Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Proposed Rules 47089 

TABLE 1—SUMMARY OF ELECTRONIC REGISTRATION AND LISTING INFORMATION

Device name Product code 510(k) or 

PMA? Last listed Last marketed 

Replaced 

by approved 

technology? 

Pacemaker Programmer ...................................................... KRG 510(k) 2011 1990s Yes 

Based on our review of electronic 

product registration and listing and 

other data, FDA concludes that there is 

currently little or no interest in 

marketing the affected devices and that 

the proposed rule would not have a 

significant economic impact. We 

specifically request detailed comment 

regarding the appropriateness of our 

assumptions regarding the potential 

economic impact of this proposed rule. 

X. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed rule, 

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 tentatively 

concludes that the proposed rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

XI. Paperwork Reduction Act of 1995 

This proposed rule refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 812 have 

been approved under OMB Control No. 

0910–0078; the collections of 

information in 21 CFR part 807 subpart 

E have been approved under OMB 

Control No. 0910–0120; the collections 

of information in 21 CFR 814 subpart B 

have been approved under OMB Control 

No. 0910–0231; and the collections of 

information under 21 CFR 801 have 

been approved under OMB Control No. 

0910–0485. 

XII. Proposed Effective Date 

FDA is proposing that any final rule 

based on this proposal become effective 

on the date of its publication in the 

Federal Register or at a later date if 

stated in the final rule. 

XIII. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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. 

List of Subjects in 21 CFR Part 870 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 870 be amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

2. Section 870.3700 is amended by 

revising paragraphs (a) and (c) to read as 

follows: 

§ 870.3700 Pacemaker programmers. 

(a) Identification. A pacemaker 

programmer is a device used to 

noninvasively change one or more of the 

electrical operating characteristics of a 

pacemaker. 

(b) * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or notice of 

completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before November 

2, 2011, for any pacemaker programmer 

that was in commercial distribution 

before May 28, 1976, or that has, on or 

before November 2, 2011, been found to 

be substantially equivalent to any 

pacemaker programmer that was in 

commercial distribution before May 28, 

1976. Any other pacemaker programmer 

shall have an approved PMA or 

declared completed PDP in effect before 

being placed in commercial 

distribution. 

Dated: July 29, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–19733 Filed 8–3–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF THE INTERIOR 

National Indian Gaming Commission 

25 CFR Chapter III 

Regulatory Review Schedule; 

Cancellation of Consultation Meetings 

AGENCY: National Indian Gaming 

Commission. 

ACTION: Notice. 

SUMMARY: On November 18, 2010, the 

National Indian Gaming Commission 

(NIGC) issued a Notice of Inquiry and 

Notice of Consultation advising the 

public that the NIGC was conducting a 

comprehensive review of its regulations 

and requesting public comment on the 

process for conducting the regulatory 

review. On April 4, 2011, after holding 

eight consultations and reviewing all 

comments, NIGC published a Notice of 

Regulatory Review Schedule setting out 

a consultation schedule and process for 

review. The purpose of this document is 

to cancel four scheduled tribal 

consultations. 

DATES: See SUPPLEMENTARY INFORMATION

below for dates and locations of 

cancelled consultations. 

FOR FURTHER INFORMATION CONTACT: Lael 

Echo-Hawk, National Indian Gaming 

Commission, 1441 L Street NW., Suite 

9100 Washington, DC 20005. 

Telephone: 202–632–7003; e-mail: 

reg.review@nigc.gov. 

SUPPLEMENTARY INFORMATION: On 

November 18, 2010, the National Indian 

Gaming Commission (NIGC) issued a 

Notice of Inquiry and Notice of 

Consultation advising the public that it 

was conducting a review of its 

regulations promulgated to implement 

25 U.S.C. 2701–2721 of the Indian 

Gaming Regulatory Act (IGRA) and 

requesting public comment on the 

process for conducting the regulatory 

review. On April 4, 2011, after holding 

eight consultations and reviewing all 


rmajette on DSK89S0YB1PROD with PROPOSALS
47090 Federal Register / Vol. 76, No. 150 / Thursday, August 4, 2011 / Proposed Rules 

comments, NIGC published a Notice of 

Regulatory Review Schedule in the 

Federal Register setting out 

consultation schedules and review 

processes. (76 FR 18457, April 4, 2011). 

The Commission’s regulatory review 

process establishes a tribal consultation 

schedule with a description of the 

regulation groups to be covered at each 

consultation. This document advises the 

public that the following tribal 

consultations have been cancelled. 

Consultation date Event Location Regulation 

group(s) 

August 25–26, 2011 ............................... NIGC Consultation—Southwest ............. Wild Horse Resort Casino, Scottsdale, 

AZ.

1, 2, 3, 4, 5 

September 19–20, 2011 ......................... NIGC Regional Training ......................... Sky Ute Casino Resort Ignacio, CO ...... 3, 4, 5 

September 27–28, 2011 ......................... NIGC Consultation—Northeast .............. Turning Stone Casino, NY ..................... 3, 5 

November 7–12, 2011 ............................ USET Annual Meeting ........................... Mississippi Choctaw, MS ....................... 3, 4, 5 

For additional information on 

consultation locations and times, please 

refer to the Web site of the National 

Indian Gaming Commission, http:// 

www.nigc.gov. 

Dated: August 1, 2011, Washington, DC. 

Tracie L. Stevens, 

Chairwoman. 

Steffani A. Cochran, 

Vice-Chairwoman. 

Daniel J. Little, 

Associate Commissioner. 

[FR Doc. 2011–19808 Filed 8–3–11; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2011–0623; FRL–9448–1] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Maryland; Preconstruction Permitting 

Requirements for Electric Generating 

Stations in Maryland 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

a State Implementation Plan (SIP) 

revision submitted by the Maryland 

Department of the Environment (MDE) 

on May 13, 2011 and July 15, 2011. This 

SIP revision revises and supplements 

the preconstruction permitting 

requirements for electric generating 

stations that are required to receive a 

Certificate of Public Convenience and 

Necessity (CPCN) from the Maryland 

Public Service Commission (PSC) before 

commencing construction. The SIP 

revision also requires electric generating 

stations to obtain a preconstruction 

permit from the MDE when a CPCN is 

not required under the PSC regulations 

and statutes. This action is being taken 

under the Clean Air Act (CAA). 

DATES: Written comments must be 

received on or before September 6, 

2011. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R03–OAR–2011–0623 by one of the 

following methods: 

1. http://www.regulations.gov. Follow 

the on-line instructions for submitting 

comments. 

2. E-mail: cox.kathleen@epa.gov. 

3. Mail: EPA–R03–OAR–2011–0623, 

Ms. Kathleen Cox, Associate Director, 

Office of Permits and Air Toxics, 

3AP10, U.S. Environmental Protection 

Agency, Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

4. 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–2011– 

0623. 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. 

Docket: All documents in the 

electronic docket are listed in the 

http://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 http:// 

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 Maryland Department of 

the Environment, 1800 Washington 

Boulevard, Suite 705, Baltimore, 

Maryland 21230. 

FOR FURTHER INFORMATION CONTACT: 

David Talley at 215–814–2117, or by 

e-mail at talley.david@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. EPA is proposing approval of this 

SIP revision because it corrects the 

deficiencies in the Maryland SIP and 

eliminates inconsistencies between 

State statutory and regulatory 

requirements for preconstruction 

permitting for electric generating 

stations in Maryland. It will also ensure 

that the SIP is adequate to prevent 

significant deterioration of air quality in 

areas designated as attainment or 

unclassifiable as required by Sections 

110(a) and 161 of the CAA and 40 CFR 


rmajette on DSK89S0YB1PROD with PROPOSALS