This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

70885 

Vol. 88, No. 197 

Friday, October 13, 2023 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2023–1992; Project 

Identifier MCAI–2023–00414–T; Amendment 

39–22568; AD 2023–20–09] 

RIN 2120–AA64 

Airworthiness Directives; MHI RJ 

Aviation ULC (Type Certificate 

Previously Held by Bombardier Inc.) 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: The FAA is adopting a new 

airworthiness directive (AD) for all MHI 

RJ Aviation ULC Model CL–600–2E25 

(Regional Jet Series 1000) airplanes. 

This AD was prompted by a 

determination that a new airworthiness 

limitation is necessary. This AD 

requires revising the existing 

maintenance or inspection program, as 

applicable, to establish a new life limit 

for a certain main landing gear (MLG) 

retract actuator piston rod. The FAA is 

issuing this AD to address the unsafe 

condition on these products. 

DATES: This AD is effective October 30, 

2023. 

The FAA must receive comments on 

this AD by November 27, 2023. 

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 

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.

AD Docket: You may examine the AD 

docket at regulations.gov under Docket 

No. FAA–2023–1992; 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 final rule, any comments 

received, and other information. The 

street address for Docket Operations is 

listed above. 

FOR FURTHER INFORMATION CONTACT: 

Gabriel D. Kim, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, 

Suite 410, Westbury, NY 11590; 

telephone 516–228–7343; email 9-avsnyaco-cos@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

The FAA invites you to send any 

written relevant data, views, or 

arguments about this final rule. Send 

your comments to an address listed 

under ADDRESSES. Include ‘‘Docket No. 

FAA–2023–1992; Project Identifier 

MCAI–2023–00414–T’’ at the beginning 

of your comments. The most helpful 

comments reference a specific portion of 

the final rule, explain the reason for any 

recommended change, and include 

supporting data. The FAA will consider 

all comments received by the closing 

date and may amend this final rule 

because of those comments. 

Except for Confidential Business 

Information (CBI) as described in the 

following paragraph, and other 

information as described in 14 CFR 

11.35, the FAA will post all comments 

received, without change, to 

regulations.gov, including any personal 

information you provide. The agency 

will also post a report summarizing each 

substantive verbal contact received 

about this final rule. 

Confidential Business Information 

CBI is commercial or financial 

information that is both customarily and 

actually treated as private by its owner. 

Under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), CBI is exempt 

from public disclosure. If your 

comments responsive to this AD contain 

commercial or financial information 

that is customarily treated as private, 

that you actually treat as private, and 

that is relevant or responsive to this AD, 

it is important that you clearly designate 

the submitted comments as CBI. Please 

mark each page of your submission 

containing CBI as ‘‘PROPIN.’’ The FAA 

will treat such marked submissions as 

confidential under the FOIA, and they 

will not be placed in the public docket 

of this AD. Submissions containing CBI 

should be sent to Gabriel D. Kim, 

Aviation Safety Engineer, FAA, 1600 

Stewart Avenue, Suite 410, Westbury, 

NY 11590; telephone 516–228–7343; 

email 9-avs-nyaco-cos@faa.gov. Any 

commentary that the FAA receives 

which is not specifically designated as 

CBI will be placed in the public docket 

for this rulemaking. 

Background 

Transport Canada, which is the 

aviation authority for Canada, has 

issued Transport Canada AD CF–2022– 

56, dated September 26, 2022 (referred 

to after this as ‘‘the MCAI’’), to correct 

an unsafe condition on all MHI RJ 

Aviation ULC (formerly Bombardier 

Inc.) Model CL–600–2E25 (Regional Jet 

Series 1000) airplanes. The MCAI states 

MLG fatigue testing that was 

accomplished at the time of aircraft 

certification was not performed in 

accordance with the Qualification Test 

Plan. According to the MCAI, the 

pressure impulse testing was repeated 

on the CL600–2E25 MLG retract 

actuator using the required load 

spectrum, and as a result, a ‘‘safe life 

limitation’’ of 9,300 flight cycles was 

established for piston rod part number 

(P/N) 55615–1. 

The FAA is issuing this AD to 

establish a life limit for MLG retract 

actuator piston rod part number 55615– 

1. Exceeding this life limit could result

in failure of the MLG retract actuator

piston in flight, causing an undamped

MLG free fall extension, which may

result in MLG collapse on landing.

You may examine the MCAI in the 

AD docket at regulations.gov under 

Docket No. FAA–2023–1992. 

FAA’s Determination 

This product has been approved by 

the aviation authority of another 

country and is approved for operation in 

the United States. Pursuant to the FAA’s 

bilateral agreement with this State of 

Design Authority, it has notified the 

FAA of the unsafe condition described 

in the MCAI and service information 

referenced above. The FAA is issuing 

this AD after determining that the 

unsafe condition described previously is 


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70886 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 

likely to exist or develop on other 

products of the same type design. 

Requirements of the Final Rule 

This AD requires revising the existing 

maintenance or inspection program, as 

applicable, to incorporate a new life 

limit of 9,300 flight cycles for MLG 

retract actuator piston rod P/N 55615– 

1. 

Justification for Immediate Adoption 

and Determination of the Effective Date 

Section 553(b)(3)(B) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 551 et seq.) authorizes agencies 

to dispense with notice and comment 

procedures for rules when the agency, 

for ‘‘good cause,’’ finds that those 

procedures are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ Under this section, an agency, 

upon finding good cause, may issue a 

final rule without providing notice and 

seeking comment prior to issuance. 

Further, section 553(d) of the APA 

authorizes agencies to make rules 

effective in less than thirty days, upon 

a finding of good cause. 

The FAA has found that the risk to 

the flying public justifies foregoing 

notice and comment prior to adoption of 

this rule because there are no airplanes 

currently on the U.S. registry and thus, 

it is unlikely that the FAA will receive 

any adverse comments or useful 

information about this AD from U.S. 

operator. Accordingly, notice and 

opportunity for prior public comment 

are unnecessary, pursuant to 5 U.S.C. 

553(b)(3)(B). 

In addition, for the foregoing reasons, 

the FAA finds that good cause exists 

pursuant to 5 U.S.C. 553(d) for making 

this amendment effective in less than 30 

days. 

Regulatory Flexibility Act 

The requirements of the Regulatory 

Flexibility Act (RFA) do not apply when 

an agency finds good cause pursuant to 

5 U.S.C. 553 to adopt a rule without 

prior notice and comment. Because the 

FAA has determined that it has good 

cause to adopt this rule without prior 

notice and comment, RFA analysis is 

not required. 

Costs of Compliance 

Currently, there are no airplanes with 

this type certificate on the U.S. registry. 

If an affected airplane is imported and 

placed on the U.S. Registry in the 

future, the FAA provides the following 

cost estimates to comply with this AD: 

The FAA has determined that revising 

the maintenance or inspection program 

takes an average of 90 work-hours per 

operator, although the FAA recognizes 

that this number may vary from operator 

to operator. Since operators incorporate 

maintenance or inspection program 

changes for their affected fleet(s), the 

FAA has determined that a per-operator 

estimate is more accurate than a perairplane estimate. Therefore, the FAA 

estimates the total cost per operator to 

be $7,650 (90 work-hours × $85 per 

work-hour). 

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. 

The FAA is 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 

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, 

and 

(2) Will not affect intrastate aviation 

in Alaska. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

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: 

2023–20–09 MHI RJ Aviation ULC (Type 

Certificate Previously Held by 

Bombardier, Inc.): Amendment 39– 

22568; Docket No. FAA–2023–1992; 

Project Identifier MCAI–2023–00414–T. 

(a) Effective Date 

This airworthiness directive (AD) is 

effective October 30, 2023. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all MHI RJ Aviation 

ULC (type certificate previously held by 

Bombardier Inc.) Model CL–600–2E25 

(Regional Jet Series 1000) airplanes, 

certificated in any category. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 32, Landing Gear. 

(e) Reason 

This AD was prompted by a determination 

that a new airworthiness limitation is 

necessary. The FAA is issuing this AD to 

establish a life limit for main landing gear 

(MLG) retract actuator piston rod part 

number 55615–1. Exceeding this life limit 

could result in failure of the MLG retract 

actuator piston in flight, causing an 

undamped MLG free fall extension. The 

unsafe condition, if not addressed, could 

result in MLG collapse on landing. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Maintenance or Inspection Program 

Revision 

Within 60 days after the effective date of 

this AD, revise the existing maintenance or 

inspection program, as applicable, to 

establish a life limit of 9,300 flight cycles for 

the MLG retract actuator piston rod (part of 

MLG retract actuator 55600), part number 

55615–1. The initial compliance time for 

removing the part from service is at the 

applicable time specified in paragraphs (g)(1) 

through (3) of this AD. 

Note 1 to paragraph (g): The life limit in 

paragraph (g) of this AD can be found in 

Airworthiness Limitation (ALI) Task Number 

32–32–05–709 for Configuration B, ‘‘Piston 

Rod, MLG Retract Actuator (part of MLG 

Retract Actuator 55600)’’ of MHI RJ CRJ700/ 

900/1000 Temporary Revision ALI–0763, 

dated April 14, 2022 (TR ALI–0763), which 

specifies an effective date of April 14, 2022. 

(1) For a MLG retract actuator piston rod 

that has accumulated fewer than 4,300 total 

flight cycles as of April 14, 2022 (phase-in 

Effective Date of TR ALI–0763): Before 

accumulating 9,300 total flight cycles. 

(2) For a MLG retract actuator piston rod 

that has accumulated 4,300 total flight cycles 


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Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Rules and Regulations 70887 

or more and 18,000 total flight cycles or 

fewer as of April 14, 2022 (phase-in Effective 

Date of TR ALI–0763): Within 5,000 flight 

cycles from April 14, 2022, or before 

exceeding 20,000 total flight cycles, 

whichever occurs first. 

(3) For a MLG retract actuator piston rod 

that has accumulated more than 18,000 total 

flight cycles as of April 14, 2022 (phase-in 

Effective Date of TR ALI–0763): Within 2,000 

flight cycles from April 14, 2022. 

(h) No Alternative Actions or Intervals 

After the existing maintenance or 

inspection program has been revised as 

required by paragraph (g) of this AD, no 

alternative actions (e.g., inspections) or 

intervals may be used unless they are 

approved as an alternative method of 

compliance in accordance with paragraph 

(i)(1) of this AD. 

(i) Additional AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Validation 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 manager of the International Validation 

Branch, mail it to the address identified in 

paragraph (j)(3) of this AD or email to: 9- 

AVS-AIR-730-AMOC@faa.gov. If mailing 

information, also submit information by 

email. Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain instructions 

from a manufacturer, the instructions must 

be accomplished using a method approved 

by the Manager, International Validation 

Branch, FAA; or Transport Canada; or MHI 

RJ Aviation ULC Transport Canada Design 

Approval Organization (DAO). If approved by 

the DAO, the approval must include the 

DAO-authorized signature. 

(j) Additional Information 

(1) Refer to Transport Canada AD CF– 

2022–56, dated September 26, 2022, for 

related information. This Transport Canada 

AD may be found in the AD docket at 

regulations.gov under Docket No. FAA– 

2023–1992. 

(2) For more information about this AD, 

contact Gabriel D. Kim, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, Suite 

410, Westbury, NY 11590; telephone 516– 

228–7343; email 9-avs-nyaco-cos@faa.gov. 

(3) For MHI RJ service information 

identified in this AD that is not incorporated 

by reference, contact MHI RJ Aviation Group, 

Customer Response Center, 3655 Ave. des 

Grandes-Tourelles, Suite 110, Boisbriand, 

Que ́bec J7H 0E2 Canada; North America tollfree telephone 833–990–7272 or direct-dial 

telephone 450–990–7272; fax 514–855–8501; 

email thd.crj@mhirj.com; website mhirj.com. 

(k) Material Incorporated by Reference 

None. 

Issued on October 4, 2023. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2023–22486 Filed 10–12–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1 

[Docket No. FDA–2011–N–0179] 

Prior Notice of Imported Food 

Questions and Answers (Edition 4): 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 4): Guidance for Industry.’’ The 

guidance document updates the current 

version of the guidance by including 

three additional questions. One question 

relates to any effect systems recognition 

or equivalency determinations have on 

prior notice requirements. The other 

two questions relate to FDA’s notice to 

a submitter or transmitter of prior notice 

of an FDA refusal for inadequate prior 

notice or hold, if the food article is from 

a foreign facility that is not registered 

and addresses the timeframe for making 

requests for FDA review of such refusal 

or hold. FDA is also making other 

technical editorial changes. The 

guidance announced in this notice 

finalizes the draft guidance of the same 

title dated September 13, 2022. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 13, 2023. 

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. 

• 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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2011–N–0179 for ‘‘Prior Notice of 

Imported Food Questions and Answers 

(Edition 4): Guidance for Industry.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

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

Dockets Management Staff between 9 

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

Friday, 240–402–7500. 

• 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 

https://www.regulations.gov. Submit 


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