2646 Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Proposed Rules 

(h) Repetitive Inspections 

Repeat the inspection required in 

paragraph (g)(3) of this AD before 10,000 

hours since last overhaul if after last overhaul 

the HMU is exposed to TS–1 fuel. 

(i) Paperwork Reduction Act Burden 

Statement 

A federal agency may not conduct or 

sponsor, and a person is not required to 

respond to, nor shall a person be subject to 

a penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork Reduction 

Act unless that collection of information 

displays a current valid OMB Control 

Number. The OMB Control Number for this 

information collection is 2120–0056. Public 

reporting for this collection of information is 

estimated to be approximately 5 minutes per 

response, including the time for reviewing 

instructions, completing and reviewing the 

collection of information. All responses to 

this collection of information are mandatory. 

Comments concerning the accuracy of this 

burden and suggestions for reducing the 

burden should be directed to the FAA at: 800 

Independence Ave. SW., Washington, DC 

20591, Attn: Information Collection 

Clearance Officer, AES–200. 

(j) Alternative Methods of Compliance 

(AMOCs) 

The Manager, Engine Certification Office, 

may approve AMOCs for this AD. Use the 

procedures found in 14 CFR 39.19 to make 

your request. 

(k) Related Information 

(1) For more information about this AD, 

contact Martin Adler, Aerospace Engineer, 

Engine Certification Office, FAA, Engine & 

Propeller Directorate, 12 New England 

Executive Park, Burlington, MA 01803; 

phone: 781–238–7157; fax: 781–238–7199; 

email: martin.adler@faa.gov. 

(2) Refer to EASA Airworthiness Directive 

No. 2012–0123, dated July 9, 2012, and CFM 

SBs CFM56–5 S/B 73–0182, Revision 7, 

dated September 25, 2012, and CFM56–5B S/ 

B 73–0122, Revision 9, dated September 25, 

2012, for related information. 

(3) For service information identified in 

this AD, contact CFM International Inc., 

Aviation Operations Center, 1 Neumann 

Way, M/D Room 285, Cincinnati, OH 45125; 

International phone: 1–513–552–3272; USA 

phone: 877–432–3272; International fax: 1– 

513–552–3329; USA fax: 877–432–3329; 

email: geae.aoc@ge.com; or CFM 

International SA, Customer Support Center, 

International phone: 33 1 64 14 88 66; fax: 

33 1 64 79 85 55; email: 

snecma.csc@snecma.fr. 

(4) You may view this service information 

at the FAA, Engine & Propeller Directorate, 

12 New England Executive Park, Burlington, 

MA. For information on the availability of 

this material at the FAA, call 781–238–7125. 

Issued in Burlington, Massachusetts, on 

January 4, 2013. 

Robert J. Ganley, 

Acting Manager, Engine & Propeller 

Directorate, Aircraft Certification Service. 

[FR Doc. 2013–00529 Filed 1–11–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2012–0966; Airspace 

Docket No. 12–AWA–5] 

RIN 2120–AA66 

Proposed Modification of Class B 

Airspace; Las Vegas, NV 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM); Reopening of comment period. 

SUMMARY: This action reopens the 

comment period for an NPRM that was 

published on October 26, 2012. In that 

document, the FAA proposed to modify 

the Las Vegas, NV, Class B airspace area 

to ensure the containment of large 

turbine-powered aircraft within Class B 

airspace. 

DATES: The comment period for the 

NPRM published in the Federal 

Register on October 26, 2012 (77 FR 

65332) closed on December 26, 2012, is 

reopened until February 13, 2013. 

ADDRESSES: Send comments on this 

proposal to the U.S. Department of 

Transportation, Docket Operations, M– 

30, 1200 New Jersey Avenue SE., West 

Building Ground Floor, Room W12–140, 

Washington, DC 20590–0001; telephone: 

(202) 366–9826. You must identify FAA 

Docket No. FAA–2012–0966 and 

Airspace Docket No. 12–AWA–5, at the 

beginning of your comments. You may 

also submit comments through the 

Internet at http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Paul 

Gallant, Airspace Policy and ATC 

Procedures Group, Office of Airspace 

Services, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

Interested parties are invited to 

participate in this proposed rulemaking 

by submitting such written data, views, 

or arguments as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. Comments 

are specifically invited on the overall 

regulatory, aeronautical, economic, 

environmental, and energy-related 

aspects of the proposal. 

Communications should identify both 

docket numbers (FAA Docket No. FAA– 

2012–0966 and Airspace Docket No. 12– 

AWA–5) and be submitted in triplicate 

to the Docket Management Facility (see 

ADDRESSES section for address and 

phone number). You may also submit 

comments through the Internet at 

http://www.regulations.gov. 

Commenters wishing the FAA to 

acknowledge receipt of their comments 

on this action must submit with those 

comments a self-addressed, stamped 

postcard on which the following 

statement is made: ‘‘Comments to 

Docket Nos. FAA–2012–0966 and 

Airspace Docket No. 12–AWA–5.’’ The 

postcard will be date/time stamped and 

returned to the commenter. 

All communications received on or 

before the specified closing date for 

comments will be considered before 

taking action on the proposed rule. The 

proposal contained in this action may 

be changed in light of comments 

received. All comments submitted will 

be available for examination in the 

public docket both before and after the 

closing date for comments. A report 

summarizing each substantive public 

contact with FAA personnel concerned 

with this rulemaking will be filed in the 

docket. 

Availability of NPRM’s 

An electronic copy of this document 

may be downloaded through the 

Internet at http://www.regulations.gov. 

You may review the public docket 

containing the proposal, any comments 

received, and any final disposition in 

person in the Dockets Office (see 

ADDRESSES section for address and 

phone number) between 9:00 a.m. and 

5.00 p.m., Monday through Friday, 

except Federal holidays. An informal 

docket may also be examined during 

normal business hours at the office of 

the Western Service Center, Operations 

Support Group, Federal Aviation 

Administration, 1601 Lind Ave. SW., 

Renton, WA 98057. 

Persons interested in being placed on 

a mailing list for future NPRMs should 

contact the FAA’s Office of Rulemaking, 

(202) 267–9677, for a copy of Advisory 

Circular No. 11–2A, Notice of Proposed 

Rulemaking Distribution System, which 

describes the application procedure. 

Background 

In the Federal Register of October 26, 

2012, the FAA issued a NPRM entitled 


srobinson on DSK4SPTVN1PROD with 
Federal Register / Vol. 78, No. 9 / Monday, January 14, 2013 / Proposed Rules 2647 

‘‘Proposed Modification of Class B 

Airspace; Las Vegas, NV’’ (77 FR 65332). 

The FAA requested that comments on 

that proposal be received on or before 

December 26, 2012. By letter dated 

December 7, 2012, the Aircraft Owners 

and Pilots Association (AOPA) 

requested that the FAA extend the 

comment period for at least 30 days. 

AOPA stated that the original comment 

period encompassed two Federal 

holidays and that no comments had 

been posted to the docket as of the date 

of their letter. AOPA added that an 

extension would provide additional 

time for the public to review the NPRM 

and submit substantive comments on 

the proposal. 

Reopening of Comment Period 

The FAA has reviewed AOPA’s 

request for additional time to comment 

on the NPRM and has determined that 

reopening of the comment period is 

consistent with the public interest and 

that good cause exists for taking this 

action. 

Accordingly, the comment period for 

Docket No. FAA–2012–0966; Airspace 

Docket No. 12–AWA–5, is reopened as 

indicated in the DATES section, above. 

Issued in Washington, DC, on January 8, 

2013. 

Gary A. Norek, 

Manager, Airspace Policy and ATC 

Procedures Group. 

[FR Doc. 2013–00646 Filed 1–10–13; 4:15 pm] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 872 

[Docket No. FDA–2012–N–0677] 

Dental Devices; Reclassification of 

Blade-Form Endosseous Dental 

Implant 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify the blade- form endosseous 

dental implant, a preamendments class 

III device, into class II (special controls). 

On its own initiative, based on new 

information, FDA is proposing to revise 

the classification of blade-form 

endosseous dental implants. 

DATES: Submit either electronic or 

written comments on this proposed 

order by April 15, 2013. See section XI 

of this document for the proposed 

effective date of a final order based on 

this proposed order. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2012–N– 

0677, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2012–N–0677 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, 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.regulations.gov and insert Docket 

No. FDA–2012–N–0677 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: 

Melissa Burns, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1646, Silver Spring, 

MD 20993, 301–796–5616, 

melissa.burns@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (FDAMA) (Pub. L. 105–115), the 

Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250), the Medical Devices Technical 

Corrections Act (Public Law 108–214), 

the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), and the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144), 

establish a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, reflecting 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 FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(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 

automatically classified by section 

513(f) of the FD&C 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, in 

accordance with section 513(i) of the 

FD&C 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 FD&C Act (21 

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

A preamendments device that has 

been classified into class III may be 

marketed by means of premarket 

notification procedures (510(k) process) 

without submission of a premarket 

approval application (PMA) until FDA 

issues a final order under section 515(b) 

of the FD&C Act (21 U.S.C. 360e(b)) 

requiring premarket approval or until 

the device is subsequently reclassified 

into class I or class II. 

On July 9, 2012, FDASIA was enacted. 

Section 608(a) of FDASIA (126 Stat. 

1056) amended section 513(e) of the 

FD&C Act changing the process for 

reclassifying a preamendments device 

from rulemaking to an administrative 

order. 


srobinson on DSK4SPTVN1PROD with