56538 Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Proposed Rules 

Warning: Potential systemic adverse 

effects may result from use of this 

device. Drugs or solutions delivered 

with this device have the potential to 

reach the blood stream and cause 

systemic effects. Carefully read all 

labeling of the drug or solution used 

with this device to understand all 

potential adverse effects and to ensure 

appropriate dosing information. If 

systemic manifestations occur, refer to 

the drug or solution labeling for 

appropriate action. 

(iii) Appropriate analysis/testing must 

demonstrate electromagnetic 

compatibility, electrical safety, thermal 

safety, and mechanical safety. 

(iv) Appropriate software verification, 

validation, and hazard analysis must be 

performed. 

(v) The elements of the device that 

may contact the patient must be 

demonstrated to be biocompatible. 

(vi) The elements of the device that 

may contact the patient must be 

assessed for sterility. 

(vii) Performance data must support 

the shelf life of the elements of the 

device that may be affected by aging by 

demonstrating continued package 

integrity and device functionality over 

the stated shelf life. 

Dated: September 15, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–22453 Filed 9–19–14; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2014–0596; FRL–9916–81– 

Region 3] 

Approval and Promulgation of Air 

Quality Implementation Plans; West 

Virginia; 2014 Amendments to West 

Virginia’s Ambient Air Quality 

Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to approve the 

State Implementation Plan (SIP) 

revision submitted by the State of West 

Virginia for the purpose of amending 

their Legislative Rule on Ambient Air 

Quality Standards. In the Final Rules 

section of this Federal Register, EPA is 

approving the State’s SIP submittal as a 

direct final rule without prior proposal 

because EPA views this as a 

noncontroversial submittal and 

anticipates no adverse comments. A 

detailed rationale for the approval is set 

forth in the direct final rule. If no 

adverse comments are received in 

response to this action, no further 

activity is contemplated. If EPA receives 

adverse comments, the direct final rule 

will be withdrawn and all public 

comments received will be addressed in 

a subsequent final rule based on this 

proposed rule. EPA will not institute a 

second comment period. Any parties 

interested in commenting on this action 

should do so at this time. 

DATES: Comments must be received in 

writing by October 22, 2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2014–0596 by one of the 

following methods: 

A. www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Email: fernandez.cristina@epa.gov. 

C. Mail: EPA–R03–OAR–2014–0596, 

Cristina Fernandez, Associate Director, 

Office of Air Program Planning, Air 

Protection Division, Mailcode 3AP30, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

D. Hand Delivery: At the previouslylisted EPA Region III address. 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. EPA–R03–OAR–2014– 

0596. EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at 

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 www.regulations.gov 

or email. The 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 email 

comment directly to EPA without going 

through ww.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. 

Docket: All documents in the 

electronic docket are listed in the 

www.regulations.gov index. 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 www.regulations.gov or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the West Virginia 

Department of Environmental 

Protection, Division of Air Quality, 601 

57th Street SE., Charleston, West 

Virginia 25304. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Schmitt, (215) 814–5787, or by 

email at schmitt.ellen@epa.gov. 

SUPPLEMENTARY INFORMATION: For 

further information, please see the 

information provided in the direct final 

action, with the same title, that is 

located in the ‘‘Rules and Regulations’’ 

section of this Federal Register 

publication. 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. 

Dated: September 2, 2014. 

William C. Early, 

Acting Regional Administrator, Region III. 

[FR Doc. 2014–22414 Filed 9–19–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–2014–0623, 0624, and 

0625; FRL–9916–73–OSWER] 

National Priorities List, Proposed Rule 

No. 61 

AGENCY: Environmental Protection 

Agency (EPA). 


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