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

9741 

Vol. 89, No. 29 

Monday, February 12, 2024 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2024–0224; Project 

Identifier AD–2024–00055–T; Amendment 

39–22673; AD 2024–03–04] 

RIN 2120–AA64 

Airworthiness Directives; The Boeing 

Company Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: The FAA is adopting a new 

airworthiness directive (AD) for certain 

The Boeing Company (Boeing) Model 

737–8, 737–8200, and 737–9 airplanes. 

This AD was prompted by a report of a 

missing washer and nut and consequent 

migrated bolt discovered by an operator 

during scheduled maintenance. This AD 

requires a one-time inspection of the aft 

rudder quadrant and applicable oncondition actions. The FAA is issuing 

this AD to address the unsafe condition 

on these products. 

DATES: This AD is effective February 12, 

2024. 

The FAA must receive comments on 

this AD by March 28, 2024 

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 by searching 

for and locating Docket No. FAA–2024– 

0224; 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: 

Anthony Caldejon, Aviation Safety 

Engineer, FAA, 2200 South 216th St., 

Des Moines, WA 98198; phone: 206– 

231–3534; email: Anthony.V.Caldejon@

faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

The FAA invites you to send any 

written data, views, or arguments about 

this final rule. Send your comments to 

an address listed under ADDRESSES. 

Include Docket No. FAA–2024–0224 

and Project Identifier AD–2024–00055– 

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 Anthony Caldejon, 

Aviation Safety Engineer, FAA, 2200 

South 216th St., Des Moines, WA 98198; 

phone: 206–231–3534; email: 

Anthony.V.Caldejon@faa.gov. Any 

commentary that the FAA receives that 

is not specifically designated as CBI will 

be placed in the public docket for this 

rulemaking. 

Background 

The FAA has received a report of a 

missing nut and washer and of a 

migrated bolt in the aft rudder quadrant, 

which were discovered by an operator 

during a scheduled routine inspection 

in mid-December 2023. Boeing 

subsequently inspected all Model 737– 

8, –8200, and –9 airplanes in production 

and found one additional under-torqued 

nut at the same location. It was 

discovered that the required run-on and 

final torques had not been applied to the 

nut in production. 

A disconnect between the aft rudder 

quadrant and the output rod (due to the 

bolt falling out) would result in loss of 

rudder control via the rudder pedals. 

Rudder surface position would then be 

based only on the rudder trim and yaw 

damper systems. The pilots would be 

able to slowly move the rudder surface 

by adjusting the rudder trim position 

but would be limited by the maximum 

rudder trim authority. In the event of a 

disconnect, and with the limited rudder 

trim authority, there would not be 

enough rudder control to counter an 

engine-out scenario during takeoff/ 

climb out or to counter a high crosswind 

(above 20 kts) during landing. This 

condition, if not addressed, could result 

in the loss of continued safe flight and 

landing. The FAA is issuing this AD to 

address the unsafe condition on these 

products. 

FAA’s Determination 

The FAA is issuing this AD because 

the agency has determined the unsafe 

condition described previously is likely 

to exist or develop in other products of 

the same type design. 

Related Service Information 

The FAA reviewed Boeing Multi 

Operator Message MOM–MOM–23– 

0993–01B, dated December 27, 2023. 

The service information specifies 


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9742 Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Rules and Regulations 

performing a one-time detailed visual 

inspection or remote video inspection of 

the aft rudder quadrant for any missing 

bolt, nut, or washer; any gap between 

the bolt/nut/washer and quadrant; and 

insufficient thread protrusion. The 

service information also specifies the 

following corrective actions if 

necessary: inspection of the bolt and nut 

for damage and replacement as needed; 

torque application; and a rudder travel 

test. 

AD Requirements 

This AD requires accomplishing the 

actions specified in the service 

information described previously. 

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 30 days, upon a 

finding of good cause. 

An unsafe condition exists that 

requires the immediate adoption of this 

AD without providing an opportunity 

for public comments prior to adoption. 

The FAA has found that the risk to the 

flying public justifies forgoing notice 

and comment prior to adoption of this 

rule because a disconnect between the 

aft rudder quadrant and the output rod 

would result in loss of rudder control 

via the rudder pedals and insufficient 

rudder control to counter an engine-out 

scenario during takeoff/climb out or to 

counter a high crosswind during 

landing, which could result in the loss 

of continued safe flight and landing. 

The corrective actions required by this 

AD must be accomplished within 30 

days. This compliance time is shorter 

than the time necessary for the public to 

comment and for publication of the final 

rule. Accordingly, notice and 

opportunity for prior public comment 

are impracticable and contrary to the 

public interest pursuant to 5 U.S.C. 

553(b)(3)(B). 

In addition, 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, for the same reasons 

the FAA found good cause to forgo 

notice and comment. 

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 notice 

and comment, RFA analysis is not 

required. 

Costs of Compliance 

The FAA estimates that this AD 

affects 482 airplanes of U.S. registry. 

The FAA estimates the following costs 

to comply with this AD: 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

Inspection ................................. 0.50 work-hour × $85 per hour = $42.50 ................................. $0 $42.50 $20,485 

The FAA estimates the following 

costs to do any on-condition actions that 

would be required based on the results 

of the inspection. The FAA has no way 

of determining the number of airplanes 

that might need these on-condition 

actions: 

ON-CONDITION COSTS

Actions Labor cost Parts cost Cost per 

product 

Inspection/replacement of bolt/nut, torque application, 

rudder travel test.

2 work-hours × $85 per hour = $170 ........................... $3 $173 

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: 


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Federal Register / Vol. 89, No. 29 / Monday, February 12, 2024 / Rules and Regulations 9743 

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: 

2024–03–04 The Boeing Company: 

Amendment 39–22673; Docket No. 

FAA–2024–0224; Project Identifier AD– 

2024–00055–T. 

(a) Effective Date 

This airworthiness directive (AD) is 

effective February 12, 2024. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to The Boeing Company 

Model 737–8, 737–8200, and 737–9 

airplanes, certificated in any category, with 

an original airworthiness certificate or 

original export certificate of airworthiness 

issued on or before December 20, 2023. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 27, Flight controls. 

(e) Unsafe Condition 

This AD was prompted by a report of a 

missing washer and nut and consequent 

migrated bolt discovered by an operator 

during scheduled maintenance. The FAA is 

issuing this AD to address improper torque 

of the aft rudder quadrant output rod 

fasteners, which may cause a disconnect 

between the aft rudder quadrant and the 

output rod, which would result in loss of 

rudder control via the rudder pedals to 

counter an engine-out scenario during 

takeoff/climb out or to counter a high 

crosswind during landing. The unsafe 

condition, if not addressed, could result in 

loss of continued safe flight and landing. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspection 

Within 30 days after the effective date of 

this AD, perform a one-time detailed visual 

inspection or remote video inspection of the 

aft rudder quadrant for missing bolts, nuts, 

and washers; a gap between the bolt/nut/ 

washer and quadrant; and insufficient thread 

protrusion. 

Note 1 to paragraph (g): Guidance for 

accomplishing the actions required by 

paragraph (g) of this AD can be found in 

Boeing Multi Operator Message MOM– 

MOM–23–0993–01B, dated December 27, 

2023. 

(h) On-Condition Actions 

If any discrepancy is found during the 

inspection required by paragraph (g) of this 

AD, do the actions specified in paragraphs 

(h)(1) through (3) of this AD before further 

flight. 

(1) Do a detailed inspection of the bolt, 

washer, and nut for damage and, before 

further flight, replace any missing or 

damaged bolts, washers, and nuts. 

(2) Install each bolt, washer, and nut with 

a torque of 65 in-lb. 

(3) Perform a rudder travel test to ensure 

that the rudder is operating correctly. If the 

test fails, before further flight, do applicable 

corrective actions and repeat until the test is 

passed. 

Note 2 to paragraph (h) of this AD: 

Guidance for accomplishing the actions 

required by paragraph (h) of this AD can be 

found in Boeing Multi Operator Message 

MOM–MOM–23–0993–01B, dated December 

27, 2023. 

(i) Credit for Previous Actions 

This paragraph provides credit for the 

actions specified in paragraphs (g) and (h) of 

this AD, if those actions were performed 

before the effective date of this AD using 

Boeing Multi Operator Message MOM– 

MOM–23–0993–01B, dated December 27, 

2023. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, AIR–520, Continued 

Operational Safety 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 responsible Flight Standards Office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to the attention of the person 

identified in paragraph (k)(1) of this AD. 

Information may be emailed to: 9-ANMSeattle-ACO-AMOC-Requests@faa.gov. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the responsible Flight Standards Office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair, 

modification, or alteration required by this 

AD if it is approved by The Boeing Company 

Organization Designation Authorization 

(ODA) that has been authorized by the 

Manager, AIR–520, Continued Operational 

Safety Branch, FAA, to make those findings. 

To be approved, the repair method, 

modification deviation, or alteration 

deviation must meet the certification basis of 

the airplane, and the approval must 

specifically refer to this AD. 

(k) Related Information 

(1) For more information about this AD, 

contact Anthony Caldejon, Aviation Safety 

Engineer, FAA, 2200 South 216th St., Des 

Moines, WA 98198; phone: 206–231–3534; 

email: Anthony.V.Caldejon@faa.gov. 

(2) For service information identified in 

this AD that is not incorporated by reference, 

contact Boeing Commercial Airplanes, 

Attention: Contractual & Data Services 

(C&DS), 2600 Westminster Blvd., MC 110– 

SK57, Seal Beach, CA 90740–5600; telephone 

562–797–1717; website myboeingfleet.com. 

(l) Material Incorporated by Reference 

None. 

Issued on February 2, 2024. 

Caitlin Locke, 

Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2024–02930 Filed 2–8–24; 2:00 pm] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 601 

[Docket No. FDA–2019–N–1363] 

RIN 0910–AH50 

Biologics License Applications and 

Master Files 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is issuing a final rule to amend its 

regulations to address the use of master 

files by applications licensed under the 

Public Health Service Act (PHS Act). 

This final rule codifies FDA’s existing 

approach that former approved 

applications for certain biological 

products under the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) that have 

been deemed to be licenses for the 

biological products under the PHS Act 

may continue to incorporate by 

reference drug substance, drug 

substance intermediate, or drug product 

(DS/DSI/DP) information contained in a 

drug master file (DMF) if such 

information was being referenced at the 

time the application was deemed to be 

a license. This final rule also codifies 

FDA’s general practices regarding the 

referencing of information in master 

files by applications licensed under the 

PHS Act, including applications for 

combination products licensed under 

the PHS Act, and by investigational new 

drug applications (INDs) for products 

that would be subject to licensure under 

the PHS Act. 

DATES: This rule is effective March 13, 

2024. 

ADDRESSES: For access to the docket to 

read background documents or 

comments received, go to https://

www.regulations.gov and insert the 

docket number found in brackets in the 

heading of this final rule into the 

‘‘Search’’ box and follow the prompts, 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 


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