Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Proposed Rules 51317 

TABLE 4 TO SUBPART FFFFF OF PART 63.—APPLICABILITY OF GENERAL PROVISIONS TO SUBPART FFFFF 

Citation Subject Applies to Subpart 

FFFFF Explanation 

* * * * * * * 

§ 63.6(h)(2)(i) Determining Compliance with Opacity 

and VE Standards.

No ......................... Subpart FFFFF specifies methods and 

procedures for determining compliance with opacity emission and operating limits. 

* * * * * * * 

§ 63.8(a)(1)–(3), (b), (c)(1)–(3), (c)(4)(i)–

(ii), (c)(5)–(6), (c)(7)–(8), (f)(1)–(5), 

(g)(1)–(4).

Monitoring Requirements ..................... Yes ........................ CMS requirements in §§ 63.8(c)(4)(i)–

(ii), (c)(5)–(6), (d), and (e) apply only 

to COMS. 

§ 63.8(a)(4) .............................................. Additional Monitoring Requirements for 

Control Devices in § 63.11.

No ......................... Subpart FFFFF does not require 

flares. 

§ 63.8(c)(4) .............................................. Continuous Monitoring System Requirements.No ......................... Subpart FFFFF specifies requirements 

for operation of CMS. 

§ 63.8(f)(6) ............................................... RATA Alternative .................................. No.

§ 63.8(g)(5) .............................................. Data Reduction .................................... No ......................... Subpart FFFFF specifies data reduction requirements. 

§ 63.9 ...................................................... Notification Requirements .................... Yes ........................ Additional notifications for CMS in 

§ 63.9(g) apply only to COMS. 

§ 63.10(a), (b)(1), (b)(2)(i)–(xii), 

(b)(2)(xiv), (b)(3), (c)(1)–(6), (c)(9)–

(15), (d), (e)(1)–(2), (e)(4), (f) 

Recordkeeping and Reporting Requirements.Yes ........................ Additional records for CMS in 

§ 63.10(c)(1)–(6), (9)–(15), and reports in § 63.10(d)(1)–(2) apply only 

to COMS. 

§ 63.10(b)(2) (xiii) .................................... CMS Records for RATA Alternative .... No.

§ 63.10(c)(7)–(8) ..................................... Records of Excess Emissions and Parameter Monitoring Exceedances for 

CMS.

No ......................... Subpart FFFFF specifies record requirements. 

§ 63.10(e)(3) ............................................ Excess Emission Reports .................... No ......................... Subpart FFFFF specifies reporting requirements. 

* * * * * * * 

[FR Doc. 05–17193 Filed 8–29–05; 8:45 am] 

BILLING CODE 6560–50–U 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 82 

[FRL–7962–3] 

RIN 2060–AN13 

Protection of Stratospheric Ozone: 

Process for Exempting Critical Uses of 

Methyl Bromide for the 2005 

Supplemental Request 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: With this action EPA is 

proposing to authorize use of 610,665 

kilograms of methyl bromide for 

supplemental critical uses in 2005 

through the allocation of additional 

critical stock allowances (CSAs). This 

allocation would supplement the 

critical use allowances (CUAs) and 

CSAs previously allocated for 2005, as 

published in the Federal Register on 

December 23, 2004 (69 FR 76982). 

Further, EPA is proposing to amend the 

existing list of exempted critical uses. 

With today’s action EPA is proposing to 

exempt methyl bromide for critical uses 

beyond the phaseout under the 

authority of the Clean Air Act (CAA or 

the Act) and in accordance with the 

Montreal Protocol on Substances that 

Deplete the Ozone Layer (Protocol). In 

the ‘‘Rules and Regulations’’ section of 

today’s Federal Register, we are 

authorizing these CSAs and critical uses 

as a direct final rule without prior 

proposal because we view this as a 

noncontroversial action and expect no 

adverse comment. We have explained 

our reasons for this authorization in the 

Preamble to the direct final rule. If we 

receive no adverse comment, we will 

not take further action on this proposed 

rule. If we receive adverse comment, we 

will withdraw the direct final rule and 

it will not take effect. We will address 

all public comments in the subsequent 

final rule based on this proposed rule. 

We will not institute a second comment 

period on this action. Any parties 

interested in commenting must do so at 

this time. 

DATES: Written comments on the 

companion direct final rule must be 

received on or before September 29, 

2005, or October 14, 2005 if a hearing 

is requested. Any party requesting a 

public hearing must notify the contact 

person listed below by 5 p.m. Eastern 

Standard Time on September 9, 2005. If 

a hearing is requested it will be held 

September 14, 2005. Persons interested 

in attending a public hearing should 

consult with the contact person below 

regarding the location and time of the 

hearing. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. OAR–2004–

0506, by one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Agency Web site: http:// 

www.epa.gov/edocket. EDOCKET, EPA’s 

electronic public docket and comment 

system, is EPA’s preferred method for 

receiving comments. Follow the on-line 

instructions for submitting comments. 

• E-mail: mebr.allocation@epa.gov 

• Fax: 202–343–2337 attn: Marta 

Montoro 

• Mail: Air Docket, Environmental 

Protection Agency, Mailcode: 6102T, 

1200 Pennsylvania Ave., NW., 

Washington, DC 20460. In addition, 

please mail a copy of your comments on 

the information collection provisions to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

51318 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Proposed Rules 

Budget (OMB), Attn: Desk Officer for 

EPA, 725 17th St. NW., Washington, DC 

20503. 

• Hand Delivery: EPA Air Docket, 

EPA West 1301 Constitution Avenue, 

NW., Room B108, Mail Code 6102T, 

Washington, DC 20460. 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. OAR–2004–0506. 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.epa.gov/ 

edocket, 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 EDOCKET, 

regulations.gov, or e-mail. The EPA 

EDOCKET and the federal 

regulations.gov websites are 

‘‘anonymous access’’ systems, 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 

EDOCKET or regulations.gov, your email 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 name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. 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. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. For additional information 

about EPA’s public docket visit 

EDOCKET on-line or see the Federal 

Register of May 31, 2002 (67 FR 38102). 

Docket: All documents in the docket 

are listed in the EDOCKET index at 

http://www.epa.gov/edocket. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in EDOCKET or in hard 

copy at the Air Docket, EPA/DC, EPA 

West, Room B102, 1301 Constitution 

Ave., NW., Washington, DC 20460. This 

Docket Facility is open from 8:30 a.m. 

to 4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the Air Docket is (202) 566–

1742. 

FOR FURTHER INFORMATION CONTACT: For 

further information about this proposed 

rule, contact Marta Montoro by 

telephone at (202) 343–9321, or by email at mebr.allocation@epa.gov, or by 

mail at Marta Montoro, U.S. 

Environmental Protection Agency, 

Stratospheric Protection Division, 

(6205J), 1200 Pennsylvania Avenue, 

NW., Washington, DC 20460. Overnight 

or courier deliveries should be sent to 

1310 L St. NW., Washington, DC 20005, 

attn: Marta Montoro. You may also visit 

the Ozone Depletion Web site of EPA’s 

Stratospheric Protection Division at 

http://www.epa.gov/ozone/index.html 

for further information about EPA’s 

Stratospheric Ozone Protection 

regulations, the science of ozone layer 

depletion, and other topics. 

SUPPLEMENTARY INFORMATION: This 

document concerns the authorization of 

an additional 610,655 kilograms of 

methyl bromide for approved critical 

uses during 2005, through the allocation 

of CSAs. It also concerns additions to 

the list of approved critical uses for this 

control period. For further information, 

please see the information provided in 

the direct final action that is located in 

the ‘‘Rules and Regulations’’ section of 

this Federal Register publication. 

This action concerns regulation of 

methyl bromide pursuant to the CAA as 

a class I, Group VI ozone-depleting 

substance. Under the CAA, methyl 

bromide production and consumption 

(defined as production plus imports 

minus exports) were phased out on 

January 1, 2005, apart from certain 

exemptions, including the critical use 

exemption, which is the subject of 

today’s rule. In a final rule published 

December 23, 2004 (69 FR 76982), EPA 

established the framework for the 

critical use exemption; set forth a list of 

approved critical uses for 2005; and 

specified the amount of methyl bromide 

that could be supplied in 2005 from 

stocks and new production or import to 

meet approved critical uses. As part of 

that rule, EPA issued critical use 

allowances (CUAs) for new production 

and import and critical stock allowances 

(CSAs) for sale of methyl bromide 

stocks. In today’s action, EPA is 

proposing to add uses of methyl 

bromide to the list of approved critical 

uses and to issue additional CSAs for 

the 2005 control period. These actions 

are in accordance with Decision XVI/2 

of the countries that have ratified the 

Montreal Protocol (the ‘‘Parties’’), taken 

at their November 2004 meeting. 

Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order 12866, (58 FR 

51735, (October 4, 1993)) the Agency 

must determine whether the regulatory 

action is ‘‘significant’’ and therefore 

subject to OMB review and the 

requirements of the Executive Order. 

The Order defines ‘‘significant 

regulatory action’’ as one that is likely 

to result in a rule that may: 

(1) Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy, a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

State, local, or tribal governments or 

communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; 

(3) Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. 

Pursuant to the terms of Executive 

Order 12866, OMB has notified EPA 

that it considers this a ‘‘significant 

regulatory action’’ within the meaning 

of the Executive Order. EPA has 

submitted this action to OMB for 

review. Changes made in response to 

OMB suggestions will be documented in 

the public record. 

This proposed action will likely have 

a minor cost savings associated with its 

implementation, but the Agency did not 

conduct a formal analysis of savings 

given that such an analysis would have 

resulted in negligible savings. This 

proposed action represents the 

authorization only 2.5% of 1991 

consumption baseline of methyl 

bromide to be made available for critical 

uses. 

B. Paperwork Reduction Act 

The information collection 

requirements in this rule have been 

submitted for approval to the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. The Information Collection 

Request (ICR) document prepared by 

EPA has been assigned EPA ICR number 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Proposed Rules 51319 

1432.28 and OMB Control Number 

2060–0170. This rule supplements the 

rule published in the Federal Register 

on December 23, 2004 (69 FR 76982). 

The information collection under these 

rules is authorized under Sections 

603(b), 603(d) and 614(b) of the Clean 

Air Act (CAA). 

The mandatory reporting 

requirements included in these rules are 

intended to: 

(1) Satisfy U.S. obligations under the 

international treaty, The Montreal 

Protocol on Substances that Deplete the 

Ozone Layer (Protocol), to report data 

under Article 7; 

(2) Fulfill statutory obligations under 

Section 603(b) of Title VI of the Clean 

Air Act Amendments of 1990 (CAA) for 

reporting and monitoring; 

(3) Provide information to report to 

Congress on the production, use and 

consumption of class I controlled 

substances as statutorily required in 

Section 603(d) of Title VI of the CAA. 

In this rule, EPA is proposing to 

amend the Reporting and 

Recordkeeping Requirements in 40 CFR 

part 82 to require that entities report the 

amount of pre-phaseout methyl bromide 

inventory, held for sale or for transfer to 

another entity, to the Agency on an 

annual basis. Pre-phaseout refers to 

inventories of methyl bromide produced 

or imported prior to January 1, 2005. 

This additional requirement will allow 

EPA to track the drawdown of prephaseout inventories. 

Collection activity Number of 

respondents 

Total number 

of responses 

Hours per 

response Total hours 

Rule Familiarization ......................................................................................... 54 54 .5 27 

Data Compilation (annual basis) ..................................................................... 54 54 .5 27 

Data Reporting (annual basis) ......................................................................... 54 54 .5 27 

Total Burden Hours .................................................................................. ........................ 162 ........................ 81 

EPA informs respondents that they 

may assert claims of business 

confidentiality for any of the 

information they submit. Information 

claimed confidential will be treated in 

accordance with the procedures for 

handling information claimed as 

confidential under 40 CFR part 2, 

Subpart B, and will be disclosed only to 

the extent, and by means of the 

procedures, set forth in that subpart. If 

no claim of confidentiality is asserted 

when the information is received by 

EPA, it may be made available to the 

public without further notice to the 

respondents (40 CFR 2.203). 

Burden means the total time, effort, or 

financial resources expended by persons 

to generate, maintain, retain, or disclose 

or provide information to or for a 

Federal agency. This includes the time 

needed to review instructions; develop, 

acquire, install, and utilize technology 

and systems for the purposes of 

collecting, validating, and verifying 

information; process and maintain 

information; disclose and provide 

information; adjust the existing ways to 

comply with any previously applicable 

instructions and requirements; train 

personnel to be able to respond to a 

collection of information; search data 

sources; complete and review the 

collection of information; and transmit 

or otherwise disclose the information. 

An Agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations are listed 

in 40 CFR part 9 and 48 CFR Chapter 

15. 

When this ICR is approved by OMB, 

the Agency will publish a technical 

amendment to 40 CFR part 9 in the 

Federal Register to display the OMB 

control number for the approved 

information collection requirements 

contained in these rules. 

To obtain comment on the Agency’s 

need for this information, the accuracy 

of the provided burden estimates, and 

any suggested methods for minimizing 

respondent burden, including the use of 

automated collection techniques. EPA 

has established a public docket for this 

rule, which includes this ICR, under 

Electronic Docket ID number OAR–

2004–0506. Submit any comments 

related to the rule ICR for this proposed 

rule to EPA and OMB. See ‘‘Addresses’’

Section at the beginning of this notice 

for where to submit comments to EPA. 

Send comments to OMB at the Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 725 

17th Street NW., Washington DC 20503 

attn: Desk Officer for EPA. Include the 

EPA ICR number 1432.28 in 

correspondence related to this ICR. 

Since OMB is required to make a 

decision concerning the ICR between 30 

and 60 days after August 30, 2005, a 

comment to OMB is best assured of 

having its full effect if OMB receives it 

by September 29, 2005. The final rule 

will respond to any OMB or public 

concerns on the information collection 

requirements contained in this proposal. 

C. Regulatory Flexibility Act (RFA) 

The RFA generally requires an agency 

to prepare a regulatory flexibility 

analysis of any rule subject to noticeand-comment rulemaking requirements 

under the Administrative Procedure Act 

or any other statute unless the agency 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small entities include small businesses, 

small organizations, and small 

governmental jurisdictions. For 

purposes of assessing the impacts of 

today’s rule on small entities, small 

entity is defined as: (1) A small business 

that is identified by the North American 

Industry Classification System (NAICS) 

Code in the Table below; (2) a small 

governmental jurisdiction that is a 

government of a city, county, town, 

school district or special district with a 

population of less than 50,000; and (3) 

a small organization that is any not-forprofit enterprise which is independently 

owned and operated and is not 

dominant in its field. 

51320 Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Proposed Rules 

Category NAICS code SIC code 

NAICS small 

business size 

standard 

(in number of 

employees or 

millions of 

dollars) 

Agricultural Production .. 1112—Vegetable and Melon farming .................. 0171—Berry .........................................................

0171—Berry Crops ...............................................

$0.75 

1114—Greenhouse, Nursery, and Floriculture 

Production.

0181—Ornamental Floriculture and Nursery 

products.

Storage Uses ................. 115114—Postharvest crop activities (except Cotton Ginning).4221—Farm Product Warehousing and Storage $21.5 

493110—General Warehousing and Storage ...... 4225—General Warehousing and Storage.

493130—Farm product Warehousing Storage.

Agricultural producers of minor crops 

and entities that store agricultural 

commodities are categories of affected 

entities that contain small entities. This 

rule only affects entities that applied to 

EPA for a de-regulatory exemption. In 

most cases, EPA received aggregated 

requests for exemptions from industry 

consortia. On the exemption 

application, EPA asked consortia to 

describe the number and size 

distribution of entities their application 

covered. Based on the data provided, 

EPA estimates that there are 3,218 

entities that petitioned EPA for an 

exemption. Since many applicants did 

not provide information on the 

distribution of sizes of entities covered 

in their applications, EPA estimated that 

between 1⁄4 to 1⁄3 of the entities may be 

small businesses based on the definition 

given above. In addition, other 

categories of affected entities do not 

contain small businesses based on the 

above description. 

After considering the economic 

impacts of today’s proposed rule on 

small entities, EPA certifies that this 

action will not have a significant 

economic impact on a substantial 

number of small entities. The small 

entities directly regulated by this 

proposed rule are primarily agricultural 

entities, producers, importers, and 

distributors of methyl bromide, as well 

as any entities holding inventory of 

methyl bromide. 

In determining whether a rule has a 

significant economic impact on a 

substantial number of small entities, the 

impact of concern is any significant 

adverse economic impact on small 

entities, since the primary purpose of 

the regulatory flexibility analyses is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the 

proposed rule on small entities.’’ (5 

U.S.C. §§ 603–604). Thus, an Agency 

may certify that a rule will not have a 

significant economic impact on a 

substantial number of small entities if 

the rule relieves a regulatory burden, or 

otherwise has a positive economic effect 

on all of the small entities subject to the 

rule. Since this rule will make 

additional methyl bromide available for 

approved critical uses after the phaseout 

date of January 1, 2005, this is a deregulatory action which will confer a 

benefit to users of methyl bromide. EPA 

believes the estimated de-regulatory 

value for users of methyl bromide is 

between $20 million to $30 million 

annually, as a result of the entire critical 

use exemption program over its 

projected duration. We have therefore 

concluded that today’s proposed rule 

will relieve regulatory burden for all 

small entities. We continue to be 

interested in the potential impacts of the 

proposed rule on small entities and 

welcome comments on issues related to 

such impacts. 

D. Unfunded Mandates Reform Act 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA), Public 

Law 104–4, establishes requirements for 

Federal agencies to assess the effects of 

their regulatory actions on State, local 

and tribal governments and the private 

sector. Under Section 202 of the UMRA, 

EPA generally must prepare a written 

statement, including a cost-benefit 

analysis, for proposed and final rules 

with ‘‘Federal mandates’’ that may 

result in expenditures by State, local 

and tribal governments, in the aggregate, 

or by the private sector, of $100 million 

or more in any one year. Before 

promulgating an EPA rule for which a 

written statement is needed, section 205 

of the UMRA generally requires EPA to 

identify and consider a reasonable 

number of regulatory alternatives and 

adopt the least costly, most costeffective or least burdensome alternative 

that achieves the objectives of the rule. 

The provisions of section 205 do not 

apply when they are inconsistent with 

applicable law. Moreover, section 205 

allows EPA to adopt an alternative other 

than the least-costly, most cost-effective, 

or least burdensome alternative of the 

Administrator publishes with the final 

rule an explanation why that alternative 

was not adopted. Before EPA establishes 

any regulatory requirements that may 

significantly or uniquely affect small 

governments, including tribal 

governments, it must have developed 

under section 203 of UMRA a small 

government agency plan. The plan must 

provide for notifying potentially 

affected small governments, enabling 

officials of affected small governments 

to have meaningful and timely input in 

the development of EPA regulatory 

proposals with significant Federal 

intergovernmental mandates, and 

informing, educating, and advising 

small governments on compliance with 

the regulatory requirements. 

EPA has determined that this rule 

does not contain a Federal mandate that 

may result in expenditures of $100 

million or more by State, local and tribal 

governments, in the aggregate, or by the 

private sector, in any one year. Today’s 

proposed rule contains only one new 

mandate, which is the reporting 

requirement for the drawdown of prephaseout inventories. Today’s 

amendment does not create a Federal 

mandate resulting in costs of $100 

million or more in any one year for 

State, local and tribal governments, in 

the aggregate, or for the private sector. 

Thus, today’s proposed rule is not 

subject to the requirements of Sections 

202 and 205 of the UMRA. 

EPA has also determined that this 

proposed rule contains no regulatory 

requirements that might significantly or 

uniquely affect small governments; 

therefore, EPA is not required to 

develop a plan with regard to small 

governments under Section 203. Finally, 

because this proposal does not contain 

a significant intergovernmental 

mandate, the Agency is not required to 

develop a process to obtain input from 

elected State, local, and tribal officials 

under Section 204. 

Federal Register / Vol. 70, No. 167 / Tuesday, August 30, 2005 / Proposed Rules 51321 

E. Executive Order 13132: Federalism 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that 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.’’

This proposed rule does not have 

federalism implications. It will 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. Today’s 

proposed rule is expected to primarily 

affect producers, suppliers, importers 

and exporters and users of methyl 

bromide. Thus, Executive Order 13132 

does not apply to this proposed rule. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 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.’’ This proposed rule does 

not have tribal implications, as specified 

in Executive Order 13175. Today’s 

proposed rule does not significantly or 

uniquely affect the communities of 

Indian tribal governments. The 

proposed rule does not impose any 

enforceable duties on communities of 

Indian tribal governments. Thus, 

Executive Order 13175 does not apply 

to this proposed rule. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

Executive Order 13045: ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997) applies to any rule that: 

(1) is determined to be ‘‘economically 

significant’’ as defined under E.O. 

12866, and (2) concerns an 

environmental health or safety risk that 

EPA has reason to believe may have a 

disproportionate effect on children. If 

the regulatory action meets both criteria, 

the Agency must evaluate the 

environmental health or safety effects of 

the planned rule on children, and 

explain why the planned regulation is 

preferable to other potentially effective 

and reasonably feasible alternatives 

considered by the Agency. 

EPA interprets E.O. 13045 as applying 

only to those regulatory actions that are 

based on health or safety risks, such that 

the analysis required under Section 5–

501 of the Order has the potential to 

influence the regulation. This proposed 

rule is not subject to E.O. 13045 because 

it does not establish an environmental 

standard intended to mitigate health or 

safety risks. 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not a ‘‘significant energy 

action’’ as defined in Executive Order 

13211, ‘‘Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

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

22, 2001) because it is not likely to have 

a significant adverse effect on the 

supply, distribution, or use of energy. 

This rule does not pertain to any 

segment of the energy production 

economy nor does it regulate any 

manner of energy use. Further, we have 

concluded that this rule is not likely to 

have any adverse energy effects. 

I. The National Technology Transfer 

and Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Pub. L. 104–

113, section 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. This 

rulemaking does not involve technical 

standards. Therefore, EPA is not 

considering the use of any voluntary 

consensus standards. 

Dated: August 23, 2005. 

Stephen L. Johnson, 

Administrator. 

[FR Doc. 05–17190 Filed 8–29–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 410 

[CMS–6024–P] 

RIN 0938–AN10 

Medicare Program; Prior Determination 

for Certain Items and Services 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: Section 938 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 requires the 

Secretary to establish a process for 

Medicare contractors to provide eligible 

participating physicians and 

beneficiaries with a determination of 

coverage relating to medical necessity 

for certain physicians’ services before 

the services are furnished. This rule is 

intended to afford the physician and 

beneficiary the opportunity to know the 

financial liability for a service before 

expenses are incurred. This proposed 

rule would establish reasonable limits 

on physicians’ services for which a prior 

determination of coverage may be 

requested and discusses generally our 

plans for establishing the procedures by 

which those determinations may be 

obtained. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on October 31, 2005. 

ADDRESSES: In commenting, please refer 

to file code CMS–6024–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (fax) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments to http:// 

www.cms.hhs.gov/regulations/ 

ecomments or to http:// 

www.regulations.gov (attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word). 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: Centers 

for Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–6024–P, P.O. 

Box 8017, Baltimore, MD 21244–8017. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period.