42812 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 

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 proposed 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 

proposes to certify 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 proposed 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 

Proposed Rule? 

This proposed 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 Proposed Rule? 

FDA has analyzed this proposed 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 Proposed 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. E9–20415 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Parts 40, 41, 44, and 45 

[Docket No. TTB–2009–0002; Notice No. 98; 

Re: Notice No. 95, T.D. TTB–78 and T.D. 

TTB–80] 

RIN 1513–AB72 

Implementation of Statutory 

Amendments Requiring the 

Qualification of Manufacturers and 

Importers of Processed Tobacco and 

Other Amendments Related To Permit 

Requirements, and the Expanded 

Definition of Roll-Your-Own Tobacco; 

Extension of Comment Period 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notice of proposed rulemaking; 

reopening of comment period. 

SUMMARY: In response to a request filed 

on behalf of several industry members, 

the Alcohol and Tobacco Tax and Trade 

Bureau is reopening the comment 

period for Notice No. 95, a notice of 

proposed rulemaking published in the 

Federal Register on June 22, 2009. The 

proposed rule seeks comments on a 

concurrently published temporary rule 

implementing permit requirements for 

manufacturers and importers of 

processed tobacco and an expansion of 

the definition of roll-your-own tobacco 

adopted in the Children’s Health 

Insurance Program Reauthorization Act 

of 2009. The text of the regulations 

contained in the temporary rule serves 

as the text of the proposed regulations. 

DATES: The comment period for the 

proposed rule (Notice No. 95) published 

June 22, 2009, at 74 FR 29433 is 

reopened. Written comments on Notice 

No. 95 must now be received on or 

before October 20, 2009. 

ADDRESSES: You may send comments on 

Notice No. 95 to one of the following 

addresses: 

• http://www.regulations.gov (via the 

online comment form for Notice No. 95 

as posted within Docket No. TTB–2009– 

0002 at ‘‘Regulations.gov,’’ the Federal 

e-rulemaking portal); 

• Director, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, P.O. Box 14412, 

Washington, DC 20044–4412; or 

• Hand Delivery/Courier in Lieu of 

Mail: Alcohol and Tobacco Tax and 

Trade Bureau, 1310 G Street, NW., Suite 

200–E, Washington, DC 20005. 

See the Public Participation section of 

Notice No. 95 for specific instructions 

and requirements for submitting 


jlentini on DSKJ8SOYB1PROD with PROPOSALS
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Proposed Rules 42813 

comments, and for information on how 

to request a public hearing. 

You may view copies of this notice, 

Notice No. 95, any comments received, 

the related temporary rule (T.D. TTB– 

78), and a correction to the temporary 

rule (T.D. TTB–80) at http:// 

www.regulations.gov. A direct link to 

the related Regulations.gov docket also 

is available under Notice No. 95 on the 

TTB Web site at http://www.ttb.gov/ 

regulations_laws/all_rulemaking.shtml. 

You also may view copies of these 

documents by appointment at the TTB 

Information Resource Center, 1310 G 

Street, NW., Washington, DC 20220. To 

make an appointment, call 202–453– 

2270 (new phone number). 

FOR FURTHER INFORMATION CONTACT: For 

questions concerning processed tobacco 

permit and authorization procedures, 

contact the National Revenue Center, 

Alcohol and Tobacco Tax and Trade 

Bureau at 1–877–882–3277; for other 

questions concerning this document, 

Notice No. 95, or the related temporary 

rule, contact Amy Greenberg, 

Regulations and Rulings Division, 

Alcohol and Tobacco Tax and Trade 

Bureau at 202–453–2099 (new phone 

number). 

SUPPLEMENTARY INFORMATION: In the 

Federal Register issue of June 22, 2009, 

the Alcohol and Tobacco Tax and Trade 

Bureau (TTB) published a temporary 

rule (T.D. TTB–78; 74 FR 29401) setting 

forth regulatory amendments to 27 CFR 

parts 40, 41, 44, and 45 to implement 

certain changes made to the Internal 

Revenue Code of 1986 by the Children’s 

Health Insurance Program 

Reauthorization Act of 2009 (CHIPRA) 

(Pub. L. 111–3, 123 Stat. 8). The 

principal changes made by CHIPRA 

involve permit and related requirements 

for manufacturers and importers of 

processed tobacco and an expansion of 

the definition of roll-your-own tobacco. 

In the same issue of the Federal 

Register, we concurrently published a 

notice of proposed rulemaking, Notice 

No. 95 (74 FR 29433), to request 

comments on the regulatory 

amendments contained in the temporary 

rule. The preamble to the temporary 

regulations explained the proposed 

regulations. As originally published, 

comments on Notice No. 95 were due on 

August 21, 2009. (On July 29, 2009, we 

published corrections to the temporary 

rule in T.D. TTB–80 at 74 FR 37551.) 

On August 19, 2009, TTB received a 

letter from a law firm representing the 

John Middleton Co., Philip Morris USA 

Inc., and U.S. Smokeless Tobacco 

Manufacturing Co. LLC, requesting an 

extension of the comment period for 

Notice No. 95. In the letter, the requester 

noted the temporary rule’s immediate 

effective date and the fact that TTB 

issued the temporary rule and the 

related notice of proposed rulemaking 

just before the annual TTB Expo, which 

was attended by many company 

officials. The letter stated these events 

gave the companies ‘‘little time to digest 

the implications of the temporary rule 

prior to the Expo * * *.’’ Since 

returning from the Expo, the companies 

have found ‘‘the process of identifying 

all activity within the factories that 

might have implications for processed 

tobacco’’ to be ‘‘extensive and time 

consuming.’’ 

The letter also noted that the TTB 

temporary rule was issued on the same 

day as the enactment of the Family 

Smoking Prevention and Tobacco 

Control Act, which provides for 

regulation of tobacco products by the 

Food and Drug Administration. ‘‘Thus,’’ 

the letter states, ‘‘key personnel within 

the Companies and other industry 

entities were involved in evaluation of 

this legislation and identification of its 

implications for their operations.’’ The 

letter additionally noted that the 

comment period on the proposed rule 

coincided with the summer vacation 

season when company officials are most 

likely to be away from their offices. 

Given the factors cited above, TTB 

agrees that the comment period for 

Notice No. 95 should be extended by an 

additional 60 days. Therefore, 

comments on Notice No. 95 are now due 

on October 20, 2009. 

Drafting Information 

Michael Hoover of the Regulations 

and Rulings Division, Alcohol and 

Tobacco Tax and Trade Bureau, drafted 

this document. 

Signed: August 20, 2009. 

Cheri D. Mitchell, 

Acting Administrator. 

[FR Doc. E9–20404 Filed 8–24–09; 8:45 am] 

BILLING CODE 4810–31–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R02–OAR–2009–0462, FRL–8949–1] 

Approval and Promulgation of 

Implementation Plans; New York 

Reasonably Available Control 

Technology and Reasonably Available 

Control Measures 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing action on 

portions of a State Implementation Plan 

revision submitted by New York State 

that are intended to meet some Clean 

Air Act requirements for attaining the 

0.08 parts per million 8-hour ozone 

national ambient air quality standards. 

EPA is proposing to disapprove the 

reasonably available control technology 

requirement as it relates to the entire 

State of New York, including the New 

York portion of the New York-Northern 

New Jersey-Long Island, NY–NJ–CT and 

the Poughkeepsie 8-hour ozone 

moderate nonattainment areas. 

In addition, EPA is proposing to 

disapprove the reasonably available 

control measure analysis as it relates to 

the New York portion of the New YorkNorthern New Jersey-Long Island, NY– 

NJ–CT 8-hour ozone moderate 

nonattainment area. 

DATES: Comments must be received on 

or before September 24, 2009. 

ADDRESSES: Submit your comments, 

identified by Docket Number EPA–R02– 

OAR–2009–0462, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: Werner.Raymond@epa.gov. 

• Fax: 212–637–3901. 

• Mail: Raymond Werner, Chief, Air 

Programs Branch, Environmental 

Protection Agency, Region 2 Office, 290 

Broadway, 25th Floor, New York, New 

York 10007–1866. 

• Hand Delivery: Raymond Werner, 

Chief, Air Programs Branch, 

Environmental Protection Agency, 

Region 2 Office, 290 Broadway, 25th 

Floor, New York, New York 10007– 

1866. Such deliveries are only accepted 

during the Regional Office’s normal 

hours of operation. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30 

excluding Federal holidays. 

Instructions: Direct your comments to 

Docket No. EPA–R02–OAR–2009–0462. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 


jlentini on DSKJ8SOYB1PROD with PROPOSALS