52926 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 

* * * * * 

[FR Doc. 05–17538 Filed 9–2–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 81 

[R09–OAR–2005–AZ–0003; FRL–7960–8] 

Approval and Promulgation of 

Implementation Plans and Designation 

of Areas for Air Quality Planning 

Purposes; Arizona; Correction of 

Redesignation of Phoenix to 

Attainment for the Carbon Monoxide 

Standard 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: In today’s action, EPA is 

taking direct final action to amend the 

regulations that identify revisions to the 

Arizona state implementation plan and 

the regulations that identify area 

designations within Arizona. In so 

doing, EPA is acting pursuant to the 

Agency’s authority under the Clean Air 

Act to correct errors made in approving 

plan revisions and area redesignations. 

The purpose of this action is to correct 

an error in the adoption and submittal 

date shown for a revision to the 

implementation plan that EPA recently 

approved and to correct a transcription 

error in, and to make a more general 

correction to, the boundary description 

of the metropolitan Phoenix carbon 

monoxide area that EPA recently 

redesignated to attainment. 

EFFECTIVE DATE: This rule is effective on 

November 7, 2005, without further 

notice, unless we receive adverse 

comments by October 6, 2005. If we 

receive adverse comments, we will 

publish a timely withdrawal in the 

Federal Register to notify the public 

that this rule will not take effect. 

ADDRESSES: Submit comments, 

identified by docket number R09–OAR–

2005–AZ–__, by one of the following 

methods: 

1. Agency Web site: http:// 

docket.epa.gov/rmepub/. EPA prefers 

receiving comments through this 

electronic public docket and comment 

system. Follow the on-line instructions 

to submit comments. 

2. Federal eRulemaking Portal: 

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

on-line instructions. 

3. E-mail: tax.wienke@epa.gov. 

4. Mail or deliver: Wienke Tax, Office 

of Air Planning (AIR–2), U.S. 

Environmental Protection Agency, 

Region 9, 75 Hawthorne Street, San 

Francisco, CA 94105–3901. 

Instructions: All comments will be 

included in the public docket without 

change and may be made available 

online at http://docket.epa.gov/rmepub/ 

, including any personal information 

provided, unless the comment includes 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Information that 

you consider CBI or otherwise protected 

should be clearly identified as such and 

should not be submitted through the 

agency Web site, eRulemaking portal, or 

e-mail. The agency Web site and 

eRulemaking portal are ‘‘anonymous 

access’’ systems, and EPA will not know 

your identify or contact information 

unless you provide it in the body of 

your comment. If you send e-mail 

directly to EPA, your e-mail address 

will be automatically captured and 

included as part of the public comment. 

If EPA cannot read your comment due 

to technical difficulties and cannot 

contact you for clarification, EPA may 

not be able to consider your comment. 

Docket: The index to the docket for 

this action is available electronically at 

http://docket.epa.gov/rmepub and in 

hard copy at EPA Region 9, 75 

Hawthorne Street, San Francisco, 

California. While all documents in the 

docket are listed in the index, some 

information may be publicly available 

only at the hard copy location (e.g., 

copyrighted material), and some may 

not be publicly available in either 

location (e.g., CBI). To inspect the hard 

copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Wienke Tax, Air Planning Office (AIR–

2), U.S. Environmental Protection 

Agency, Region 9, (520) 622–1622 or email to tax.wienke@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, the terms 

‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA. 

Table of Contents 

I. Background 

II. Final Action 

III. Statutory and Executive Order Reviews 

I. Background 

On March 9, 2005, pursuant to the 

Clean Air Act (CAA), we published a 

final rulemaking action (1) approving 

various plan elements contained in two 

submittals of revisions to the Arizona 

state implementation plan (SIP) by the 

Arizona Department of Environmental 

Quality (ADEQ), (2) approving Arizona’s 

request for the redesignation of the 

metropolitan Phoenix carbon monoxide 

(CO) area to attainment for the carbon 

monoxide (CO) national ambient air 

quality standard (NAAQS), and (3) 

redesignating the boundary of the 

metropolitan Phoenix CO area to 

exclude the Gila River Indian 

Reservation. See 70 FR 11553 (March 9, 

2005). Our March 9th final rulemaking 

contained amendments to 40 CFR part 

52 relating to the two SIP submittals and 

amendments to 40 CFR part 81 relating 

to the redesignation actions. Three of 

these amendments were incorrect. 

First, in the regulatory language we 

added as 40 CFR 52.120(c)(118), we 

incorrectly listed ADEQ’s adoption and 

submittal date for the Revised MAG 

1999 Serious Area Carbon Monoxide 

Plan for the Maricopa County 

Nonattainment Area (March 2001) as 

March 30, 2001. The correct date for 

both ADEQ’s adoption and submittal of 

this plan (to EPA) as a revision to the 

Arizona SIP is April 18, 2001 and 

today’s action revises 40 CFR 

52.120(c)(118) accordingly. 

Second, in 40 CFR 81.303, which 

contains a table describing in detail the 

metropolitan Phoenix CO area, we did 

not intend any change to paragraph 13 

as codified prior to our March 9th final 

rule except for the added phrase at the 

end of the paragraph (‘‘except that 

portion in the Gila River Indian 

Reservation’’), but, through 

transcription error, we made other 

changes to that paragraph that were 

unintended. In today’s notice, we are 

correcting paragraph 13 by reinstating 

the prior language. 

Third, also in the CO table in 40 CFR 

81.303, we codified our action to 

redesignate the boundary of the 

metropolitan Phoenix CO area to 

exclude the Gila River Indian 

Reservation by adding the phrase, 

‘‘except that portion in the Gila River 

Indian Reservation,’’ to the end of each 

of the 28 paragraphs that describe the 

metropolitan Phoenix CO area. In 40 

CFR 81.303, the metropolitan Phoenix 

CO area is described by reference to a 

point of origin (paragraph 1) that lies at 

the southeast corner of the area followed 

by a series of 27 contiguous lines 

(paragraphs 2 through 28) that starts at 

the point of origin and proceeds in a 

counter-clockwise direction back to the 

point of origin. We now find that 

excluding ‘‘the portion in the Gila River 

Indian Reservation’’ from the point of 

origin and from each of the lines that 

collectively define the CO area was 

erroneous because the description, as 

revised in our March 9th final rule, is 

ambiguous as to its southern boundary. 

We continue to believe that the 

redesignation of the boundary of the 

metropolitan Phoenix CO area to 

Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 52927 

exclude the Gila River Indian 

Reservation is appropriate and are 

taking action today to re-codify this 

redesignation in a manner that avoids 

the unintended ambiguity introduced by 

the regulatory text we used in our 

March 9th final rule. Specifically, in 

this action, we are revising each of the 

28 paragraphs that define the 

metropolitan Phoenix CO area in 40 

CFR 81.303 to remove the phrase that 

we added in our March 9th final rule 

(i.e., ‘‘except that portion in the Gila 

River Indian Reservation’’) and are 

instead adding a new paragraph 29 that 

states: ‘‘except that portion of the area 

defined by paragraphs 1 through 28 

above that lies within the Gila River 

Indian Reservation.’’

We are taking this action under our 

authority in CAA section 110(k)(6). 

Section 110(k)(6) provides, ‘‘Whenever 

the Administrator determines that the 

Administrator’s action approving, 

disapproving, or promulgating any plan 

or plan revision (or part thereof), area 

designation, redesignation, 

classification, or reclassification was in 

error, the Administrator may in the 

same manner as the approval, 

disapproval, or promulgation revise 

such action as appropriate without 

requiring any further submission from 

the State.’’ For the reasons stated above, 

we are correcting errors in the 

regulatory language we promulgated in 

approving a revision to the Arizona SIP, 

in redesignating the metropolitan 

Phoenix CO area to attainment, and in 

redesignating the boundary of the 

metropolitan Phoenix CO area to 

exclude the Gila River Indian 

Reservation. 

II. Final Action 

In this action, EPA is correcting 

amendments to 40 CFR part 52, subpart 

D, and 40 CFR part 81, subpart C, that 

were contained in the final Federal 

Register notice published on March 9, 

2005 approving submittals of revisions 

to the Arizona state implementation 

plan, redesignating the metropolitan 

Phoenix carbon monoxide area to 

attainment for the carbon monoxide 

National Ambient Air Quality 

Standards, and redesignating the 

boundary of the metropolitan Phoenix 

CO area to exclude the Gila River Indian 

Reservation. Specifically, this action 

amends 40 CFR 52.120 relating to the 

Arizona SIP and 40 CFR 81.303 

describing the boundaries of the 

metropolitan Phoenix CO area. 

The EPA is publishing this rule 

without prior proposal because the 

Agency views this as a noncontroversial 

amendment and anticipates no adverse 

comments. However, in the proposed 

rules section of this Federal Register 

publication, EPA is publishing a 

separate document that will serve as the 

proposal to correct the errors described 

herein should adverse comments be 

filed. This action will be effective 

November 7, 2005, without further 

notice unless the EPA receives relevant 

adverse comments by October 6, 2005. 

If the EPA receives such comments, 

then EPA will publish a document 

withdrawing the final rule and 

informing the public that the rule will 

not take effect. All public comments 

received will then be addressed in a 

subsequent final rule based on the 

proposed rule. The EPA will not 

institute a second comment period. 

Parties interested in commenting should 

do so at this time. If no such comments 

are received, the public is advised that 

this rule will be effective on November 

7, 2005 and no further action will be 

taken on the proposed rule. Please note 

that if EPA receives adverse comment 

on an amendment, paragraph, or section 

of this rule, and if that provision may be 

severed from the remainder of the rule, 

EPA may adopt as final those provisions 

of the rule that are not the subject of an 

adverse comment. 

III. Statutory and Executive Order 

Reviews 

Under Executive Order 12866 (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

therefore is not subject to review by the 

Office of Management and Budget. For 

this reason, this action is also not 

subject to Executive Order 13211, 

‘‘Actions Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001). This action merely corrects a 

previous EPA action and imposes no 

additional requirements. Accordingly, 

the Administrator 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.). Because this 

rule corrects a previous EPA action and 

does not impose any additional 

enforceable duty, it does not contain 

any unfunded mandate or significantly 

or uniquely affect small governments, as 

described in the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 6, 2000), requires EPA 

to develop an accountable process to 

ensure ‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ are defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

government and Indian tribes.’’

Under section 5(b) of Executive Order 

13175, EPA may not issue a regulation 

that has tribal implications, that 

imposes substantial direct compliance 

costs, and that is not required by statute, 

unless the Federal government provides 

the funds necessary to pay the direct 

compliance costs incurred by tribal 

governments, or EPA consults with 

tribal officials early in the process of 

developing the proposed regulation. 

Under section 5(c) of Executive Order 

13175, EPA may not issue a regulation 

that has tribal implications and that 

preempts tribal law, unless the Agency 

consults with tribal officials early in the 

process of developing the proposed 

regulation. 

As discussed above, in a previous 

action, EPA excluded the Gila River 

Indian Reservation from the 

metropolitan Phoenix CO area, and this 

action merely corrects the 

corresponding regulatory text. 

Consistent with EPA policy, EPA has 

discussed the need for correction of the 

previous action with representatives of 

the Gila River Indian Community. EPA 

finds that this action, which simply 

corrects an action that the Agency has 

previously taken, will neither impose 

substantial direct compliance costs on 

tribal governments, nor preempt tribal 

law. Thus, the requirements of sections 

5(b) and 5(c) of the Executive Order do 

not apply to this rule. 

This action also does not have 

Federalism implications because it does 

not 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, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

corrects a previous EPA rule, and does 

not alter the relationship or the 

distribution of power and 

responsibilities established in the Clean 

Air Act. This rule also is not subject to 

Executive Order 13045 ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997), because it is not 

economically significant as defined in 

Executive Order 12866, and because the 

Agency does not have reason to believe 

the environmental health or safety risks 

addressed by this rule present a 

disproportionate risk to children. 

52928 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 

This rule does not involve 

establishment of technical standards, 

and thus, the requirements of section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(15 U.S.C. 272 note) do not apply. This 

rule does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.). 

The Congressional Review Act, 5 

U.S.C. section 801 et seq., as added by 

the Small Business Regulatory 

Enforcement Fairness Act of 1996, 

generally provides that before a rule 

may take effect, the agency 

promulgating the rule must submit a 

rule report, which includes a copy of 

the rule, to each House of the Congress 

and to the Comptroller General of the 

United States. EPA will submit a report 

containing this rule and other required 

information to the U.S. Senate, the U.S. 

House of Representatives, and the 

Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. section 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by November 7, 

2005. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this rule for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See CAA 

section 307(b)(2).) 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon monoxide, 

Incorporation by reference, 

Intergovernmental relations, Reporting 

and recordkeeping requirements. 

40 CFR Part 81 

Environmental protection, Air 

pollution control, National parks, 

Wilderness areas. 

Dated: July 15, 2005. 

Laura Yoshii, 

Deputy Regional Administrator, Region IX. 

■ Chapter I, title 40 of the Code of 

Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart D—Arizona 

■ 2. Section 52.120 is amended by 

revising paragraph (c)(118) to read as 

follows: 

§ 52.120 Identification of plan. 

* * * * * 

(c) * * * 

(118) The following plan was 

submitted on April 18, 2001, by the 

Governor’s designee. 

(i) Incorporation by reference. 

(A) Arizona Department of 

Environmental Quality. 

(1) Revised MAG 1999 Serious Area 

Carbon Monoxide Plan for the Maricopa 

County Nonattainment Area, dated 

March 2001, adopted by the Maricopa 

Association of Governments on March 

28, 2001, and adopted by the Arizona 

Department of Environmental Quality 

on April 18, 2001. 

PART 81—[AMENDED] 

■ 1. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart C—Section 107 Attainment 

Status Designations 

■ 2. In § 81.303, the table entitled 

‘‘Arizona—Carbon Monoxide’’ is 

amended by revising the entry for the 

Phoenix Area to read as follows: 

§ 81.303 Arizona. 

* * * * * 

ARIZONA—CARBON MONOXIDE

Designated area 

Designation Classification 

Date Type Date Type 

Phoenix Area: 

Maricopa County (part) ................................................................................................. 4/8/2005 Attainment 

Phoenix nonattainment area boundary: 

1. Commencing at a point which is the intersection of the eastern line of Range 7 

East, Gila and Salt River Baseline and Meridian, and the southern line of point 

Township 2 South, said point is the southeastern corner of Maricopa Association 

of Governments Urban Planning Area, which is the point of beginning; 

2. thence, proceed northerly along the eastern line of Range 7 East, which is the 

common boundary between Maricopa and Pinal Counties, as described in Arizona Revised Statutes Section 11–109, to a point where the eastern line of 

Range 7 East intersects the northern line of Township 1 North, said point is also 

the intersection of the Maricopa County Line and the Tonto National Forest 

Boundary, as established by Executive Order 869 dated July 1, 1908, as amended and and the shown on the U.S. Forest Service 1969 Planimetric Maps; 

3. thence, westerly along the northern line of Township 1 North to pproximately the 

southwest corner of the southeast quarter of Section 35, Township 2 North, 

Range 7 East, said point being the boundary of the Tonto National Forest and 

Usery Mountain Semi-Regional Park; 

4. thence, northerly along the Tonto National Forest Boundary, which is generally 

the western line of the east half of Sections 26 and 35 of Township 2 North, 

Range 7 East, to a point which is where the quarter section line intersects with 

the northern line of Section 26, Township 2 North, Range 7 East, said point also 

being the northeast corner of the Usery Mountain Semi-Regional Park; 

Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 52929 

ARIZONA—CARBON MONOXIDE—Continued 

Designated area 

Designation Classification 

Date Type Date Type 

5. thence, westerly along the Tonto National Forest Boundary, which is generally 

the south line of Sections 19, 20, 21 and 22 and the southern line of the west 

half of Section 23, Township 2 North, Range 7 East, to a point whcih is the 

southwest corner of Section 19, Township 2 North, Range 7 East; 

6. thence, northeasterly along the Tonto National Forest Boundary to a point where 

the Tonto National Forest Boundary intersects with the eastern boundary of the 

Salt River Indian Reservation, generally described as the center line of the Salt 

River Channel; 

7. thence, northeasterly and northerly along the common boundary of the Tonto National Forest and the Salt River Indian Reservation to a point which is the northeast corner of the Salt River Indian Reservation and the southeast corner of the 

Fort McDowell Indian Reservation, as shown on the plat dated July 22, 1902, and 

recorded with the U.S. Government on June 15, 1902; 

8. thence, northeasterly along the common boundary between the Tonto National 

Forest and the Fort McDowell Indian Reservation to a point which is the northeast corner of the Fort McDowell Indian Reservation; 

9. thence, southwesterly along the northern boundary of the Fort McDowell Indian 

Reservation, which line is a common boundary with the Tonto National Forest, to 

a point where the boundary intersects with the eastern line of Section 12, Township 4 North, Range 6 East; 

10. thence, northerly along the eastern line of Range 6 East to a point where the 

eastern line of Range 6 East intersects with the southern line of Township 5 

North, said line is the boundary between the Tonto National Forest and the east 

boundary of McDowell Mountain Regional Park; 

11. thence, westerly along the southern line of Township 5 North to a point where 

the southern line intersects with the eastern line of Range 5 East which line is 

the boundary of Tonto National Forest and the north boundary of McDowell 

Mountain Regional Park; 

12. thence, northerly along the eastern line of Range 5 East to a point where the 

eastern line of Range 5 East intersects with the northern line of Township 5 

North, which line is the boundary of the Tonto National Forest; 

13. thence, westerly along the northern line of Township 5 North to a point where 

the northern line of Township 5 North intersects with the easterly line of Range 4 

East, said line is the boundary of Tonto National Forest; 

14. thence, northerly along the eastern line of Range 4 East to a point where the 

eastern line of Range 4 East intersects with the northern line of Township 6 

North, which line is the boundary of the Tonto National Forest; 

15. thence, westerly along the northern line of Township 6 North to a point of intersection with the Maricopa-Yavapai County line, which is generally described in 

Arizona Revised Statutes Section 11–109 as the center line of the Aqua Fria 

River (Also the north end of Lake Pleasant); 

16. thence, southwesterly and southerly along the Maricopa-Yavapai County line to 

a point which is described by Arizona Revised Statutes Section 11–109 as being 

on the center line of the Aqua Fria River, two miles southerly and below the 

mouth of Humbug Creek; 

17. thence, southerly along the center line of Aqua Fria River to the intersection of 

the center line of the Aqua Fria River and the center line of Beardsley Canal, 

said point is generally in the northeast quarter of Section 17, Township 5 North, 

Range 1 East, as shown on the U.S. Geological Survey’s Baldy Mountain, Arizona Quadrangle Map, 7.5 Minute series (Topographic), dated 1964; 

18. thence, southwesterly and southerly along the center line of Beardsley Canal to 

a point which is the center line of Beardsley Canal where it intersects with the 

center line of Indian School Road; 

19. thence, westerly along the center line of West Indian School Road to a point 

where the center line of West Indian School Road intersects with the center line 

of North Jackrabbit Trail; 

20. thence, southerly along the center line of Jackrabbit Trail approximately nine 

and three-quarter miles to a point where the center line of Jackrabbit Trail intersects with the Gila River, said point is generally on the north-south quarter section line of Section 8, Township 1 South, Range 2 West; 

21. thence, northeasterly and easterly up the Gila River to a point where the Gila 

River intersects with the northern extension of the western boundary of Estrella 

Mountain Regional Park, which point is generally the quarter corner of the northern line of Section 31, Township 1 North, Range 1 West; 

22. thence, southerly along the extension of the western boundary and along the 

western boundary of Estrella Mountain Regional Park to a point where the southern extension of the western boundary of Estrella Mountain Regional Park intersects with the southern line of Township 1 South; 

52930 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 

ARIZONA—CARBON MONOXIDE—Continued 

Designated area 

Designation Classification 

Date Type Date Type 

23. thence, easterly along the southern line of Township 1 South to a point where 

the south line of Township 1 South intersects with the western line of Range 1 

East, which line is generally the southern boundary of Estrella Mountain Regional 

Park; 

24. thence, southerly along the western line of Range 1 East to the southwest corner of Section 18, Township 2 South, Range 1 East, said line is the western 

boundary of the Gila River Indian Reservation; 

25. thence, easterly along the southern boundary of the Gila River Indian Reservation which is the southern line of Sections 13, 14, 15, 16, 17, and 18, Township 2 

South, Range 1 East, to the boundary between Maricopa and Pinal Counties as 

described in Arizona Revised Statutes Sections 11–109 and 11–113, which is the 

eastern line of Range 1 East; 

26. thence, northerly along the eastern boundary of Range 1 East, which is the 

common boundary between Maricopa and Pinal Counties, to a point where the 

eastern line of Range 1 East intersects the Gila River; 

27. thence, southerly up the Gila River to a point where the Gila River intersects 

with the southern line of Township 2 South; and 

28. thence, easterly along the southern line of Township 2 South to the point of beginning which is a point where the southern line of Township 2 South intersects 

with the easter line Range 7 East; 

29. except that portion of the area defined by paragraphs 1 through 28 above that 

lies within the Gila River Indian Reservation. 

* * * * * 

[FR Doc. 05–17539 Filed 9–2–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

CMS–1325–IFC2 

RIN 0938–AN58 

Medicare Program; Competitive 

Acquisition of Outpatient Drugs and 

Biologicals Under Part B: 

Interpretation and Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule; interpretation 

and correction. 

SUMMARY: This interim final rule 

clarifies our timeline for 

implementation of the competitive 

acquisition program under section 

1847B of the Social Security Act and 

corrects technical errors that appeared 

in the addenda to the interim final rule 

with comment period published in the 

Federal Register on July 6, 2005 entitled 

‘‘Competitive Acquisition of Outpatient 

Drugs and Biologicals Under Part B.’’

EFFECTIVE DATE: This rule is effective 

September 6, 2005. 

FOR FURTHER INFORMATION CONTACT: Lia 

Prela, (410) 786–0548. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Clarification of Timeline for 

Implementation of CAP 

On July 6, 2005, we published an 

interim final rule with comment period 

(70 FR 39022) in the Federal Register 

with respect to provisions of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) that require the 

implementation of a competitive 

acquisition program (CAP) for certain 

Medicare Part B drugs not paid on a cost 

or prospective payment system basis. 

Physicians will generally be given a 

choice between obtaining these drugs 

from vendors selected through a 

competitive bidding process or directly 

purchasing these drugs and being paid 

under the average sales price (ASP) 

system. 

In the July 6, 2005 interim final rule, 

we stated that implementation of the 

CAP would take place on January 1, 

2006 to coordinate the CAP physician 

election process with the Medicare 

participating physician election process 

described in section 1842(h) of Social 

Security Act (the Act). Subsequent to 

the publication of the July 6, 2005 

interim final rule, we received 

comments requesting a delay in 

implementation of the CAP from a 

variety of sources including written 

public comments as well as comments 

voiced during the conference call for 

potential vendors that we held on July 

8, 2005. 

Effective August 3, 2005, we 

suspended the vendor bidding process 

that began with publication of the 

interim final rule on July 6, 2005, to 

allow us more time to fully review 

public comments on the interim final 

rule and also to further refine the 

bidding process. We provided 

notification of the suspension on the 

CMS Web site http://www.cms.hhs.gov/ 

providers/drugs/compbid/ and through 

the pharmacy and physician Listservs. 

We will publish a final rule for 

implementing the CAP after we analyze 

the additional comments on the interim 

final rule and determine the best 

manner for improving the efficiency of 

the CAP and increasing potential 

participation of both vendors and 

physicians in the program. 

We will announce the dates for the 

new vendor bidding period concurrent 

with the publication of the final rule. 

We also will be announcing a special 

physician election period. Currently, we 

expect that drugs will first be delivered 

through the CAP by July 2006. During 

the special election period, physicians 

will have the opportunity to elect to 

participate in the CAP from its start date 

in 2006 through the end of calendar year 

2006. 

As we specified in the July 2005 

Federal Register document, we will 

continue to accept comments on the 

interim final rule until September 6, 

2005. 

In section II of this document, we 

provide clarification of the timeline for 

implementation of the CAP as well as 

further interpretation of what will