Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Rules and Regulations 42773 

references to specific standards under 

U.S. GAAP in the Commission’s rules 

and staff guidance. 

It should be noted that although the 

FASB has stated that the FASB 

Codification supersedes existing 

references in U.S. GAAP, the FASB 

Codification does not supersede 

Commission rules or regulations. We 

understand that the FASB Codification, 

as a service to users, includes references 

to some Commission rules and staff 

guidance. However, the FASB 

Codification is not the authoritative 

source for such content, nor does its 

inclusion in the FASB Codification 

affect how such content may be updated 

in the future. 

III. Codification Update 

The ‘‘Codification of Financial 

Reporting Policies’’ announced in 

Financial Reporting Release No. 1 (April 

15, 1982) [47 FR 21028] is updated by 

adding at the end of Section 101, under 

the Financial Reporting Number (FR– 

80A) assigned to this interpretive 

release, the text in Sections I and II of 

this release. 

The Codification is a separate 

publication of the Commission. It will 

not be published in the Federal 

Register/Code of Federal Regulations. 

List of Subjects 

17 CFR Part 211 

Reporting and recordkeeping 

requirements, Securities. 

17 CFR Parts 231 and 241 

Securities. 

Amendments to the Code of Federal 

Regulations 

■ For the reasons set out in the 

preamble, the Commission is amending 

title 17, chapter II of the Code of Federal 

Regulations as set forth below: 

PART 211—INTERPRETATIONS 

RELATING TO FINANCIAL REPORTING 

MATTERS 

■ Part 211, Subpart A, is amended by 

adding Release No. FR–80A and the 

release date of August 18, 2009 to the 

list of interpretive releases. 

PART 231—INTERPRETATIVE 

RELEASES RELATING TO THE 

SECURITIES ACT OF 1933 AND 

GENERAL RULES AND REGULATIONS 

THEREUNDER 

■ Part 231 is amended by adding 

Release No. 33–9062A and the release 

date of August 18, 2009 to the list of 

interpretive releases. 

PART 241—INTERPRETATIVE 

RELEASES RELATING TO THE 

SECURITIES EXCHANGE ACT OF 1934 

AND GENERAL RULES AND 

REGULATIONS THEREUNDER 

■ Part 241 is amended by adding 

Release No. 34–60519A and the release 

date of August 18, 2009 to the list of 

interpretive releases. 

By the Commission. 

Dated: August 19, 2009. 

Florence E. Harmon, 

Deputy Secretary. 

[FR Doc. E9–20381 Filed 8–24–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2009–N–0344] 

Microbiology Devices; Reclassification 

of Herpes Simplex Virus Types 1 and 

2 Serological Assays 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is implementing a 

direct final rule correcting the 

regulation classifying herpes simplex 

virus (HSV) serological assays by 

removing the reference to HSV 

serological assays other than type 1 and 

type 2. When reclassifying this device, 

FDA mistakenly distinguished between 

HSV serological assays type 1 and type 

2 and all other HSV serological assays. 

At that time, and today, the only 

preamendments HSV serological assays 

which FDA was aware of were type 1 

and type 2 and, therefore, the 

classification of HSV assays other than 

type 1 and type 2 was incorrect. FDA is 

correcting the classification of this 

device to eliminate possible confusion 

resulting from this error. Elsewhere in 

this issue of the Federal Register, we are 

publishing a companion proposed rule 

under FDA’s usual procedure for notice 

and comment to provide a procedural 

framework to finalize the rule in the 

event we receive significant adverse 

comment and withdraw this direct final 

rule. 

DATES: This rule is effective December 7, 

2009. Submit written or electronic 

comments on the direct final rule by 

October 8, 2009. If we receive no 

significant adverse comments within the 

specified comment period, we intend to 

publish a document confirming the 

effective date of the final rule in the 

Federal Register within 30 days after 

the comment period on this direct final 

rule ends. If we receive any timely 

significant adverse comment, we will 

withdraw this final rule in part or in 

whole by publication of a document in 

the Federal Register within 30 days 

after the comment period ends. 

ADDRESSES: You may submit comments, 

identified by Docket No FDA–2009–N– 

0344, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously, in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Scott McFarland, Center for Devices and 

Radiological Health WO/66, rm. 5543, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, 

MD, 301–796–6217. 

SUPPLEMENTARY INFORMATION: 


srobinson on DSKHWCL6B1PROD with RULES
42774 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Rules and Regulations 

I. What Is the Background of the Rule? 

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Public Law 94– 

295), the Safe Medical Devices Act of 

1990 (SMDA) (Public Law 101–629), the 

Food and Drug Modernization Act of 

1997 (FDAMA) (Public Law 105–115), 

and the Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85), among other 

amendments, established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Devices that were in commercial 

distribution before May 28, 1976 (the 

date of enactment of the 1976 

amendments), are commonly referred to 

as ‘‘preamendments devices.’’ Under 

section 513 of the act, FDA classifies 

preamendments devices according to 

the following steps: (1) FDA receives a 

recommendation from a device 

classification panel (an FDA advisory 

committee); (2) FDA publishes the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) FDA 

publishes a final regulation classifying 

the device. FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution before May 28, 1976, are 

commonly referred to as 

‘‘postamendments devices.’’ These 

devices are classified automatically by 

statute (section 513(f) of the act (21 

U.S.C. 360c(f)) into class III and require 

premarket approval, unless and until: 

(1) FDA reclassifies the device into class 

I or II; (2) FDA issues an order 

classifying the device into class I or II 

in accordance with section 513(f)(2) of 

the act; or (3) FDA issues an order under 

section 513(i) of the act (21 U.S.C. 

360c(i)) finding the device to be 

substantially equivalent to a predicate 

device that does not require premarket 

approval. 

In the Federal Register of November 

9, 1983 (47 FR 50823), FDA classified 

the preamendments devices, herpes 

simplex virus serological reagents, into 

class III (§ 866.3305 (21 CFR 866.3305)). 

At the time FDA classified the device, 

the only preamendments HSV 

serological assays FDA was aware of 

were type 1 and type 2 HSV serological 

assays. Since that time, FDA has not 

become aware of any other 

preamendments HSV serological assays, 

nor has it received a premarket 

notification for a HSV serological assay 

other than a type 1 or type 2 HSV 

serological assay. 

In the Federal Register of April 3, 

2007 (72 FR 15828), FDA published a 

final rule reclassifying the 

preamendments device HSV serological 

assays from class III to class II. In that 

rulemaking FDA identified the device 

being reclassified as type 1 and type 2 

HSV serological assays and identified 

other HSV serological assays as class III 

devices. However, as stated previously, 

the only preamendments HSV 

serological assays of which FDA is 

aware are type 1 and type 2 HSV 

serological assays. To avoid any 

possible confusion, FDA is correcting 

the regulation to accurately describe this 

generic type of device. This direct final 

rule corrects the classification 

regulation by removing the reference to 

HSV serological assays other than type 

1 and type 2. 

II. What Does This Direct Final 

Rulemaking Do? 

In this direct final rule, FDA is 

correcting § 866.3305 by removing from 

the regulation the reference to HSV 

serological assays other than type 1 and 

type 2. 

III. What Are the Procedures for Issuing 

a Direct Final Rule? 

In the Federal Register of November 

21, 1997 (62 FR 62466), FDA announced 

the availability of the guidance 

document entitled ‘‘Guidance for FDA 

and Industry: Direct Final Rule 

Procedures’’ that described when and 

how FDA will employ direct final 

rulemaking. We believe that this rule is 

appropriate for direct final rulemaking 

because it is intended to make 

noncontroversial changes to existing 

regulations. We anticipate no significant 

adverse comment. Consistent with 

FDA’s procedures on direct final 

rulemaking, we are publishing 

elsewhere in this issue of the Federal 

Register a companion proposed rule 

that is identical to the direct final rule. 

The companion proposed rule provides 

a procedural framework within which 

the rule may be finalized in the event 

the direct final rule is withdrawn 

because of any significant adverse 

comment. The comment period for this 

direct final rule runs concurrently with 

the comment period of the companion 

proposed rule. Any comments received 

in response to the companion proposed 

rule will also be considered as 

comments regarding this direct final 

rule. 

We are providing a comment period 

on the direct final rule of 75 days after 

the date of publication in the Federal 

Register. If we receive any significant 

adverse comment, we intend to 

withdraw this final rule before its 

effective date by publication of a notice 

in the Federal Register within 30 days 

after the comment period ends. A 

significant adverse comment is defined 

as a comment that explains why the rule 

would be inappropriate, including 

challenges to the rule’s underlying 

premise or approach, or would be 

ineffective or unacceptable without 

change. In determining whether an 

adverse comment is significant and 

warrants withdrawing a direct final 

rulemaking, we will consider whether 

the comment raises an issue serious 

enough to warrant a substantive 

response in a notice-and-comment 

process in accordance with section 553 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553). Comments that are 

frivolous, insubstantial, or outside the 

scope of the rule will not be considered 

significant or adverse under this 

procedure. For example, a comment 

recommending an additional change to 

the rule will not be considered a 

significant adverse comment, unless the 

comment states why the rule would be 

ineffective without the additional 

change. In addition, if a significant 

adverse comment applies to part of a 

rule and that part can be severed from 

the remainder of the rule, we may adopt 

as final those parts of the rule that are 

not the subject of a significant adverse 

comment. If we withdraw the direct 

final rule, all comments received will be 

considered under the companion 

proposed rule in developing a final rule 

under the usual notice-and-comment 

procedures under the APA (5 U.S.C. 

552a et seq.). If we receive no significant 

adverse comment during the specified 

comment period, we intend to publish 

a confirmation document in the Federal 

Register within 30 days after the 

comment period ends. 

IV. What is the Legal Authority for This 

Rule? 

FDA is issuing this direct final rule 

under the device and general 

administrative provisions of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

321, 331, 351, 352, 360i, 371, and 374). 

V. What is the Environmental Impact of 

This Rule? 

FDA has determined under 21 CFR 

25.30(i) and 25.34(b) that this action is 

of a type that does not individually or 

cumulatively have a significant effect on 


srobinson on DSKHWCL6B1PROD with RULES
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 


srobinson on DSKHWCL6B1PROD with RULES