohibiting U.S. civil flight operations 

in these two FIRS in their entirety. Prior 

to the issuance of the July 18, 2014 

(UTC) NOTAM, the FAA had already 

prohibited U.S. civil flight operations in 

a portion of the UKFV FIR due to a 

dispute between Ukraine and the 

Russian Federation over which country 

is responsible for providing air 

navigation services in the area, first via 

NOTAM and subsequently when the 

FAA initially published SFAR No. 113, 

§ 91.1607, on April 25, 2014. 

Consequently, no U.S. operators were 

operating in that portion of the UKFV 

FIR at the time of the December 29, 2014 

amendment to the rule. 

Because of the continuing significant 

hazards to U.S. civil aviation discussed 

in the Background section of this final 

rule, the FAA believes that few, if any, 

U.S. operators presently wish to 

conduct operations in either of these 

two FIRS. Moreover, both the 

amendment published on December 29, 

2014, and this rule, permit a U.S. 

Government department, agency, or 

instrumentality to request FAA approval 

on behalf of a person described in 

paragraph (a) of SFAR No. 113, 

§ 91.1607, to conduct operations under 

a contract (or subcontract), grant, or 

cooperative agreement with that 

department, agency, or instrumentality. 

As no U.S. Government department, 

agency, or instrumentality has requested 

such approval since December 29, 2014, 

there is apparently little demand for 

such approvals. Finally, the possibility 

of obtaining an approval, should one be 

requested, lowers the expected cost of 

the extended rule. Accordingly, the 

FAA believes the incremental costs of 

this final rule will be minimal. These 

minimal costs will be exceeded by the 

benefits of avoiding the deaths, injuries, 

and/or property damage that would 

result from a U.S. operator’s aircraft 

being shot down (or otherwise damaged) 

while operating in either or both of the 

UKFV and UKDV FIRs. 

B. Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives of the rule and of 

applicable statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. If 

the agency determines that it will, the 

agency must prepare a regulatory 

flexibility analysis, as described in the 

RFA. 

However, if an agency determines that 

a rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, 

section 605(b) of the RFA provides that 

the head of the agency may so certify 

and a regulatory flexibility analysis is 

not required. The certification must 

include a statement providing the 

factual basis for this determination, and 

the reasoning should be clear. 

As described in the Regulatory 

Evaluation section of this preamble, the 

incremental costs of this rule are 

minimal. Therefore, as provided in 

§ 605(b), the head of the FAA certifies 

that this rulemaking will not result in a 

significant economic impact on a 

substantial number of small entities. 

C. International Trade Impact 

Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended, prohibits 

Federal agencies from establishing 

standards or engaging in related 

activities that create unnecessary 

obstacles to the foreign commerce of the 

United States. Pursuant to this Act, the 

establishment of standards is not 

considered an unnecessary obstacle to 

the foreign commerce of the United 

States, so long as the standard has a 

legitimate domestic objective, such as 

the protection of safety, and does not 

operate in a manner that excludes 

imports that meet this objective. The 

statute also requires consideration of 

international standards and, where 

appropriate, that they be the basis for 

U.S. standards. 

The FAA has assessed the effect of 

this final rule and determined that its 

purpose is to protect the safety of U.S. 

civil aviation from a hazard outside the 

U.S. Therefore, the rule is in compliance 

with the Trade Agreements Act. 

D. Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more (in 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 65625 

1995 dollars) in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector; such 

a mandate is deemed to be a ‘‘significant 

regulatory action.’’ The FAA currently 

uses an inflation-adjusted value of 

$155.0 million in lieu of $100 million. 

This final rule does not contain such 

a mandate. Therefore, the requirements 

of Title II of the Act do not apply. 

E. Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that the 

FAA consider the impact of paperwork 

and other information collection 

burdens imposed on the public. The 

FAA has determined that there is no 

new requirement for information 

collection associated with this 

immediately adopted final rule. 

F. International Compatibility and 

Cooperation 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, it is FAA policy to 

conform to International Civil Aviation 

Organization (ICAO) Standards and 

Recommended Practices to the 

maximum extent practicable. The FAA 

has determined that there are no ICAO 

Standards and Recommended Practices 

that correspond to this regulation. 

G. Environmental Analysis 

FAA Order 1050.1F identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act (NEPA) in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 5–6.6f of this order and 

involves no extraordinary 

circumstances. 

The FAA has reviewed the 

implementation of this SFAR and 

determined it is categorically excluded 

from further environmental review 

according to FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures,’’ paragraph 5–6.6f. The 

FAA has examined possible 

extraordinary circumstances and 

determined that no such circumstances 

exist. After careful and thorough 

consideration of the action, the FAA 

finds that this Federal action does not 

require preparation of an Environmental 

Assessment or Environmental Impact 

Statement in accordance with the 

requirements of NEPA, Council on 

Environmental Quality (CEQ) 

regulations, and FAA Order 1050.1F. 

VIII. Executive Order Determinations 

A. Executive Order 13132, Federalism 

The FAA has analyzed this 

immediately adopted final rule under 

the principles and criteria of Executive 

Order 13132, Federalism. The agency 

has determined that this action would 

not have a substantial direct effect on 

the States, or the relationship between 

the Federal Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, and, therefore, 

would not have Federalism 

implications. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this immediately 

adopted final rule under Executive 

Order 13211, Actions Concerning 

Regulations that Significantly Affect 

Energy Supply, Distribution, or Use 

(May 18, 2001). The agency has 

determined that it would not be a 

‘‘significant energy action’’ under the 

executive order and would not be likely 

to have a significant adverse effect on 

the supply, distribution, or use of 

energy. 

C. Executive Order 13609, Promoting 

International Regulatory Cooperation 

Executive Order 13609, Promoting 

International Regulatory Cooperation, 

(77 FR 26413, May 4, 2012) promotes 

international regulatory cooperation to 

meet shared challenges involving 

health, safety, labor, security, 

environmental, and other issues and to 

reduce, eliminate, or prevent 

unnecessary differences in regulatory 

requirements. The FAA has analyzed 

this action under the policies and 

agency responsibilities of Executive 

Order 13609, and has determined that 

this action would have no effect on 

international regulatory cooperation. 

IX. Additional Information 

A. Availability of Rulemaking 

Documents 

An electronic copy of rulemaking 

documents may be obtained from the 

Internet by— 

• Searching the Federal eRulemaking 

Portal (http://www.regulations.gov); 

• Visiting the FAA’s Regulations and 

Policies Web page at http://

www.faa.gov/regulations_policies or 

• Accessing the Government 

Publishing Office’s Web page at http:// 

www.fdsys.gov 

Copies may also be obtained by 

sending a request (identified by docket 

or amendment number of the rule) to 

the Federal Aviation Administration, 

Office of Rulemaking, ARM–1, 800 

Independence Avenue SW., 

Washington, DC 20591, or by calling 

(202) 267–9677. 

All documents the FAA considered in 

developing this rule, including 

economic analyses and technical 

reports, may be accessed from the 

Internet through the Federal 

eRulemaking Portal referenced above. 

B. Small Business Regulatory 

Enforcement Fairness Act 

The Small Business Regulatory 

Enforcement Fairness Act of 1996 

(SBREFA) requires FAA to comply with 

small entity requests for information or 

advice about compliance with statutes 

and regulations within its jurisdiction. 

A small entity with questions regarding 

this document may contact its local 

FAA official, or the person listed under 

the FOR FURTHER INFORMATION CONTACT

heading at the beginning of the 

preamble. To find out more about 

SBREFA on the Internet, visit http://

www.faa.gov/regulations_policies/

rulemaking/sbre_act/. 

List of Subjects in 14 CFR Part 91 

Air traffic control, Aircraft, Airmen, 

Airports, Aviation safety, Freight, 

Ukraine. 

The Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends chapter I of title 14, Code of 

Federal Regulations, as follows: 

PART 91—GENERAL OPERATING AND 

FLIGHT RULES 

■ 1. The authority citation for part 91 is 

revised to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g), 1155, 

40101, 40103, 40105, 40113, 40120, 44101, 

44111, 44701, 44704, 44709, 44711, 44712, 

44715, 44716, 44717, 44722, 46306, 46315, 

46316, 46504, 46506–46507, 47122, 47508, 

47528–47531, 47534, articles 12 and 29 of the 

Convention on International Civil Aviation 

(61 Stat. 1180), (126 Stat. 11). 

■ 2. Amend § 91.1607 by revising 

paragraphs (a)(2), (c), and (e) to read as 

follows: 

§ 91.1607 Special Federal Aviation 

Regulation No. 113—Prohibition Against 

Certain Flights in the Simferopol (UKFV) 

and Dnipropetrovsk (UKDV) Flight 

Information Regions (FIRs). 

(a) * * * 

(2) All persons exercising the 

privileges of an airman certificate issued 

by the FAA, except when such persons 

are operating U.S.-registered aircraft for 

a foreign air carrier; and 

* * * * * 


tkelley on DSK3SPTVN1PROD with RULES
65626 Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Rules and Regulations 

(c) Permitted operations. This section 

does not prohibit persons described in 

paragraph (a) of this section from 

conducting flight operations in either or 

both of the Simferopol (UKFV) or 

Dnipropetrovsk (UKDV) FIRs, provided 

that such flight operations are 

conducted under a contract, grant, or 

cooperative agreement with a 

department, agency, or instrumentality 

of the U.S. government (or under a 

subcontract between the prime 

contractor of the department, agency, or 

instrumentality and the person 

described in paragraph (a) of this 

section) with the approval of the FAA, 

or under an exemption issued by the 

FAA. The FAA will process requests for 

approval or exemption in a timely 

manner, with the order of preference 

being: first, for those operations in 

support of U.S. government-sponsored 

activities; second, for those operations 

in support of government-sponsored 

activities of a foreign country with the 

support of a U.S. government 

department, agency, or instrumentality; 

and third, for all other operations. 

* * * * * 

(e) Expiration. This SFAR will remain 

in effect until October 27, 2016. The 

FAA may amend, rescind, or extend this 

SFAR as necessary. 

Issued in Washington, DC, under the 

authority of 49 U.S.C. 106(f), 40101(d)(1), 

40105(b)(1)(A), and 44701(a)(5), on October 

22, 2015. 

Michael P. Huerta, 

Administrator. 

[FR Doc. 2015–27334 Filed 10–22–15; 4:15 pm] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2015–N–3472] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

Autosomal Recessive Carrier 

Screening Gene Mutation Detection 

System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) has classified an 

autosomal recessive carrier screening 

gene mutation detection system into 

class II (special controls). The special 

controls that apply to this device are 

identified in this order and will be part 

of the codified language for the 

autosomal recessive carrier screening 

gene mutation detection system 

classification. The Agency has classified 

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 October 

27, 2015. The classification was 

applicable February 19, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Sunita Shukla, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4647, Silver Spring, 

MD 20993–0002, 301–796–6406. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

the Federal Food, Drug, and Cosmetic 

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

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

commercial distribution before May 28, 

1976 (the date of enactment of the 

Medical Device Amendments of 1976), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

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

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

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

807 (21 CFR part 807) of the regulations. 

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

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

provides two procedures by which a 

person may request FDA to classify a 

device under the criteria set forth in 

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

procedure, the person submits a 

premarket notification under section 

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

has not previously been classified and, 

after receiving an order classifying the 

device into class III under section 

513(f)(1) of the FD&C Act, the person 

requests a classification under section 

513(f)(2). Under the second procedure, 

rather than first submitting a premarket 

notification under section 510(k) of the 

FD&C Act and then a request for 

classification under the first procedure, 

the person determines that there is no 

legally marketed device upon which to 

base a determination of substantial 

equivalence and requests a classification 

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

If the person submits a request to 

classify the device under this second 

procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

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

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

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

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. 

23andMe, Inc., submitted a direct de 

novo request for classification of the 

23andMe PGS Carrier Screening Test for 

Bloom Syndrome under section 

513(f)(2)(A)(ii) of the FD&C Act, based 

on a determination that there is no 

legally marketed device on which to 

base a determination of substantial 

equivalence. 

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

the FD&C Act, FDA reviewed the 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. After review of the information 

submitted in the de novo request, FDA 

classified the device into class II 

because general controls by themselves 

are insufficient to provide reasonable 

assurance of safety and effectiveness, 

and there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. 

Therefore, on February 19, 2015, FDA 

issued an order to the requestor 

classifying the device into class II. The 

classification of the device will be 

codified at 21 CFR 866.5940. 

The device is assigned the generic 

name autosomal recessive carrier 

screening gene mutation detection 

system, and it is identified as a 

qualitative in vitro molecular diagnostic 

system used for genotyping of clinically 

relevant variants in genomic DNA 

isolated from human specimens 

intended for prescription use or overthe-counter use. The device is intended 

for autosomal recessive disease carrier 

screening in adults of reproductive age. 

The device is not intended for copy 

number variation, cytogenetic, or 

biochemical testing. 


tkelley on DSK3SPTVN1PROD with RULES