47458 Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2008–HA–0060] 

RIN 0720–AB26 

TRICARE; Rare Diseases Definition 

AGENCY: Office of the Secretary, DoD. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

definition of rare diseases to adopt the 

definition of a rare disease as 

promulgated by the National Institutes 

of Health, Office of Rare Diseases. The 

rule modification will result in the 

definition used by the TRICARE 

program for a rare disease to be 

consistent with the definition used by 

the National Institutes of Health and the 

Food and Drug Administration. 

TRICARE has generally been applying 

the broader National Institutes of Health 

and Food and Drug Administration 

definitions when making coverage 

decisions for treatments; therefore, there 

will be no practical changes for 

beneficiaries. 

DATES: Effective Date: This rule is 

effective September 7, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Commander James Ellzy, TRICARE 

Management Activity, Office of the 

Chief Medical Officer, telephone (703) 

681–0064. 

SUPPLEMENTARY INFORMATION: 

A. Background 

On January 6, 1997, the Office of the 

Secretary of Defense published a final 

rule in the Federal Register (62 FR 627– 

631) clarifying the TRICARE exclusion 

of unproven drugs, devices and medical 

treatments and procedures and adding a 

definition of rare diseases to be used in 

the TRICARE Program. TRICARE 

defined a rare disease as one which 

affects fewer than one in 200,000 

Americans. Upon further review, 

TRICARE is revising the definition to be 

in compliance with the definition of 

other federal agencies. The Office of 

Rare Diseases was initially established 

as part of the National Institutes of 

Health in 1993 to promote research and 

collaboration on rare and orphan 

diseases. The Rare Diseases Act of 2002 

(Pub. L. 107–280) codified the 

establishment of the Office of Rare 

Diseases by adding a section 404F to the 

Public Health Service Act (42 U.S.C. 

283h). This statute defines a rare disease 

as ‘‘any disease or condition that affects 

less than 200,000 persons in the United 

States.’’ Additionally, Section 526(a)(2) 

of the Federal Food, Drug and Cosmetic 

Act (21 U.S.C. 360bb(a)(2)), provides, in 

part, that the term ‘‘rare disease or 

condition’’ means any disease or 

condition which affects less than 

200,000 persons in the United States. 

This rule modification will result in the 

definition used by the TRICARE 

program for a rare disease to be 

consistent with the definition used by 

the National Institutes of Health and the 

Food and Drug Administration. 

B. Public Comments 

The Department of Defense published 

a proposed rule on July 24, 2009 (74 FR 

36639–36640). No comments were 

received on the proposed rule before the 

comment period closed. 

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, or a 

significant regulatory action under the 

provisions of E.O. 12866. 

Section 202, Public Law 104–4, 

‘‘Unfunded Mandates Reform Act’’ 

It has been certified that his 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 199.2(b) is amended by 

revising the definition of ‘‘Rare diseases’’ 

as follows: 

§ 199.2 Definitions. 

* * * * * 

(b) * * * 

Rare diseases. TRICARE/CHAMPUS 

defines a rare disease as any disease or 

condition that has a prevalence of less 

than 200,000 persons in the United 

States. 

* * * * * 

Dated: July 26, 2010. 

Patricia Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2010–19308 Filed 8–5–10; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2009–HA–0094] 

RIN 0720–AB32 

TRICARE; Diabetic Education 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Final rule. 

SUMMARY: The Department of Defense is 

publishing this final rule to clarify 

TRICARE coverage for diabetic 

education. This rule introduces new 

definitions and addresses revisions or 


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