Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Rules and Regulations 42775 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VI. What is the Economic Impact of 

This Rule? 

FDA has examined the impacts of the 

direct 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 direct 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 we do not believe any 

companies are currently selling or 

producing these devices, 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. 

VII. How Does the Paperwork 

Reduction Act of 1995 Apply to This 

Rule? 

This direct final rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

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

3520) is not required. 

VIII. What are the Federalism Impacts 

of This Rule? 

FDA has analyzed this direct final 

rule in accordance with the principles 

set forth in Executive Order 13132. FDA 

has determined that the rule does not 

contain policies that have substantial 

direct effects 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. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

IX. How Do You Submit Comments on 

This Rule? 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, and Medical 

devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed to 

amend 21 CFR part 866 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 866.3305 is amended by 

removing paragraph (c) and by revising 

paragraph (b) to read as follows: 

§ 866.3305 Herpes simplex virus 

serological assays. 

* * * * * 

(b) Classification. Class II (special 

controls). The device is classified as 

class II (special controls). The special 

control for the device is FDA’s guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Herpes 

Simplex Virus Types 1 and 2 

Serological Assays.’’ For availability of 

the guidance document, see § 866.1(e). 

Dated: August 17, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20411 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Parts 502, 514, 531, 533, 535, 

537, 539, 556, 558, 571, and 573 

RIN 3141–0001 

Amendments to Various National 

Indian Gaming Commission 

Regulations 

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 concerning various 

amendments to the National Indian 

Gaming Commission regulations. The 

final rule was published in the Federal 

Register on July 27, 2009. The 

Commission has changed the effective 

date to December 31, 2009, in order to 

extend the transition time. 

DATES: Effective Date: The effective date 

for the final rule published July 27, 

2009, at 74 FR 36926, is delayed from 

August 26, 2009, until December 31, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Chapman, Staff 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 updating various NIGC regulations 

and streamlining procedures, which was 

published in the Federal Register on 

July 27, 2009 (74 FR 36926). The final 

rule provided an effective date of 

August 26, 2009. The NIGC is extending 

the effective date to December 31, 2009. 

Philip N. Hogen, 

Chairman. 

Norman H. DesRosiers, 

Vice Chairman. 

[FR Doc. E9–20511 Filed 8–24–09; 8:45 am] 

BILLING CODE 7565–01–P 


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