3630 Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 

Issued in Fort Worth, Texas, on January 12, 

2018. 

Lance T. Gant, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2018–01194 Filed 1–25–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2018–0036; Product 

Identifier 2017–SW–015–AD] 

RIN 2120–AA64 

Airworthiness Directives; Bell 

Helicopter Textron Inc. 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for Bell 

Helicopter Textron Inc. (Bell) Model 

212, Model 412, and Model 412EP 

helicopters. This proposed AD would 

require replacing the emergency 

flotation system (EFS) tube assembly. 

This proposed AD is prompted by a 

report of an EFS tube assembly failure. 

The actions of this proposed AD are 

intended to address an unsafe condition 

on these helicopters. 

DATES: We must receive comments on 

this proposed AD by March 27, 2018. 

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–2018– 

0036; or in person at Docket Operations 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The AD docket contains this proposed 

AD, the economic evaluation, any 

comments received, and other 

information. The street address for 

Docket Operations (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 Bell 

Helicopter Textron, Inc., P.O. Box 482, 

Fort Worth, TX 76101; telephone (817) 

280–3391; fax (817) 280–6466; or at 

http://www.bellcustomer.com/files/. 

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: Rory 

Rieger, Aviation Safety Engineer, DSCO 

Branch, AIR–7J0, FAA, 10101 Hillwood 

Pkwy., Fort Worth, TX 76177; telephone 

(817) 222–5193; email rory.rieger@

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 

We propose to adopt a new AD for 

Bell Model 212, Model 412, and Model 

412EP helicopters with an EFS tube 

assembly part number (P/N) 412–073– 

820–101 with a date of manufacture 

before July 28, 2016. This proposed AD 

is prompted by a report from Bell that 

an EFS tube assembly separated from 

the valve during a 2-year inflation test. 

A subsequent investigation found that 

excessive sleeve preset force during 

manufacturing caused cracks in the 

sleeve of the tube assembly, which may 

result in the EFS float failing to deploy. 

Bell determined that only those EFS 

tube assemblies with P/N 412–073–820– 

101 that were shipped prior to July 28, 

2016, were subject to this manufacturing 

defect. Bell states that because this 

manufacturing defect is difficult to 

detect, affected EFS tube assemblies in 

service must be replaced. The affected 

parts were associated with a single Bell 

supplier that is no longer manufacturing 

the tube assembly. 

Accordingly, this proposed AD would 

require replacing the EFS tube 

assemblies and would prohibit 

installing an affected EFS tube assembly 

on any helicopter. We are proposing this 

AD to prevent installing a cracked EFS 

tube assembly, which could result in 

failure of the EFS floats to deploy 

during an emergency water landing. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all known relevant 

information and determined that an 

unsafe condition exists and is likely to 

exist or develop on other helicopters of 

these same type designs. 

Related Service Information 

We reviewed Bell Alert Service 

Bulletin (ASB) 212–11–143 and ASB 

412–11–147, both Revision C and dated 

December 22, 2016. Each ASB describes 

and illustrates procedures to replace the 

tube assembly within 600 flight hours or 

by March 31, 2017. 

Proposed AD Requirements 

This proposed AD would require, 

within 300 hours time-in-service (TIS), 

replacing any EFS tube assembly P/N 

412–073–820–101 that was 

manufactured before July 28, 2016. This 

proposed AD would also prohibit 

installing an EFS tube assembly P/N 

412–073–820–101 that was 

manufactured before July 28, 2016 on 

any helicopter. 

Differences Between This Proposed AD 

and the Service Information 

The ASBs require compliance within 

600 flight hours or by March 31, 2017; 

this proposed AD would require 

compliance within 300 hours TIS. 

Costs of Compliance 

We estimate that this proposed AD 

would affect 250 helicopters of U.S. 

Registry. 

We estimate that operators may incur 

the following costs in order to comply 

with this proposed AD. At an average 


daltland on DSKBBV9HB2PROD with PROPOSALS
Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Proposed Rules 3631 

labor rate of $85 per hour, replacing a 

tube assembly would require about 6 

work-hours and required parts would 

cost $4,902, for a total cost of $5,412 per 

helicopter and $1,353,000 for the U.S. 

fleet. 

According to Bell’s 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 Bell. 

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): 

Bell Helicopter Textron Inc.: Docket No. 

FAA–2018–0036; Product Identifier 

2017–SW–015–AD. 

(a) Applicability 

This AD applies to Bell Helicopter Textron 

Inc. (Bell) Model 212, Model 412, and Model 

412EP helicopters, certificated in any 

category, with an emergency flotation system 

(EFS) tube assembly part number (P/N) 412– 

073–820–101 with a date of manufacture 

before July 28, 2016, or an unknown date of 

manufacture installed. 

(b) Unsafe Condition 

This AD defines the unsafe condition as a 

crack on an EFS tube assembly. This 

condition could result in failure of the 

emergency floats to inflate during an 

emergency water landing. 

(c) Comments Due Date 

We must receive comments by March 27, 

2018. 

(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 300 hours time-in-service: 

(i) Remove the EFS tube assembly from 

service. 

(ii) Lubricate the shoulder of the sleeves, 

threads, and seat of each mating fitting with 

anti-seize compound. 

(iii) Install an EFS tube assembly not listed 

in paragraph (a) of this AD. 

(2) After the effective date of this AD, do 

not install an EFS tube assembly listed in 

paragraph (a) of this AD on any helicopter. 

(f) Alternative Methods of Compliance 

(AMOC) 

(1) The Manager, DSCO Branch, FAA, may 

approve AMOCs for this AD. Send your 

proposal to: Rory Rieger, Aviation Safety 

Engineer, DSCO Branch, AIR–7J0, FAA, 

10101 Hillwood Pkwy., Fort Worth, TX 

76177; telephone (817) 222–5193; email 

rory.rieger@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 

Bell Helicopter Alert Service Bulletins 

212–11–143 and 412–11–147, both Revision 

C and dated December 22, 2016, which are 

not incorporated by reference, contain 

additional information about the subject of 

this AD. For service information identified in 

this proposed rule, contact Bell Helicopter 

Textron, Inc., P.O. Box 482, Fort Worth, TX 

76101; telephone (817) 280–3391; fax (817) 

280–6466; or at http://

www.bellcustomer.com/files/. You may 

review a copy of information at the FAA, 

Office of the Regional Counsel, Southwest 

Region, 10101 Hillwood Pkwy., Room 6N– 

321, Fort Worth, TX 76177. 

(h) Subject 

Joint Aircraft Service Component (JASC) 

Code: 3212 Emergency Flotation Section. 

Issued in Fort Worth, Texas, on January 12, 

2018. 

Scott A. Horn, 

Deputy Director for Regulatory Operations, 

Compliance & Airworthiness Division, 

Aircraft Certification Service. 

[FR Doc. 2018–01195 Filed 1–25–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 600 

[Docket No. FDA–2017–N–7007] 

RIN 0910–AH49 

Removal of Certain Time of Inspection 

and Duties of Inspector Regulations 

for Biological Products; Companion to 

Direct Final Rule 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

proposing to amend the general 

biologics regulations relating to time of 

inspection requirements and also 

removing duties of inspector 

requirements. FDA is proposing this 

action to remove outdated requirements 

and accommodate new approaches, 


daltland on DSKBBV9HB2PROD with PROPOSALS