Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Proposed Rules 6335 

effect on the supply, distribution, or use 

of energy, a Statement of Energy Effects 

is not required. 

National Environmental Policy Act 

This rule does not require an 

environmental impact statement 

because section 702(d) of SMCRA (30 

U.S.C. 1292(d)) provides that agency 

decisions on proposed State regulatory 

program provisions do not constitute 

major Federal actions within the 

meaning of section 102(2)(C) of the 

National Environmental Policy Act (42 

U.S.C. 4321 et seq). 

Paperwork Reduction Act 

This rule does not contain 

information collection requirements that 

require approval by OMB under the 

Paperwork Reduction Act (44 U.S.C. 

3501 et seq.). 

Regulatory Flexibility Act 

The Department of the Interior 

certifies that this rule will not have a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.). The State submittal, 

which is the subject of this rule, is based 

upon counterpart Federal regulations for 

which an economic analysis was 

prepared and certification made that 

such regulations would not have a 

significant economic effect upon a 

substantial number of small entities. In 

making the determination as to whether 

this rule would have a significant 

economic impact, the Department relied 

upon the data and assumptions for the 

counterpart Federal regulations. 

Small Business Regulatory Enforcement 

Fairness Act 

This rule is not a major rule under 5 

U.S.C. 804(2), of the Small Business 

Regulatory Enforcement Fairness Act. 

This rule: 

a. Does not have an annual effect on 

the economy of $100 million. 

b. Will not cause a major increase in 

costs or prices for consumers, 

individual industries, Federal, State, or 

local government agencies, or 

geographic regions. 

c. Does not have significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

the ability of U.S. based enterprises to 

compete with foreign-based enterprises. 

This determination is based upon the 

fact that the State submittal which is the 

subject of this rule is based upon 

counterpart Federal regulations for 

which an analysis was prepared and a 

determination made that the Federal 

regulation was not considered a major 

rule. 

Unfunded Mandates 

This rule will not impose an 

unfunded mandate on State, local, or 

tribal governments or the private sector 

of $100 million or more in any given 

year. This determination is based upon 

the fact that the State submittal, which 

is the subject of this rule, is based upon 

counterpart Federal regulations for 

which an analysis was prepared and a 

determination made that the Federal 

regulation did not impose an unfunded 

mandate. 

List of Subjects in 30 CFR Part 950 

Intergovernmental relations, Surface 

mining, Underground mining. 

Dated: October 28, 2009. 

James F. Fulton, 

Acting Regional Director, Western Region. 

[FR Doc. 2010–2781 Filed 2–8–10; 8:45 am] 

BILLING CODE 4310–05–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[DoD–2008–HA–0029; 0720–AB22] 

32 CFR Part 199 

Civilian Health and Medical Program of 

the Uniformed Services (CHAMPUS)/ 

TRICARE: Inclusion of TRICARE Retail 

Pharmacy Program in Federal 

Procurement of Pharmaceuticals 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Reconsideration and request for 

comments. 

SUMMARY: This is notification of an 

additional opportunity to comment on 

the final rule of March 17, 2009, 

implementing provisions of section 703 

of the National Defense Authorization 

Act (NDAA) for Fiscal Year 2008). This 

statute extended pharmaceutical Federal 

Ceiling Prices (FCPs) to TRICARE Retail 

Pharmacy Program prescriptions. The 

Department of Defense (DoD) issued a 

final rule on March 17, 2009, 

implementing the law. On November 

30, 2009, the U.S. District Court for the 

District of Columbia ‘‘ordered that the 

final rule is remanded without vacatur 

for the Defense Department to consider 

in its discretion whether to readopt the 

current iteration of the rule or adopt 

another approach to implement 10 

U.S.C. 1074g(f).’’ As part of DoD’s 

reconsideration, DoD solicits public 

comments on the implementation of the 

statute, DoD’s resulting regulations, and 

the matters addressed for DoD’s 

consideration in the Court’s 

Memorandum Opinion. 

DATES: Written comments received at 

the address indicated below by March 

11, 2010 will be considered and 

addressed in the final rule. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Information Number (RIN) 

number and title, 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 FR 

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: Rear 

Admiral Thomas McGinnis, Chief, 

Pharmacy Operations Directorate, 

TRICARE Management Activity, 

telephone (703) 681–2890. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 703 of NDAA–08 enacted 10 

U.S.C. 1074g(f). It provides that with 

respect to any prescription filled on or 

after the date of enactment (January 28, 

2008), the TRICARE Retail Pharmacy 

Program shall be treated as an element 

of DoD for purposes of the procurement 

of drugs by Federal agencies under 38 

U.S.C. 8126 to the extent necessary to 

ensure pharmaceuticals paid for by DoD 

that are provided by network retail 

pharmacies to TRICARE beneficiaries 

are subject to FCPs. This section 8126 

established FCPs for covered drugs 

(requiring a minimum 24 percent 

discount) procured by DoD and three 

other agencies from manufacturers. The 

NDAA required implementing 

regulations. 

DoD issued a proposed rule July 25, 

2008 (73 FR 43394–97). It featured 

voluntary agreements with 

manufacturers, tied to preferred 

Uniform Formulary status, to pay DoD 

refunds for drugs entered into the 

normal commercial chain of 

transactions that end up as prescriptions 

given to TRICARE beneficiaries and 

paid for by DoD, the refund amount 

being the portion of the price of the drug 

sold by the manufacturer that exceeds 

the FCPs. The proposed rule also 


Cprice-sewell on DSK2BSOYB1PROD with PROPOSALS
6336 Federal Register / Vol. 75, No. 26 / Tuesday, February 9, 2010 / Proposed Rules 

solicited comment regarding any other 

appropriate and legally permissible 

implementation approach. 

DoD issued a final rule March 17, 

2009 (74 FR 11279–93), which was 

similar to the proposed rule. The 

preamble to the final rule discussed 

DoD’s effort, particularly in the use of 

voluntary agreements tied to formulary 

status, to find ‘‘common ground’’ with 

the drug industry, which opposes FCPs. 

The preamble also stated that DoD 

interpreted the statute as automatically 

capping the price manufacturers may 

charge for those drugs that enter into the 

commercial chain of transactions that 

end up as TRICARE-paid prescriptions, 

resulting in the conclusion that the 

amount above the FCP was an 

overpayment by DoD, which in turn 

required a refund of the overpayment. 

After the final rule became effective, 

May 26, 2009, drug companies signed 

voluntary agreements covering 

approximately 99 percent of TRICARE 

retail prescriptions. 

However, at the same time, there was 

a litigation challenge to the validity of 

the final rule in a case called Coalition 

for Common Sense in Government 

Procurement v. U.S., U.S. District Court 

for the District of Columbia, Civ. No. 

08–996 (JDB), 2009 U.S. Dist. LEXIS 

110746. The Court issued a decision 

November 30, 2009. This decision had 

four major points: 

• Although 10 U.S.C. 1074g(f) 

requires that FCPs shall apply, the 

statute does not specify how they will 

apply. DoD incorrectly interpreted the 

statute as requiring manufacturer 

refunds, to the exclusion of other 

possible approaches. DoD must 

reconsider the implementation of the 

statute as a function of its discretionary 

judgment, rather than only as a legal 

interpretation. For example, DoD should 

exercise its discretion to consider 

‘‘which of the five parties that 

participate in the retail pharmacy 

program—manufacturers, wholesalers, 

network pharmacies, private pharmacy 

benefit managers, and TRICARE 

beneficiaries—must bear any costs 

associated with imposing the Federal 

Ceiling Prices.’’ 

• While DoD considers whether to 

readopt the final rule as it currently 

stands or to change it, the final rule will 

remain in effect, as will the 

manufacturer agreements that cover 

approximately 99 percent of TRICARE 

retail prescriptions. (This is the effect of 

the Court’s Order that the final rule is 

‘‘remanded without vacatur.’’) 

• DoD correctly interpreted the 

statute as applying FCPs to all 

prescriptions filled on or after January 

28, 2008. 

• The Court ordered that DoD file a 

status report with the Court by not later 

than March 1, 2010, ‘‘documenting its 

consideration on remand.’’ 

B. Invitation of Additional Public 

Comments 

Although the Court did not 

specifically require more public 

comments, DoD invites public 

comments on the final rule issued 

March 17, 2009, as well as additional 

comments regarding any other 

appropriate and legally permissible 

implementation approach. DoD 

recommends that interested parties 

focus their comments on those matters 

that the Court addressed as requiring 

DoD reconsideration on the remand of 

the final rule. In considering alternative 

approaches, DoD intends to use at least 

the following three criteria (and 

welcomes comment on other suggested 

criteria): (1) Harmony with the statute 

and legislative history; (2) consistency 

with best business practice; and (3) 

practicability of administration. In 

addition to the citations noted above, to 

assist interested parties, the final rule 

and the Court’s Order and 

Memorandum Opinion are posted on 

the TRICARE Pharmacy Program Web 

site at: http://www.tricare.mil/ 

pharm_mfg/default.cfm. 

Dated: February 3, 2010. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2010–2666 Filed 2–8–10; 8:45 am] 

BILLING CODE 5001–06–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2009–0706; FRL–9111–6] 

Approval and Promulgation of Air 

Quality Implementation Plans; West 

Virginia; Removal of NOX SIP Call 

Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the State of West 

Virginia that removes West Virginia’s 

nitrogen oxides (NOx) SIP Call rules. In 

the Final Rules section of this Federal 

Register, EPA is approving the State’s 

SIP submittal as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this action, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

DATES: Comments must be received in 

writing by March 11, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2009–0706 by one of the 

following methods: 

A. http://www.regulations.gov. Follow 

the on-line instructions for submitting 

comments. 

B. E-mail: 

fernandez.cristina@epa.gov. 

C. Mail: EPA–R03–OAR–2009–0706, 

Cristina Fernandez, Associate Director, 

Office of Air Program Planning, 

Mailcode 3AP30, U.S. Environmental 

Protection Agency, Region III, 1650 

Arch Street, Philadelphia, Pennsylvania 

19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket=s normal hours of operation, 

and special arrangements should be 

made for deliveries of boxed 

information. 

Instructions: Direct your comments to 

Docket ID No. EPA–R03–OAR–2009– 

0706. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 


Cprice-sewell on DSK2BSOYB1PROD with PROPOSALS