This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

29433 

Vol. 74, No. 118 

Monday, June 22, 2009 

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. 95; 

Re: T.D. TTB–78] 

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 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Notice of proposed rulemaking; 

cross-reference to temporary rule. 

SUMMARY: Elsewhere in this issue of the 

Federal Register, the Alcohol and 

Tobacco Tax and Trade Bureau is 

issuing a temporary rule to implement 

certain changes made to the Internal 

Revenue Code of 1986 by the Children’s 

Health Insurance Program 

Reauthorization Act of 2009. The 

principal changes involve permit and 

related requirements for manufacturers 

and importers of processed tobacco and 

an expansion of the definition of rollyour-own tobacco. The text of the 

regulations in the temporary rule 

published in the Rules and Regulations 

section of this issue of the Federal 

Register serves as the text of the 

proposed regulations. 

DATES: Comments must be received on 

or before August 21, 2009. 

ADDRESSES: You may send comments on 

this notice to one of the following 

addresses: 

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

online comment form for this notice as 

posted within Docket No. TTB–2009– 

0001 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 

this notice for specific instructions and 

requirements for submitting comments, 

and for information on how to request 

a public hearing. 

You may view copies of this notice, 

any comments received, and the related 

temporary rule at http:// 

www.regulations.gov. A direct link to 

the appropriate Regulations.gov docket 

is also 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 202–927– 

2400. 

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 (1–877–882–3277); for other 

questions concerning this document, 

contact Amy Greenberg, Regulations 

and Rulings Division, Alcohol and 

Tobacco Tax and Trade Bureau (202– 

927–8210). 

SUPPLEMENTARY INFORMATION: 

Background 

In the Rules and Regulations section 

of this issue of the Federal Register, we 

are publishing a temporary rule setting 

forth regulatory amendments to 

implement certain provisions of the 

Children’s Health Insurance Program 

Reauthorization Act of 2009 (CHIPRA) 

(Pub. L. 111–3, 123 Stat. 8). The 

principal changes made by CHIPRA that 

are the basis for the regulatory 

amendments contained in this 

document involve permit and related 

requirements for manufacturers and 

importers of processed tobacco and an 

expansion of the definition of roll-yourown tobacco. 

The temporary regulations published 

elsewhere in this issue of the Federal 

Register involve amendments to parts 

40, 41, 44, and 45 of the TTB regulations 

(27 CFR parts 40, 41, 44, and 45). The 

text of the temporary regulations serves 

as the text of these proposed 

regulations. The preamble to the 

temporary regulations explains the 

proposed regulations. 

Public Participation 

Comments Invited 

We invite comments from interested 

members of the public on this proposed 

rulemaking. 

Submitting Comments 

You may submit comments on this 

notice by one of the following three 

methods: 

• Federal e-Rulemaking Portal: You 

may electronically submit comments on 

this notice through ‘‘Regulations.gov,’’ 

the Federal e-rulemaking portal. A 

direct link to the Regulations.gov docket 

containing this notice and its related 

comment submission form is available 

on the TTB Web site at http:// 

www.ttb.gov/regulations_laws/ 

all_rulemaking.shtml under Notice No. 

95. You may also reach this notice and 

its related comment form via the 

Regulations.gov search page at http:// 

www.regulations.gov. Supplemental 

files may be attached to comments 

submitted via Regulations.gov. For 

complete instructions on how to use 

Regulations.gov, visit the site and click 

on ‘‘User Guide’’ under ‘‘How to Use 

this Site.’’ 

• Mail: You may send written 

comments to the Director, Regulations 

and Rulings Division, Alcohol and 

Tobacco Tax and Trade Bureau, P.O. 

Box 14412, Washington, DC 20044– 

4412. 

• Hand Delivery/Courier: You may 

hand-carry your comments or have them 

hand-carried to the Alcohol and 

Tobacco Tax and Trade Bureau, 1310 G 

Street, NW., Suite 200–E, Washington, 

DC 20005. 

Please submit your comments by the 

closing date shown above in this notice. 

Your comments must reference Notice 

No. 95 and include your name and 

mailing address. Your comments also 

must be made in English, be legible, and 

be written in language acceptable for 

public disclosure. We do not 

acknowledge receipt of comments, and 

we consider all comments as originals. 

If you are commenting on behalf of an 

association, business, or other entity, 

your comment must include the entity’s 

name as well as your name and position 

title. If you comment via http:// 

www.regulations.gov, please enter the 


sroberts on PROD1PC70 with PROPOSALS
29434 Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Proposed Rules 

entity’s name in the ‘‘Organization’’ 

blank of the comment form. If you 

comment via mail, please submit your 

entity’s comment on letterhead. 

You may also write to the 

Administrator before the comment 

closing date to ask for a public hearing. 

The Administrator reserves the right to 

determine whether to hold a public 

hearing. 

Confidentiality 

All submitted comments and 

attachments are part of the public record 

and subject to disclosure. Do not 

enclose any material in your comments 

that you consider to be confidential or 

inappropriate for public disclosure. 

Public Disclosure 

On the Federal e-rulemaking portal, 

Regulations.gov, we will post, and you 

may view, copies of this notice, any 

electronic or mailed comments we 

receive about this proposal, and the 

related temporary rule. A direct link to 

the Regulations.gov docket containing 

this notice and the comments received 

on this proposal is available on the TTB 

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

regulations_laws/all_rulemaking.shtml 

under Notice No. 95. You may also 

reach the relevant docket through the 

Regulations.gov search page at http:// 

www.regulations.gov. 

All posted comments will display the 

commenter’s name, organization (if 

any), city, and State, and, in the case of 

mailed comments, all address 

information, including e-mail addresses. 

We may omit voluminous attachments 

or material that we consider unsuitable 

for posting. 

You also may view copies of this 

notice, any electronic or mailed 

comments we receive about this 

proposal, and the related temporary rule 

by appointment at the TTB Information 

Resource Center, 1310 G Street, NW., 

Washington, DC 20220. You may also 

obtain copies at 20 cents per 8.5- x 11- 

inch page. Contact our information 

specialist at the above address or by 

telephone at 202–927–2400 to schedule 

an appointment or to request copies of 

comments or other materials. 

Regulatory Flexibility Act, Paperwork 

Reduction Act, and Executive Order 

12866 

Since the regulatory text proposed in 

this notice of proposed rulemaking is 

identical to that contained in the 

companion temporary rule published 

elsewhere in this issue of the Federal 

Register, the analyses contained in the 

preamble of the temporary rule 

concerning the Regulatory Flexibility 

Act, the Paperwork Reduction Act, and 

Executive Order 12866 also apply to this 

proposed rule. 

Drafting Information 

Amy Greenberg of the Regulations 

and Rulings Division, Alcohol and 

Tobacco Tax and Trade Bureau, drafted 

this document. However, other 

personnel participated in its 

development. 

List of Subjects 

27 CFR Part 40 

Cigars and cigarettes, Claims, 

Electronic funds transfers, Excise taxes, 

Imports, Labeling, Packaging and 

containers, Reporting and recordkeeping 

requirements, Surety bonds, Tobacco. 

27 CFR Part 41 

Cigars and cigarettes, Claims, Customs 

duties and inspection, Electronic funds 

transfers, Excise taxes, Imports, 

Labeling, Packaging and containers, 

Puerto Rico, Reporting and 

recordkeeping requirements, Surety 

bonds, Tobacco, Virgin Islands, 

Warehouses. 

27 CFR Part 44 

Aircraft, Armed forces, Cigars and 

cigarettes, Claims, Customs duties and 

inspection, Excise taxes, Exports, 

Foreign trade zones, Labeling, Packaging 

and containers, Reporting and 

recordkeeping requirements, Surety 

bonds, Tobacco, Vessels, Warehouses. 

27 CFR Part 45 

Administrative practice and 

procedure, Authority delegations 

(Government agencies), Cigars and 

cigarettes, Excise taxes, Labeling, 

Packaging and containers, Reporting 

and recordkeeping requirements, 

Tobacco. 

Proposed Amendments to the 

Regulations 

For the reasons discussed in the 

preamble, TTB proposes to amend 27 

CFR, chapter I, parts 40, 41, 44, and 45 

as follows: 

PART 40—MANUFACTURE OF 

TOBACCO PRODUCTS AND 

CIGARETTE PAPERS AND TUBES 

1. The authority citation for part 40 is 

revised to read as follows: 

Authority: 26 U.S.C. 5142, 5143, 5146, 

5701–5705, 5711–5713, 5721–5723, 5731, 

5741, 5751, 5753, 5761–5763, 6061, 6065, 

6109, 6151, 6301, 6302, 6311, 6313, 6402, 

6404, 6423, 6676, 6806, 7011, 7212, 7325, 

7342, 7502, 7503, 7606, 7805; 31 U.S.C. 9301, 

9303, 9304, 9306. 

2. [The proposed amendatory 

instructions and the proposed amended 

regulatory text for part 40 are the same 

as the amendatory instructions and the 

amended regulatory text set forth in the 

temporary rule on this subject published 

in the Rules and Regulations section of 

this issue of the Federal Register.] 

PART 41—IMPORTATION OF 

TOBACCO PRODUCTS AND 

CIGARETTE PAPERS AND TUBES 

3. The authority citation for part 41 is 

revised to read as follows: 

Authority: 26 U.S.C. 5701–5705, 5708, 

5712, 5713, 5721–5723, 5741, 5754, 5761– 

5763, 6301, 6302, 6313, 6402, 6404, 7101, 

7212, 7342, 7606, 7651, 7652, 7805; 31 U.S.C. 

9301, 9303, 9304, 9306. 

4. [The proposed amendatory 

instructions and the proposed amended 

regulatory text for part 41 are the same 

as the amendatory instructions and the 

amended regulatory text set forth in the 

temporary rule on this subject published 

in the Rules and Regulations section of 

this issue of the Federal Register.] 

PART 44—EXPORTATION OF 

TOBACCO PRODUCTS AND 

CIGARETTE PAPERS AND TUBES, 

WITHOUT PAYMENT OF TAX, OR WITH 

DRAWBACK OF TAX 

5. The authority citation for part 44 is 

revised to read as follows: 

Authority: 26 U.S.C. 5701–5705, 5708, 

5711–5713, 5721–5723, 5731, 5741, 5751, 

5754, 6061, 6065, 6151, 6402, 6404, 6806, 

7011, 7212, 7342, 7606, 7805; 31 U.S.C. 9301, 

9303, 9304, 9306. 

6. [The proposed amendatory 

instructions and the proposed amended 

regulatory text for part 44 are the same 

as the amendatory instructions and the 

amended regulatory text set forth in the 

temporary rule on this subject published 

in the Rules and Regulations section of 

this issue of the Federal Register.] 

PART 45—REMOVAL OF TOBACCO 

PRODUCTS AND CIGARETTE PAPERS 

AND TUBES, WITHOUT PAYMENT OF 

TAX, FOR USE OF THE UNITED 

STATES 

7. The authority citation for part 45 is 

revised to read as follows: 

Authority: 26 U.S.C. 5702–5705, 5723, 

5741, 5751, 5762, 5763, 6313, 7212, 7342, 

7606, 7805; 44 U.S.C. 3504(h). 

8. [The proposed amendatory 

instructions and the proposed amended 

regulatory text for part 45 are the same 

as the amendatory instructions and the 

amended regulatory text set forth in the 

temporary rule on this subject published 

in the Rules and Regulations section of 

this issue of the Federal Register.] 


sroberts on PROD1PC70 with PROPOSALS
Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Proposed Rules 29435 

Signed: April 15, 2009. 

John J. Manfreda, 

Administrator. 

Approved: May 26, 2009. 

Timothy E. Skud, 

Deputy Assistant Secretary (Tax, Trade, and 

Tariff Policy). 

[FR Doc. E9–14548 Filed 6–19–09; 8:45 am] 

BILLING CODE 4810–31–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2009–HA–0051] 

RIN 0720–AB31 

TRICARE; Coverage of National 

Cancer Institute (NCI) Sponsored 

Phase I Studies 

AGENCY: Office of the Secretary, DoD. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule adds 

coverage of National Cancer Institute 

(NCI) sponsored Phase I studies for 

certain beneficiaries. The NCI sponsored 

clinical treatment trials are conducted 

in a series of steps called phases. Phase 

I trials are the first studies conducted in 

people. They evaluate how a new drug 

should be given (by mouth, injected into 

the blood, or injected into the muscle), 

how often, and what dose is safe. 

DATES: Written comments received at 

the address indicated below by August 

21, 2009 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Information Number (RIN) 

number and title, by either of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 1160 Defense Pentagon, 

Washington, DC 20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

Colonel John Kugler, TRICARE 

Management Activity, Office of the 

Chief Medical Officer, telephone (703) 

681–0064. 

SUPPLEMENTARY INFORMATION: This 

proposed rule adds the coverage of a 

subset of National Cancer Institute (NCI) 

sponsored Phase I trials for certain 

TRICARE patients. The NCI sponsored 

clinical treatment trials are conducted 

in a series of steps called phases. Phase 

I trials are the first studies conducted in 

people. They evaluate how a new drug 

should be given (by mouth, injected into 

the blood, or injected into the muscle), 

how often, and what dose is safe. A 

Phase I trial usually enrolls only a small 

number of patients, sometimes as few as 

a dozen. A Phase II trial continues to 

test the safety of the drug, and begins to 

evaluate how well the new drug works. 

Phase II studies usually focus on a 

particular type of cancer. A Phase III 

trial tests a new drug, a new 

combination of drugs, or a new surgical 

procedure in comparison to the current 

standard. A participant will usually be 

assigned to the standard group or the 

new group at random. Phase III trials 

often enroll large numbers of people and 

may be conducted at many doctors’ 

offices, clinics, and cancer centers 

nationwide. 

This proposed rule adds coverage 

only of NCI sponsored Phase I trials 

with clinical or preclinical data 

providing a reasonable expectation that 

the treatment will be at least as effective 

as the non-investigational alternative. 

Additionally, only those TRICARE 

patients for whom standard treatment 

has been or would be ineffective, does 

not exist, or there is no superior noninvestigational treatment alternative, 

would be eligible for these additional 

trials. TRICARE has covered NCI 

sponsored Phase II and III trials since 

1996. The NCI estimates that Phase I 

trial participants represent about 3.4 

percent of overall Phase II and III 

participants combined. Based on the 

history of DoD participation in these 

studies, it is estimated that there would 

be a maximum of one thousand new 

patients annually enrolling in Phase I 

trials. It is estimated that the net cost to 

TRICARE of adding Phase I treatment 

trials will increase costs by 12.8 percent 

of the total gross costs (approximately 

$150,000 in FY09). Currently ten states 

mandate coverage of at least some Phase 

I trials. 

Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ 

Section 801 of title 5, United States 

Code (U.S.C.), and Executive Order 

(E.O.) 12866 requires certain regulatory 

assessments and procedures for any 

major rule or significant regulatory 

action, defined as one that would result 

in an annual effect of $100 million or 

more on the national economy or which 

would have other substantial impacts. It 

has been certified that this rule is not an 

economically significant rule, however, 

it is a regulatory action which has been 

reviewed by the Office of Management 

and Budget as required under the 

provisions of E.O. 12866. 

Sec. 202, Public Law 104–4, ‘‘Unfunded 

Mandates Reform Act’’ 

It has been certified that this rule does 

not contain a Federal mandate that may 

result in the expenditure by State, local 

and tribal governments, in aggregate, or 

by the private sector, of $100 million or 

more in any one year. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. 601) 

The Regulatory Flexibility Act (RFA) 

requires each Federal agency prepare, 

and make available for public comment, 

a regulatory flexibility analysis when 

the agency issues a regulation which 

would have a significant impact on a 

substantial number of small entities. 

This proposed rule will not significantly 

affect a substantial number of small 

entities for purposes of the RFA. 

Public Law 96–511, ‘‘Paperwork 

Reduction Act’’ (44 U.S.C. Chapter 35) 

This rule will not impose additional 

information collection requirements on 

the public under the Paperwork 

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

3511). 

Executive Order 13132, ‘‘Federalism’’ 

This proposed rule has been 

examined for its impact under E.O. 

13132 and it does not contain policies 

that have federalism implications that 

would 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; therefore, 

consultation with State and local 

officials is not required. 

List of Subjects in 32 CFR Part 199 

Claims, Dental health, Health care, 

Health insurance, Individuals with 

disabilities, Military personnel. 

Accordingly, 32 CFR Part 199 is 

proposed to be amended as follows: 

PART 199—[AMENDED] 

1. The authority citation for Part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. Chapter 

55. 

2. Section 199.4 is amended by: 


sroberts on PROD1PC70 with PROPOSALS