This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

69391 

Vol. 77, No. 223 

Monday, November 19, 2012 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2012–1164; Directorate 

Identifier 2012–NM–075–AD] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for certain 

Airbus Model A310–204, –222, –304, 

–322, and –324 airplanes. This proposed 

AD was prompted by the manufacturer 

re-classifying slat extension eccentric 

bolts as principle structural elements 

(PSE) with replacement due at or before 

newly calculated fatigue life limits. This 

proposed AD would require replacing 

slat extension eccentric bolts, and 

associated washers with new slat 

extension eccentric bolts and washers. 

We are proposing this AD to prevent 

fatigue cracking, which could result in 

the loss of structural integrity of the 

airplane. 

DATES: We must receive comments on 

this proposed AD by January 3, 2013. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

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

instructions for submitting comments. 

• Fax: (202) 493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this proposed AD, contact Airbus SAS— 

EAW (Airworthiness Office), 1 Rond 

Point Maurice Bellonte, 31707 Blagnac 

Cedex, France; telephone +33 5 61 93 36 

96; fax +33 5 61 93 44 51; email 

account.airworth-eas@airbus.com; 

Internet http://www.airbus.com. You 

may review copies of the referenced 

service information at the FAA, 

Transport Airplane Directorate, 1601 

Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov; or in person at the 

Docket Operations office between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Operations 

office (telephone (800) 647–5527) is in 

the ADDRESSES section. Comments will 

be available in the AD docket shortly 

after receipt. 

FOR FURTHER INFORMATION CONTACT: Dan 

Rodina, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue SW., Renton, WA 

98057–3356; telephone (425) 227–2125; 

fax (425) 227–1149. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2012–1164; Directorate Identifier 

2012–NM–075–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD based on those comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

The European Aviation Safety Agency 

(EASA), which is the aviation authority 

for the Member States of the European 

Community, has issued EASA 

Airworthiness Directive 2012–0042, 

dated April 10, 2012 (referred to after 

this as ‘‘the MCAI’’), to correct an unsafe 

condition for the specified products. 

The MCAI states: 

Slat extension eccentric bolts have been 

reclassified as Principal Structural Elements 

(PSE). As a result, associated fatigue lives 

will be published in the Airbus A310 

Airworthiness Limitation Section (ALS) Part 

1 and bolts must be replaced at or before 

their calculated fatigue lives. 

Failure to replace the bolts within the new 

fatigue life limits constitutes an unsafe 

condition. 

For the reasons explained above, this 

[EASA] AD requires: 

—For A310–300 aeroplanes, the replacement 

of slat extension eccentric bolts, Part 

Number (P/N) A57844015200, with slat 

extension eccentric bolts P/N 

A57844015204 at the slat 2 tracks 4 and 7 

and slat 3 track 8 positions on both Left 

Hand (LH) and Right Hand (RH) wings, and 

—For A310–300 and A310–200 aeroplanes 

that incorporate Airbus modification 

04809, the replacement of slat extension 

eccentric bolts, P/N A57843624200 and 

associated washers P/N A57844016200, 

with slat extension eccentric bolts P/N 

A57843624202 and washers P/N 

A57844391200 at the slat 2 track 5 

position, on both LH and RH wings. 

The unsafe condition is fatigue cracking, 

which could result in the loss of 

structural integrity of the airplane. You 

may obtain further information by 

examining the MCAI in the AD docket. 

Relevant Service Information 

Airbus has issued Mandatory Service 

Bulletin A310–57–2100, Revision 01, 

dated February 3, 2012. The actions 

described in this service information are 

intended to correct the unsafe condition 

identified in the MCAI. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 

bilateral agreement with the State of 

Design Authority, we have been notified 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are proposing this 

AD because we evaluated all pertinent 


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69392 Federal Register / Vol. 77, No. 223 / Monday, November 19, 2012 / Proposed Rules 

information and determined an unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

Costs of Compliance 

Based on the service information, we 

estimate that this proposed AD would 

affect about 1 product of U.S. registry. 

We also estimate that it would take 

about 9 work-hours per product to 

comply with the basic requirements of 

this proposed AD. The average labor 

rate is $85 per work-hour. Required 

parts would cost about $25,250 per 

product. Where the service information 

lists required parts costs that are 

covered under warranty, we have 

assumed that there will be no charge for 

these parts. As we do not control 

warranty coverage for affected parties, 

some parties may incur costs higher 

than estimated here. Based on these 

figures, we estimate the cost of the 

proposed AD on U.S. operators to be 

$26,015, or $26,015 per product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect 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. 

For the reasons discussed above, I 

certify this proposed regulation: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska; and 

4. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this proposed AD and placed it in the 

AD docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new AD: 

Airbus: Docket No. FAA–2012–1164; 

Directorate Identifier 2012–NM–075–AD. 

(a) Comments Due Date 

We must receive comments by January 3, 

2013. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Airbus Model A310– 

204, –222, –304, –322, and –324 airplanes, 

certificated in any category, having received 

in production Airbus modification 04809 

without Airbus modification 06243 or 13596. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 57, Wings. 

(e) Reason 

This AD was prompted by the 

manufacturer re-classifying slat extension 

eccentric bolts as principle structural 

elements (PSE) with replacement due at or 

before newly calculated fatigue life limits. 

We are issuing this AD to prevent fatigue 

cracking, which could result in the loss of 

structural integrity of the airplane. 

(f) Compliance 

You are responsible for having the actions 

required by this AD performed within the 

compliance times specified, unless the 

actions have already been done. 

(g) Compliance Times 

At the applicable time specified in 

paragraphs (g)(1), (g)(2), and (g)(3) of this AD: 

Do the replacements specified in paragraphs 

(h)(1) and (h)(2) of this AD, as applicable. For 

the purposes of this AD, to establish the 

average flight time (AFT), take the 

accumulated flight time (counted from the 

take-off up to the landing) and divide it by 

the number of accumulated flight cycles. 

This gives the AFT per flight cycle. 

(1) For Model A310–304, –322, and –324 

airplanes operated with an AFT of less than 

4 hours: Before the accumulation of 66,000 

total flight hours or 40,000 total flight cycles, 

whichever occurs first. 

(2) For Model A310–304, –322, and –324 

airplanes operated with an AFT of 4 hours 

or more: Before the accumulation of 66,000 

total flight hours or 31,400 total flight cycles, 

whichever occurs first. 

(3) For Model A310–204 and –222 

airplanes with Airbus modification 04809: 

Before the accumulation of 71,800 total flight 

hours or 35,900 total flight cycles, whichever 

occurs first. 

(h) Replacement of Slat Extension Eccentric 

Bolt and Hardware on Both Wings 

(1) For Model A310–304, –322, and –324 

airplanes: Replace the slat extension 

eccentric bolts, part number (P/N) 

A57844015200, at the slat 2 tracks 4 and 7 

and slat 3 track 8 positions with new slat 

extension bolts, P/N A57844015204, in 

accordance with the Accomplishment 

Instructions of Airbus Mandatory Service 

Bulletin A310–57–2100, Revision 01, dated 

February 3, 2012. 

(2) For Model A310–304, –322, and –324 

airplanes, and Model A310–204 and –222 

airplanes that have incorporated Airbus 

modification 04809: Replace the slat 

extension eccentric bolts, P/N 

A57843624200, at the slat 2 track 5 position 

with new slat extension bolts, P/N 

A57843624202; and replace the associated 

washers of eccentric bolts, P/N 

A57844016200, at slat 2 track 5 position with 

washers, P/N A57844391200; in accordance 

with the Accomplishment Instructions of 

Airbus Mandatory Service Bulletin A310–57– 

2100, Revision 01, dated February 3, 2012. 

(i) Parts Installation Prohibition 

After the modification of the airplane with 

the replacement of slat extension eccentric 

bolts and associated hardware required by 

paragraphs (g) and (h) of this AD, no person 

may install any slat extension eccentric bolt, 

P/N A57844015200 or P/N A57843624200, 

with associated washer P/N A57844016200, 

on that airplane. 

(j) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 


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appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Dan Rodina, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

telephone (425) 227–2125; fax (425) 227– 

1149. Information may be emailed to: 9- 

ANM-116-AMOC-REQUESTS@faa.gov. 

Before using any approved AMOC, notify 

your appropriate principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office/ 

certificate holding district office. The AMOC 

approval letter must specifically reference 

this AD. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(k) Related Information 

(1) Refer to MCAI European Aviation 

Safety Agency Airworthiness Directive 2012– 

0042, dated April 10, 2012; and Airbus 

Mandatory Service Bulletin A310–57–2100, 

Revision 01, dated February 3, 2012; for 

related information. 

(2) For service information identified in 

this AD, contact Airbus SAS–EAW 

(Airworthiness Office), 1 Rond Point Maurice 

Bellonte, 31707 Blagnac Cedex, France; 

telephone +33 5 61 93 36 96; fax +33 5 61 

93 44 51; email account.airwortheas@airbus.com; Internet http:// 

www.airbus.com. You may review copies of 

the referenced service information at the 

FAA, Transport Airplane Directorate, 1601 

Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on 

November 9, 2012. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–27999 Filed 11–16–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 801 

[Docket No. FDA–2011–N–0090] 

RIN 0910–AG31 

Unique Device Identification System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

July 10, 2012, proposed rule (77 FR 

40736) to establish a unique device 

identification system as required by 

recent amendments to the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act). 

On July 9, 2012, the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) was signed into law; 

section 614 of FDASIA amends the 

FD&C Act in ways that require 

modification of the timeframe for 

implementation of the proposed rule’s 

requirements as they apply to devices 

that are implantable, life-saving (lifesupporting), or life-sustaining. 

DATES: Submit either electronic or 

written comments on the amendment to 

the Proposed Rule by December 19, 

2012. See section VII for the proposed 

effective dates of a final rule based on 

the amended proposed rule. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2011–N– 

0090 and/or RIN Number 0910–AG31, 

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: 

• Fax: 301–827–6870. 

• 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, Docket 

Number, and Regulatory Information 

Number (RIN) 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 the 

docket number, 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: Jay 

Crowley, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–5995, email: cdrhudi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, FDASIA was signed 

into law (Pub. L. 112–144). On July 10, 

2012, FDA published a proposed rule to 

establish a unique device identification 

system, as required by section 519(f) of 

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

Section 614 of FDASIA amends section 

519(f) of the FD&C Act in ways that 

require modification of the timeframe 

for implementation of the proposed 

rule’s requirements as they apply to 

devices that are implantable, life-saving 

(life-supporting), or life-sustaining. This 

document explains how FDA is 

amending the July 10, 2012, proposed 

rule to meet the requirements of 

amended section 519(f) of the FD&C 

Act. 

II. Description of the Proposed Rule 

A. FDA’s July 10, 2012, Proposed Rule 

Our July 10, 2012, document provides 

a detailed description of the proposed 

rule. The proposed rule includes unique 

device identifier (UDI) labeling 

requirements (proposed for inclusion in 

21 CFR part 801), requirements relating 

to issuing Agencies and submission of 

data to the Global Unique Device 

Identification Database (GUDID) 

(proposed new part 830), and 

conforming amendments to several 

existing FDA regulations. FDA proposed 

a phased implementation of the rule’s 

requirements, with some requirements 

going into effect immediately after 

publication of a final rule, and other 

requirements going into effect 1 year, 3 

years, 5 years, and 7 years after 

publication of a final rule. This phased 

implementation is summarized in the 

July 10, 2012, proposed rule by Table 

7—Effective Dates of UDI Regulatory 

Requirements (77 FR 40736 at 40764). 

B. Changes Required by the Enactment 

of FDASIA 

Section 614 of FDASIA amends 

section 519(f) of the FD&C Act, the 

provision that requires FDA to establish 

a unique device identification system. 

Prior to the enactment of FDASIA, 

section 519(f) of the FD&C Act did not 

specify the date by which a proposed 

rule is required, did not identify any 

particular devices as requiring 

expedited implementation of UDI 

requirements, and did not specify 

timeframes for publication of a final 

rule. The FDASIA amendments to 

section 519(f) address each of those 

points. As amended by FDASIA, section 


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