[Federal Register Volume 74, Number 141 (Friday, July 24, 2009)]
[Proposed Rules]
[Pages 36639-36640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17650]


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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: Proposed rule.

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SUMMARY: This proposed 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: Written comments received at the address indicated below by 
September 22, 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: LCDR James Ellzy, TRICARE Management 
Activity, Office of the Chief Medical Officer, telephone (703) 681-
0064.

SUPPLEMENTARY INFORMATION: 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 proposes to revise 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. The proposed 
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.

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 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,

[[Page 36640]]

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:


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 17, 2009.
Patricia Toppings,
OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. E9-17650 Filed 7-23-09; 8:45 am]
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