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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Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Rules and Regulations 52137 

1 (FDA has verified the Web site addresses, but 

FDA is not responsible for any subsequent changes 

to the Web sites after this document publishes in 

the Federal Register.) 

Respiratory illness caused by various 

commonly circulating respiratory 

viruses (e.g., Influenza A, RSV) can 

cause high morbidity and mortality, 

particularly in at-risk populations such 

as the elderly and the very young. 

Therefore, FDA has identified the 

following issues of safety or 

effectiveness requiring special controls 

for a respiratory viral panel multiplex 

nucleic acid assay, i.e. potential risks to 

health associated with this assay. These 

include (1) Failure of the device to 

perform as indicated, leading to 

inaccurate results or lack of results and 

(2) incorrect interpretation of results; 

both of these potential risks may lead to 

incorrect patient management decisions. 

For example, a false positive result 

could lead to unnecessary or 

inappropriate treatment for the 

misidentified viral illness, as well as 

delayed treatment of the actual 

infection, which may potentially be a 

more serious infection caused by 

bacteria or other pathogens. A false 

negative result could lead to failure to 

provide a diagnosis and the correct 

treatment, and may contribute to 

unnecessary treatment. A lack of result 

could lead to delayed diagnosis and 

inadequate treatment. Additionally, for 

assays that both detect Influenza A and 

differentiate between Influenza A 

subtypes, if a specimen yields a positive 

test result for Influenza A, but produces 

negative test results for all specific 

influenza A subtypes intended to be 

differentiated (i.e., H1 or H3), then local, 

state or federal public health authorities 

should be notified to determine whether 

the specimen represents a novel strain 

of Influenza A, in accordance with the 

Morbidity and Mortality Weekly Report 

(http://www.cdc.gov/mmwr/preview/

mmwrhtml/mm5613a4.htm and http:// 

www.cste.org/ps/2007pdfs/novelflu

anndssjan10final23.pdf).1 Therefore, 

inaccurate results for influenza types 

and subtypes included in the respiratory 

viral panel may lead to inappropriate 

public health responses. Failure to 

interpret assay results in the context of 

the other laboratory results and the 

clinical presentation could lead to 

inappropriate or delayed treatment. The 

virus or viruses detected may not 

necessarily be the cause of the clinical 

symptoms, therefore positive assay 

results do not rule out bacterial coinfection, or co-infection with other 

viruses. 

FDA believes the class II special 

controls guidance documents will help 

mitigate potential risks by providing 

recommendations for performance 

evaluation, labeling, and measures to 

address the effects of ancillary reagents 

(specific reagents required under 

instructions for use of the assay but not 

provided) on safety and effectiveness of 

respiratory viral panel multiplex nucleic 

acid assays. The guidance documents 

also provide information on how to 

meet premarket (510(k)) submission 

requirements for the device. FDA 

believes that following the class II 

special controls guidance documents 

generally addresses the risks to health 

identified in the previous paragraph. 

Therefore, on January 3, 2008, FDA 

issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying this classification by adding 

21 CFR 866.3980. 

Any firm submitting a 510(k) 

premarket notification for a respiratory 

viral panel multiplex nucleic acid assay 

will need to address the issues covered 

in the special controls guidances. 

However, the firm need only show that 

its device meets the recommendations 

of the guidances, 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) of the 

act, 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 review of the 

system’s key performance 

characteristics, test methodology, 

labeling, and other requirements as 

outlined in § 807.87, will provide 

reasonable assurance that acceptable 

levels of performance for both safety 

and effectiveness will be addressed 

before marketing clearance. Thus, 

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 respiratory viral 

panel multiplex nucleic acid assay they 

intend to market. 

II. What Is the Environmental Impact of 

This Rule? 

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. What Is the Economic Impact of 

This Rule? 

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 these 

devices into class II will relieve 

manufacturers of the device of the cost 

of complying with the premarket 

approval requirements of section 515 of 

the act (21 U.S.C. 360e), 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 $130 

million, using the most current (2007) 

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. Does This Final Rule Have 

Federalism Implications? 

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 


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52138 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Rules and Regulations 

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; 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. (Papike v. Tambrands, 

Inc., 107 F.3d 737, 740–42 (9th Cir. 

1997)). 

V. How Does This Rule Comply With 

the Paperwork Reduction Act of 1995? 

This final rule establishes as special 

controls three guidance documents that 

refer 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 Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). 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. 

VI. What References Are on Display? 

The following reference has 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 Luminex Molecular 

Diagnostics, Inc., dated December 1, 2007. 

List of Subjects in 21 CFR Part 866 

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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

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

360j, 371. 

■ 2. Section 866.3980 is added to 

subpart D to read as follows: 

§ 866.3980 Respiratory viral panel 

multiplex nucleic acid assay. 

(a) Identification. A respiratory viral 

panel multiplex nucleic acid assay is a 

qualitative in vitro diagnostic device 

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. The 

device is intended for detection and 

identification of a combination of the 

following viruses: 

(1) Influenza A and Influenza B; 

(2) Influenza A subtype H1 and 

Influenza A subtype H3; 

(3) Respiratory Syncytial Virus 

subtype A and Respiratory Syncytial 

Virus subtype B; 

(4) Parainfluenza 1, Parainfluenza 2, 

and Parainfluenza 3 virus; 

(5) Human Metapneumovirus; 

(6) Rhinovirus; and 

(7) Adenovirus. 

(b) Classification. Class II (special 

controls). The special controls are: 

(1) FDA’s guidance document entitled 

‘‘Class II Special Controls Guidance 

Document: Respiratory Viral Panel 

Multiplex Nucleic Acid Assay;’’ 

(2) For a device that detects and 

identifies Human Metapneumovirus, 

FDA’s guidance document entitled 

‘‘Class II Special Controls Guidance 

Document: Testing for Human 

Metapneumovirus (hMPV) Using 

Nucleic Acid Assays;’’ and 

(3) For a device that detects and 

differentiates Influenza A subtype H1 

and subtype H3, FDA’s guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Testing 

for Detection and Differentiation of 

Influenza A Virus Subtypes Using 

Multiplex Nucleic Acid Assays.’’ See 

§ 866.1(e) for the availability of these 

guidance documents. 

Dated: October 1, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24432 Filed 10–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Parts 542 and 543 

RIN 3141–AA–37 

Minimum Internal Control Standards 

for Class II Gaming 

AGENCY: National Indian Gaming 

Commission. 

ACTION: Final rule; delay of effective 

date. 

SUMMARY: The National Indian Gaming 

Commission (‘‘NIGC’’) announces the 

extension of the effective date on the 

final rule for Minimum Internal Control 

Standards for Class II Gaming. The final 

rule was published in the Federal 

Register on October 10, 2008. The 

Commission has changed the effective 

date for the amendments to §§ 542.7 and 

542.16 as well as the date for operations 

to implement tribal internal controls 

found in 543.3(c)(3) to October 13, 2010, 

in order to extend the transition time. 

DATES: Effective Date: The effective date 

for the amendments to §§ 542.7 and 

542.16 for the final rule published 

October 10, 2008, at 73 FR 60492, is 

delayed from October 13, 2009, until 

October 13, 2010. The effective date for 

the amendment to § 543.3(c)(3) is 

October 9, 2009. 

FOR FURTHER INFORMATION CONTACT: John 

R. Hay, Attorney, Office of General 

Counsel, at (202) 632–7003; fax (202) 

632–7066 (not toll-free numbers). 

SUPPLEMENTARY INFORMATION: Congress 

established the National Indian Gaming 

Commission under the Indian Gaming 

Regulatory Act of 1988 (25 U.S.C. 2701– 

21) (‘‘IGRA’’) to regulate gaming on 

Indian lands. The NIGC issued a final 

rule that superseded specified sections 

of established Minimum Internal 

Control Standards and replaced them 

with a new part titled Minimum 

Internal Control Standards Class II 

Gaming, that was published in the 

Federal Register on October 10, 2008 

(73 FR 60492). The final rule provided 

an effective date for amendments to 

§§ 542.7 and 542.16 of October 13, 2009. 

The NIGC is extending the effective date 

for these amendments to October 13, 

2010. The rule at § 543.3(c)(3) also set a 

deadline of within six months of the 

date the tribal gaming regulatory 

authorities’ enactment of tribal internal 

controls for tribal operators to come into 

compliance with tribal internal controls. 

This deadline has likewise been 

extended to October 13, 2010. 


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