596 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 

(e) Reason 

This AD was prompted by a report of an 

engine multiple fan blade release event. We 

are issuing this AD to detect and correct an 

incorrect adjustment of the (emergency) 

maximum reverse thrust stop, which could 

result in engine fan blade release causing 

injury to occupants, damage to the airplane, 

and consequent uncontrollability of the 

airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Action(s) 

Within 30 days after the effective date of 

this AD, request instructions from the 

Manager, International Section, Transport 

Standards Branch, FAA, to address the 

unsafe condition specified in paragraph (e) of 

this AD; and accomplish the actions at the 

times specified in, and in accordance with, 

those instructions. Guidance can be found in 

Mandatory Continuing Airworthiness 

Information (MCAI) European Aviation 

Safety Agency (EASA) AD 2013–0010, 

January 14, 2013. 

(h) Alternative Methods of Compliance 

(AMOCs) 

The Manager, International Section, 

Transport Standards Branch, 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 Section, send it to the 

attention of the person identified in 

paragraph (i)(2) of this AD. Information may 

be emailed to: 9-ANM-116-AMOCREQUESTS@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. 

(i) Related Information 

(1) Refer to MCAI EASA AD 2013–0010, 

January 14, 2013 for related information. You 

may examine the MCAI on the internet at 

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

and locating Docket No. FAA–2017–1183. 

(2) For more information about this AD, 

contact Tom Rodriguez, Aerospace Engineer, 

International Section, Transport Standards 

Branch, FAA, 1601 Lind Avenue SW, 

Renton, WA 98057–3356; telephone: 425– 

227–1137; fax: 425–227–1149. 

(j) Material Incorporated by Reference 

None. 

Issued in Renton, Washington, on 

December 26, 2017. 

John P. Piccola, Jr., 

Acting Director, System Oversight Division, 

Aircraft Certification Service. 

[FR Doc. 2017–28486 Filed 1–4–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2017–1182; Product 

Identifier 2013–NM–093–AD; Amendment 

39–19146; AD 2018–01–05] 

RIN 2120–AA64 

Airworthiness Directives; Fokker 

Services B.V. 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for certain 

Fokker Services B.V. Model F28 Mark 

0070 and 0100 airplanes. This AD 

requires contacting the FAA to obtain 

instructions for addressing the unsafe 

condition on these products, and doing 

the actions specified in those 

instructions. This AD was prompted by 

an evaluation by the design approval 

holder (DAH) indicating that the 

fuselage frames are subject to 

widespread fatigue damage (WFD). We 

are issuing this AD to address the unsafe 

condition on these products. 

DATES: This AD becomes effective 

January 22, 2018. 

We must receive comments on this 

AD by February 20, 2018. 

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: 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. 

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–2017– 

1182; 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 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: Tom 

Rodriguez, Aerospace Engineer, 

International Section, Transport 

Standards Branch, FAA, 1601 Lind 

Avenue SW, Renton, WA 98057–3356; 

telephone: 425–227–1137; fax: 425– 

227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

Fatigue damage can occur locally, in 

small areas or structural design details, 

or globally, in widespread areas. 

Multiple-site damage is widespread 

damage that occurs in a large structural 

element such as a single rivet line of a 

lap splice joining two large skin panels. 

Widespread damage can also occur in 

multiple elements such as adjacent 

frames or stringers. Multiple-site 

damage and multiple-element damage 

cracks are typically too small initially to 

be reliably detected with normal 

inspection methods. Without 

intervention, these cracks will grow, 

and eventually compromise the 

structural integrity of the airplane. This 

condition is known as WFD. It is 

associated with general degradation of 

large areas of structure with similar 

structural details and stress levels. As 

an airplane ages, WFD will likely occur, 

and will certainly occur if the airplane 

is operated long enough without any 

intervention. 

The FAA’s WFD final rule (75 FR 

69746, November 15, 2010) became 

effective on January 14, 2011. The WFD 

rule requires certain actions to prevent 

structural failure due to WFD 

throughout the operational life of 

certain existing transport category 

airplanes and all of these airplanes that 

will be certificated in the future. For 

existing and future airplanes subject to 

the WFD rule, the rule requires that 

DAHs establish a limit of validity (LOV) 

of the engineering data that support the 

structural maintenance program. 

Operators affected by the WFD rule may 

not fly an airplane beyond its LOV, 

unless an extended LOV is approved. 

The WFD rule (75 FR 69746, 

November 15, 2010) does not require 

identifying and developing maintenance 

actions if the DAHs can show that such 

actions are not necessary to prevent 

WFD before the airplane reaches the 

LOV. Many LOVs, however, do depend 

on accomplishment of future 

maintenance actions. As stated in the 

WFD rule, any maintenance actions 


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Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 597 

necessary to reach the LOV will be 

mandated by airworthiness directives 

through separate rulemaking actions. 

In the context of WFD, this action is 

necessary to enable DAHs to propose 

LOVs that allow operators the longest 

operational lives for their airplanes, and 

still ensure that WFD will not occur. 

This approach allows for an 

implementation strategy that provides 

flexibility to DAHs in determining the 

timing of service information 

development (with FAA approval), 

while providing operators with certainty 

regarding the LOV applicable to their 

airplanes. 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Union, has issued EASA AD 2013–0102, 

dated May 2, 2013 (referred to after this 

as the Mandatory Continuing 

Airworthiness Information, or ‘‘the 

MCAI’’), to correct an unsafe condition 

for certain Fokker Services B.V. Model 

F28 Mark 0070 and 0100 airplanes. The 

MCAI states: 

From service experience, it was concluded 

that the fuselage frames, which act as backup structure for the hook latch fitting 

brackets of the large cargo doors, are sensitive 

to fatigue cracking. To ensure the continued 

structural integrity with respect to fatigue, a 

repetitive inspection was included in the 

Airworthiness Limitations Section (ALS) of 

the Instructions for Continued Airworthiness 

under tasks 533026–00–03 and 533026–01– 

03. 

Since those tasks were implemented, it was 

determined, as part of a re-evaluation for 

Widespread Fatigue Damage, that the current 

repetitive fatigue inspections in the ALS do 

not provide a sufficient level of protection 

against fatigue-induced cracks. 

This condition, if not corrected, would 

affect the structural integrity of the centre 

fuselage. 

For the reasons described above, this 

[EASA] AD requires modification of the 

affected fuselage frames. 

Post-modification inspections will be 

included in a revision to the ALS, which will 

likely be the subject of further [EASA] AD 

action. 

You may examine the MCAI on the 

internet at http://www.regulations.gov 

by searching for and locating Docket No. 

FAA–2017–1182. 

FAA’s Determination and Requirements 

of This 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. We are issuing this AD because 

we evaluated all pertinent information 

and determined the unsafe condition 

exists and is likely to exist or develop 

on other products of the same type 

design. 

FAA’s Determination of the Effective 

Date 

Since there are currently no domestic 

operators of this product, we find good 

cause that notice and opportunity for 

prior public comment are unnecessary. 

In addition, for the reason(s) stated 

above, we find that good cause exists for 

making this amendment effective in less 

than 30 days. 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety, and 

we did not precede it by notice and 

opportunity for public comment. We 

invite you to send any written relevant 

data, views, or arguments about this AD. 

Send your comments to an address 

listed under the ADDRESSES section. 

Include ‘‘Docket No. FAA–2017–1182; 

Product Identifier 2013–NM–093–AD’’ 

at the beginning of your comments. We 

specifically invite comments on the 

overall regulatory, economic, 

environmental, and energy aspects of 

this AD. We will consider all comments 

received by the closing date and may 

amend this 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 AD. 

Costs of Compliance 

Currently, there are no affected U.S.- 

registered airplanes. This AD requires 

contacting the FAA to obtain 

instructions for addressing the unsafe 

condition, and doing the actions 

specified in those instructions. Based on 

the actions specified in the MCAI AD, 

we are providing the following cost 

estimates for an affected airplane that is 

placed on the U.S. Register in the future: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Modification ................................................................... 102 work-hours × $85 per hour = $8,670 .................... $18,600 $27,270 

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. 

This AD is issued in accordance with 

authority delegated by the Executive 

Director, Aircraft Certification Service, 

as authorized by FAA Order 8000.51C. 

In accordance with that order, issuance 

of ADs is normally a function of the 

Compliance and Airworthiness 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to transport category 

airplanes to the Director of the System 

Oversight Division. 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

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 that this AD: 

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); 


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598 Federal Register / Vol. 83, No. 4 / Friday, January 5, 2018 / Rules and Regulations 

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. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 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): 

2018–01–05 Fokker Services B.V.: 

Amendment 39–19146; Docket No. 

FAA–2017–1182; Product Identifier 

2013–NM–093–AD. 

(a) Effective Date 

This AD becomes effective January 22, 

2018. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Fokker Services B.V. 

Model F28 Mark 0070 and 0100 airplanes, 

certificated in any category, having serial 

numbers 11268 through 11283 inclusive, 

11286, 11289, 11291, 11293, 11295, 11300, 

11303, 11306, 11308, 11310, 11312 through 

11314 inclusive, 11316, 11318, 11321, 11323 

through 11335 inclusive, 11337, 11338, 

11340, 11345, 11349, 11352 through 11361 

inclusive, 11365 through 11367 inclusive, 

11369, 11370, 11372, 11373, 11376 through 

11380 inclusive, 11387, 11388, 11391, 11395, 

11397, 11399, 11404, 11405, 11407, 11411 

through 11419 inclusive, 11425 through 

11428 inclusive, 11432, 11435 through 11439 

inclusive, 11444 through 11450 inclusive, 

11456 through 11460 inclusive, 11464 

through 11469 inclusive. and 11475 through 

11585 inclusive. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 53, Fuselage. 

(e) Reason 

This AD was prompted by an evaluation by 

the design approval holder (DAH) indicating 

that the fuselage frames are subject to 

widespread fatigue damage (WFD). We are 

issuing this AD to prevent cracking of the 

center fuselage, which could result in 

reduced structural integrity of the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Action(s) 

Within 30 days after the effective date of 

this AD, request instructions from the 

Manager, International Section, Transport 

Standards Branch, FAA, to address the 

unsafe condition specified in paragraph (e) of 

this AD; and accomplish the actions at the 

times specified in, and in accordance with, 

those instructions. Guidance can be found in 

Mandatory Continuing Airworthiness 

Information (MCAI) European Aviation 

Safety Agency (EASA) AD 2013–0102, dated 

May 2, 2013. 

(h) Alternative Methods of Compliance 

(AMOCs) 

The Manager, International Section, 

Transport Standards Branch, 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 Section, send it to the 

attention of the person identified in 

paragraph (i)(2) of this AD. Information may 

be emailed to: 9-ANM-116-AMOCREQUESTS@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. 

(i) Related Information 

(1) Refer to MCAI EASA AD 2013–0102, 

dated May 2, 2013, for related information. 

You may examine the MCAI on the internet 

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

for and locating Docket No. FAA–2017–1182. 

(2) For more information about this AD, 

contact Tom Rodriguez, Aerospace Engineer, 

International Section, Transport Standards 

Branch, FAA, 1601 Lind Avenue SW, 

Renton, WA 98057–3356; telephone: 425– 

227–1137; fax: 425–227–1149. 

(j) Material Incorporated by Reference 

None. 

Issued in Renton, Washington, on 

December 26, 2017. 

John P. Piccola, Jr., 

Acting Director, System Oversight Division, 

Aircraft Certification Service. 

[FR Doc. 2017–28487 Filed 1–4–18; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 11, 16, 106, 110, 111, 

112, 114, 117, 120, 123, 129, 179, 211, 

and 507 

[Docket No. FDA–2017–N–6908] 

Policy Regarding Certain Entities 

Subject to the Current Good 

Manufacturing Practice and Preventive 

Controls, Produce Safety, and/or 

Foreign Supplier Verification 

Programs; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a 

guidance for industry entitled ‘‘Policy 

Regarding Certain Entities Subject to the 

Current Good Manufacturing Practice 

and Preventive Controls, Produce 

Safety, and/or Foreign Supplier 

Verification Programs.’’ This guidance 

states agency compliance policy 

regarding certain entities and/or 

activities related to the ‘‘farm’’ 

definition, written assurances, food 

contact substances, and human food byproducts for use as animal food. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 5, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://www.regulations.gov. 


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