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

15171 

Vol. 81, No. 55 

Tuesday, March 22, 2016 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–3781; Directorate 

Identifier 2015–SW–048–AD] 

RIN 2120–AA64 

Airworthiness Directives; Agusta 

S.p.A. Helicopters 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for Agusta 

S.p.A. (Agusta) Model A109A, A109A II, 

A109C, A109E, A109K2, A109S and 

AW109SP helicopters. This proposed 

AD would require visually inspecting 

the tail rotor drive shaft assembly (drive 

shaft) for a crack. This proposed AD is 

prompted by the discovery of three 

cracks on the drive shaft of a Model 

A109S helicopter. The proposed actions 

are intended to detect a crack on the 

drive shaft to prevent failure of the 

driveshaft, failure of the tail rotor, and 

subsequent loss of helicopter control. 

DATES: We must receive comments on 

this proposed AD by May 23, 2016. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Docket: Go to 

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

online instructions for sending your 

comments electronically. 

• Fax: 202–493–2251. 

• Mail: Send comments to the U.S. 

Department of Transportation, Docket 

Operations, M–30, West Building 

Ground Floor, Room W12–140, 1200 

New Jersey Avenue SE., Washington, 

DC 20590–0001. 

• Hand Delivery: Deliver to the 

‘‘Mail’’ address between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

3781; 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 

European Aviation Safety Agency 

(EASA) AD, the economic 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 service information identified in 

this proposed rule, contact 

AgustaWestland, Product Support 

Engineering, Via del Gregge, 100, 21015 

Lonate Pozzolo (VA) Italy, ATTN: 

Maurizio D’Angelo; telephone 39–0331– 

664757; fax 39–0331–664680; or at 

http://www.agustawestland.com/

technical-bulletins. You may review the 

referenced service information at the 

FAA, Office of the Regional Counsel, 

Southwest Region, 10101 Hillwood 

Pkwy., Room 6N–321, Fort Worth, TX 

76177. 

FOR FURTHER INFORMATION CONTACT: 

Martin R. Crane, Aviation Safety 

Engineer, Safety Management Group, 

Rotorcraft Directorate, FAA, 10101 

Hillwood Pkwy., Fort Worth, TX 76177; 

telephone (817) 222–5110; email 

martin.r.crane@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to participate in this 

rulemaking by submitting written 

comments, data, or views. We also 

invite comments relating to the 

economic, environmental, energy, or 

federalism impacts that might result 

from adopting the proposals in this 

document. The most helpful comments 

reference a specific portion of the 

proposal, explain the reason for any 

recommended change, and include 

supporting data. To ensure the docket 

does not contain duplicate comments, 

commenters should send only one copy 

of written comments, or if comments are 

filed electronically, commenters should 

submit only one time. 

We will file in the docket all 

comments that we receive, as well as a 

report summarizing each substantive 

public contact with FAA personnel 

concerning this proposed rulemaking. 

Before acting on this proposal, we will 

consider all comments we receive on or 

before the closing date for comments. 

We will consider comments filed after 

the comment period has closed if it is 

possible to do so without incurring 

expense or delay. We may change this 

proposal in light of the comments we 

receive. 

Discussion 

EASA, which is the aviation authority 

for Italy, has issued AD No. 2015–0054, 

dated March 27, 2015, to correct an 

unsafe condition for Model A109A with 

retrofit kit part number 109–0820–27– 

101 installed, and Model A109A II, 

A109C, A109E, A109K2, A109LUH, 

A109S, and AW109SP helicopters. 

EASA advises that during scheduled 

maintenance on a Model A109S 

helicopter, three cracks were found on 

the drive shaft. An investigation could 

not determine the cause of the cracking 

but concluded it could not have been 

caused by fatigue. This condition, if not 

detected and corrected, could lead to 

tail rotor failure, possibly resulting in 

loss of helicopter control, EASA 

advises. EASA AD No. 2015–0054 

consequently requires a one-time 

inspection of the drive shaft, and 

replacing the drive shaft if cracks are 

found. 

FAA’s Determination 

These helicopters have been approved 

by the aviation authority of Italy and are 

approved for operation in the United 

States. Pursuant to our bilateral 

agreement with Italy, EASA, its 

technical representative, has notified us 

of the unsafe condition described in its 

AD. We are proposing this AD because 

we evaluated all known relevant 

information and determined that an 

unsafe condition is likely to exist or 

develop on other products of the same 

type design. 

Related Service Information Under 1 

CFR Part 51 

We reviewed AgustaWestland 

Bollettino Tecnico (BT) No. 109–147 for 

Model A109A helicopters with retrofit 

kit P/N 109–0820–27–101 installed, 

Model A109A II, and Model A109C 

helicopters; BT No. 109EP–143 for 

Model A109E helicopters; BT No. 109K– 

68 for Model A109K2 helicopters; BT 

No. 109S–067 for Model A109S 


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15172 Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules 

helicopters; and BT No. 109SP–094 for 

Model AW109SP helicopters. All of the 

BTs are dated March 25, 2015. 

AgustaWestland reports that during a 

scheduled servicing of an A109S 

helicopter, three cracks were found on 

drive shaft P/N 109–8412–02–1. The 

BTs prescribe a one-time drive shaft 

inspection for cracks. 

This service information is reasonably 

available because the interested parties 

have access to it through their normal 

course of business or by the means 

identified in the ADDRESSES section. 

Proposed AD Requirements 

This proposed AD would require, 

within 50 hours time-in-service, 

visually inspecting the drive shaft for a 

crack and replacing the drive shaft if it 

is cracked. 

Differences Between This Proposed AD 

and the EASA AD 

The EASA AD applies to Agusta 

Model A109LUH helicopters. This 

proposed AD would not because that 

model does not have an FAA type 

certificate. 

Interim Action 

We consider this proposed AD to be 

an interim action. The design approval 

holder has not determined the cause of 

the unsafe condition identified in this 

proposed AD. If a cause is determined 

and actions developed to address the 

cause, we might consider additional 

rulemaking. 

Costs of Compliance 

We estimate that this proposed AD 

would affect 142 helicopters of U.S. 

Registry and that labor costs average $85 

per work-hour. Based on these 

estimates, we expect the following costs: 

• Inspecting the drive shaft would 

require 9 work-hours and no parts. The 

estimated cost would be $765 per 

helicopter and $108,630 for the U.S. 

fleet. 

• Replacing the drive shaft would not 

require additional labor hours. Parts 

would cost $6,082 per helicopter. 

According to Agusta service 

information, some 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 by 

Agusta. Accordingly, 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, 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 to the extent that it justifies 

making a regulatory distinction; 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 an economic 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 airworthiness 

directive (AD): 

Agusta S.p.A.: Docket No. FAA–2015–3781; 

Directorate Identifier 2015–SW–048–AD. 

(a) Applicability 

This AD applies to Agusta S.p.A. Model 

A109A, A109A II, A109C, A109E, A109K2, 

A109S, and AW109SP helicopters with a tail 

rotor drive shaft assembly (drive shaft), part 

number 109–8412–02–1 or 109–8412–02–3, 

installed, certificated in any category. 

(b) Unsafe Condition 

This AD defines the unsafe condition as a 

crack in a drive shaft. This condition could 

result in failure of a drive shaft, failure of the 

tail rotor, and subsequent loss of helicopter 

control. 

(c) Comments Due Date 

We must receive comments by May 23, 

2016. 

(d) Compliance 

You are responsible for performing each 

action required by this AD within the 

specified compliance time unless it has 

already been accomplished prior to that time. 

(e) Required Actions 

Within 50 hours time-in-service: 

(1) Visually inspect each drive shaft in 

accordance with the Compliance 

Instructions, paragraph 4, of AgustaWestland 

Bollettino Tecnico (BT) No. 109–147, dated 

March 25, 2015; BT No. 109EP–143, dated 

March 25, 2015; BT No. 109K–68, dated 

March 25, 2015; BT No. 109S–067, dated 

March 25, 2015; or BT No. 109SP–094, dated 

March 25, 2015, as applicable for your model 

helicopter. 

(2) If there is a crack, replace the drive 

shaft before further flight. 

(f) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Safety Management 

Group, FAA, may approve AMOCs for this 

AD. Send your proposal to: Martin R. Crane, 

Aviation Safety Engineer, Safety Management 

Group, Rotorcraft Directorate, FAA, 10101 

Hillwood Pkwy, Fort Worth, TX 76177; 

telephone (817) 222–5110; email 9-ASWFTW-AMOC-Requests@faa.gov. 

(2) For operations conducted under a 14 

CFR part 119 operating certificate or under 

14 CFR part 91, subpart K, we suggest that 

you notify your principal inspector, or 

lacking a principal inspector, the manager of 

the local flight standards district office or 

certificate holding district office before 

operating any aircraft complying with this 

AD through an AMOC. 

(g) Additional Information 

The subject of this AD is addressed in 

European Aviation Safety Agency (EASA) AD 

No. 2015–0054, dated March 27, 2015. You 

may view the EASA AD on the Internet at 

http://www.regulations.gov by searching for 

and locating it in Docket No. FAA–2015– 

3781. 


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Federal Register / Vol. 81, No. 55 / Tuesday, March 22, 2016 / Proposed Rules 15173 

(h) Subject 

Joint Aircraft Service Component (JASC) 

Code: 6510, Tail Rotor Drive Shaft. 

Issued in Fort Worth, Texas, on March 15, 

2016. 

Scott A. Horn, 

Acting Manager, Rotorcraft Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–06373 Filed 3–21–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 73 and 74 

[Docket No. FDA–2016–F–0821] 

Milton W. Chu, M.D.; Filing of Color 

Additive Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of petition. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that we have filed a 

petition, submitted by Milton W. Chu, 

M.D., proposing that the color additive 

regulations be amended to provide for 

the safe use of titanium dioxide and 

[phthalocyaninato (2-)] copper as 

orientation marks for intraocular lenses. 

DATES: The color additive petition was 

filed on February 19, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Laura Dye, Center for Food Safety and 

Applied Nutrition (HFS–265), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740–3835, 

240–402–1275. 

SUPPLEMENTARY INFORMATION: Under 

section 721(d)(1) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

379e(d)(1)), we are giving notice that we 

have filed a color additive petition (CAP 

6C0305), submitted by Milton W. Chu, 

M.D., 5800 Santa Rosa Rd., Suite 111, 

Camarillo, CA 93012. The petition 

proposes to amend the color additive 

regulations in § 73.3126 Titanium 

dioxide (21 CFR 73.3126) and § 74.3045 

[Phthalocyaninato (2-)] copper (21 CFR 

74.3045) to provide for the safe use of 

titanium dioxide and [phthalocyaninato 

(2-)] copper as orientation marks for 

intraocular lenses. 

We have determined under 21 CFR 

25.32(l) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

Dated: March 17, 2016. 

Dennis M. Keefe, 

Director, Office of Food Additive Safety, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. 2016–06397 Filed 3–21–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 878, 880, and 895 

[Docket No. FDA–2015–N–5017] 

RIN 0910–AH02 

Banned Devices; Proposal To Ban 

Powdered Surgeon’s Gloves, 

Powdered Patient Examination Gloves, 

and Absorbable Powder for 

Lubricating a Surgeon’s Glove 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that Powdered Surgeon’s 

Gloves, Powdered Patient Examination 

Gloves, and Absorbable Powder for 

Lubricating a Surgeon’s Glove present 

an unreasonable and substantial risk of 

illness or injury and that the risk cannot 

be corrected or eliminated by labeling or 

a change in labeling. Consequently, FDA 

is proposing these devices be banned. 

DATES: Submit either electronic or 

written comments by June 20, 2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, FDA will post your 

comment, as well as any attachments, 

except for information submitted, 

marked and identified, as confidential, 

if submitted as detailed in 

‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–5017 for ‘‘Banned Devices; 

Proposal to Ban Powdered Surgeon’s 

Gloves, Powdered Patient Examination 

Gloves, and Absorbable Powder for 

Lubricating a Surgeon’s Glove.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://www.regulations.gov or at the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

http://www.regulations.gov. Submit 

both copies to the Division of Dockets 

Management. If you do not wish your 

name and contact information to be 

made publicly available, you can 

provide this information on the cover 

sheet and not in the body of your 

comments and you must identify this 

information as ‘‘confidential.’’ Any 

information marked as ‘‘confidential’’ 

will not be disclosed except in 

accordance with 21 CFR 10.20 and other 

applicable disclosure law. For more 

information about FDA’s posting of 


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