[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]]
-----------------------------------------------------------------------
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.
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.
0
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]
BILLING CODE 5001-06-P