9346 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 

the inspection required by paragraph (t) of 

this AD thereafter at the applicable interval 

specified in paragraphs (u)(1), (u)(2), and 

(u)(3) of this AD. 

(1) For airplanes fitted with twin wheel 

MLG that have been equipped with EMM 

BSCU standard L4.8: At intervals not to 

exceed 20 months, or 6,000 flight hours, or 

4,500 flight cycles, whichever occurs first. 

(2) For airplanes fitted with twin wheel 

MLG that have been equipped with EMM 

BSCU standard L4.1 or L4.5: At intervals not 

to exceed 6 months, or 1,800 flight hours, or 

1,350 flight cycles, whichever occurs first. 

(3) For airplanes fitted with bogie MLG: At 

intervals not to exceed 20 months, or 6,000 

flight hours, or 4,500 flight cycles, whichever 

occurs first. 

(v) Modification 

For airplanes fitted with twin wheel MLG: 

Within 6 months after the effective date of 

this AD, modify the airplane by installing 

EMM BSCU standard L4.9B, in accordance 

with the Accomplishment Instructions of 

Airbus Service Bulletin A320–32–1350, 

dated July 3, 2008. 

(w) Optional Method of Modification 

Doing a modification specified in 

paragraph (w)(1), (w)(2), or (w)(3) of this AD, 

is acceptable for compliance with the 

requirements of paragraph (v) of this AD. 

(1) Modification of the airplane by 

installing EMM BSCU standard L4.9B, in 

accordance with the Accomplishment 

Instructions of Airbus Service Bulletin A320– 

32–1387, dated April 7, 2011. 

(2) Modification of the airplane by 

installing conventional EMM BSCU standard 

10, in accordance with the Accomplishment 

Instructions of Airbus Service Bulletin A320– 

32–1360, dated March 18, 2009; or Airbus 

Mandatory Service Bulletin A320–32–1336, 

Revision 01, dated January 10, 2008. 

(3) Modification of the airplane by 

installing conventional EMM BSCU standard 

10.1 in accordance with the Accomplishment 

Instructions of Airbus Service Bulletin A320– 

32–1369, Revision 01, dated March 31, 2010. 

(x) Terminating Action 

In-service modification of an airplane fitted 

with twin wheel MLG as required by 

paragraph (v) of this AD constitutes 

terminating action for the initial and 

repetitive inspections required by paragraph 

(t) of this AD. In addition, the AFM changes 

required by paragraph (r) of this AD may be 

removed from the AFM; and the 

requirements of paragraph (s) of this AD are 

no longer required. 

(y) Exemption From Certain Actions 

Except for paragraph (y) of this AD, 

airplanes that have been delivered with 

Airbus modification 38973 and/or Airbus 

modification 151575 that install EMM BSCU 

standard L4.9B are not affected by the 

requirements of this AD, provided that no 

installation of previous EMM BSCU 

standards L4.1, L4.5, or L4.8 has been 

performed since the airplane first flight. 

(z) Parts Installation 

For airplanes that do not have EMM BSCU 

L4.1, or EMM BSCU L4.5, or EMM BSCU 

L4.8 installed: As of the effective date of this 

AD, no person may modify an airplane by 

installing EMM BSCU standards L4.1, L4.5, 

or L4.8 on any airplane. 

(aa) Credit for Previous Actions 

(1) This paragraph restates the 

requirements of paragraph (n) of AD 2007– 

18–09, Amendment 39–15189 (72 FR 51164, 

September 6, 2007). This paragraph provides 

credit for the inspections required by 

paragraph (j) of this AD, if those inspections 

were performed before October 11, 2007 (the 

effective date of AD 2007–18–09, 

Amendment 39–15189 (72 FR 51164, 

September 6, 2007)) using Chapter 12, 

Subject 12–14–32 of the Airbus A318/A319/ 

A320/A321 AMM, as revised by Airbus 

A318/A319/A320/A321 AMM Temporary 

Revision 12–001, dated November 13, 2005. 

(2) This paragraph provides credit for the 

inspections and related investigative/ 

corrective actions required by paragraphs (j), 

(k), and (l) of this AD, if those inspections 

were performed before the effective date of 

this AD using Airbus Service Bulletin A320– 

32–1310, dated February 8, 2006. 

(3) This paragraph provides credit for the 

modifications specified in paragraph (w)(2) 

of this AD, if those modifications were 

performed before the effective date of this AD 

using Airbus Mandatory Service Bulletin 

A320–32–1336, dated September 19, 2007. 

(4) This paragraph provides credit for the 

modifications required by paragraph (w)(3) of 

this AD, if those modifications were 

performed before the effective date of this AD 

using Airbus Service Bulletin A320–32–1369, 

dated March 22, 2009. 

(bb) 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 

appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Sanjay Ralhan, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

telephone (425) 227–1405; 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. AMOCs approved previously in 

accordance with AD 2007–18–09, 

Amendment 39–15189 (72 FR 51164, 

September 6, 2007), are not approved as 

AMOCs with 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. 

(cc) Related Information 

(1) Refer to MCAI EASA Airworthiness 

Directive 2011–0201, dated October 13, 2011, 

and the service information service 

information identified in paragraphs (cc)(1)(i) 

through (cc)(1)(viii) for related information. 

(i) Airbus A318/A319/A320/A321, Task 

12–12–32–610–001–A Check NLG Shock 

Absorber Fluid Level and Charge Pressure 

(‘‘Two-Point Check’’—Aircraft on Jacks to 

start), Revision August 1, 2012. 

(ii) Airbus Mandatory Service Bulletin 

A320–32–1310, Revision 01, dated June 23, 

2011. 

(iii) Airbus Mandatory Service Bulletin 

A320–32–1336, Revision 01, dated January 

10, 2008. 

(iv) Airbus Service Bulletin A320–32– 

1350, dated July 31, 2008. 

(v) Airbus Service Bulletin A320–32–1360, 

dated March 18, 2009. 

(vi) Airbus Service Bulletin A320–32– 

1369, Revision 01, dated March 31, 2010. 

(vii) Airbus Service Bulletin A320–32– 

1387, dated April 7, 2011. 

(viii) Airbus Technical Note 957.1901/05, 

dated October 18, 2005. 

(2) For service information identified in 

this AD, contact Airbus, Airworthiness 

Office—EAS, 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. 

Issued in Renton, Washington, on January 

31, 2013. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2013–02898 Filed 2–7–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2013–0090; Directorate 

Identifier 2012–NM–149–AD] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company 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 


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Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 9347 

The Boeing Company Model 747–100, 

747–100B, 747–100B SUD, 747–200B, 

747–200C, 747–300, 747–400, 747– 

400D, and 747SP series airplanes. This 

proposed AD was prompted by reports 

of worn or incorrectly assembled latches 

on main deck escape slides installed on 

airplane doors. This proposed AD 

would require determining if the latches 

are correctly assembled; and corrective 

actions if necessary. This proposed AD 

also would require, for certain airplanes, 

modifications to the escape slide/rafts 

and escape slides. We are proposing this 

AD to prevent a latch hook moving from 

closed to open in an escape slide/raft or 

escape slide, which could result in the 

escape slide/raft or escape slide not 

deploying correctly in an emergency, or 

releasing/inflating into the passenger 

cabin and causing injury to passengers 

and crew. 

DATES: We must receive comments on 

this proposed AD by March 25, 2013. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, 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: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For Boeing service information 

identified in this proposed AD, contact 

Boeing Commercial Airplanes, 

Attention: Data & Services Management, 

P. O. Box 3707, MC 2H–65, Seattle, WA 

98124–2207; telephone 206–544–5000, 

extension 1; fax 206–766–5680; Internet 

https://www.myboeingfleet.com. For 

Goodrich service information identified 

in this proposed AD, contact Goodrich 

Corporation, Aircraft Interior Products, 

ATTN: Technical Publications, 3414 

South Fifth Street, Phoenix, AZ 85040– 

1169; telephone 602–243–2200; Internet 

http://www.goodrich.com/TechPubs. 

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 Management Facility 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 Office 

(phone: 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Piccola, Aerospace Engineer, 

Cabin Safety and Environmental 

Systems Branch, ANM–150S, FAA, 

Seattle Aircraft Certification Office, 

1601 Lind Avenue SW., Renton, WA 

98057–3356; phone: 425–917–6483; fax: 

425–917–6590; email: 

sarah.piccola@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposal. Send your comments to 

an address listed under the ADDRESSES

section. Include ‘‘Docket No. FAA– 

2013–0090; Directorate Identifier 2012– 

NM–149–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 because of 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 

We received reports that, in service, 

latches in the main deck escape slide/ 

rafts and escape slides installed on 

airplane doors were not fully closed. 

The current latch design uses friction to 

keep the latch hook closed. Corrosion 

and worn parts reduce friction between 

the parts of the latch that keep it closed. 

The new latch design has a retention 

feature to make sure the latch stays 

closed. A latch hook moving from the 

closed to the open position in an escape 

slide/raft or escape slide, if not 

corrected, could result in an escape 

slide/raft or escape slide not deploying 

correctly in an emergency, or releasing/ 

inflating into the passenger cabin and 

causing injury to passengers and crew. 

Relevant Service Information 

We reviewed Boeing Special 

Attention Service Bulletin 747–25– 

3428, Revision 3, dated June 14, 2012. 

For information on the procedures and 

compliance times, see this service 

information at http:// 

www.regulations.gov by searching for 

Docket No. FAA–2013–0090. 

Concurrent Service Information 

Boeing Special Attention Service 

Bulletin 747–25–3428, Revision 3, dated 

June 14, 2012, specifies concurrent or 

prior accomplishment of Boeing Service 

Bulletin 747–25–2425, Revision 1, dated 

September 7, 1979. For information on 

the procedures, see this service 

information at http:// 

www.regulations.gov by searching for 

Docket No. FAA 2013 0090. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

Proposed AD Requirements 

This proposed AD would require 

accomplishing the actions specified in 

the service information described 

previously. 

The phrase ‘‘related investigative 

actions’’ might be used in this proposed 

AD. ‘‘Related investigative actions’’ are 

follow-on actions that (1) are related to 

the primary action, and (2) are actions 

that further investigate the nature of any 

condition found. Related investigative 

actions in an AD could include, for 

example, inspections. 

In addition, the phrase ‘‘corrective 

actions’’ might be used in this proposed 

AD. ‘‘Corrective actions’’ are actions 

that correct or address any condition 

found. Corrective actions in an AD 

could include, for example, repairs. 

Costs of Compliance 

We estimate that this proposed AD 

affects 121 airplanes of U.S. registry. 

We estimate the following costs to 

comply with this proposed AD: 


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9348 Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per product Cost on U.S. 

operators 

Determine if latches are correctly assembled.1 work-hour × $85 per hour = 

$85.

$0 ............................................ $85 .......................................... $10,285. 

Option to rework/replace 

latches instead of determining if latches are correctly assembled.

Between 3 and 24 work-hours 

× $85 per hour = Between 

$255 and $2,040.

$286 per latch ........................ Between $541 and $2,326 ..... Between 

$65,461 

and 

$281,446. 

We estimate the following costs to do 

any necessary replacements that would 

be required based on the results of the 

proposed latch assembly determination. 

We have no way of determining the 

number of aircraft that might need this 

replacement: 

ON-CONDITION COSTS

Action Labor cost Parts cost Cost per 

product 

Corrective action ....................................... Between 3 and 24 work-hours × $85 per 

hour = Between $255 and $ 2,040.

$286 per latch .......................................... Between 

$541 and 

$2,326. 

According to the manufacturer, all of 

the costs of this proposed AD may be 

covered under warranty, thereby 

reducing the cost impact on affected 

individuals. We do not control warranty 

coverage for affected individuals. As a 

result, we have included all costs in our 

cost estimate. 

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. 

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 airworthiness 

directive (AD): 

The Boeing Company: Docket No. FAA– 

2013–0090; Directorate Identifier 2012– 

NM–149–AD. 

(a) Comments Due Date 

We must receive comments by March 25, 

2013. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 747–100, 747–100B, 747–100B SUD, 

747–200B, 747–200C, 747–300, 747–400, 

747–400D, and 747SP series airplanes; 

certificated in any category; as identified in 

Boeing Special Attention Service Bulletin 

747–25–3428, Revision 3, dated June 14, 

2012; except for Groups 3–4, Configuration 2, 

and Group 9, Configuration 2, airplanes. 

(d) Subject 

Joint Aircraft System Component (JASC)/ 

Air Transport Association (ATA) of America 

Code 25, Equipment/furnishings. 

(e) Unsafe Condition 

This AD was prompted by reports of worn 

or incorrectly assembled latches on main 

deck escape slides installed on airplane 

doors. We are issuing this AD to prevent a 

latch hook moving from closed to open in an 

escape slide/raft or escape slide, which could 

result in the escape slide/raft or escape slide 

not deploying correctly in an emergency, or 

releasing/inflating into the passenger cabin 

and causing injury to passengers and crew. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Replacement or Rework of Escape Slide 

Latch Assembly 

Within 48 months after the effective date 

of this AD: Determine if the latches in the 

main deck escape slide/rafts and the escape 

slides installed on the airplane doors are 

correctly assembled, and do all applicable 

corrective actions, in accordance with the 


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Federal Register / Vol. 78, No. 27 / Friday, February 8, 2013 / Proposed Rules 9349 

Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 747–25– 

3428, Revision 3, dated June 14, 2012. Do all 

applicable corrective actions before further 

flight. Options provided in Boeing Special 

Attention Service Bulletin 747–25–3428, 

Revision 3, dated June 14, 2012, for 

determining the correct assembly of the 

latches are acceptable for the corresponding 

requirement of this paragraph. 

(h) Concurrent Requirements 

For Groups 1, 5, 10, and 13 airplanes, as 

identified in Boeing Special Attention 

Service Bulletin 747–25–3428, Revision 3, 

dated June 14, 2012: Prior to or concurrently 

with accomplishing the actions required by 

paragraph (g) of this AD, replace the 

packboard cap nuts with flush-type inserts, 

reinforce the lower packboard support 

bracket attachments, install hooks, modify 

the lower liner of the main entry door and 

packboard, and remove the ‘‘Press to Test’’ 

circuit panel and associated circuitry, in 

accordance with the Accomplishment 

Instructions of Boeing Service Bulletin 747– 

25–2425, Revision 1, dated September 7, 

1979. 

(i) Credit for Previous Actions 

This paragraph provides credit for the 

applicable concurrent actions required by 

paragraph (h) of this AD, if those actions 

were performed before the effective date of 

this AD using Boeing Service Bulletin 747– 

25–2425, dated August 25, 1978, which is not 

incorporated by reference in this AD. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Seattle Aircraft 

Certification Office (ACO) 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 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in the 

Related Information section of this AD. 

Information may be emailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. 

(2) 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. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair 

required by this AD if it is approved by the 

Boeing Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Seattle 

ACO, to make those findings. For a repair 

method to be approved, the repair must meet 

the certification basis of the airplane, and the 

approval must specifically refer to this AD. 

(k) Related Information 

(1) For more information about this AD, 

contact Sarah Piccola, Aerospace Engineer, 

Cabin Safety and Environmental Systems 

Branch, ANM–150S, FAA, Seattle Aircraft 

Certification Office, 1601 Lind Avenue SW., 

Renton, WA 98057–3356; phone: 425–917– 

6483; fax: 425–917–6590; email: 

sarah.piccola@faa.gov. 

(2) For Boeing service information 

identified in this AD, contact Boeing 

Commercial Airplanes, Attention: Data & 

Services Management, P. O. Box 3707, MC 

2H–65, Seattle, WA 98124–2207; telephone 

206- 544–5000, extension 1; fax 206–766– 

5680; Internet https:// 

www.myboeingfleet.com. For Goodrich 

service information identified in this AD, 

contact Goodrich Corporation, Aircraft 

Interior Products, ATTN: Technical 

Publications, 3414 South Fifth Street, 

Phoenix, AZ 85040–1169; telephone 602– 

243–2200; Internet http:// 

www.goodrich.com/TechPubs. You may also 

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 February 

1, 2013. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2013–02896 Filed 2–7–13; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2013–N–0069] 

Medical Devices; Ophthalmic Devices; 

Classification of the Eyelid Weight 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

classify the eyelid weight into class II 

(special controls). The eyelid weight 

may be adhered to the outer skin of the 

upper eyelid (external eyelid weight) or 

implanted into the upper eyelid 

(implantable eyelid weight), and is 

intended for the gravity assisted 

treatment of lagophthalmos (incomplete 

eyelid closure). FDA is also giving 

notice of its intent to exempt the 

external eyelid weight device from the 

premarket notification requirements of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). After considering 

public comments on the proposed 

classification, FDA will publish a final 

regulation classifying this device type. 

DATES: Submit either electronic or 

written comments by May 9, 2013. See 

section IV of this document for the 

proposed effective date of a final rule 

that may issue based on this proposal. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2013–N– 

0069, 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 way: 

• 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–2013–N–0069 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: Tina 

Kiang, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 2414, Silver Spring, 

MD 20993–0002, 301–796–6860, 

Tina.Kiang@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION:

I. Background 

A. Statutory and Regulatory Authorities 

The FD&C Act (21 U.S.C. 301 et seq.), 

as amended by the Medical Device 

Amendments of 1976 (Pub. L. 94–295), 

the Safe Medical Devices Act of 1990 

(Pub. L. 101–629), and the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115), among other 

amendments, established 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, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 


wreier-aviles on DSK7SPTVN1PROD with PROPOSALS