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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 E.PA 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-OAR2005-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 difficultiesand 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 (AIR2), U.S. Environmental Protection

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

SUPPLEMENTARY INFORMATION:

Throughout this document, the terms

"we," "us," and "our" refer to EPA.

Table of Contents

I. Background

II. Final Action

II. Statutory and Executive Order Reviews

I. Background

On March 9, 2005, pursuant to the

Clean Air Act (CAA), we publishedi 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

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

exclude the Gila River Indian

Reservation is appropriate and are

taking action today to re-codify this

redesignation in a manner that avoids

theunintended 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 remoee the phrase that we added in our March 9th final rule

(i.e., "except-that portion ih 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,

cl assification, 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 8'1, 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 moffoxide

National Ambient Air Quality

Standards, and redesignating the

boundary of the metropolitan Phoenix

CO area to exclude the Gila River Indian

Reservation. Specifically, this adtion

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 publislh 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.

Ill. 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 Governmehts" (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 FederaJ

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.

52927

HeinOnline -- 70 Fed. Reg. 52927 2005
52928 Federal Register/Vol. 70, No. 171 / Tuesday, September 6, 2005 /Rules -and Regulations

This rule does not involve

establishm'ent 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 Represeritatives, 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.

w Chapter I, title 40 of the Code of

Federal Regulations is amended as

follows:

PART 52-[AMENDED]

m 1. The authority citation for part 52

continues to read as follows:

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

Subpart D-Arizona

m. 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]

m 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

m 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

Designation" Classification

Designated area Date Type Date Type

Phoenix Area:

M aricopa C ounty (part) ..................................................................................................

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 Planirnetric 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 comer of the Usery Mountain Semi-Regional Park;

4/8/2005 1 Attainment

HeinOnline -- 70 Fed. Reg. 52928 2005
Federal: Register / Vol.,' 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations

ARIZONA-CARBON MONOXIDE-Continued

Designation Classification

Designated area Date Type Date Type

52929

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 Natiorfal 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 Easito a point where the

eastern line of Range 5 East intersects with., the northern line of To~vnship 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 northem 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

Arzona 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 asbeing

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 Fra 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 N6rth 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;

HeinOnline -- 70 Fed. Reg. 52929 2005
52930 Federal Registqr/Vol. 70, No. 171,/Tuesday, September_ 6, 2005i/RRjtes and Reguiations:

ARIZONA-CARBON MONOXIDE -Continued

Designation. Classification

Designated area

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 boundaryof 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 Manc6pa 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.govproviders/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 pro gra.

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

HeinOnline -- 70 Fed. Reg. 52930 2005