[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Rules and Regulations]
[Page 47458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19308]



[[Page 47458]]

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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.

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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.

0
Accordingly, 32 CFR Part 199 is amended as follows:

PART 199--[AMENDED]

0
1. The authority citation for Part 199 continues to read as follows:

    Authority:  5 U.S.C. 301; 10 U.S.C. Chapter 55.


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2. Section 199.2(b) is amended by revising the definition of ``Rare 
diseases'' as follows:


Sec.  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]
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