52134 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Rules and Regulations 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use 

The FAA has analyzed this rescission 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (May 18, 2001). The 

agency has determined that it is not a 

‘‘significant energy action’’ under the 

executive order because while a 

‘‘significant regulatory action’’ under 

Executive Order 12866, it is not likely 

to have a significant adverse effect on 

the supply, distribution, or use of 

energy. 

Availability of Rulemaking Documents 

You can get an electronic copy of 

rulemaking documents using the 

Internet by— 

1. Searching the Federal eRulemaking 

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

2. Visiting the FAA’s Regulations and 

Policies web page at http:// 

www.faa.gov/regulations_policies/; or 

3. Accessing the Government Printing 

Office’s Web page at http:// 

www.gpoaccess.gov/fr/index.html. 

You can also get a copy by sending a 

request to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. Make sure to 

identify the docket number, notice 

number, or amendment number of this 

rulemaking. 

You may access all documents the 

FAA considered in developing this 

rescission from the internet through the 

Federal eRulemaking Portal referenced 

in paragraph (1). 

List of Subjects in 14 CFR Part 93 

Air traffic control, Airports, 

Navigation (air), Reporting and 

recordkeeping requirements. 

The Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends Chapter I of Title 14, Code of 

Federal Regulations, as follows: 

PART 93—SPECIAL AIR TRAFFIC 

RULES 

■ 1. The authority citation for part 93 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40109, 40113, 44502, 44514, 44701, 44719, 

46301. 

Subpart C—[Removed and Reserved] 

■ 2. Remove and reserve Subpart C of 

Part 93. 

Issued in Washington, DC, on October 1, 

2009. 

J. Randolph Babbitt, 

Administrator. 

[FR Doc. E9–24232 Filed 10–8–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 93 

[Docket No. FAA–2008–0517; Notice No. 93– 

93] 

RIN 2120–AJ48 

Congestion Management Rule for John 

F. Kennedy International Airport and 

Newark Liberty International Airport 

AGENCY: Federal Aviation 

Administration (FAA). 

ACTION: Final rule; rescission. 

SUMMARY: The FAA is rescinding the 

final rule Congestion Management Rule 

for John F. Kennedy International 

Airport and Newark Liberty 

International Airport. The final rule 

established procedures to address 

congestion in the New York City area by 

assigning slots for scheduled services at 

John F. Kennedy (JFK) and Newark 

Liberty (Newark) International Airports, 

assigning to existing operators the 

majority of slots at the airports, and 

creating a market by annually 

auctioning off a limited number of slots 

in each of the first five years of the rule. 

The final rule also contained provisions 

for minimum usage, requiring 

reservations for unscheduled 

operations, and withdrawal for 

operational need. The rule was 

scheduled to sunset in ten years. 

DATES: Effective Date: October 9, 2009. 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning this rulemaking, 

contact: Molly W. Smith, Office of 

Aviation Policy and Plans, APO–200, 

Federal Aviation Administration, 800 

Independence Avenue, SW., 

Washington, DC 20591; telephone (202) 

267–3275; e-mail 

molly.w.smith@faa.gov. For legal 

questions concerning this rulemaking, 

contact: Rebecca MacPherson, FAA 

Office of the Chief Counsel, 800 

Independence Ave., SW., Washington, 

DC 20591; telephone (202) 267–3073; 

e-mail rebecca.macpherson@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA has broad authority under 

49 U.S.C. 40103 to regulate the use of 

the navigable airspace of the United 

States. This section authorizes the FAA 

to develop plans and policy for the use 

of navigable airspace and to assign the 

use that the FAA deems necessary for its 

safe and efficient utilization. It further 

directs the FAA to prescribe air traffic 

rules and regulations governing the 

efficient utilization of thenavigable 

airspace. 

I. Background 

The final rule Congestion 

Management Rule for John F. Kennedy 

International Airport and Newark 

Liberty International Airport was 

published in the Federal Register on 

October 10, 2008 (73 FR 60544) (2008 

final rule). The 2008 final rule 

established procedures to address 

congestion in the New York City area by 

assigning slots at John F. Kennedy (JFK) 

and Newark Liberty (Newark) 

International Airports, assigning to 

existing operators the majority of slots at 

the airports, and creating a market by 

annually auctioning off a limited 

number of slots in each of the first five 

years of the rule. The final rule also 

contained provisions for minimum slot 

usage, withdrawal of slots for 

operational need, and requiring 

reservations for unscheduled 

operations. The rule was scheduled to 

sunset in ten years and added to the 

Code of Federal Regulations December 

9, 2008. The rulemaking was highly 

controversial. The final rule was 

challenged by several parties before it 

could take effect. On December 8, 2008, 

the United States Court of Appeals for 

the District of Columbia Circuit stayed 

the rule. On January 22, 2009, the ATA 

requested the Secretary of 

Transportation, Ray LaHood, withdraw 

the final rule in light of the court’s stay. 

While the regulations were incorporated 

into the Code of Federal Regulations, 

due to the courts ruling, they had no 

force and effect. 

On March 11, 2009, the President 

signed Public Law 111–8, Omnibus 

Appropriations Act, 2009. That 

legislation provides several departments 

within the executive branch, including 

the Department of Transportation, with 

the funds to operate until the end of this 

fiscal year. That legislation also contains 

a provision in Division I, section 115 

that prohibits the Secretary of 

Transportation from promulgating 

regulations or taking any action 

regarding the scheduling of airline 

operations that involve auctioning rights 

or permission to conduct airline 

operations at such an airport or 

withdrawing a right or permission to 

conduct operations at such an airport 

(except when the withdrawal is for 

operational reasons or pursuant to the 


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Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Rules and Regulations 52135 

terms or conditions of such operating 

right or permission). The prohibition is 

limited to this fiscal year. 

At present, both airports remain 

limited by order at 81 scheduled 

operations per hour until October 2009. 

Order Limiting Scheduled Operations at 

John F. Kennedy International Airport 

(73 FR 3519 (Jan. 18, 2008), as amended 

73 FR 8737 (Feb. 14, 2008)); Order 

Limiting Scheduled Operations at 

Newark Liberty International Airport (73 

FR 29550 (May 21, 2008)). 

On May 14, 2009 the FAA published 

a notice proposing to rescind the 2008 

final rule citing the impact of the 

Omnibus Appropriations Act on the 

rule and the state of the economy in 

general. The comment period closed 

June 15, 2009. The FAA received six 

sets of comments, all of which 

supported rescission of the rule. 

For the reasons stated in the NPRM, 

the FAA has decided to rescind the 

2008 final rule effective immediately. 

The FAA has determined that good 

cause exists for implementing this rule 

immediately. As discussed above, the 

rule has been stayed by court action and 

has not been implemented. Accordingly, 

no further action is required by the 

regulated parties and delaying the 

effective date serves no useful purpose. 

The agency will consider its options 

with regard to managing congestion at 

the airport in ways that provide a means 

for carriers either to commence or 

expand operations at the airport in 

future rulemaking. 

In order to prevent over-scheduling at 

JFK and Newark while the agency 

considers alternative congestion 

management options the FAA has 

published orders to show cause 

proposing to extend the existing orders 

until October 2010. 74 FR 27059 (June 

5, 2009); 74 FR 27060 (June 5, 2009). 

II. Regulatory Notices and Analyses 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 directs 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 requires agencies to analyze the 

economic impact of regulatory changes 

on small entities. Third, the Trade 

Agreements Act (19 U.S.C. 4 2531–2533) 

prohibits agencies from setting 

standards that create unnecessary 

obstacles to the foreign commerce of the 

United States. In developing U.S. 

standards, this Trade Act requires 

agencies to consider international 

standards and, where appropriate, to be 

the basis of U.S. standards. Fourth, the 

Unfunded Mandate Reform Act of 1995 

(Pub. L. 104–4) 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). The 

FAA currently uses an inflationadjusted value of $136.1 million in lieu 

of $100 million. 

The FAA conducted all of these 

analyses when it originally issued the 

2008 final rule. The agency has 

determined the rescission does not 

require any further economic analysis. 

Practically speaking, due to the 

rescission, the status quo remains in 

effect, and neither costs nor benefits 

anticipated by the final rule will accrue. 

Likewise, the paperwork burden 

anticipated under the rule will not be 

imposed on any parties. The FAA has 

already determined that the rule will 

not have a significant economic impact 

on a substantial number of small entities 

under the Regulatory Flexibility Act. 

Rescission of the 2008 final rule 

likewise imposes no such burden. As 

the rescission of the 2008 final rule does 

not impose any standard on any party, 

the FAA has assessed the potential 

effect of this rescission and determined 

that it will impose no costs on 

international entities and thus have a no 

trade impact. Nor will the rescission 

impose a Federal mandate that may 

result in an expenditure of $100 million 

or more (adjusted annually for inflation) 

in any one year by State, local, and 

tribal governments, in the aggregate, or 

by the private sector, and the 

requirements of Title II of the Unfunded 

Mandate Reform Act of 1995 do not 

apply. 

The rescission of the 2008 final rule 

is a ‘‘significant regulatory action’’ 

under Executive Order 12866 and is 

‘‘significant’’ as defined in DOT’s 

Regulatory Policies and Procedures. 

Accordingly, it has been reviewed by 

DOT and OMB. 

Executive Order 13132, Federalism 

The FAA has analyzed this rescission 

under the principles and criteria of 

Executive Order 13132, Federalism. We 

have determined that this action will 

not have a substantial direct effect on 

the States, on the relationship between 

the national Government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, and, therefore, 

does not have federalism implications. 

Environmental Analysis 

FAA Order 1050.1E, ‘‘Environmental 

Impacts: Policies and Procedures’’ 

identifies FAA actions that are normally 

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 previously 

determined that the final rule qualified 

for the categorical exclusions identified 

in paragraph 312d ‘‘Issuance of 

regulatory documents (e.g., Notices of 

Proposed Rulemaking and issuance of 

Final Rules) covering administration or 

procedural requirements (does not 

include Air Traffic procedures; specific 

Air traffic procedures that are 

categorically excluded are identified 

under paragraph 311 of this Order)’’ and 

paragraph 312f, ‘‘Regulations, standards, 

and exemptions (excluding those which 

if implemented may cause a significant 

impact on the human environment.’’ It 

has further been determined that no 

extraordinary circumstances exist that 

may cause a significant impact and 

therefore no further environmental 

review is required. The FAA 

documented this categorical exclusion 

determination. A copy of the 

determination and underlying 

documents has been included in the 

Docket for the rule. The FAA has 

determined that the rescission of the 

2008 final rule also qualifies for a 

categorical exclusion since it will have 

no impact on the environment. 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use 

The FAA has analyzed this rescission 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (May 18, 2001). The 

agency has determined that it is not a 

‘‘significant energy action’’ under the 

executive order because while a 

‘‘significant regulatory action’’ under 

Executive Order 12866, it is not likely 

to have a significant adverse effect on 

the supply, distribution, or use of 

energy. 

Availability of Rulemaking Documents 

You can get an electronic copy of 

rulemaking documents using the 

Internet by— 

1. Searching the Federal eRulemaking 

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

2. Visiting the FAA’s Regulations and 

Policies Web page at http:// 

www.faa.gov/regulations_policies/; or 

3. Accessing the Government Printing 

Office’s Web page at http:// 

www.gpoaccess.gov/fr/index.html. 


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52136 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Rules and Regulations 

You can also get a copy by sending a 

request to the Federal Aviation 

Administration, Office of Rulemaking, 

ARM–1, 800 Independence Avenue 

SW., Washington, DC 20591, or by 

calling (202) 267–9680. Make sure to 

identify the docket number, notice 

number, or amendment number of this 

rulemaking. 

You may access all documents the 

FAA considered in developing this 

resission from the internet through the 

Federal eRulemaking Portal referenced 

in paragraph (1). 

List of Subjects in 14 CFR Part 93 

Air traffic control, Airports, 

Navigation (air), Recordkeeping and 

reporting requirements. 

The Amendment 

■ In consideration of the foregoing, the 

Federal Aviation Administration 

amends Chapter I of Title 14, Code of 

Federal Regulations, as follows: 

PART 93—SPECIAL AIR TRAFFIC 

RULES 

■ 1. The authority citation for part 93 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40106, 

40109, 40113, 44502, 44514, 44701, 44719, 

46301. 

Subpart N—[Removed and Reserved] 

■ 2. Remove and reserve Subpart N of 

Part 93. 

Issued in Washington, DC, on October 1, 

2009. 

J. Randolph Babbitt, 

Administrator. 

[FR Doc. E9–24235 Filed 10–8–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2009–N–0119] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

Respiratory Viral Panel Multiplex 

Nucleic Acid Assay 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

classification of the respiratory viral 

panel multiplex nucleic acid assay into 

class II (special controls). The special 

controls that will apply to the device are 

three guidance documents entitled: 

‘‘Class II Special Controls Guidance 

Document: Respiratory Viral Panel 

Multiplex Nucleic Acid Assay,’’ as 

applicable, ‘‘Class II Special Controls 

Guidance Document: Testing for Human 

Metapneumovirus (hMPV) Using 

Nucleic Acid Assays,’’ and as 

applicable,‘‘Class II Special Controls 

Guidance Document: Testing for 

Detection and Differentiation of 

Influenza A Virus Subtypes Using 

Multiplex Nucleic Acid Assays.’’ The 

agency classified the device into class II 

(special controls) in order to provide a 

reasonable assurance of safety and 

effectiveness of the device. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of the 

guidance documents that will serve as 

the special controls for this device. 

DATES: This final rule is effective 

November 9, 2009. The classification 

was effective January 3, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Zivana Tezak, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5550, Silver Spring, 

MD 20993, 301–796–6204. 

SUPPLEMENTARY INFORMATION: 

I. What Is the Background of This 

Rulemaking? 

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

the Federal Food, Drug, and Cosmetic 

Act (the 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 (the amendments), 

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 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 act 

(21 U.S.C. 360(k) and part 807 (21 CFR 

part 807) of FDA’s regulations. 

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1), request FDA to classify 

the device under the criteria set forth in 

section 513(a)(1). FDA shall, within 60 

days of receiving such a request, classify 

the device by written order. This 

classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification (section 

513(f)(2) of the act). 

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

the act, FDA issued an order on 

November 30, 2007, classifying the 

Luminex Molecular Diagnostics, Inc., 

xTAGTM RVP (Respiratory Viral Panel) 

as class III, because it was not 

substantially equivalent to a device that 

was introduced or delivered for 

introduction into interstate commerce 

for commercial distribution before May 

28, 1976, or a device that was 

subsequently reclassified into class I or 

class II. On December 1, 2007, Luminex 

Molecular Diagnostics, Inc., submitted a 

petition requesting classification of the 

xTAGTM RVP under section 513(f)(2) of 

the act. The manufacturer recommended 

that the device be classified into class II. 

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

the act, FDA reviewed the petition in 

order to classify the device under the 

criteria for classification set forth in 

section 513(a)(1) of the act. Devices are 

to be classified into class II if general 

controls, by themselves, are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but there is 

sufficient information to establish 

special controls to provide reasonable 

assurance of the safety and effectiveness 

of the device for its intended use. After 

review of the information submitted in 

the petition, FDA determined that the 

Luminex Molecular Diagnostics, Inc., 

xTAGTM RVP can be classified in class 

II with the establishment of special 

controls. FDA believes these special 

controls, in addition to general controls, 

will provide reasonable assurance of 

safety and effectiveness of the device. 

The device is assigned the generic 

name ‘‘respiratory viral panel multiplex 

nucleic acid assay.’’ It is identified as a 

qualitative in vitro diagnostic device 

that is intended to simultaneously 

detect and identify multiple viral 

nucleic acids extracted from human 

respiratory specimens or viral culture. 

The detection and identification of a 

specific viral nucleic acid from 

individuals exhibiting signs and 

symptoms of respiratory infection aids 

in the diagnosis of respiratory viral 

infection when used in conjunction 

with other clinical and laboratory 

findings. 


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