Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules 1951 

engines installed on the same airplane at the 

same time, if at all possible. 

Alternative Methods of Compliance 

(i) The Manager, Engine Certification 

Office, FAA, has the authority to approve 

alternative methods of compliance for this 

AD if requested using the procedures found 

in 14 CFR 39.19. 

Related Information 

(j) GE Service Bulletin No. CF34–10E S/B 

73–0013, dated December 15, 2006, pertains 

to the subject of this AD. 

(k) Contact Tara Fitzgerald, Aerospace 

Engineer, Engine Certification Office, FAA, 

Engine and Propeller Directorate, 12 New 

England Executive Park, Burlington, MA 

01803; telephone (781) 238–7138, fax (781) 

238–7199; e-mail: tara.fitzgerald@faa.gov for 

more information about this AD. 

Issued in Burlington, Massachusetts, on 

January 10, 2007. 

Francis A. Favara, 

Manager, Engine and Propeller Directorate, 

Aircraft Certification Service. 

[FR Doc. E7–498 Filed 1–16–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. 2005P–0121] 

Orthopedic Devices; Reclassification 

of Non-Invasive Bone Growth 

Stimulator 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of panel 

recommendation. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing for 

public comment the recommendation of 

the Orthopaedic and Rehabilitation 

Devices Panel to deny a petition to 

reclassify the non-invasive bone growth 

stimulator from class III to class II. The 

Panel made this recommendation after 

reviewing the reclassification petition 

submitted by RS Medical Corp., as well 

as consideration of presentations made 

at the Panel meeting by the petitioner, 

FDA, and members of the public. FDA 

is also issuing for public comment its 

findings on the Panel’s 

recommendation. After considering any 

public comments on the Panel’s 

recommendation and FDA’s findings, 

FDA will approve or deny the 

reclassification petition by order in the 

form of a letter to the petitioner. FDA’s 

decision on the reclassification petition 

will be announced in the Federal 

Register. 

DATES: Submit written or electronic 

comments by April 17, 2007. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2005P–0121, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No. 2005P–0121 for this notice. 

All comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michel Janda, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background (Regulatory Authorities) 

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et. seq.), as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 (the 

SMDA) (Public Law 101–629), and the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA) 

(Public Law 105–115), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513 of the act, devices 

that were in commercial distribution 

before May 28, 1976 (the date of 

enactment of the 1976 amendments), 

generally referred to as preamendments 

devices, are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976, 

generally referred to as postamendments 

devices, are classified automatically by 

statute (section 513(f) of the act into 

class III without any FDA rulemaking 

process. Those devices remain in class 

III and require premarket approval, 

unless and until the device is 

reclassified into class I or II or FDA 

issues an order finding the device to be 

substantially equivalent, under section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the act 

(21 U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). 

Reclassification of classified 

postamendments devices is governed by 

section 513(f)(3) of the act. This section 

provides that FDA may initiate the 

reclassification of a device classified 

into class III under section 513(f)(1) of 

the act, or the manufacturer or importer 

of a device may petition the Secretary of 

Health and Human Services (the 

Secretary) for the issuance of an order 

classifying the device in class I or class 

II. FDA’s regulations in 21 CFR 860.134 

set forth the procedures for the filing 

and review of a petition for 

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1952 Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules 

reclassification of such class III devices. 

In order to change the classification of 

the device, it is necessary that the 

proposed new class have sufficient 

regulatory controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. 

Under section 513(f)(3)(B)(i) of the 

act, the Secretary may, for good cause 

shown, refer a petition to a device 

classification panel. The Panel shall 

make a recommendation to the 

Secretary respecting approval or denial 

of the petition. Any such 

recommendation shall contain (1) A 

summary of the reasons for the 

recommendation, (2) a summary of the 

data upon which the recommendation is 

based, and (3) an identification of the 

risks to health (if any) presented by the 

device with respect to which the 

petition was filed. 

II. Regulatory History of the Device 

In accordance with section 513(f)(1) of 

the act, the non-invasive bone growth 

stimulators were automatically 

classified into class III because they 

were not introduced or delivered for 

introduction into interstate commerce 

for commercial distribution before May 

28, 1976, and have not been found 

substantially equivalent to a device 

placed in commercial distribution after 

May 28, 1976, which was subsequently 

classified or reclassified into class II or 

class I. Therefore, the device can not be 

placed in commercial distribution 

unless it is reclassified under section 

513(f)(3), or subject to an approved 

premarket approval application (PMA) 

under section 515 of the act (21 U.S.C. 

360e). 

In a petition dated February 7, 2005, 

that was received by FDA on February 

9, 2005, RS Medical Corp. requested 

that FDA reclassify the non-invasive 

bone growth stimulator from class III to 

class II. (Ref. 1) The petition was 

submitted under section 513(e) of the 

act but FDA is reviewing the petition 

under section 513(f)(3) of the act 

because that section contains the 

appropriate procedures for 

reclassification of postamendments 

devices. FDA requested additional 

information and the petitioner amended 

the petition on August 1, 2005. In 

accordance with the act and the 

regulations, FDA referred the petition as 

amended to an FDA Advisory 

Committee, the Orthopedic and 

Rehabilitation Devices Panel (the Panel) 

for its recommendations on the 

requested reclassification. 

III. Description of Device Proposed for 

Reclassification 

The Petitioner identified the device as 

follows: 

A non-invasive bone growth 

stimulator is a device that provides 

stimulation through electrical and/or 

magnetic fields to facilitate the healing 

of nonunion fractures and lumbar spinal 

fusions. The stimulation may be 

delivered through capacitive coupling 

(CC) with electrodes placed directly 

over the treatment site or through 

pulsed electromagnetic fields (PEMF) 

with treatment coils placed into a brace 

or over a cast at the treatment site. The 

device is intended for use: (1) For the 

treatment of established nonunion 

fractures acquired secondary to trauma 

(excluding vertebrae and flat bone), and 

(2) as an adjunct to the treatment of 

lumbar spinal fusion surgery for one or 

two levels. The device consists of an 

output waveform generator, either 

battery-powered or AC-powered; a user 

interface with visual and/or audible 

alarms; and electrodes or coils to deliver 

the stimulation. 

IV. Recommendations of the Panel 

On June 2, 2006, the Panel deliberated 

on information in RS Medical’s petition; 

the presentations made by RS Medical, 

FDA, and members of the public; and 

their own experience with non-invasive 

bone growth stimulators (Ref. 2). The 

Panel voted four to two to recommend 

that non-invasive bone growth 

stimulators be retained in class III. 

V. Risks to Health 

The Panel identified the following 

risks to health associated with the noninvasive bone growth stimulator: 

A. Electric Shock 

A patient or health care professional 

could be shocked from the use and 

operation of the device via an AC line 

voltage exposure during charging, 

circuitry malfunction, connection/ 

disconnection of electrodes or coils, 

control circuit failure, damaged channel 

jacks, defective electrodes/coil 

delivering inappropriate output, faulty 

lead wires, inappropriate output, poor 

connection between electrodes/coils 

and lead wires, poor solder on circuit 

board, reposition of electrodes/coils 

during treatment, and use of AC current 

source during treatment. 

B. Burn 

A patient or health care professional 

could be burned from the use and 

operation of the device via an AC line 

voltage exposure during charging, 

connection/disconnection of the 

electrodes/coils or control unit while 

receiving treatment, defective 

electrodes/coil delivering inappropriate 

output, incorrect electrode/coil size or 

alteration, inappropriate output, use of 

AC current source for treatment, and use 

of control unit and battery charger while 

sleeping. 

C. Skin Irritation and/or Allergic 

Reaction 

A patient could experience skin 

irritation and/or allergic reaction 

associated with the use and operation of 

the device via the use of nonbiocompatible device materials and/or 

non-biocompatible electrode gel. 

D. Inconsistent or Ineffective Treatment 

A patient could receive inconsistent 

or ineffective treatment via battery 

deterioration, control circuit failure, 

defective electrode/coils, device damage 

from dropping or bumping, device short 

circuits, driver circuit failure, 

electromagnetic interference (EMI) or 

radio frequency interference (RFI), 

failure to follow prescribed use, 

hardware failure, improper position of 

electrodes/coil, inappropriate output, 

incorrect battery/battery charger, 

ineffective output, low battery voltage, 

poor interface between electrodes/coil 

and patient, and switch failure. 

E. Adverse Interaction with Electrical 

Implants 

A patient with electrically-powered 

implants (such as cardiac pacemakers, 

cardiac defibrillators, and neurostimulators) could experience an 

adverse interaction with an implanted 

electrical device via EMI or RFI. 

F. Internal/External Fixation Devices 

A patient with internal or external 

fixation devices could receive 

inconsistent or ineffective treatment due 

to interaction of the device with the 

metallic fixation devices via 

interference with treatment field 

through magnetic field interaction and/ 

or electrical inductance within metallic 

device. 

G. Biological Risks: Carcinogenicity, 

Genotoxicity, Mutagenicity, and 

Teratology 

A patient may experience adverse 

biologic affects resulting from prolonged 

exposure to the treatment signal via 

biologic interaction with the treatment 

signal at a cellular level. 

VI. Summary of Reasons for 

Recommendation 

The Panel believes that the noninvasive bone growth stimulator should 

be retained in class III because there is 

insufficient information in this petition 

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to establish that special controls in 

association with general controls would 

provide a reasonable assurance of the 

safety and effectiveness of the device. 

VII. Summary of Data Upon Which the 

Panel Recommendation is Based 

The petitioner provided the following 

information: 

A. Reports on Non-Unions 

The petitioner submitted 35 articles (5 

describing capacitive coupling devices 

and 30 describing the use of pulsed 

electromagnetic field devices) reporting 

outcomes for over 5,600 patients. 

According to the petitioner, these 

studies indicate the device’s ability to 

promote osteogenesis in patients with 

an established non-union, which may 

include previously failed surgical 

attempts to establish union. 

B. Reports on Adjunctive Lumbar Spinal 

Fusion 

The petitioner has submitted eight 

articles (one utilizing capacitive 

coupling devices and seven utilizing 

pulsed electromagnetic field devices) 

reporting outcomes for over 1,100 

patients. According to the petitioner, 

these studies indicate the device’s 

ability to promote osteogenesis in 

patients as an adjunct to the treatment 

of lumbar spinal fusion for one or two 

levels. 

C. Reports on Preclinical Findings 

The petitioner has cited 21 articles in 

the petition amendment describing 

studies in animal models. The animal 

studies described in the petition 

amendment were designed to evaluate 

new signals, dose/response 

relationships, and the potential 

pathways of bone repair processes. In 

addition, 14 articles were presented that 

describe studies in cell culture systems 

designed to examine the mechanism(s) 

of action of various electrical stimuli in 

bone. These studies, conducted at the 

cellular level, were intended to 

investigate the sequence of events that 

occur as a result of electrical 

stimulation, the interaction of the fields 

at the level of the cell membrane with 

regard to ion channels and receptor 

interaction, and signal transduction; and 

to identify cell types that do or do not 

respond to electrical stimulation. 

The Panel recommended that the 

proposed special controls (Ref 1.) were 

sufficient to control for the risk of 

electric shock, burn, skin irritation, and/ 

or allergic reaction; adverse interaction 

with electrical implants; adverse 

interaction with internal/external 

fixation devices; and biological risks 

(carcinogenicity, genotoxicity, 

mutagenicity and teratology). However, 

the Panel believed that there was 

insufficient evidence presented by the 

petitioner to control for the risk of 

inconsistent or ineffective treatment 

because there is a lack of knowledge 

about how waveform characteristics 

(e.g., pulse duration, amplitude, power, 

frequency) affect the clinical response to 

treatment. This concern was also 

expressed by the Panel regarding 

potential modifications made to the 

device. It is not known how a change to 

the device output due to device 

modifications may impact the clinical 

response to treatment. The Panel 

requested additional clinical data and/ 

or special controls to control for the risk 

of inconsistent or ineffective treatment 

that may occur as the result of device 

modifications (Ref. 2). 

VIII. FDA’s Findings 

FDA believes that certain device 

modifications are unlikely to adversely 

affect device safety and effectiveness 

and such changes could be adequately 

validated using bench-top testing. 

However, FDA also believes that there 

was not adequate evidence in the 

petition to establish that the petitioner’s 

proposed special controls could be used 

to adequately mitigate the risk of 

inconsistent or ineffective treatment. 

Additional evidence is required to 

establish special controls, including 

preclinical test methods, to mitigate the 

risk of inconsistent or ineffective 

treatment. 

Because FDA has concerns about the 

ability of the petitioner’s proposed 

special controls to control the risk of 

inconsistent and ineffective treatment, 

FDA is unable to conclude that general 

controls and the petitioner’s proposed 

special controls would provide a 

reasonable assurance of safety and 

effectiveness for this device type. 

Therefore, based on the currently 

available information, FDA concurs 

with the Panel’s recommendation to 

retain the non-invasive bone growth 

stimulator as a class III device. 

IX. Environmental Impact 

The agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment, 

nor an environmental impact statement 

is required. 

X. Analysis of Impacts 

FDA has examined the impacts of this 

notice under Executive Order 12866 and 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this reclassification 

petition denial, if finalized, is not a 

significant regulatory action as defined 

by the Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. If FDA accepts the Panel 

recommendation and denies the petition 

for reclassification, the regulatory status 

of the device will remain the same as it 

is now. Because this action, if finalized, 

will maintain the status quo, the agency 

certifies that the reclassification petition 

denial will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this reclassification petition action to 

result in any 1-year expenditure that 

would meet or exceed this amount. 

XI. Federalism 

FDA has analyzed this action in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the action, if finalized, 

would not contain policies that would 

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. Accordingly, the 

agency concludes that the action does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

has not been prepared. 

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1954 Federal Register / Vol. 72, No. 10 / Wednesday, January 17, 2007 / Proposed Rules 

XII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this notice. Submit 

a single copy of electronic comments or 

two paper copies of mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

XIII. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Reclassification petition from RS 

Medical Corp., dated February 7, 2005, and 

amendment dated November 30, 2005. 

2. Orthopedic and Rehabilitation Devices 

Panel Meeting Transcript, June 2, 2006. 

Dated: January 5, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–476 Filed 1–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 292 

RIN 1076–AE81 

Gaming on Trust Lands Acquired After 

October 17, 1988 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: This document reopens the 

comment period for the proposed rule 

published on December 4, 2006 (71 FR 

70335), which establishes procedures 

that an Indian tribe must follow in 

seeking to conduct gaming on lands 

acquired after October 17, 1988. 

DATES: Comments must be received on 

or before February 1, 2007. 

ADDRESSES: You may submit comments 

identified by the number 1076–AE81, by 

any of the following methods: 

• Federal rulemaking portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–273–3153. 

• Mail: Mr. George Skibine, Director, 

Office of Indian Gaming, Office of the 

Deputy Assistant Secretary—Policy and 

Economic Development, 1849 C Street, 

NW., Mail Stop 3657–MIB, Washington, 

DC 20240. 

• Hand Delivery: Office of Indian 

Gaming, Office of the Deputy Assistant 

Secretary—Policy and Economic 

Development, 1849 C Street, NW., Mail 

Stop 3657–MIB, Washington, DC, from 

9 a.m. to 4 p.m., Monday through 

Friday. 

FOR FURTHER INFORMATION CONTACT: 

George Skibine, Office of Indian 

Gaming, Acting Deputy Assistant 

Secretary—Policy and Economic 

Development, Mail Stop 3657–MIB, 

1849 C Street, NW., Washington, DC 

20240; Telephone (202) 219–4066. 

SUPPLEMENTARY INFORMATION: On 

October 5, 2006 (71 FR 58769), the 

Bureau of Indian Affairs (BIA) 

published a proposed rule to establish 

procedures that an Indian tribe must 

follow in seeking to conduct gaming on 

lands acquired after October 17, 1988. 

The Indian Gaming Regulatory Act 

allows Indian tribes to conduct class II 

and class III gaming activities on land 

acquired after October 17, 1988, only if 

the land meets certain exceptions. This 

proposed rule establishes a process for 

submitting and considering applications 

from Indian tribes seeking to conduct 

class II or class III gaming activities on 

lands acquired in trust after October 17, 

1988. 

On December 4, 2006, the BIA 

published a notice making corrections 

to the proposed rule and extended the 

comment period until December 19, 

2006. Eighteen comments were received 

after December 19, 2006. Several of 

these comments raise substantive issues 

that may result in modification of the 

proposed rule. The comment period is 

reopened to allow consideration of the 

comments received after December 19, 

2006, and to allow additional time for 

comment on the proposed rule. 

Comments must be received on or 

before February 1, 2007. 

Dated: January 11, 2007. 

Michael D. Olsen, 

Principal Deputy Assistant Secretary—Indian 

Affairs. 

[FR Doc. E7–511 Filed 1–16–07; 8:45 am] 

BILLING CODE 4310–4N–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2005–KY–0004–200609; 

FRL–8269–4] 

Approval and Promulgation of 

Implementation Plans; Kentucky: 

Performance Testing and Open 

Burning 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

revisions to the Kentucky State 

Implementation Plan (SIP), submitted 

by the Commonwealth of Kentucky, 

through the Kentucky Department of Air 

Quality (KDAQ), on September 6, 2005. 

The revisions include changes to 

Kentucky Administrative Regulations 

(KAR) Title 401, Chapters 50:045, 

‘‘Performance tests,’’ and 63:005, ‘‘Open 

burning.’’ The changes included in the 

proposed SIP revisions are part of 

Kentucky’s strategy to attain and 

maintain the 8-hour ozone and fine 

particulate (PM2.5) national ambient air 

quality standards (NAAQS) by reducing 

emissions of PM2.5 and precursors to 

ozone. EPA is proposing to approve 

Kentucky’s SIP revisions pursuant to 

section 110 of the Clean Air Act (CAA). 

DATES: Written comments must be 

received on or before February 16, 2007. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number, ‘‘EPA–

R04–OAR–2005–KY–0004,’’ by one of 

the following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. E-mail: hou.james@epa.gov. 

3. Fax: 404–562–9019. 

4. Mail: ‘‘EPA–R04–OAR–2005–KY–

0004,’’ Regulatory Development Section, 

Air Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. 

5. Hand Delivery or Courier: James 

Hou, Regulatory Development Section, 

Air Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. Such 

deliveries are only accepted during the 

Regional Office’s normal hours of 

operation. The Regional Office’s official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Instructions: Direct your comments to 

Docket ID Number, ‘‘EPA–R04–OAR–

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