77448 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 

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 (n)(1) of this AD. 

Information may be emailed to: AMOC@

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, 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. 

(n) Related Information 

(1) For more information about this AD, 

contact Douglas Y. Tsuji, Aviation Safety 

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

Moines, WA 98198; phone: 206–231–3548; 

email: Douglas.Tsuji@faa.gov. 

(2) Material identified in this AD that is not 

incorporated by reference is available at the 

addresses specified in paragraph (o)(3) of this 

AD. 

(o) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the material listed in this paragraph 

under 5 U.S.C. 552(a) and 1 CFR part 51. 

(2) You must use this material as 

applicable to do the actions required by this 

AD, unless the AD specifies otherwise. 

(i) Boeing Alert Requirements Bulletin 

737–31A1880 RB, Revision 1, dated 

September 16, 2020. 

(ii) [Reserved] 

(3) For Boeing material identified in this 

AD, 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. 

(4) You may view this material at the FAA, 

Airworthiness Products Section, Operational 

Safety Branch, 2200 South 216th St., Des 

Moines, WA. For information on the 

availability of this material at the FAA, call 

206–231–3195. 

(5) You may view this material that is 

incorporated by reference at the National 

Archives and Records Administration 

(NARA). For information on the availability 

of this material at NARA, email 

fr.inspection@nara.gov, or go to: 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued on August 1, 2024. 

Peter A. White, 

Deputy Director, Integrated Certificate 

Management Division, Aircraft Certification 

Service. 

[FR Doc. 2024–21557 Filed 9–20–24; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2016–N–2880] 

Microbiology Devices; Reclassification 

of Cytomegalovirus Deoxyribonucleic 

Acid Quantitative Assay Devices 

Intended for Transplant Patient 

Management 

AGENCY: Food and Drug Administration 

(FDA), Department of Health and 

Human Services (HHS). 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

issuing a final order to reclassify 

cytomegalovirus (CMV) 

deoxyribonucleic acid (DNA) 

quantitative assay devices intended for 

transplant patient management, a 

postamendments class III device 

(product code PAB) into class II (general 

controls and special controls), subject to 

premarket notification. 

DATES: This order is effective October 

23, 2024. 

ADDRESSES: For access to the docket to 

read background documents or the 

electronic and-written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, 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. 

FOR FURTHER INFORMATION CONTACT: 

Silke Schlottmann, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3258, Silver Spring, 

MD 20993–0002, 301–796–9551, 

Silke.Schlottmann@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended, by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115), the Medical 

Device User Fee and Modernization Act 

of 2002 (Pub. L. 107–250), the Medical 

Devices Technical Corrections Act (Pub. 

L. 108–214), the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), and the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144), 

among other amendments, establishes a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three classes of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three classes of 

devices are class I (general controls), 

class II (general controls and special 

controls), and class III (general controls 

and premarket approval). 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices) are 

automatically classified by section 

513(f)(1) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval, unless and 

until: (1) FDA reclassifies the device 

into class I or class II or (2) FDA issues 

an order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. FDA determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807), subpart E, of 

FDA’s regulations. 

A postamendments device that has 

been initially classified in class III 

under section 513(f)(1) of the FD&C Act 

may be reclassified into class I or II 

under section 513(f)(3) of the FD&C Act. 

Section 513(f)(3) of the FD&C Act 

provides that FDA, acting by 

administrative order, can reclassify the 

device into class I or class II on its own 

initiative, or in response to a petition 

from the manufacturer or importer of 

the device. To change the classification 

of the device, the proposed new class 

must have sufficient regulatory controls 

to provide a reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. 

In the Federal Register of September 

18, 2020 (85 FR 58300), FDA published 

a proposed order to reclassify CMV 

DNA quantitative assay devices 

intended for transplant patient 

management (‘‘CMV transplant assays’’) 

from class III into class II (general and 

special controls), subject to premarket 

notification. The comment period on the 

proposed order closed on November 17, 

2020. FDA received two comments on 

the proposed order, both of which were 

supportive of the reclassification from 

Class III to Class II and agreed with FDA 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 77449 

1 In December 2019, FDA began adding the term 

‘‘Final amendment’’ to the ‘‘ACTION’’ caption for 

these documents, typically styled ‘‘Final order,’’ to 

indicate an amendment to the Code of Federal 

Regulations. This editorial change was made in 

accordance with the Office of Federal Register’s 

interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 2See 21 CFR 807.81(a)(3)(i). 

that CMV transplant assays should be 

subject to premarket notification. 

II. The Final Order 

Based on the information discussed in 

the preamble to the proposed order (85 

FR 58300), the supportive comments 

received on the proposed order, and 

FDA’s experience over the years with 

this device type, FDA concludes that 

special controls, in conjunction with 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of CMV transplant assays. 

Therefore, in accordance with section 

513(f)(3) of the FD&C Act, FDA is 

issuing this final order to reclassify 

CMV transplant assays from class III 

into class II, subject to premarket 

notification. This final order will be 

codified at 21 CFR 866.3180.1 In this 

final order, FDA has identified special 

controls under section 513(a)(1)(B) of 

the FD&C Act, which in addition to 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of the device. FDA is 

reclassifying these devices and 

establishing the special controls as 

published in the proposed order 

without change. 

Section 510(m) of the FD&C Act 

provides that a class II device may be 

exempted from the premarket 

notification requirements under section 

510(k) of the FD&C Act, if the Agency 

determines that premarket notification 

is not necessary to reasonably assure the 

safety and effectiveness of the device. 

FDA has determined that premarket 

notification is necessary to reasonably 

assure the safety and effectiveness of 

CMV transplant assays. Therefore, the 

Agency does not intend to exempt these 

class II devices from premarket 

notification (510(k)) submission as 

provided under section 510(m) of the 

FD&C Act. 

The devices that are the subject of this 

reclassification are assigned the generic 

name ‘‘quantitative CMV nucleic acid 

tests for transplant patient 

management.’’ These devices are 

identified as a quantitative CMV nucleic 

acid test for transplant patient 

management, a device intended for 

prescription use in the detection of 

CMV and as an aid in the management 

of transplant patients to measure CMV 

DNA levels in human plasma and/or 

whole blood using specified specimen 

processing, amplification, and detection 

instrumentation. The test is intended for 

use as an aid in the management of 

transplant patients with active CMV 

infection or at risk for developing CMV 

infection. The test results are intended 

to be interpreted by qualified healthcare 

professionals in conjunction with other 

relevant clinical and laboratory 

findings. 

Under this final order, CMV 

transplant assays are prescription 

devices requiring the supervision of a 

practitioner licensed by law to direct the 

use of the devices in order to ensure 

accurate interpretation of results, 

ensuring the devices provide a 

reasonable assurance of safety and 

effectiveness. As such, the prescription 

device must satisfy prescription labeling 

requirements for in vitro diagnostic 

products (see 21 CFR 809.10(a)(4) and 

(b)(5)(ii)). 

In addition, the Agency believes that 

certain changes could be made to CMV 

transplant assays that could 

significantly affect the safety and 

effectiveness of those devices and for 

which a new 510(k) is likely required.2

Based on FDA’s accumulated 

experience with these devices, changes 

that likely could significantly affect the 

safety and effectiveness of these devices 

include, but are not limited to, changes 

to critical reagents, changes to final 

release specifications, and changes in 

shelf life of the device. For more 

information about when to submit a 

new 510(k), manufacturers should refer 

to FDA’s guidance entitled ‘‘Deciding 

When to Submit at 510(k) for a Change 

to an Existing Device’’ (Ref. 3). 

III. Implementation Strategy 

The order is effective 30 days after its 

date of publication in the Federal 

Register. 

IV. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

V. Paperwork Reduction Act of 1995 

This final order establishes special 

controls that refer to previously 

approved collections of information 

found in other FDA regulations and 

guidance. Those collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

21 CFR part 807, subpart E, have been 

approved under OMB control number 

0910–0120, the collections of 

information in 21 CFR part 820 have 

been approved under OMB control 

number 0910–0073, and the collections 

of information in 21 CFR parts 801 and 

809 have been approved under OMB 

control number 0910–0485. 

VI. Codification of Orders 

Under section 513(f)(3) of the FD&C 

Act, FDA may issue final orders to 

reclassify devices. FDA will continue to 

codify classifications and 

reclassifications in the Code of Federal 

Regulations (CFR). Changes resulting 

from final orders will appear in the CFR 

as newly codified orders. Therefore, 

under section 513(f)(3), CMV transplant 

assays are codified in the new 21 CFR 

866.3180 under which CMV transplant 

assays are renamed quantitative CMV 

nucleic acid tests for transplant patient 

management and are reclassified from 

class III into class II. 

VII. References 

The following references marked with 

an asterisk (*) are on display in the 

Dockets Management Staff (see 

ADDRESSES; and are available for 

viewing by interested persons between 

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

Friday; they are also available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

1. Ljungman P., M. Boeckh, H.H. Hirsch, et 

al., ‘‘Definitions of CMV Infection and 

Disease in Transplant Patients for Use in 

Clinical Trials,’’ Clinical Infectious 

Diseases, 64(1):87–91, 2017. 

2. Singh, N. and A.P. Limaye, ‘‘Infections in 

Solid-Organ Transplant Recipients,’’ 

Mandell, Douglas, and Bennett’s 

Principles and Practice of Infectious 

Diseases, 7th Edition, Philadelphia 

(PA):Elsevier, pp. 3440–3452, 2015. 

*3. ‘‘Deciding When to Submit a 510(k) for 

a Change to an Existing Device— 

Guidance for Industry and Food and 

Drug Administration Staff,’’ issued 

October 25, 2017 (available at https://

www.fda.gov/MedicalDevices/Device

RegulationandGuidance/Guidance

Documents/UCM514771). 


khammond on DSKJM1Z7X2PROD with RULES
77450 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 

*4. Transcript of the FDA Microbiology 

Devices Panel Meeting, November 9, 

2016 (available at https://www.fda.gov/ 

advisory-committees/microbiologydevices-panel/2016-meeting-materialsmicrobiology-devices-panel). 

5. Kotton, C.N., D. Kumar, A.M. Caliendo, et 

al., ‘‘Updated International Consensus 

Guidelines on the Management of 

Cytomegalovirus in Solid-Organ 

Transplantation,’’ Transplantation 

96(4):333–360, 2013. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 866.3180 to subpart D to 

read as follows: 

§ 866.3180 Quantitative cytomegalovirus 

nucleic acid tests for transplant patient 

management. 

(a) Identification. A quantitative 

cytomegalovirus (CMV) nucleic acid test 

for transplant patient management is 

identified as a device intended for 

prescription use in the detection of 

CMV and as an aid in the management 

of transplant patients to measure CMV 

deoxyribonucleic acid (DNA) levels in 

human plasma and/or whole blood 

using specified specimen processing, 

amplification, and detection 

instrumentation. The test is intended for 

use as an aid in the management of 

transplant patients with active CMV 

infection or at risk for developing CMV 

infection. The test results are intended 

to be interpreted by qualified healthcare 

professionals in conjunction with other 

relevant clinical and laboratory 

findings. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The labeling required under 

§ 809.10(b) of this chapter must include: 

(i) A prominent statement that the 

device is not intended for use as a donor 

screening test for the presence of CMV 

DNA in blood or blood products. 

(ii) Limitations, which must be 

updated to reflect current clinical 

practice. The limitations must include, 

but are not limited to, statements that 

indicate: 

(A) Test results are to be interpreted 

by qualified licensed healthcare 

professionals in conjunction with 

clinical signs and symptoms and other 

relevant laboratory results; 

(B) Negative test results do not 

preclude CMV infection or tissue 

invasive CMV disease, and that CMV 

test results must not be the sole basis for 

patient management decisions. 

(iii) A detailed explanation of the 

interpretation of results and acceptance 

criteria must be provided and include 

specific warnings regarding the 

potential for variability in CMV viral 

load measurement when samples are 

measured by different devices. 

Warnings must include the following 

statement, where applicable: ‘‘Due to 

the potential for variability in CMV viral 

load measurements across different 

CMV assays, it is recommended that the 

same device be used for the quantitation 

of CMV viral load when managing CMV 

infection in individual patients.’’ 

(iv) A detailed explanation of the 

principles of operation and procedures 

for assay performance. 

(2) Design verification and validation 

must include the following: 

(i) Detailed documentation of the 

device description, including all parts 

that make up the device, reagents 

required for use with the CMV assay but 

not provided, an explanation of the 

methodology, design of the primer/ 

probe sequences, rationale for the 

selected gene target, and specifications 

for amplicon size, guanine-cytosine 

content, and degree of nucleic acid 

sequence conservation. The design and 

nature of all primary, secondary, and 

tertiary quantitation standards used for 

calibration must also be described. 

(ii) A detailed description of the 

impact of any software, including 

software applications and hardwarebased devices that incorporate software, 

on the device’s function. 

(iii) Documentation and 

characterization of all critical reagents 

(e.g., determination of the identity, 

supplier, purity, and stability) and 

protocols for maintaining product 

integrity throughout its labeled shelf 

life. 

(iv) Stability data for reagents 

provided with the device and indicated 

specimen types, in addition to the basis 

for the stability acceptance criteria at all 

time points chosen across the spectrum 

of the device’s indicated life cycle, 

which must include a time point at the 

end of shelf life. 

(v) All stability protocols, including 

acceptance criteria. 

(vi) Final lot release criteria, along 

with documentation of an appropriate 

justification that lots released at the 

extremes of the specifications will meet 

the claimed analytical and clinical 

performance characteristics as well as 

the stability claims. 

(vii) Risk analysis and documentation 

demonstrating how risk control 

measures are implemented to address 

device system hazards, such as Failure 

Modes Effects Analysis and/or Hazard 

Analysis. This documentation must 

include a detailed description of a 

protocol (including all procedures and 

methods) for the continuous monitoring, 

identification, and handling of genetic 

mutations and/or novel CMV stains 

(e.g., regular review of published 

literature and annual in silico analysis 

of target sequences to detect possible 

primer or probe mismatches). All results 

of this protocol, including any findings, 

must be documented. 

(viii) Analytical performance testing 

that includes: 

(A) Detailed documentation of the 

following analytical performance 

studies: Limit of detection, upper and 

lower limits of quantitation, inclusivity, 

precision, reproducibility, interference, 

cross reactivity, carryover, quality 

control, specimen stability studies, and 

additional studies as applicable to 

specimen type and intended use for the 

device. 

(B) Identification of the CMV strains 

selected for use in analytical studies, 

which must be representative of 

clinically relevant circulating strains. 

(C) Inclusivity study results obtained 

with a variety of CMV genotypes as 

applicable to the specific assay target 

and supplemented by in silico analysis. 

(D) Reproducibility studies that 

include the testing of three independent 

production lots. 

(E) Documentation of calibration to a 

standardized reference material that 

FDA has determined is appropriate for 

the quantification of CMV DNA (e.g., a 

recognized consensus standard). 

(F) Documentation of traceability 

performed each time a new lot of the 

standardized reference material to 

which the device is traceable is 

released, or when the field transitions to 

a new standardized reference material. 

(ix) Clinical performance testing that 

includes: 

(A) Detailed documentation of device 

performance data from either a method 

comparison study with a comparator 

that FDA has determined is appropriate, 

or results from a prospective clinical 

study demonstrating clinical validity of 

the device. 

(B) Data from patient samples, with an 

acceptable number of the CMV positive 

samples containing an analyte 

concentration near the lower limit of 

quantitation and any clinically relevant 

decision points. 


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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Rules and Regulations 77451 

(C) The method comparison study 

must include predefined maximum 

acceptable differences between the test 

and comparator method across all 

primary outcome measures in the 

clinical study protocol. 

(D) The final release test results for 

each lot used in the clinical study. 

Dated: September 17, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21616 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2024–0820] 

RIN 1625–AA00 

Safety Zone; Kernwood Avenue Bridge 

Repairs—Danvers River, Salem, MA, 

and Beverly, MA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary Interim Rule and 

request for comments. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the navigable waters at mile 1.0 Danvers 

River, within a 100-yard radius of the 

center point of the Kernwood Avenue 

Bridge between Salem, MA and Beverly, 

MA. The temporary safety zone is 

necessary to protect personnel, vessels 

and the marine environment from 

potential hazards created during bridge 

repairs. When enforced, entry of vessels 

or persons into this zone is prohibited 

unless specifically authorized by the 

Captain of the Port Boston or a 

designated representative. 

DATES: 

Effective date: This rule is effective 

without actual notice from September 

23, 2024 through 11:59 p.m. on 

December 31, 2024. For the purposes of 

enforcement, actual notice will be used 

from September 15, 2024, until 

September 23, 2024. 

Comments due date: Comments and 

related material must be received by the 

Coast Guard on or before October 23, 

2024. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2024–0820 using the Federal eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

rulemaking, call or email Mr. Timothy 

Chase, Waterways Management 

Division, U.S. Coast Guard Sector 

Boston, telephone 617–447–1620, or 

email Timothy.w.chase@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

NAD 83 North American Datum 1983 

§ Section 

U.S.C. United States Code 

MASSDOT Massachusetts Department of 

Transportation 

II. Background Information and 

Regulatory History 

On August 28, 2024, the 

Massachusetts Department of 

Transportation (MassDOT) bridge 

division notified the Waterways 

Management Division of U. S. Coast 

Guard Sector Boston that operations to 

make repairs to the Kernwood Avenue 

Bridge, spanning the Danvers River 

between Salem, MA, and Beverly, MA, 

will begin September 15, 2024. 

The Coast Guard is issuing this 

temporary rule under the authority in 5 

U.S.C. 553(b)(B). This statutory 

provision authorizes an agency to issue 

a rule without prior notice and 

opportunity to comment when the 

agency for good cause finds that those 

procedures are ‘‘impracticable, 

unnecessary, or contrary to the public 

interest.’’ The Coast Guard finds that 

good cause exists for not publishing a 

notice of proposed rulemaking (NPRM) 

with respect to this rule because the 

construction schedule for Kernwood 

Avenue Bridge was only recently 

finalized and prompt action is needed to 

respond to the potential safety hazards 

associated with this project. It is 

impracticable and contrary to the public 

interest to publish an NPRM because 

prompt action is needed to establish this 

safety zone by September 15, 2024, to 

allow for the timely repairs to the 

Kernwood Avenue Bridge and ensure 

the safety of mariners transiting the area 

from the dangers associated with the 

operations associated with these repairs. 

Also, under 5 U.S.C. 553(d)(3), the 

Coast Guard finds that good cause exists 

for making this rule effective less than 

30 days after publication in the Federal 

Register. Delaying the effective date of 

this rule would be impracticable 

because prompt action is needed to 

ensure public safety during repair 

operations to the Kernwood Avenue 

Bridge. 

Although this regulation is published 

as an interim rule without prior notice, 

public comment is nevertheless 

desirable to ensure that the regulation is 

both workable and reasonable. 

Accordingly, persons wishing to 

comment may do so by submitting 

written comments as set out under 

ADDRESSES in this preamble. 

Commenters should include their names 

and addresses, identify the docket 

number for the regulation, and give 

reasons for their comments. If the Coast 

Guard determines that changes to the 

temporary interim rule are necessary, 

we will publish a temporary final rule 

or other appropriate document. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority in 46 U.S.C. 70034. The 

Captain of the Port Boston (COTP) has 

determined that potential hazards 

associated with bridge repair operations 

starting September 15, 2024, will be a 

safety concern for anyone within a 100- 

yard radius of the center point of the 

Kernwood Avenue Bridge. This rule is 

needed to protect personnel, vessels, 

and the marine environment in the 

navigable waters within the safety zone 

while bridge repair operations are taking 

place. 

IV. Discussion of Rule 

This rule establishes a safety zone 

from September 15, 2024, through 11:59 

p.m. on December 31, 2024. While the 

safety zone will be effective through this 

period, it will only be enforced during 

active repair operations, when work 

barges and cranes will be placed in the 

narrow navigable channel, or other 

instances which may create a hazard to 

navigation. The active repair operations 

will take place during the overnight 

hours, from 9 p.m. through 5 a.m., 

Sunday through Thursday, when 

boating traffic is minimal. 

The safety zone will cover all 

navigable waters within a 100-yard 

radius of the center point of the 

MassDOT Kernwood Avenue Bridge, at 

mile 1.0, spanning the Danvers River, 

between Salem, MA, and Beverly, MA, 

in approximate position 42°32′34.8′′ N 

70°53′54.2′′ W (NAD 83). During times 

of enforcement, all persons or vessels 

will be prohibited from entering the 

safety zone without permission from the 

COTP or a designated representative. 

The Coast Guard will make notice of 

the safety zone via the Local Notice to 

Mariners and issue a Broadcast Notice 

to Mariners via marine channel 16 

(VHF–FM) as soon as practicable in 


khammond on DSKJM1Z7X2PROD with RULES