36424 Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules 

Applicability 

(c) This AD applies to Rolls-Royce plc 

models RB211 Trent 875–17, –877–17, –884– 

17, –884B–17, –892–17, –892B–17, and 

–895–17 turbofan engines with fuel-to-oil 

heat exchangers, part numbers 55003001–1 

and 55003001–11, installed. These engines 

are installed on, but not limited to, Boeing 

777 series airplanes. 

Reason 

(d) This AD results from the risk of engine 

fuel-to-oil heat exchanger (FOHE) blockage. 

We are issuing this AD to prevent ice from 

blocking the FOHE, which could result in an 

unacceptable engine power loss, and loss of 

control of the airplane. 

Actions and Compliance 

(e) Unless already done, within 6,000 flight 

hours after the effective date of this AD, but 

no later than January 1, 2011, replace the 

FOHE, P/N 55003001–1 or 55003001–11, 

with an FOHE that does not have a P/N or 

equivalent listed in this AD. 

FAA AD Differences 

(f) This AD differs from the Mandatory 

Continuing Airworthiness Information 

(MCAI) by requiring replacing the FOHE 

within 6,000 flight hours after the effective 

date of this AD, but no later than January 1, 

2011. 

Other FAA AD Provisions 

(g) Alternative Methods of Compliance 

(AMOCs): The Manager, Engine Certification 

Office, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. 

Related Information 

(h) Refer to MCAI Airworthiness Directive 

2009–0142, dated July 13, 2009, and RollsRoyce plc Alert Service Bulletin RB.211–79– 

AG257, dated June 24, 2009, for related 

information. Contact Rolls-Royce plc, P.O. 

Box 31, DERBY, DE24 8BJ, UK; telephone 44 

(0) 1332 242424; fax 44 (0) 1332 249936, for 

a copy of this service information. 

(i) Contact James Lawrence, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine and Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; e-mail: james.lawrence@faa.gov; 

telephone (781) 238–7176; fax (781) 238– 

7199, for more information about this AD. 

Issued in Burlington, Massachusetts, on 

July 17, 2009. 

Peter A. White, 

Assistant Manager, Engine and Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. E9–17470 Filed 7–22–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–327] 

Schedules of Controlled Substances: 

Placement of Fospropofol Into 

Schedule IV 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposed rule is issued 

by the Deputy Administrator of the Drug 

Enforcement Administration (DEA) to 

place the substance fospropofol, 

including its salts, isomers and salts of 

isomers whenever the existence of such 

salts, isomers, and salts of isomers is 

possible, into schedule IV of the 

Controlled Substances Act (CSA). This 

proposed action is based on a 

recommendation from the Acting 

Assistant Secretary for Health of the 

Department of Health and Human 

Services (DHHS) and on an evaluation 

of the relevant data by DEA. If finalized, 

this action would impose the regulatory 

controls and criminal sanctions of 

schedule IV on those who handle 

fospropofol and products containing 

fospropofol. 

DATES: Written comments must be 

postmarked on or before August 24, 

2009, and electronic comments must be 

sent on or before midnight Eastern time 

August 24, 2009. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–327’’ on all written and 

electronic correspondence. Written 

comments sent via regular or express 

mail should be sent to the Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, Virginia 22152. Comments 

may be sent to DEA by sending an 

electronic message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the 

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

DEA will accept electronic comments 

containing Microsoft Word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file format other than those specifically 

listed here. 

Please note that DEA is requesting 

that electronic comments be submitted 

before midnight Eastern Time on the 

day the comment period closes because 

http://www.regulations.gov terminates 

the public’s ability to submit comments 

at midnight Eastern time on the day the 

comment period closes. Commenters in 

time zones other than Eastern time may 

want to consider this so that their 

electronic comments are received. All 

comments sent via regular or express 

mail will be considered timely if 

postmarked on the day the comment 

period closes. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, Ph.D., Chief, 

Drug and Chemical Evaluation Section, 

Office of Diversion Control, Drug 

Enforcement Administration, 8701 

Morrissette Drive, Springfield, Virginia 

22152, Telephone: (202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments: Please 

note that all comments received are 

considered part of the public record and 

made available for public inspection 

online at http://www.regulations.gov 

and in the DEA’s public docket. Such 

information includes personal 

identifying information (such as your 

name, address, etc.) voluntarily 

submitted by the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the DEA’s public docket file. 

Please note that the Freedom of 


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Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules 36425 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the ‘‘For 

Further Information’’ paragraph. 

Background 

On December 12, 2008, the Food and 

Drug Administration (FDA) approved 

fospropofol for marketing under the 

trade name Lusedra® in the United 

States as a drug product indicated for 

monitored anesthesia care (MAC) 

sedation in adult patients undergoing 

diagnostic or therapeutic procedures. 

Lusedra® will be available as 35 

milligrams/ml of fospropofol disodium 

solution for intravenous (i.v.) use. 

Fospropofol acts as a central nervous 

system (CNS) depressant and is 

classified as a sedative-hypnotic. 

Fospropofol, 2,6- 

diisopropopylphenoxymethyl 

phosphate disodium, is a water soluble, 

phosphono-O-methyl prodrug of 

propofol. It is metabolized in the body 

to propofol, the active metabolite. 

Propofol has been available for medical 

use in the United States since 1989 and 

is not currently a controlled substance. 

The pharmacological effects of 

fospropofol are attributed to the 

pharmacological actions of propofol. 

Fospropofol elicits behavioral effects 

similar to methohexital and midazolam, 

schedule IV sedative-hypnotics. 

The receptor binding profile of 

fospropofol has been shown to be 

similar to that of propofol (DHHS 

evaluation, 2008). Propofol binds to gaminobutyric acid (GABAA) receptor 

and acts as a modulator by potentiating 

the activity of GABA at this receptor. 

Other psychoactive drugs, e.g., 

barbiturates, benzodiazepines, and 

volatile anesthetics, potentiate activity 

of GABA at the GABAA receptor. 

Propofol also inhibits the activity of the 

N-methyl-D-asparate (NMDA) receptor; 

as does ketamine, another anesthetic 

with significant abuse potential. 

Since propofol is the active metabolite 

of fospropofol, the abuse potential of 

fospropofol is comparable to that of 

propofol. Animal self-administration 

studies demonstrated that the 

reinforcing effects of propofol are 

relatively low and comparable to 

midazolam and other schedule IV 

benzodiazepines. Both drug-naı ̈ve and 

methohexital-trained (schedule IV 

barbiturate) rats self-administer propofol 

under a fixed ratio schedule. In baboons 

after substituting for cocaine, 

subanesthetic doses of propofol 

maintained low-to-high levels of selfadministration. 

Schedule IV sedative-hypnotics like 

methohexital and midazolam are known 

to produce euphoric moods as adverse 

events and have histories of abuse in the 

U.S. and elsewhere. The adverse events 

associated with fospropofol are similar 

to those experienced with schedule IV 

sedative-hypnotics. In humans, the most 

commonly reported adverse events were 

paresthesia (abnormal skin sensations, 

e.g., burning, itching), pruritus (itching), 

headache, and dizziness. In nine 

clinical studies in healthy humans (n = 

273), subjects were administered 

intravenous (i.v.) fospropofol. Within 

that population, 0.7 percent reported 

euphoria and disorientation adverse 

events (DHHS evaluation, 2008). 

The current abuse profiles of 

propofol, the active metabolite of 

fospropofol, indicate that propofol is 

abused by medical professionals since 

they have access to the drug in medical 

facilities which perform anesthesia, 

according to the Adverse Event 

Reporting System (AERS) DataMart 

database (DHHS evaluation, 2008). 

Although the fospropofol product 

Lusedra® will be marketed as an i.v. 

dosage form, in the New Drug 

Application (NDA) submitted to the 

DHHS, it has been demonstrated that 

after oral administration fospropofol is 

active in the body. The oral activity of 

fospropofol increases the likelihood of 

its abuse by other routes of 

administration and its use to commit 

other crimes (e.g., date-rape). 

Withdrawal symptoms observed upon 

ceasing long-term administration of a 

substance are indicative of a substance’s 

ability to produce physical dependence. 

The effects of long-term administration 

of fospropofol were not studied in the 

clinical trials so the dependence 

potential of fospropofol is best 

demonstrated by the withdrawal 

syndrome associated with long-term use 

of propofol. There have been published 

reports of withdrawal symptoms upon 

abrupt cessation of administration of 

propofol after several days of treatment. 

The symptoms included agitation, 

tremors, tachycardia, tachypnea, 

hyperpyrexia, confusion, and 

hallucinations. These symptoms are 

similar to the symptoms observed upon 

withdrawal from benzodiazepines. 

Withdrawal symptoms improve once 

administration of propofol is reinitiated. 

A delusional state lasting up to seven 

days may occur before full mental 

functioning returns. 

References to the above studies may 

be found in the Health and Human 

Services scheduling recommendation 

and DEA’s independent analysis, both 

of which are available on the electronic 

docket associated with this rule making. 

Since fospropofol is a new molecular 

entity, there has been no evidence of 

diversion, abuse, or law enforcement 

encounters involving the drug. On 

February 27, 2009, the Acting Assistant 

Secretary for Health, Department of 

Health and Human Services (DHHS), 

sent the Deputy Administrator of DEA a 

scientific and medical evaluation and a 

letter recommending that fospropofol be 

placed into schedule IV of the CSA. 

Enclosed with the February 27, 2009, 

letter was a document prepared by the 

FDA entitled, ‘‘Basis for the 

Recommendation for Control of 

Fospropofol and Its Salts in Schedule IV 

of the CSA.’’ The document contained a 

review of the factors which the CSA 

requires the Secretary to consider (21 

U.S.C. 811(b)). 

The factors considered by the 

Assistant Secretary of Health and DEA 

with respect to fospropofol were: 

1. Its actual or relative potential for 

abuse; 

2. Scientific evidence of its 

pharmacological effects; 

3. The state of current scientific 

knowledge regarding the drug; 

4. Its history and current pattern of 

abuse; 

5. The scope, duration, and 

significance of abuse; 

6. What, if any, risk there is to the 

public health; 

7. Its psychic or physiological 

dependence liability; and 

8. Whether the substance is an 

immediate precursor of a substance 

already controlled under this 

subchapter. (21 U.S.C. 811(c)) 

Based on the recommendation of the 

Assistant Secretary for Health, received 

in accordance with section 201(b) of the 

Act (21 U.S.C. 811(b)), and the 

independent review of the available 

data by DEA, the Deputy Administrator 

of DEA, pursuant to sections 201(a) and 

201(b) of the Act (21 U.S.C. 811(a) and 

811(b)), finds that: 

1. Fospropofol has a low potential for 

abuse relative to the drugs or substances 

in schedule III. Although there is no 

direct comparison to a schedule III 

substance, this finding is based on the 

demonstration of the abuse potential of 

propofol, the active metabolite, relative 

to the schedule IV substances, 

methohexital and midazolam; 

2. Fospropofol has a currently 

accepted medical use in treatment in the 

U.S.; Fospropofol under the trade name 

Lusedra® was approved for marketing as 

a product indicated for monitored 

anesthesia care by FDA on December 12, 

2008; and 

3. Abuse of fospropofol may lead to 

limited physical dependence or 

psychological dependence relative to 

the drugs or other substances in 

schedule III. This finding is based on 


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36426 Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules 

the symptoms exhibited upon 

withdrawal from propofol. 

Based on these findings, the Deputy 

Administrator of DEA concludes that 

fospropofol, including its salts, isomers 

and salts of isomers whenever the 

existence of such salts, isomers, and 

salts of isomers is possible warrants 

control in schedule IV of the CSA. (21 

U.S.C. 812(b)(4)) 

Comments and Requests for Hearing 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of the Administrative 

Procedure Act (5 U.S.C. 556 and 557). 

All persons are invited to submit their 

comments or objections with regard to 

this proposal. Requests for a hearing 

may be submitted by interested persons 

and must conform to the requirements 

of 21 CFR 1308.44 and 1316.47. The 

request should state, with particularity, 

the issues concerning which the person 

desires to be heard and the requestor’s 

interest in the proceeding. Only 

interested persons, defined in the 

regulations as those ‘‘adversely affected 

or aggrieved by any rule or proposed 

rule issuable pursuant to section 201 of 

the Act (21 U.S.C. 811),’’ may request a 

hearing. 21 CFR 1308.42. Please note 

that DEA may grant a hearing only ‘‘for 

the purpose of receiving factual 

evidence and expert opinion regarding 

the issues involved in the issuance, 

amendment or repeal of a rule issuable’’ 

pursuant to 21 U.S.C. 811(a). All 

correspondence regarding this matter 

including comments, objections, and 

requests for hearing should be 

submitted to DEA using the address 

information provided above. 

Requirements for Handling Fospropofol 

If this rule is finalized as proposed, 

fospropofol would be subject to CSA 

regulatory controls and administrative, 

civil and criminal sanctions applicable 

to the manufacture, distribution, 

dispensing, importing and exporting of 

a schedule IV controlled substance, 

including the following: 

Registration. Any person who 

manufactures, distributes, dispenses, 

imports, exports, engages in research or 

conducts instructional activities with 

fospropofol, or who desires to 

manufacture, distribute, dispense, 

import, export, engage in instructional 

activities or conduct research with 

fospropofol, would need to be registered 

to conduct such activities in accordance 

with 21 CFR part 1301. 

Security. Fospropofol would be 

subject to Schedules III–V security 

requirements and would need to be 

manufactured, distributed, and stored in 

accordance with 21 CFR 1301.71, 

1301.72(b), (c), and (d), 1301.73, 

1301.74, 1301.75(b) and (c), 1301.76, 

and 1301.77. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of fospropofol which are distributed on 

or after finalization of this rule would 

need to comply with requirements of 21 

CFR 1302.03–1302.07. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of fospropofol would be 

required to keep an inventory of all 

stocks of fospropofol on hand pursuant 

to 21 CFR 1304.03, 1304.04 and 1304. 

Every registrant who desires registration 

in schedule IV for fospropofol would be 

required to conduct an inventory of all 

stocks of the substance on hand at the 

time of registration. 

Records. All registrants would be 

required to keep records pursuant to 21 

CFR 1304.03, 1304.04, 1304.21, 1304.22, 

and 1304.23. 

Prescriptions. All prescriptions for 

fospropofol or prescriptions for 

products containing fospropofol would 

be required to be issued pursuant to 21 

CFR 1306.03–1306.06 and 1306.21, 

1306.22–1306.27. 

Importation and Exportation. All 

importation and exportation of 

fospropofol would need to be in 

compliance with 21 CFR part 1312. 

Criminal Liability. Any activity with 

fospropofol not authorized by, or in 

violation of, the CSA or the Controlled 

Substances Import and Export Act 

occurring on or after finalization of this 

proposed rule would be unlawful. 

Regulatory Certifications 

Executive Order 12866 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

section 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), has 

reviewed this proposed rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

Fospropofol products will be used for 

monitored anesthesia care (MAC) 

sedation in adult patients undergoing 

diagnostic or therapeutic procedures. 

Handlers of fospropofol will also handle 

other controlled substances used for 

sedation which are already subject to 

the regulatory requirements of the CSA. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of State law; nor 

does it impose enforcement 

responsibilities on any State; nor does it 

diminish the power of any State to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local and Tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

provisions of the Unfunded Mandates 

Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in costs or prices: or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

Under the authority vested in the 

Attorney General by section 201(a) of 

the CSA (21 U.S.C. 811(a)), and 

delegated to the Administrator of DEA 

by Department of Justice regulations (28 

CFR 0.100), and redelegated to the 

Deputy Administrator pursuant to 28 

CFR 0.104, the Deputy Administrator 

hereby proposes that 21 CFR part 1308 

be amended as follows: 


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Federal Register / Vol. 74, No. 140 / Thursday, July 23, 2009 / Proposed Rules 36427 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

2. Section 1308.14 is amended in 

paragraph (c), by redesignating 

paragraphs (c)(23) through (c)(51) as 

paragraphs (c)(24) through (c)(52) and 

adding a new paragraph (c)(23) as 

follows: 

§ 1308.14 Schedule IV. 

* * * * * 

(c) * * * 

(23) Fospropofol .................................. 2138 

* * * * * 

Dated: July 16, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–17538 Filed 7–22–09; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–HQ–OAR–2003–0062: FRL–8934–3] 

RIN 2060–AP65 

Implementation of the New Source 

Review (NSR) Program for Particulate 

Matter Less Than 2.5 Micrometers 

(PM2.5); Proposal To Extend 

Administrative Stay 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The EPA is proposing to 

extend for an additional nine months 

the existing administrative stay of the 

‘‘grandfathering’’ provision for 

particulate matter less than 2.5 

micrometers (PM2.5) requirements in the 

Federal Prevention of Significant 

Deterioration (PSD) program published 

in the Federal Register on May 16, 2008 

as part of the final rule entitled, 

‘‘Implementation of the New Source 

Review (NSR) Program for Particulate 

Matter Less Than 2.5 Micrometers 

(PM2.5).’’ The grandfathering provision 

under the Federal PSD program allows 

the permitting authority to review PSD 

permit applications received before July 

15, 2008 according to EPA’s 1997 policy 

of satisfying the requirements for 

particulate matter less than 10 

micrometers (PM10) as a surrogate for 

meeting the new requirements for PM2.5. 

The existing administrative stay is in 

effect for three months; that is, from 

June 1, 2009 until September 1, 2009. 

This action proposes to extend the 

existing administrative stay by an 

additional nine months, which we 

believe will allow for sufficient time for 

EPA to propose, take public comment 

on, and issue a final action concerning 

the repeal of the grandfathering 

provision for PM2.5 in the Federal PSD 

program. 

DATES: Comments must be received on 

or before August 24, 2009. 

Public Hearing. If anyone contacts 

EPA requesting the opportunity to speak 

at a public hearing concerning the 

proposed regulation by August 3, 2009, 

we will hold a public hearing on August 

7, 2009. If a hearing is held, the record 

for the hearing will remain open until 

September 8, 2009. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OAR–2003–0062, by one of the 

following methods: 

• http://www.regulations.gov. Follow 

the online instructions for submitting 

comments. 

• E-mail: a-and-r-docket@epa.gov. 

• Fax: (202) 566–1741. 

• Mail: Air and Radiation Docket, 

Environmental Protection Agency, Mail 

code 6102T, 1200 Pennsylvania Avenue, 

NW., Washington, DC 20460. 

• Hand Delivery: EPA Docket Center, 

Public Reading Room, EPA West, Room 

3334, 1301 Constitution Ave., NW., 

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 

the applicable docket. EPA’s policy is 

that all comments received will be 

included in the public docket without 

change and may be made available 

online at http://www.regulations.gov, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information that you consider to be CBI 

or otherwise protected through http:// 

www.regulations.gov or e-mail. The 

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

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

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. 

Public Hearing. If a public hearing is 

held, it will be held at the U.S. 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20004. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, e.g., 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 through http:// 

www.regulations.gov or in hard copy at 

the EPA Docket Center, Public Reading 

Room, EPA West, Room 3334, 1301 

Constitution Ave., NW., Washington, 

DC 20460. The Public Reading Room 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) 566–1742, 

and the telephone number for the Air 

Docket is (202) 566–1744. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Dan deRoeck, Air Quality Policy 

Division, (C504–03), U.S. 

Environmental Protection Agency, 

Research Triangle Park, NC 27711; 

telephone number (919) 541–5593; fax 

number (919) 541–5509; or e-mail 

address: deroeck.dan@epa.gov. 

To request a public hearing or 

information pertaining to a public 

hearing on this document, contact Ms. 

Pamela Long, Air Quality Policy 

Division, Office of Air Quality Planning 

and Standards (C504–03), 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number (919) 541– 

0641; fax number (919) 541–5509; 

e-mail address: long.pam@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

Entities affected by this proposed 

action are the owners and operators of 

proposed new sources and 


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