Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 16325 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–0673; Directorate 

Identifier 2014–SW–034–AD] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Helicopters (Previously Eurocopter 

France) 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for Airbus 

Helicopters Model AS350B, AS350BA, 

AS350B1, AS350B2, AS350B3, AS350C, 

AS350D, AS350D1, AS355E, AS355F, 

AS355F1, AS355F2, AS355N, AS355NP, 

EC130B4, and EC130T2 helicopters. 

This proposed AD would require 

inspecting the swashplate assembly 

rotating star to determine whether a 

ferrule was installed. If a ferrule exists, 

this proposed AD would require 

inspecting the rotating star for a crack 

and removing any cracked rotating star. 

This proposed AD is prompted by a 

report that reconditioning the rotating 

swashplate per a certain repair 

procedure could result in the rotating 

star cracking. The proposed actions are 

intended to detect a crack in the rotating 

star and prevent failure of the rotating 

star and subsequent loss of control of 

the helicopter. 

DATES: We must receive comments on 

this proposed AD by May 26, 2015. 

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 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 AD, contact Airbus 

Helicopters, Inc., 2701 N. Forum Drive, 

Grand Prairie, TX 75052; telephone 

(972) 641–0000 or (800) 232–0323; fax 

(972) 641–3775; or at http://

www.airbushelicopters.com/techpub. 

You may review the referenced service 

information at the FAA, Office of the 

Regional Counsel, Southwest Region, 

2601 Meacham Blvd., Room 663, Fort 

Worth, Texas 76137. It is also available 

on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0673. 

FOR FURTHER INFORMATION CONTACT: 

Robert Grant, Aviation Safety Engineer, 

Safety Management Group, FAA, 2601 

Meacham Blvd., Fort Worth, Texas 

76137; telephone (817) 222–5110; email 

robert.grant@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 Technical Agent 

for the Member States of the European 

Union, issued EASA AD No. 2014– 

0132R1, dated June 2, 2014, to correct 

an unsafe condition for Airbus 

Helicopters (previously Eurocopter 

France) Model AS 350 B, BA, BB, B1, 

B2, B3, D, AS 355 E, F, F1, F2, N, NP, 

EC 130 B4, and T2 helicopters if 

equipped with a swashplate assembly 

with a rotating star, part number (P/N) 

350A371003–04, P/N 350A371003–05, 

P/N 350A371003–06, P/N 350A371003– 

07, or P/N 350A371003–08. EASA 

advises that during a repair of a 

helicopter, it was discovered that 

rotating swashplates reconditioned in 

accordance with a certain repair 

procedure could experience a high 

stress level. This condition, if not 

corrected, could affect the service life of 

the part. To address this unsafe 

condition, EASA AD No. 2014–0132R1 

requires repetitive inspections and 

replacement of the rotating star. 

FAA’s Determination 

These helicopters have been approved 

by the aviation authority of France and 

are approved for operation in the United 

States. Pursuant to our bilateral 

agreement with France, 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 Airbus Helicopters Alert 

Service Bulletin (ASB) No. EC130 

62A010 for Model EC130B4 and 

EC130T2 helicopters; ASB No. AS355 

62.00.33 for Model AS355E, AS355F, 

AS355F1, AS355F2, AS355N, and 

AS355NP helicopters; and ASB No. 

AS350 62.00.34 for Model AS350B, 

AS350BA, AS350BB, AS350B1, 

AS350B2, AS350B3, AS350D, and 

military version AS350L1 helicopters; 

all Revision 0 and all dated April 28, 

2014. 

The ASBs report that a certain repair 

sheet instruction, which requires 

reconditioning the rotating swashplate 

by machining and adding a steel ferrule 

to accommodate a swashplate bearing, 

potentially affects the service life limit 

specified in the airworthiness 

limitations section. The ASBs provide 

procedures for inspecting the 

swashplate assembly’s rotating star for a 

ferrule and if a ferrule exists, inspecting 


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16326 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 

for a crack. The ASBs call for replacing 

the rotating star before further flight if 

a crack exists, and before December 31, 

2014, if a ferrule is present and there are 

no cracks. If there is no ferrule, the 

ASBs require no additional action. 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 of 

this NPRM. 

Proposed AD Requirements 

This proposed AD would require, 

within 165 hours time-in-service (TIS), 

visually inspecting the swashplate 

assembly to determine whether a ferrule 

is installed with the rotating star. If no 

ferrule exists, no further action would 

be needed. If a ferrule is installed, the 

proposed AD would require, before 

further flight, dye-penetrant inspecting 

the rotating star for a crack. The 

proposed AD would also require 

removing the rotating star and all 

attachment hardware before further 

flight if the rotating star has a crack, or 

within 160 hours TIS if the rotating star 

has a ferrule installed but does not have 

a crack. 

This proposed AD would also 

prohibit installing a rotating star with a 

ferrule. 

Differences Between This Proposed AD 

and the EASA AD 

The EASA AD requires reporting 

inspection findings to Airbus 

Helicopters. This proposed AD would 

make no such requirement. The EASA 

AD does not apply to Airbus Model 

AS350C and AS350D1 helicopters, 

whereas this proposed AD would apply 

to those models. The EASA AD applies 

to Model AS350BB helicopters, and this 

proposed AD would not because that 

model is not type certificated in the 

United States. The EASA AD would 

require replacing the rotating star, 

unless already accomplished, by 

December 31, 2014, while we would 

require replacing the rotating star within 

160 hours TIS, unless already 

accomplished. 

Costs of Compliance 

We estimate that this proposed AD 

would affect 1,132 helicopters of U.S. 

Registry and that labor costs would 

average $85 a work hour. Based on these 

estimates, we would expect the 

following costs: 

• Visually inspecting the swashplate 

assembly would require 0.25 work-hour 

for a labor cost of about $21 per 

inspection. No parts would be needed 

for a total cost of about $21 per 

inspection per helicopter, or about 

$23,772 for the U.S. fleet. 

• Dye-penetrant inspecting the 

rotating star would require 1 work-hour 

for a labor cost of about $85 per 

helicopter. No parts would be needed 

for a total cost of $85 per inspection 

helicopter and $96,220 for the U.S. fleet. 

• Replacing the rotating star, ferrule, 

and associated parts would require 16 

work hours and parts would cost 

$8,354, for a total cost of $9,714 per 

helicopter. 

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): 

Airbus Helicopters: Docket No. FAA–2015– 

0673; Directorate Identifier 2014–SW– 

034–AD. 

(a) Applicability 

This AD applies to Airbus Helicopters 

Model AS350B, AS350BA, AS350B1, 

AS350B2, AS350B3,AS350C, AS350D, 

AS350D1, AS355E, AS355F, AS355F1, 

AS355F2, AS355N, AS355NP, EC130B4, and 

EC130T2 helicopters with a swashplate 

assembly with rotating star, part number (P/ 

N) 350A371003–04, 350A371003–05, 

350A371003–06, 350A371003–07, or 

350A371003–08, certificated in any category. 

(b) Unsafe Condition 

This AD defines the unsafe condition as a 

crack in a rotating star in a main rotor blade 

(M/R) swashplate assembly. This condition 

could result in loss of the M/R pitch control 

and subsequent loss of helicopter control. 

(c) Comments Due Date 

We must receive comments by May 26, 

2015. 

(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 

(1) Within 165 hours time-in-service (TIS), 

visually inspect the swashplate assembly to 

determine whether a ferrule is installed on 

the rotating star. If the ferrule is not visible, 

use a magnetic retriever positioned in Area 

(X) as shown in the pictures under paragraph 

3.B.2.b., Accomplishment Instructions, of 

Airbus Helicopters Alert Service Bulletin 

(ASB) No. EC130 62A010, ASB No. AS350 

62.00.34, or ASB No. AS355 62.00.33, all 

Revision 0, and all dated April 28, 2014, 

whichever is applicable to your helicopter, to 

determine whether the ferrule is installed. 

The magnetic retriever will be magnetized if 

a ferrule is installed. 

(2) If a ferrule is not installed, no further 

action is needed. 


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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Proposed Rules 16327 

(3) If a ferrule is installed on the rotating 

star, before further flight, dye-penetrant 

inspect the rotating star for a crack in areas 

‘‘Z’’ depicted in Figure 1 of Airbus 

Helicopters ASB No. EC130 62A010, ASB 

No. AS350 62.00.34, or ASB No. AS355 

62.00.33, all Revision 0, and all dated April 

28, 2014, as applicable to your model 

helicopter. 

(i) If the rotating star has a crack, before 

further flight, remove from service the 

rotating star; ferrule; and the screws, washers 

and nuts used to attach the pitch change 

rods, compass, and the rotating star deflector. 

(ii) If the rotating star does not have a 

crack, within 160 hours TIS, remove from 

service the rotating star; ferrule; and the 

screws, washers and nuts used to attach the 

pitch change rods, compass, and the rotating 

star deflector. 

(4) Do not install a rotating star P/N 

350A371003–04, 350A371003–05, 

350A371003–06, 350A371003–07, or 

350A371003–08 with a ferrule. 

(f) Special Flight Permit 

Special flight permits are prohibited. 

(g) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Safety Management 

Group, FAA, may approve AMOCs for this 

AD. Send your proposal to: Robert Grant, 

Aviation Safety Engineer, Safety Management 

Group, FAA, 2601 Meacham Blvd., Fort 

Worth, Texas 76137; telephone (817) 222– 

5110; email robert.grant@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. 

(h) Additional Information 

The subject of this AD is addressed in the 

European Aviation Safety Agency (EASA) AD 

No. 2014–0132R1, dated June 2, 2014. You 

may view the EASA AD on the Internet at 

http://www.regulations.gov in the AD Docket. 

(i) Subject 

Joint Aircraft Service Component (JASC) 

Code: 6200, Main Rotor System. 

Issued in Fort Worth, Texas, on March 18, 

2015. 

Lance T. Gant, 

Acting Directorate Manager, Rotorcraft 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–06805 Filed 3–26–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. FDA–2015–N–0540] 

Homeopathic Product Regulation: 

Evaluating the Food and Drug 

Administration’s Regulatory 

Framework After a Quarter-Century; 

Public Hearing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing to obtain information 

and comments from stakeholders about 

the current use of human drug and 

biological products labeled as 

homeopathic, as well as the Agency’s 

regulatory framework for such products. 

These products include prescription 

drugs and biological products labeled as 

homeopathic and over-the-counter 

(OTC) drugs labeled as homeopathic. 

FDA is seeking participants for the 

public hearing and written comments 

from all interested parties, including, 

but not limited to, consumers, patients, 

caregivers, health care professionals, 

patient groups, and industry. FDA is 

seeking input on a number of specific 

questions, but is interested in any other 

pertinent information participants 

would like to share. 

DATES: The public hearing will be held 

on April 20 and 21, 2015, from 9 a.m. 

to 4 p.m. The meeting may be extended 

or may end early depending on the level 

of public participation. Register to 

attend or provide oral testimony at the 

hearing by April 13, 2015. See 

Registration and Request to Provide Oral 

Testimony for information on how to 

register or make an oral presentation at 

the hearing. Written or electronic 

comments will be accepted until June 

22, 2015. 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503A, Silver Spring, MD, 20993– 

0002. Participants must enter through 

Building 1 and undergo security 

screening. For parking and security 

information, please refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Lesley DeRenzo, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903–0002, 240–402–4612, FAX: 301– 

847–8747, Lesley.derenzo@fda.hhs.gov; 

or Cynthia Ng, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Silver Spring, MD 

20903–0002, 301–796–7512, FAX: 301– 

847–8747, cynthia.ng.@fda.hhs.gov. 

Registration and Request to Provide 

Oral Testimony: The public hearing is 

free and seating will be on a first-come, 

first-served basis. If you wish to attend 

or make an oral presentation, see section 

III (Attendance and/or Participation in 

the Public Hearing) for information on 

how to register and the deadline for 

registration. If you cannot attend in 

person, information about how you can 

access a live Webcast will be located at 

https://collaboration.fda.gov/

hprapril2015/. 

Comments and Transcripts: You may 

submit either electronic comments 

regarding this document to http://

www.regulations.gov or written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. You should 

annotate and organize your comments to 

identify the specific questions or topic 

to which they refer. It is only necessary 

to send one set of comments. Please 

identify your comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and at http://

www.regulations.gov approximately 45 

days after the hearing. You may submit 

a request to obtain a hard copy or CD– 

ROM transcript. Send your request to 

the Division of Freedom of Information 

(ELEM–1029), Office of Management 

Programs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: FDA is 

evaluating its current enforcement 

policies for drug products labeled as 

homeopathic from scientific, risk, and 

process perspectives. The Agency is 

now soliciting opinions about whether 

and how to adjust the current 

enforcement policies to reflect changes 

in the homeopathic product 

marketplace over the last approximately 

25 years. 


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