72986 Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 

III. 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. 

IV. 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. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3521). The 

collections of information in part 860, 

subpart D, regarding De Novo 

classification have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 814, subparts A through E, 

regarding premarket approval, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in part 807, subpart E, 

regarding premarket notification 

submissions, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 820, regarding quality system 

regulation, have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 

part 801, regarding labeling, have been 

approved under OMB control number 

0910–0485. 

List of Subjects in 21 CFR Part 876 

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 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGYUROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 876.4330 to subpart E to read 

as follows: 

§ 876.4330 Endoscopic pancreatic 

debridement device. 

(a) Identification. An endoscopic 

pancreatic debridement device is 

inserted via an endoscope and placed 

through a cystogastrostomy fistula into 

the pancreatic cavity. It is intended for 

removal of necrotic tissue from a walled 

off pancreatic necrosis (WOPN) cavity. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Clinical performance testing must 

demonstrate that the device performs as 

intended under anticipated conditions 

of use, including evaluation of 

debridement of walled off pancreatic 

necrosis and all adverse events. 

(2) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(3) Performance data must 

demonstrate the sterility of the patientcontacting components of the device. 

(4) The patient-contacting 

components of the device must be 

demonstrated to be non-pyrogenic. 

(5) Performance testing must support 

the shelf life of device components 

provided sterile by demonstrating 

continued sterility, package integrity, 

and device functionality over the 

labeled shelf life. 

(6) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Testing of rotational speeds and 

vacuum pressure; 

(ii) Functional testing including 

testing with all device components and 

the ability to torque the device; and 

(iii) Functional testing in a relevant 

tissue model to demonstrate the ability 

to resect and remove tissue. 

(7) Performance data must 

demonstrate the electromagnetic 

compatibility (EMC) and electrical 

safety of the device. 

(8) Software verification, validation, 

and hazard analysis must be performed. 

(9) Training must be provided so that 

upon completion of the training 

program, the user can resect and remove 

tissue of interest while preserving nontarget tissue. 

(10) Labeling must include the 

following: 

(i) A summary of the clinical 

performance testing conducted with the 

device; 

(ii) Instructions for use, including the 

creation of a conduit for passage of 

endoscope and device into a walled off 

pancreatic necrotic cavity; 

(iii) Unless clinical performance data 

demonstrates that it can be removed or 

modified, a boxed warning stating that 

the device should not be used in 

patients with known or suspected 

pancreatic cancer; 

(iv) The recommended training for 

safe use of the device; and 

(v) A shelf life for any sterile 

components. 

Dated: September 4, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20248 Filed 9–6–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 591 

Publication of Venezuela Sanctions 

Regulations Web General License 5P 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Publication of web general 

license. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control (OFAC) is publishing one 

general license (GL) issued pursuant to 

the Venezuela Sanctions Regulations: 

GL 5P, which was previously made 

available on OFAC’s website. 

DATES: GL 5P was issued on August 12, 

2024. See SUPPLEMENTARY INFORMATION

for additional relevant dates. 

FOR FURTHER INFORMATION CONTACT: 

OFAC: Assistant Director for Licensing, 

202–622–2480; Assistant Director for 

Regulatory Affairs, 202–622–4855; or 

Assistant Director for Compliance, 202– 

622–2490. 

SUPPLEMENTARY INFORMATION: 

Electronic Availability 

This document and additional 

information concerning OFAC are 

available on OFAC’s website: https://

ofac.treasury.gov. 

Background 

On August 12, 2024, OFAC issued GL 

5P to authorize certain transactions 

otherwise prohibited by the Venezuela 

Sanctions Regulations (VSR), 31 CFR 

part 591. GL 5P was made available on 

OFAC’s website (https://

ofac.treasury.gov) when it was issued. 

GL 5P supersedes GL 5O, which was 

issued on April 15, 2024. The text of GL 

5P is provided below. 

OFFICE OF FOREIGN ASSETS 

CONTROL 

Venezuela Sanctions Regulations 

31 CFR Part 591 

GENERAL LICENSE NO. 5P 

Authorizing Certain Transactions 

Related to the Petro ́leos de Venezuela, 

S.A. 2020 8.5 Percent Bond on or After 

November 12, 2024 

(a) Except as provided in paragraph 

(b) of this general license, on or after 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 174 / Monday, September 9, 2024 / Rules and Regulations 72987 

November 12, 2024, all transactions 

related to, the provision of financing for, 

and other dealings in the Petro ́leos de 

Venezuela, S.A. 2020 8.5 Percent Bond 

that would be prohibited by subsection 

l(a)(iii) of Executive Order (E.O.) 13835 

of May 21, 2018, as amended by E.O. 

13857 of January 25, 2019, and 

incorporated into the Venezuela 

Sanctions Regulations, 31 CFR part 591 

(the VSR), are authorized. 

(b) This general license does not 

authorize any transactions or activities 

otherwise prohibited by the VSR, or any 

other part of 31 CFR chapter V. 

(c) Effective August 12, 2024, General 

License No. 5O, dated April 15, 2024, is 

replaced and superseded in its entirety 

by this General License No. 5P. 

Lisa M. Palluconi, 

Acting Director Office of Foreign Assets 

Control. 

Dated: August 12, 2024. 

Lisa M. Palluconi, 

Acting Director, Office of Foreign Assets 

Control. 

[FR Doc. 2024–20224 Filed 9–6–24; 8:45 am] 

BILLING CODE 4810–AL–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2024–0741] 

RIN 1625–AA00 

Safety Zone; Missouri River Mile 

Markers 19–20 Florissant, MO 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

the Missouri River at mile markers 

(MM) 19 through 20. The safety zone is 

needed to protect personnel, vessels, 

and the marine environment from 

potential hazards created by a power 

line wire crossing near Florissant, MO. 

Entry of vessels or persons into this 

zone is prohibited unless specifically 

authorized by the Captain of the Port, 

Sector Upper Mississippi River. 

DATES: For the purposes of enforcement, 

actual notice will be used from 

September 5, 2024, until September 9, 

2024. This rule is effective without 

actual notice from September 9, 2024 

through September 20, 2024. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2024– 

0741 in the search box and click 

‘‘Search.’’ Next, in the Document Type 

column, select ‘‘Supporting & Related 

Material.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this rule, call 

or email MST1 Benjamin Conger, Sector 

Upper Mississippi River Waterways 

Management Division, U.S. Coast 

Guard; telephone 314–269–2573, email 

Benjamin.D.Conger@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

MM Mile marker 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

The Coast Guard is issuing this 

temporary rule under 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 of 

potential hazards created by the power 

line crossing over the Missouri River 

that need to be addressed. As such, the 

Coast Guard lacks sufficient time to 

provide a reasonable comment period 

and then consider those comments 

before issuing the rule. It is 

impracticable to publish an NPRM 

because we must establish this safety 

zone by September 5, 2024. 

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 immediate action is needed to 

respond to the potential safety hazards 

associated with the power line crossing 

starting September 5, 2024. 

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 Sector Upper 

Mississippi (COTP) has determined that 

potential hazards associated with the 

power line crossing starting September 

5, 2024, will be a safety concern for 

anyone operating in or transiting the 

Missouri River from or between MM 19– 

20. This rule is needed to protect 

personnel, vessels, and the marine 

environment in the navigable waters 

within the safety zone while the power 

line crossing is being conducted. 

IV. Discussion of the Rule 

This rule establishes a safety zone 

during a power line crossing project 

over the Missouri River on September 5, 

2024 through September 20, 2024. The 

safety zone will cover all navigable 

waters from MM 19–20. The duration of 

the zone is intended to protect 

personnel, vessels, and the marine 

environment in these navigable waters 

while the power line crosses the 

Missouri River. No vessel or person will 

be permitted to enter the safety zone 

without obtaining permission from the 

COTP or a designated representative via 

VHF–FM channel 16, or through USCG 

Sector Upper Mississippi River at 314– 

269–2332. Persons and vessels 

permitted to enter the safety zone must 

comply with all lawful orders or 

directions issued by the COTP or 

designated representative. The COTP or 

a designated representative will inform 

the public of the effective period for the 

safety zone as well as any changes in the 

dates and times of enforcement, as well 

as reductions in the size of the safety 

zone as conditions improve, through 

Local Notice to Mariners (LNMs), 

Broadcast Notices to Mariners (BNMs), 

and/or Safety Marine Information 

Broadcast (SMIB), as appropriate. 

V. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

Executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive orders, and we discuss First 

Amendment rights of protestors. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

This rule has not been designated a 

‘‘significant regulatory action,’’ under 

section 3(f) of Executive Order 12866, as 

amended by Executive Order 14094 

(Modernizing Regulatory Review). 

Accordingly, this rule has not been 

reviewed by the Office of Management 

and Budget (OMB). 

This regulatory action determination 

is based on a safety zone located on the 

Missouri River between MM 19–20 near 

Florissant, MO. The safety zone will be 

active only while work associated with 

the power line crossing is being 


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