53882 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 

1Sections 403(1) and 411 of the Homeland 

Security Act of 2002 (‘‘the Act,’’ Pub. L. 107–296) 

transferred the United States Customs Service and 

its functions from the Department of the Treasury 

to the Department of Homeland Security; pursuant 

to section 1502 of the Act, the President renamed 

the ‘‘Customs Service’’ as the ‘‘Bureau of Customs 

and Border Protection.’’ Effective on March 31, 

2007, DHS changed the name of ‘‘Bureau of 

Customs and Border Protection’’ to ‘‘U.S. Customs 

and Border Protection (CBP)’’ (See 72 FR 20131, 

April 23, 2007). 

Regulatory Flexibility Act and 

Executive Order 12866 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. This 

amendment does not meet the criteria 

for a ‘‘significant regulatory action’’ as 

specified in Executive Order 12866. 

Signing Authority 

This document is limited to a 

technical correction of CBP regulations. 

Accordingly, it is being signed under 

the authority of 19 CFR 0.1(b). 

List of Subjects in 19 CFR Part 122 

Air carriers, Aircraft, Airports, 

Customs duties and inspection, Freight. 

Amendments to Regulations 

■ Part 122, Code of Federal Regulations 

(19 CFR part 122) is amended as set 

forth below: 

PART 122—AIR COMMERCE 

REGULATIONS 

■ 1. The authority citation for part 122 

continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66, 

1431, 1433, 1436, 1448, 1459, 1590, 1594, 

1623, 1624, 1644, 1644a, 2071 note. 

§ 122.15 [Amended] 

■ 2. The listing of user fee airports in 

§ 122.15(b) is amended by removing 

from the ‘‘Location’’ column, ‘‘Santa 

Maria, California,’’ and by removing on 

the same line, from the ‘‘Name’’ column, 

‘‘Santa Maria Public Airport.’’ 

Dated: October 15, 2009. 

Jayson P. Ahern, 

Acting Commissioner, U.S. Customs and 

Border Protection. 

[FR Doc. E9–25321 Filed 10–20–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

19 CFR Part 122 

[CBP Dec. 09–41] 

Technical Amendments to List of User 

Fee Airports: Removal of User Fee 

Status for Roswell Industrial Air 

Center, Roswell, NM and March Inland 

Port Airport, Riverside, CA and Name 

Change for Capital City Airport, 

Lansing, MI 

AGENCY: Customs and Border Protection, 

DHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: This document amends the 

Customs and Border Protection (CBP) 

Regulations by revising the list of user 

fee airports to reflect the removal of the 

user fee designations for the Roswell 

Industrial Air Center in Roswell, New 

Mexico and the March Inland Port 

Airport in Riverside, California, as well 

as indicating that the Capital City 

Airport in Lansing, Michigan has 

changed its name to the Capital Region 

International Airport. User fee airports 

are those airports which, while not 

qualifying for designation as 

international or landing rights airports, 

have been approved by the 

Commissioner of CBP to receive, for a 

fee, the services of CBP officers for the 

processing of aircraft entering the 

United States, and the passengers and 

cargo of those aircraft. 

DATES: Effective Date: October 21, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Wendy M. Cooper, Office of Field 

Operations, 202–344–2057. 

SUPPLEMENTARY INFORMATION: 

Background 

Title 19, Part 122, Code of Federal 

Regulations (CFR), sets forth regulations 

relating to the entry and clearance of 

aircraft in international commerce and 

the transportation of persons and cargo 

by aircraft in international commerce. 

Generally, a civil aircraft arriving 

from a place outside of the United States 

is required to land at an airport 

designated as an international airport. 

Alternatively, the pilot of a civil aircraft 

may request permission to land at a 

specific airport, and, if landing rights 

are granted, the civil aircraft may land 

at that landing rights airport. 

Section 236 of Public Law 98–573 (the 

Trade and Tariff Act of 1984), codified 

at 19 U.S.C. 58b, created an option for 

civil aircraft desiring to land at an 

airport other than an international 

airport or a landing rights airport. A 

civil aircraft arriving from a place 

outside of the United States may ask for 

permission to land at an airport 

designated by the Secretary of 

Homeland Security 1 as a user fee 

airport. 

Pursuant to 19 U.S.C. 58b, an airport 

may be designated as a user fee airport 

if the Commissioner of CBP as delegated 

by the Secretary of Homeland Security 

determines that the volume of business 

at the airport is insufficient to justify 

customs services at the airport and the 

governor of the state in which the 

airport is located approves the 

designation. Generally, the type of 

airport that would seek designation as a 

user fee airport would be one at which 

a company, such as an air courier 

service, has a specialized interest in 

regularly landing. 

As the volume of business anticipated 

at this type of airport is insufficient to 

justify its designation as an 

international or landing rights airport, 

the availability of customs services is 

not paid for out of appropriations from 

the general treasury of the United States. 

Instead, customs services are provided 

on a fully reimbursable basis to be paid 

for by the user fee airport on behalf of 

the recipients of the services. 

Pursuant to 19 U.S.C. 58b, the fees 

which are to be charged at user fee 

airports shall be paid by each person 

using the customs services at the airport 

and shall be in the amount equal to the 

expenses incurred by the Commissioner 

of CBP in providing customs services 

which are rendered to such person at 

such airport, including the salary and 

expenses of those employed by the 

Commissioner of CBP to provide the 

customs services. To implement this 

provision, the airport seeking the 

designation as a user fee airport or that 

airport’s authority generally agrees to 

pay a flat fee for which the users of the 

airport are to reimburse the airport/ 

airport authority. The airport/airport 

authority agrees to set and periodically 

review the charges to ensure that they 

are in accord with the airport’s 

expenses. 

The Commissioner of CBP designates 

airports as user fee airports pursuant to 

19 U.S.C. 58b. See 19 CFR 122.15. If the 

Commissioner decides that the 

conditions for designation as a user fee 

airport are satisfied, a Memorandum of 

Agreement (MOA) is executed between 

the Commissioner of CBP and the local 

responsible official signing on behalf of 

the state, city or municipality in which 

the airport is located. In this manner, 

user fee airports are designated on a 

case-by-case basis. Periodically, CBP 

updates the list of user fee airports at 19 

CFR 122.15(b) to reflect changes in the 

status of user fee airports. 

Recent Changes Requiring Updates to 

the List of User Fee Airports 

Section 19 CFR 122.15(c)(1) provides 

that the designation as a user fee airport 


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Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 53883 

shall be withdrawn if either CBP or the 

airport authority gives 120 days written 

notice of termination to the other party. 

On January 15, 2009, CBP gave written 

notice to the Roswell Industrial Air 

Center in Roswell, New Mexico 

terminating their status as a user fee 

facility, in accordance with 19 CFR 

122.15(c)(1). On November 6, 2008, the 

March Inland Port Airport Authority 

gave written notice terminating their 

MOA with CBP, in accordance with 19 

CFR 122.15(c)(1). 

On January 26, 2009, Capital City 

Airport notified CBP that it had 

officially changed its name to the 

Capital Region International Airport. 

This document updates the list of user 

fee airports by deleting the Roswell 

Industrial Air Center in Roswell, New 

Mexico and the March Inland Port 

Airport in Riverside, California, and 

changing the name of the Capital City 

Airport in Lansing, Michigan to the 

Capital Region International Airport. 

Inapplicability of Public Notice and 

Delayed Effective Date Requirements 

Because this amendment merely 

updates the list of user fee airports to 

reflect a name change and to remove 

airports already approved for 

withdrawal by the Commissioner of CBP 

in accordance with 19 CFR 122.15(c)(1) 

and neither imposes additional burdens 

on, nor takes away any existing rights or 

privileges from, the public, pursuant to 

5 U.S.C. 553(b)(B), notice and public 

procedure are unnecessary, and for the 

same reasons, pursuant to 5 U.S.C. 

553(d)(3), a delayed effective date is not 

required. 

The Regulatory Flexibility Act and 

Executive Order 12866 

Because no notice of proposed 

rulemaking is required, the provisions 

of the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) do not apply. This 

amendment does not meet the criteria 

for a ‘‘significant regulatory action’’ as 

specified in Executive Order 12866. 

Signing Authority 

This document is limited to technical 

corrections of CBP regulations. 

Accordingly, it is being signed under 

the authority of 19 CFR 0.1(b). 

List of Subjects in 19 CFR Part 122 

Air carriers, Aircraft, Airports, 

Customs duties and inspection, Freight. 

Amendments to Regulations 

■ Part 122, Code of Federal Regulations 

(19 CFR part 122) is amended as set 

forth below: 

PART 122—AIR COMMERCE 

REGULATIONS 

■ 1. The authority citation for part 122 

continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66, 

1431, 1433, 1436, 1448, 1459, 1590, 1594, 

1623, 1624, 1644, 1644a, 2071 note. 

§ 122.15 [Amended] 

■ 2. The listing of user fee airports in 

§ 122.15(b) is amended as follows: by 

removing, in the ‘‘Location’’ column, 

‘‘Roswell, New Mexico’’ and by 

removing on the same line, in the 

‘‘Name’’ column, ‘‘Roswell Air 

Industrial Center.’’; by removing, in the 

‘‘Location’’ column, ‘‘Riverside, 

California’’ and by removing on the 

same line, in the ‘‘Name’’ column, 

‘‘March Inland Port Airport.’’; and, by 

removing, in the ‘‘Name’’ column, 

‘‘Capital City Airport’’ and adding in its 

place ‘‘Capital Region International 

Airport.’’ 

Dated: October 15, 2009. 

Jayson P. Ahern, 

Acting Commissioner, Customs and Border 

Protection. 

[FR Doc. E9–25318 Filed 10–20–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 862 

[Docket No. FDA–2009–N–0472] 

Medical Devices; Clinical Chemistry 

and Clinical Toxicology Devices; 

Classification of the Cardiac Allograft 

Gene Expression Profiling Test 

Systems 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

classification of cardiac allograft gene 

expression profiling test systems into 

class II (special controls). The special 

control that will apply to the device is 

the guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Cardiac Allograft Gene Expression 

Profiling Test Systems.’’ FDA 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 document that will serve as 

the special control for this device. 

DATES: This final rule is effective 

November 20, 2009. The classification 

was effective August 26, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Kellie B. Kelm, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5625, Silver Spring, 

MD 20993, 301–796–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 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 this classification (section 

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

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

the act, FDA issued an order on August 

8, 2008, classifying the XDx AlloMap 

Test in 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 August 15, 2008, XDx, Inc., 

submitted a petition requesting 


sroberts on DSKD5P82C1PROD with RULES