Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 9015 

of Food and Drugs, it is proposed that 

21 CFR part 872 be amended as follows: 

PART 872—DENTAL DEVICES 

■ 1. The authority citation for 21 CFR 

part 872 continues to read as follows: 

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

360j, 371. 

■ 2. Section 872.3960 is amended by 

revising paragraph (c) to read as follows: 

§ 872.3960 Mandibular condyle prosthesis. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or a notice 

of completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before March 30, 

1999, for any mandibular condyle 

prosthesis that was in commercial 

distribution before May 28, 1976, or that 

has, on or before March 30, 1999, been 

found to be substantially equivalent to 

a mandibular condyle prosthesis that 

was in commercial distribution before 

May 28, 1976. Any other mandibular 

condyle prosthesis shall have an 

approved PMA or a declared completed 

PDP in effect before being placed in 

commercial distribution. 

■ 3. Section 872.4770 is added to 

subpart E to read as follows: 

§ 872.4770 Temporary mandibular condyle 

reconstruction plate. 

(a) Identification. A temporary 

mandibular condyle reconstruction 

plate is a device that is intended to 

stabilize mandibular bone and provide 

for temporary reconstruction of the 

mandibular condyle until permanent 

reconstruction is completed in patients 

who have undergone resective surgical 

procedures requiring removal of the 

mandibular condyle and mandibular 

bone. This device is not intended for 

treatment of temporomandibular joint 

disorders. 

(b) Classification. Class II (special 

controls). The special controls is FDA’s 

guideline, ‘‘Class II Special Controls 

Guideline: Temporary Mandibular 

Condyle Reconstruction Plate.’’ See 

§ 872.1(e) for the availability of this 

guidance document. 

Dated: February 1, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–02688 Filed 2–6–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 226 

Osage Negotiated Rulemaking 

Committee 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Meetings. 

SUMMARY: In accordance with the 

requirements of the Federal Advisory 

Committee Act, the U.S. Department of 

the Interior, Bureau of Indian Affairs, 

Osage Negotiated Rulemaking 

Committee, will meet as indicated in the 

DATES section of this document. 

DATES: Meetings: The meetings will be 

held as follows: February: Monday, 

February 25, 2013, from 8 a.m. to 3:30 

p.m.; Tuesday, February 26, 2013, from 

8 a.m. to 6 p.m.; and Wednesday, 

February 27, 2013, from 8 a.m. to 6 p.m. 

March: Wednesday, March 13, 2013, 

from 8 a.m. to 6 p.m. and Thursday, 

March 14, 2013, from 8 a.m. to 6 p.m. 

ADDRESSES: February Meeting: Wah Zha 

Zhi Cultural Center, 1449 W. Main, 

Pawhuska, Oklahoma 74056; March 

Meeting: Osage Casino Event Center, 

951 W. 36 Street North, Tulsa, 

Oklahoma 74127. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Eddie Streater, Designated Federal 

Officer, Bureau of Indian Affairs, 

Wewoka Agency, P.O. Box 1540, 

Seminole, OK 74818; telephone (405) 

257–6250; fax (405) 257–3875; or email 

osageregneg@bia.gov. Additional 

Committee information can be found at: 

http://www.bia.gov/osageregneg. 

SUPPLEMENTARY INFORMATION: On 

October 14, 2011, the United States and 

the Osage Nation (formerly known as 

the Osage Tribe) signed a Settlement 

Agreement to resolve litigation 

regarding alleged mismanagement of the 

Osage Nation’s oil and gas mineral 

estate, among other claims. As part of 

the Settlement Agreement, the parties 

agreed that it would be mutually 

beneficial ‘‘to address means of 

improving the trust management of the 

Osage Mineral Estate, the Osage Tribal 

Trust Account, and Other Osage 

Accounts.’’ Settlement Agreement, 

Paragraph 1.i. The parties agreed that a 

review and revision of the existing 

regulations is warranted to better assist 

the Bureau of Indian Affairs (BIA) in 

managing the Osage Mineral Estate. The 

parties agreed to engage in a negotiated 

rulemaking for this purpose. Settlement 

Agreement, Paragraph 9.b. After the 

Committee submits its report, BIA will 

develop a proposed rule to be published 

in the Federal Register. 

Meeting Agenda: February: Present 

and review specific proposed changes to 

or additions to 25 CFR part 226 in the 

following categories: General/ 

Definitions, Rents, Royalties & 

Reporting, Operations, Surface Issues, 

Bonds, Pentalies & Enforcement. March: 

Follow-up discussions and committee 

decisions on specific proposed changes 

to or additions to 25 CFR part 226 in the 

following categories: General/ 

Definitions, Rents, Royalties & 

Reporting, Operations, Surface issues, 

Bonds, Penalties & Enforcement. The 

final agenda will be posted on 

www.bia.gov/osagenegreg prior to each 

meeting. 

Public Input: All Committee meetings 

are open to the public. Interested 

members of the public may present, 

either orally or through written 

comments, information for the 

Committee to consider during the public 

meeting. Written comments should be 

submitted, prior to, during, or after the 

meeting, to Mr. Eddie Streater, 

Designated Federal Officer, preferably 

via email, at osagenegneg@bia.gov, or by 

U.S. mail to: Mr. Eddie Streater, 

Designated Federal Officer, Bureau of 

Indian Affairs, Wewoka Agency, P.O. 

Box 1540, Seminole, OK 74818. Due to 

time constraints during the meeting, the 

Committee is not able to read written 

public comments submitted into the 

record. 

Individuals or groups requesting to 

make oral comments at the public 

Committee meeting will be limited to 5 

minutes per speaker. Speakers who 

wish to expand their oral statements, or 

those who had wished to speak, but 

could not be accommodated during the 

public comment period, are encouraged 

to submit their comments in written 

form to the Committee after the meeting 

at the address provided above. There 

will be a sign-up sheet at the meeting for 

those wishing to speak during the 

public comment period. 

The meeting location is open to the 

public. Space is limited, however, so we 

strongly encourage all interested in 

attending to preregister by submitting 

your name and contact information via 

email to Mr. Eddie Streater at 

osageregneg@bia.gov. Persons with 

disabilities requiring special services, 

such as an interpreter for the hearing 

impaired, should contact Mr. Streater at 

(405) 257–6250 at least seven calendar 

days prior to the meeting. We will do 

our best to accommodate those who are 

unable to meet this deadline. 

mstockstill on DSK4VPTVN1PROD with PROPOSALS

9016 Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Proposed Rules 

Dated: February 4, 2013. 

Michael S. Black, 

Director, Bureau of Indian Affairs. 

[FR Doc. 2013–02871 Filed 2–6–13; 8:45 am] 

BILLING CODE 4310–02–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R01–OAR–2012–0951; FRL– 9778–6] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Massachusetts; Revisions to Fossil 

Fuel Utilization and Source 

Registration Regulations and Boiler 

Industrial Standards 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The EPA is proposing to 

approve several State Implementation 

Plan (SIP) revisions submitted by the 

State of Massachusetts. The revisions 

add new monitoring, inspection, 

maintenance and testing requirements 

for certain fossil fuel utilization 

facilities, rename and clarify stationary 

source emission reporting requirements, 

and establish compliance and 

certification standards for new boilers. 

The intended effect of this action is to 

propose approval of the state’s revised 

fossil fuel utilization facility regulation, 

source registration regulation, and new 

industrial performance standards for 

boilers. This action is being taken under 

the Clean Air Act. 

DATES: Written comments must be 

received on or before March 11, 2013. 

ADDRESSES: Submit your comments, 

identified by Docket ID Number EPA– 

R01–OAR–2012–0951 by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: mcdonnell.ida@epa.gov. 

3. Fax: (617) 918–0653. 

4. Mail: ‘‘Docket Identification 

Number EPA–R01–OAR–2012–0951’’, 

Ida E. McDonnell, U.S. Environmental 

Protection Agency, EPA New England 

Regional Office, Office of Ecosystem 

Protection, Air Permits, Toxics and 

Indoor Programs Unit, 5 Post Office 

Square—Suite 100, (Mail Code OEP05– 

2), Boston, MA 02109–3912. 

5. Hand Delivery or Courier. Deliver 

your comments to: Ida E. McDonnell, 

Manager, Air Permits, Toxics, and 

Indoor Programs Unit, U.S. 

Environmental Protection Agency, EPA 

New England Regional Office, Office of 

Ecosystem Protection, Air Permits, 

Toxics and Indoor Programs Unit, 5 Post 

Office Square—Suite 100, (mail code 

OEP05–2), Boston, MA 02109–3912. 

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 to 4:30, 

excluding legal holidays. 

Instructions: Direct your comments to 

Docket ID No. EPA–R01–OAR–2012– 

0951. 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 through 

www.regulations.gov, or email, 

information that you consider to be CBI 

or otherwise protected. 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 

www.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 at Office of Ecosystem 

Protection, U.S. Environmental 

Protection Agency, EPA New England 

Regional Office, Office of Ecosystem 

Protection, Air Permits, Toxics and 

Indoor Programs, 5 Post Office Square— 

Suite 100, Boston, MA. EPA requests 

that if at all possible, you contact the 

contact listed in the FOR FURTHER

INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30, 

excluding legal holidays. 

In addition, copies of the state 

submittal and EPA’s technical support 

document are also available for public 

inspection during normal business 

hours, by appointment at the Division of 

Air Quality Control, Department of 

Environmental Protection, One Winter 

Street, 7th Floor, Boston, MA 02108. 

FOR FURTHER INFORMATION CONTACT: 

Brendan McCahill, Air Permits, Toxics 

and Indoor Programs Unit, Office of 

Ecosystem Protection, U.S. 

Environmental Protection Agency 

Region 1, 5 Post Office Square—Suite 

100, (Mail code OEP05–2), Boston, MA 

02109–3912, Telephone number (617) 

918–1652, Fax number (617) 918–0652, 

Email McCahill.Brendan@EPA.GOV. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

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

EPA. 

Organization of this document. The 

following outline is provided to aid in 

locating information in this preamble. 

Table of Contents 

I. What action is EPA proposing in this 

document? 

II. What is the background for the action 

proposed by EPA in this document? 

III. What is EPA’s analysis of Massachusetts’s 

SIP revisions? 

A. 310 CMR 7.04: U Fossil Fuel Utilization 

Facilities 

B. 310 CMR 7.12: U Source Registration 

C. 310 CMR 7.26(30)–(37) Industrial 

Performance Standard—U Boilers 

D. Miscellaneous Changes 

IV. Proposed Action 

V. Statutory and Executive Order Reviews 

I. What action is EPA proposing in this 

document? 

On June 28, 1990 and July 11, 2001, 

the Massachusetts Department of 

Environmental Protection (MassDEP) 

submitted SIP amendments revising 310 

CMR 7.04 ‘‘U Fossil Fuel Utilization 

Facilities.’’ On July 11, 2001, the 

MassDEP submitted a SIP amendment 

revising 310 Code of Massachusetts 

Regulations (CMR) 7.12, ‘‘U Source 

Registration.’’ On September 14, 2006, 

the MassDEP submitted a SIP 

amendment adopting 310 CMR 

7.26(30)–(37), ‘‘Industrial Performance 

Standard—U Boilers.’’ On February 13, 

2008, the MassDEP submitted an 

additional amendment to revise 310 

CMR 7.04 ‘‘U Fossil Fuel Utilization 

mstockstill on DSK4VPTVN1PROD with PROPOSALS