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. 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Rules and Regulations 52139 

List of Subjects in 25 CFR Part 543 

Administrative practice and 

procedure, Gambling, Indians—lands, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set forth in the 

preamble, under the authority at 25 

U.S.C. 2701, 2702, 2706, et seq., 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 and 25 CFR 

Part 543.3 is amended as set forth 

below: 

PART 543—MINIMUM INTERNAL 

CONTROL STANDARDS FOR CLASS II 

GAMING 

■ 1. The authority citation for Part 543 

continues to read as follows: 

Authority: 25 U.S.C. 2701 et seq. 

■ 2. Section 543.3 is amended by 

revising paragraph (c)(3) to read as 

follows: 

§ 543.3 How do tribal governments comply 

with this part? 

* * * * * 

(c) * * * 

(3) Establish a deadline, no later than 

October 13, 2010, by which a gaming 

operation must come into compliance 

with the tribal internal control 

standards. However, the tribal gaming 

regulatory authority may extend the 

deadline by six months if written notice 

citing justification is provided to the 

Commission no later than two weeks 

before the deadline. 

* * * * * 

Dated: October 5, 2009. 

George T. Skibine, 

Acting Chairman. 

Norman H. DesRosiers, 

Vice Chairman. 

[FR Doc. E9–24434 Filed 10–8–09; 8:45 am] 

BILLING CODE 7565–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 100, 117, 147, and 165 

[USCG–2009–0909] 

Quarterly Listings; Safety Zones, 

Security Zones, Special Local 

Regulations, Regulated Navigation 

Areas, and Drawbridge Operation 

Regulations 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of expired temporary 

rules issued. 

SUMMARY: This document provides 

required notice of substantive rules 

issued by the Coast Guard and 

temporarily effective between February 

2006 and January 2008, that expired 

before they could be published in the 

Federal Register. This notice lists 

temporary safety zones, security zones, 

special local regulations, regulated 

navigation areas and drawbridge 

operation regulations, all of limited 

duration and for which timely 

publication in the Federal Register was 

not possible. 

DATES: This document lists temporary 

Coast Guard rules between February 9, 

2006 and January 12, 2008 that became 

effective and were terminated before 

they could be published in the Federal 

Register. 

ADDRESSES: The Docket Management 

Facility maintains the public docket for 

this notice. Documents indicated in this 

notice will be 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: For 

questions on this notice contact Yeoman 

First Class Denise Johnson, Office of 

Regulations and Administrative Law, 

telephone (202) 372–3862. For questions 

on viewing, or on submitting material to 

the docket, contact Ms. Angie Ames, 

Docket Operations, telephone 202–366– 

5115. 

SUPPLEMENTARY INFORMATION: Coast 

Guard District Commanders and 

Captains of the Port (COTP) must be 

immediately responsive to the safety 

and security needs within their 

jurisdiction; therefore, District 

Commanders and COTPs have been 

delegated the authority to issue certain 

local regulations. Safety zones may be 

established for safety or environmental 

purposes. A safety zone may be 

stationary and described by fixed limits 

or it may be described as a zone around 

a vessel in motion. Security zones limit 

access to prevent injury or damage to 

vessels, ports, or waterfront facilities 

and may also describe a zone around a 

vessel in motion. Special local 

regulations are issued to enhance the 

safety of participants and spectators at 

regattas and other marine events. 

Drawbridge operation regulations 

authorize changes to drawbridge 

schedules to accommodate bridge 

repairs, seasonal vessel traffic, and local 

public events. Regulated Navigation 

Areas are water areas within a defined 

boundary for which regulations for 

vessels navigating within the area have 

been established by the regional Coast 

Guard District Commander. Timely 

publication of these rules in the Federal 

Register is often precluded when a rule 

responds to an emergency, or when an 

event occurs without sufficient advance 

notice. The affected public is, however, 

informed of these rules through Local 

Notices to Mariners, press releases, and 

other means. Moreover, actual 

notification is provided by Coast Guard 

patrol vessels enforcing the restrictions 

imposed by the rule. Because Federal 

Register publication was not possible 

before the beginning of the effective 

period, mariners were personally 

notified of the contents of these safety 

zones, security zones, special local 

regulations, regulated navigation areas 

or drawbridge operation regulations by 

Coast Guard officials’ on-scene prior to 

any enforcement action. However, the 

Coast Guard, by law, must publish in 

the Federal Register notice of 

substantive rules adopted. To meet this 

obligation without imposing undue 

expense on the public, the Coast Guard 

periodically publishes a list of these 

temporary safety zones, security zones, 

special local regulations, regulated 

navigation areas and drawbridge 

operation regulations. Permanent rules 

are not included in this list because they 

are published in their entirety in the 

Federal Register. 

Temporary rules are also published in 

their entirety if sufficient time is 

available to do so before they are placed 

in effect or terminated. The temporary 

rules listed in this notice have been 

exempted from review under Executive 

Order 12666, Regulatory Planning and 

Review, because of their emergency 

nature, or limited scope and temporary 

effectiveness. 

The following unpublished rules were 

placed in effect temporarily during the 

period between February 2006 and 

January 2008, unless otherwise 

indicated. 

Dated: September 30, 2009. 

S.G. Venckus, 

Chief, Office of Regulations and 

Administrative Law. 


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