Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Rules and Regulations 2253 

ASD(HD&ASA), guidance regarding this 

part as it relates to National Guard 

matters. 

Dated: December 22, 2010. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2011–620 Filed 1–12–11; 8:45 am] 

BILLING CODE 5001–06–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: Final rule. 

SUMMARY: This final 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: Effective Date: This rule is 

effective February 14, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Commander James Ellzy, TRICARE 

Management Activity, Office of the 

Chief Medical Officer, telephone (703) 

681–0064. 

SUPPLEMENTARY INFORMATION: 

A. Background 

This final 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 final rule adds coverage only of 

NCI sponsored Phase I trials with 

clinical or pre-clinical 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 Department of Defense 

participation in these studies, it is 

estimated that there would be a 

maximum of 1,000 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. 

B. Public Comments 

The DoD published a proposed rule 

on June 22, 2009 (74 FR 29435–29436). 

One set of comments was received on 

the proposed rule. The sole commenter 

strongly supported the proposed rule 

and urged the DoD to make it final. We 

agree with this recommendation and 

have not made any modifications to the 

proposed rule. 

C. 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 final 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 final 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 

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: 

■ 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 

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); 


srobinson on DSKHWCL6B1PROD with RULES
2254 Federal Register / Vol. 76, No. 9 / Thursday, January 13, 2011 / Rules and Regulations 

■ E. Adding 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 

(iii) of this section. 

* * * * * 

Dated: January 4, 2011. 

Patricia L. Toppings, 

OSD Federal Register, Liaison Officer, 

Department of Defense. 

[FR Doc. 2011–621 Filed 1–12–11; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 146 

[Docket No. USCG–2008–1088] 

RIN 1625–AB28 

Notice of Arrival on the Outer 

Continental Shelf 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard revises its 

regulations on Outer Continental Shelf 

(OCS) Activities to enhance maritime 

domain safety and security awareness 

on the OCS by issuing regulations 

which will require notice of arrival for 

floating facilities, mobile offshore 

drilling units (MODUs), and vessels 

planning to engage in OCS activities. 

This final rule implements provisions of 

the Security and Accountability for 

Every Port Act of 2006 and increases 

overall maritime domain awareness by 

requiring owners or operators of United 

States and foreign flag floating facilities, 

MODUs, and vessels to submit notice of 

arrival information to the National 

Vessel Movement Center prior to 

engaging in OCS activities. 

DATES: This final rule is effective 

February 14, 2011. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2008–1088 and are 

available for inspection or copying at 

the 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, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet by going 

to http://www.regulations.gov, inserting 

USCG–2008–1088 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Kevin Pekarek, Vessel and 

Facility Operating Standards Division 

(CG–5222), Coast Guard; telephone 202– 

372–1386, e-mail 

Kevin.Y.Pekarek2@uscg.mil. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble 

I. Abbreviations 

II. Regulatory History 

III. Basis and Purpose 

IV. Background 

V. Discussion of Comments and Changes 

VI. Regulatory Analyses 

A. Regulatory Planning and Review 

B. Small Entities 

C. Assistance for Small Entities 

D. Collection of Information 

E. Federalism 

F. Unfunded Mandates Reform Act 

G. Taking of Private Property 

H. Civil Justice Reform 

I. Protection of Children 

J. Indian Tribal Governments 

K. Energy Effects 

L. Technical Standards 

M. Environment 

I. Abbreviations 

BOEMRE Bureau of Ocean Energy 

Management, Regulation and 

Enforcement. 

CFR Code of Federal Regulations. 

DHS Department of Homeland 

Security. 

FR FEDERAL REGISTER. 

ISM International Safety Management. 

ISSC International Ship Security 

Certificate. 

MMS Minerals Management Service. 

MODU Mobile Offshore Drilling Unit. 

NAICS North American Industry 

Classification System. 

NOA Notice of Arrival. 

NOA OCS Notice of Arrival on the 

Outer Continental Shelf. 

NPRM Notice of Proposed 

Rulemaking. 

NTTAA National Technology Transfer 

and Advancement Act, 15 U.S.C. 272 

note. 

NVMC National Vessel Movement 

Center. 

OCS Outer Continental Shelf. 

OCSLA Outer Continental Shelf Lands 

Act. 

OIRA Office of Information and 

Regulatory Affairs. 

OMB Office of Management and 

Budget. 

RFA Regulatory Flexibility Act, 5 

U.S.C. 601–612. 

SAFE Port Act Security and 

Accountability for Every Port Act of 

2006, Pub. L. 109–347, 120 Stat. 1884 

(2006). 

U.S.C. United States Code. 

U.S.C.A. United States Code 

Annotated. 

II. Regulatory History 

On June 22, 2009, we published a 

notice of proposed rulemaking (NPRM) 

entitled Notice of Arrival (NOA) on the 

Outer Continental Shelf in the Federal 

Register (74 FR 29439). We received two 

sets of comments on the proposed rule 

prior to the close of the comment 

period. One additional set of comments 

was received after the close of the 


srobinson on DSKHWCL6B1PROD with RULES