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shall be withdrawn if either CBP or the 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 


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53884 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 

classification of the AlloMap Test under 

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

manufacturer recommended that the 

device be classified into class II (Ref. 1). 

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). 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 

AlloMap Test 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 ‘‘Cardiac allograft gene expression 

profiling test system.’’ It is identified as 

a device that measures the RNA 

expression level of multiple genes and 

combines this information to yield a 

signature (pattern, classifier, index, 

score) to aid in the identification of a 

low probability of acute cellular 

rejection (ACR) in heart transplant 

recipients with stable allograft function. 

FDA has identified the following 

issues of safety or effectiveness 

requiring special controls for a cardiac 

allograft gene expression profiling test 

system. Failure of this device to perform 

as indicated may lead to erroneous test 

results. False positive results will 

misclassify the patient into a higher risk 

group and false negative results will 

misclassify the patient into a lower risk 

group. Misclassification of ACR may 

lead to incorrect patient management 

with attendant psychological distress, 

inaccurate counseling, and suboptimal 

patient care. 

FDA believes the class II special 

controls guidance document generally 

addresses the risks to health identified 

in the previous paragraph and will aid 

in mitigating potential risks by 

providing recommendations on labeling 

and validation of performance 

characteristics. The guidance document 

also provides information on how to 

meet 510(k) premarket notification 

submission requirements for the device. 

FDA believes that the special controls, 

in addition to general controls, provide 

reasonable assurances of the safety and 

effectiveness of the device type. 

Therefore, on August 26, 2008, FDA 

issued an order to the petitioner 

classifying the device into class II (Ref. 

2). FDA is codifying this classification 

by adding § 862.1163. 

Any firm submitting a premarket 

notification submission for a cardiac 

allograft gene expression profiling test 

system will need to address the issues 

covered in the special controls 

guidance. However, the firm need only 

show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirements under section 510(k) if 

FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. For this type 

of device, however, FDA has 

determined that premarket notification 

is necessary to provide a reasonable 

assurance of the safety and effectiveness 

of the device and, therefore, this type of 

device is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the cardiac allograft gene 

expression profiling test system they 

intend to market. 

II. Environmental Impact 

The agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this final rule is not a 

significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of this 

device into class II will relieve 

manufacturers of the cost of complying 

with the premarket approval 

requirements of section 515 of the act 

and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the agency certifies 

that the final rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $133 

million, using the most current (2008) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. 21 

U.S.C. 360k; See Medtronic v. Lohr, 518 

U.S. 470 (1996); Riegel v. Medtronic, 

128 S. Ct. 999 (2008). The special 

controls established by this final rule 

create ‘‘requirements’’ for specific 

medical devices under 21 U.S.C. 360k, 

even though product sponsors have 

some flexibility in how they meet those 

requirements. See Papike v. Tambrands, 

Inc., 107 F.3d 737, 740–42 (9th Cir. 

1997). 

V. Paperwork Reduction Act of 1995 

This final rule establishes as special 

controls a guidance document that 

refers to previously approved 

collections of information found in 

other FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 


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Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Rules and Regulations 53885 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) (the PRA). The collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB Control No. 0910–0120. The 

collections of information in 21 CFR 

part 801 and 21 CFR 809.10, regarding 

labeling, have been approved under 

OMB Control No. 0910–0485. The 

collections of information in 21 CFR 

part 820 have been approved under 

OMB Control No. 0910–0073. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from XDx, Inc., dated August 

15, 2008. 

2. Order classifying XDx AlloMap Test, 

dated August 26, 2008. 

List of Subjects in 21 CFR Part 862 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 862 is 

amended as follows: 

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 862 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 862.1163 is added to 

subpart B to read as follows: 

§ 862.1163 Cardiac allograft gene 

expression profiling test system. 

(a) Identification. A cardiac allograft 

gene expression profiling test system is 

a device that measures the ribonucleic 

acid (RNA) expression level of multiple 

genes and combines this information to 

yield a signature (pattern, classifier, 

index, score) to aid in the identification 

of a low probability of acute cellular 

rejection (ACR) in heart transplant 

recipients with stable allograft function. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Cardiac Allograft Gene Expression 

Profiling Test Systems.’’ See § 862.1(d) 

for the availability of this guidance 

document. 

Dated: October 9, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–25315 Filed 10–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0895] 

RIN 1625–AA11 

Regulated Navigation Area; 

Portsmouth Naval Shipyard, 

Portsmouth, NH 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a regulated navigation area 

on the Piscataqua River near 

Portsmouth, NH. This temporary final 

rule places speed restrictions on all 

vessels transiting the navigable waters 

on the Piscataqua River, Portsmouth, 

NH near the Portsmouth Naval Shipyard 

between Henderson Point Light on 

Seavey Island and Badgers Island Buoy 

14. This rule is necessary to provide for 

the safety of life on the navigable waters 

during ongoing ship construction. 

DATES: This temporary final rule is 

effective from 7 a.m. on October 21, 

2009, until 5 p.m. on November 15, 

2009. This temporary final rule is 

enforceable with actual notice by Coast 

Guard personnel beginning October 15, 

2009. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket USCG–2009– 

0895 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2009–0895 in the ‘‘Keyword’’ 

box and then clicking ‘‘Search.’’ They 

are also available for inspection or 

copying at the Docket Management 

Facility (M–30), U.S. Department of 

Transportation, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

final rule, call Lieutenant Junior Grade 

Laura van der Pol, Waterways 

Management Division Chief, U.S. Coast 

Guard Sector Northern New England, 

telephone 207–741–5421, e-mail 

laura.k.vanderpol1@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

The Coast Guard is issuing this 

temporary final rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b)(B), the Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

Portsmouth Naval Facility will be 

beginning diving operations in this area 

within a short timeframe thus making 

publication of a NPRM and Final Rule 

impractical. Further, this regulated 

navigation area is necessary to provide 

for the safety of the divers and others 

working in the area as wake from 

passing vessels could cause the ship to 

move erratically and unexpectedly, 

injuring the divers and their support 

crews. Not providing for the safety of 

the divers and others in the area is 

contrary to the public interest of 

creating a safe work environment. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register as immediate action is 

necessary to provide for the safety of 

divers and workers on the vessel as well 

as to minimize the risk to commercial 

vessels and recreational boaters who 

transit the area. In addition to the 

reasons stated within this preamble, a 

delay in the effective date of this rule is 

contrary to the public’s interest in 

ensuring the ship construction project 

continues as scheduled. 

Background and Purpose 

As part of ongoing ship construction 

projects at the Portsmouth Naval 

Shipyard, vessels are being launched, 

creating a period of particular 

sensitivity to the personnel and 

equipment involved. Specifically, divers 

will be working on the hull of a vessel 

for approximately four weeks beginning 

on October 15, 2009. Underwater work 

includes the removal and installation of 

heavy equipment. Unexpected and 

uncontrolled movement of the vessel 

while divers are in the water creates a 

significant risk of serious injury or 

death. Additionally, loading operations 


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