36638 Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Proposed Rules 

and Gas/Electric Operational 

Communications Standards) (Version 

1.8, September 30, 2006); 

(ii) Nominations Related Standards 

(Version 1.8, September 30, 2006) and 

including the standards contained in 

NAESB WGQ 2007 Annual Plan Item 

7b/NAESB WGQ 2008 Annual Plan Item 

4b (August 25, 2008); 

(iii) Flowing Gas Related Standards 

(Version 1.8, September 30, 2006); 

(iv) Invoicing Related Standards 

(Version 1.8, September 30, 2006); 

(v) Quadrant Electronic Delivery 

Mechanism Related Standards (Version 

1.8, September 30, 2006) with the 

exception of Standard 4.3.4; 

(vi) Capacity Release Related 

Standards (Sep. 3, 2008) and including 

the standards contained in NAESB 

WGQ 2007 Annual Plan Item 7a/NAESB 

WGQ 2008 Annual Plan Item 4a (August 

25, 2008) and the Standards included in 

NAESB WGQ 2007 Annual Plan Item 

7a/NAESB WGQ 2008 Annual Plan Item 

4a/NAESB WGQ 2009 Annual Plan Item 

4; and 

(vii) Internet Electronic Transport 

Related Standards (Version 1.8, 

September 30, 2006) with the exception 

of Standard 10.3.2. 

* * * * * 

[FR Doc. E9–17333 Filed 7–23–09; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2008–HA–0025; 0720–AB20] 

TRICARE; Changes Included in the 

National Defense Authorization Act for 

Fiscal Year 2007; Improvements to 

Descriptions of Cancer Screening for 

Women 

AGENCY: TRICARE Management 

Activity, Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department is publishing 

this proposed rule to implement section 

703 of the National Defense 

Authorization Act (NDAA) for Fiscal 

Year 2007 (FY07), Public Law 109–364. 

Specifically, that legislation authorizes 

breast cancer screening and cervical 

cancer screening for female beneficiaries 

of the Military Health System, instead of 

constraining such testing to 

mammograms and Papanicolaou smears. 

The rule allows coverage for ‘‘breast 

cancer screening’’ and ‘‘cervical cancer 

screening’’ for female beneficiaries of 

the Military Health System, instead of 

constraining such testing to 

mammograms and Papanicolaou tests. 

This rule ensures new breast and 

cervical cancer screening procedures 

can be added to the TRICARE benefit as 

such procedures are proven to be a safe, 

effective, and nationally accepted 

medical practice. This amends the 

cancer specific recommendations for 

breast and cervical cancer screenings to 

be brought in line with the processes for 

updating other cancer screening 

recommendations. 

DATES: Written comments will be 

accepted at the address indicated below 

until September 22, 2009. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

RIN, by any of the following methods: 

• Federal eRulemaking 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: 

Colonel John Kugler, Office of the Chief 

Medical Officer, TRICARE Management 

Activity, telephone (703) 681–0064. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Department of Defense updated 

coverage for screening with the use of 

the breast MRI for women in a 

designated high risk category as advised 

by the American Cancer Society. In the 

process of providing this additional 

coverage, it was discovered that because 

of statutory wording, there was a group 

of high risk women that are standard 

beneficiaries under the age of 35 for 

whom this coverage could not be 

provided without an amendment in the 

Code of Federal Regulations (CFR). 

Amending the CFR will provide 

coverage for breast MRI screening for all 

Department of Defense beneficiaries in 

the high risk category recommended by 

the American Cancer Society. 

II. Regulatory Procedures 

Executive Order (EO) 12866 and 

Regulatory Flexibility Act 

E.O. 12866 requires a comprehensive 

regulatory impact analysis be performed 

on any economically 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. 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 that would 

have a significant impact on a 

substantial number of small entities. 

This rule is not an economically 

significant regulatory action and will 

not have a significant impact on a 

substantial number of small entities for 

purposes of the RFA, thus this proposed 

rule is not subject to any of these 

requirements. This rule, although not 

economically significant, is a significant 

rule under E.O. 12866 and has been 

reviewed by the Office of Management 

and Budget. Amending the CFR will 

provide coverage for breast MRI 

screening for all Department of Defense 

beneficiaries in the high risk category, if 

necessary. It is critically important that 

we eliminate any potential gaps in 

coverage for high risk individuals as 

quickly as possible. 

Paperwork Reduction Act 

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). 

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 tribunal governments, in aggregate, 

or by the private section, of $100 

million or more in any one year. 

Executive Order (EO) 13132 

We have examined the impact(s) of 

the proposed rule under E.O. 13132 and 

it does not have 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 

proposed to be amended as follows: 


srobinson on DSKHWCL6B1PROD with PROPOSALS
Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Proposed Rules 36639 

PART 199—CIVILIAN HEALTH AND 

MEDICAL PROGRAM OF THE 

UNIFORMED SERVICES 

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. In § 199.4: 

A. Revise paragraphs (g)(37)(viii) and 

(ix). 

B. Redesignate paragraphs (g)(27)(x) 

through (g)(37)(xii) as (g)(37)(xi) through 

(g)(37)(xiii). 

C. Add a new paragraph (g)(37)(x). 

The revisions and additions read as 

follows: 

§ 199.4 Basic program benefits. 

* * * * * 

(g) * * * 

(37) * * * 

(viii) Cancer screenings authorized by 

10 U.S.C. 1079. 

(ix) Health promotion and disease 

preventions visits (which may include 

all of the services provided pursuant to 

§ 199.18(b)(2)) may include all of the 

services provided pursuant to 

§ 199.18(b)(2)) may be provided in 

connection with immunizations and 

cancer screening examinations 

authorized by paragraphs (g)(37)(ii) or 

(g)(37)(viii) of this section. 

(x) Physical examinations for 

beneficiaries ages 5–11 that are required 

in connection with school enrollment. 

* * * * * 

Dated: July 17, 2009. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. E9–17651 Filed 7–23–09; 8:45 am] 

BILLING CODE 5001–06–P 

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. 

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, 


srobinson on DSKHWCL6B1PROD with PROPOSALS