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
29436 Federal Register / Vol. 74, No. 118 / Monday, June 22, 2009 / Proposed Rules 

A. Redesignating paragraphs 

(e)(26)(ii)(B)(2), (3) and (4) as paragraphs 

(e)(26)(ii)(B)(3), (4) and (5); 

B. Adding a sentence to the end of the 

introductory text in paragraph 

(e)(26)(ii)(B); 

C. Revising paragraph 

(e)(26)(ii)(B)(1)(ii); 

D. Revising paragraph 

(e)(26)(ii)(B)(1)(iv); 

E. Adding new paragraph 

(e)(26)(ii)(B)(1)(v); and 

F. Adding a new paragraph 

(e)(26)(ii)(B)(2) to read as follows: 

§ 199.4 Basic program benefits. 

* * * * * 

(e) * * * 

(26) * * * 

(ii) * * * 

(B) * * * Additionally, Phase I 

studies may be approved on a case by 

case basis when the requirements below 

are met. 

(1) * * * 

(ii) Such treatments are NCI 

sponsored Phase I, Phase II or Phase III 

protocols; and 

* * * * * 

(iv) The institutional and individual 

providers are CHAMPUS authorized 

providers; and, 

(v) The requirements for Phase I 

protocols in paragraph (e)(26)(ii)(B)(2) of 

this section are met: 

(2) Requirements for Phase I protocols 

are: 

(i) Standard treatment has been or 

would be ineffective, does not exist, or 

there is no superior non-investigational 

treatment alternative; and, 

(ii) The available clinical or 

preclinical data provide a reasonable 

expectation that the treatment will be at 

least as effective as the noninvestigational alternative; and, 

(iii) The facility and personnel 

providing the treatment are capable of 

doing so by virtue of their experience, 

training, and volume of patients treated 

to maintain expertise; and, 

(iv) The referring physician has 

concluded that the enrollee’s 

participation in such a trial would be 

appropriate based upon the satisfaction 

of paragraphs (e)(26)(ii)(B)(2)(i) through 

(e)(26)(ii)(B)(2)(iii) of this section. 

* * * * * 

Dated: May 15, 2009. 

Patricia Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. E9–14441 Filed 6–19–09; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[USCG–2009–0400] 

RIN 1625–AA08 

Regattas and Marine Parades; Great 

Lakes Annual Marine Events 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

amend special local regulations for 

annual regattas and marine parades in 

the Captain of the Port Sault Sainte 

Marie zone. This action is necessary to 

protect and separate the public from the 

hazards of these events. This proposed 

rule will establish restrictions upon, and 

control movement of, vessels in a 

specified area immediately prior to, 

during, and immediately after regattas 

or marine parades. 

DATES: Comments and related materials 

must reach the Coast Guard on or before 

July 22, 2009. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number USCG–2009–0400 to the Docket 

Management Facility at the U.S. 

Department of Transportation. To avoid 

duplication, please use only one of the 

following methods: 

(1) Online: http:// 

www.regulations.gov. 

(2) Mail: 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– 

0001. 

(3) Hand delivery: Room W12–140 on 

the Ground Floor of the West Building, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The telephone 

number is 202–366–9329. 

(4) Fax: 202–493–2251. 

FOR FURTHER INFORMATION CONTACT: 

LCDR Christopher Friese, Prevention 

Dept. Chief, Sector Sault Sainte Marie, 

337 Water St., Sault Sainte Marie, MI 

49783; 906–635–3220. 

I. Public Participation and Request for 

Comments 

We encourage you to participate in 

this rulemaking by submitting 

comments and related materials. All 

comments received will be posted, 

without change, to http:// 

www.regulations.gov and will include 

any personal information you have 

provided. We have an agreement with 

the Department of Transportation (DOT) 

to use the Docket Management Facility. 

Please see DOT’s ‘‘Privacy Act’’ 

paragraph below. 

A. Submitting Comments 

If you submit a comment, please 

include the docket number for this 

rulemaking (USCG–2009–0400), 

indicate the specific section of this 

document to which each comment 

applies, and give the reason for each 

comment. We recommend that you 

include your name, mailing address, 

and an e-mail address or other contact 

information in the body of your 

document to ensure that you can be 

identified as the submitter. This also 

allows us to contact you in the event 

further information is needed or if there 

are questions. For example, if we cannot 

read your submission due to technical 

difficulties and you cannot be 

contacted; your submission may not be 

considered. You may submit your 

comments and material by electronic 

means, mail, fax, or delivery to the 

Docket Management Facility at the 

address under ADDRESSES; but please 

submit your comments and material by 

only one means. If you submit them by 

mail or delivery, submit them in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying and 

electronic filing. If you submit them by 

mail and would like to know that they 

reached the Facility, please enclose a 

stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period. We may change 

this proposed rule in view of them. 

B. Viewing Comments and Documents 

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

http://www.regulations.gov at any time, 

click on ‘‘Search for Dockets,’’ and enter 

the docket number for this rulemaking 

(USCG–2008–XXXX) in the Docket ID 

box, and click enter. You may also visit 

the Docket Management Facility in 

Room W12–140 on the ground floor of 

the DOT West Building, 1200 New 

Jersey Avenue, SE., Washington, DC 

20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. 

C. Privacy Act 

Anyone can search the electronic 

form of all comments received into any 

of our dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review the 


sroberts on PROD1PC70 with PROPOSALS