60336 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Rules and Regulations 

1The Office of the Federal Register has published 

this document under the category ‘‘Rules and 

Regulations’’ pursuant to its interpretation of 1 CFR 

5.9(b). We note that the categorization as such for 

purposes of publication in the Federal Register 

does not affect the content or intent of the 

document. See 1 CFR 5.1(c). 

processes in place to meet the 

requirements of section 582(g) of the 

FD&C Act, FDA recognizes that some 

technical and operational issues may 

not be fully resolved by November 27, 

2023. The Agency believes the 

Enhanced Drug Distribution Security 

Compliance Policies can help trading 

partners address such issues by 

accommodating the additional time that 

may be needed to implement, 

troubleshoot, and mature their systems 

and processes. For additional 

information about enhanced drug 

distribution security please see the June 

2021 draft guidance for industry entitled 

‘‘Enhanced Drug Distribution Security at 

the Package Level Under the Drug 

Supply Chain Security Act’’ (available 

at: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/enhanced-drug-distributionsecurity-package-level-under-drugsupply-chain-security-act). 

This guidance represents the current 

thinking of FDA on ‘‘Wholesale 

Distributor Verification Requirement for 

Saleable Returned Drug Product and 

Dispenser Verification Requirements 

When Investigating a Suspect or 

Illegitimate Product—Compliance 

Policies.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations.1

II. Paperwork Reduction Act of 1995 

FDA concludes that this guidance 

contains no collection of information. 

Therefore, clearance by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 is not 

required. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: August 28, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–18899 Filed 8–31–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2023–0651] 

Special Local Regulations; Portland 

Dragon Boat Races, Willamette River, 

Portland, OR 

AGENCY: Coast Guard, DHS. 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

special local regulations for the Portland 

Dragon Boat Races from September 9 

through 10, 2023, to provide for the 

safety of life on navigable waterways 

during this event. Our regulation for 

marine events within the Thirteenth 

Coast Guard District identifies the 

regulated area for this event on the 

Willamette River in Portland, OR. 

During the enforcement periods, the 

operator of any vessel in the regulated 

area must comply with the directions 

from the Patrol Commander or any 

official patrol vessel. Official patrol 

vessels may consist of any Coast Guard, 

Coast Guard Auxiliary, state, or local 

law enforcement vessels assigned or 

approved by the Captain of the Port, 

Sector Columbia River. 

DATES: The regulations in 33 CFR 

100.1302 will be enforced from 7:30 

a.m. until 5:30 p.m., each day from 

September 9 through 10, 2023. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 

notification of enforcement, call or 

email LT Carlie Gilligan, Waterways 

Management Division, Sector Columbia 

River, Coast Guard; telephone 503–240– 

9319, email SCRWWM@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce special local 

regulations in 33 CFR 100.1302 for the 

Portland Dragon Boat Races regulated 

area from 7:30 a.m. to 5:30 p.m. on 

September 9 and 10, 2023. This action 

is being taken to provide for the safety 

of life on navigable waterways during 

this event. Our regulation for marine 

events within the Thirteenth Coast 

Guard District, § 100.1302, specifies the 

location of the regulated area for the 

Portland Dragon Boat Races which 

encompasses portions of the Willamette 

River in Portland, OR. During the 

enforcement periods, as reflected in 

§ 100.1302, vessels may not transit the 

regulated areas without approval from 

the Patrol Commander or an Official 

Patrol Vessel. Vessels permitted to 

transit must operate at a no wake speed, 

in a manner which will not endanger 

participants or other crafts in the event. 

In addition to this notification of 

enforcement in the Federal Register, the 

Coast Guard plans to provide 

notification of this enforcement period 

via the Local Notice to Mariners and 

marine information broadcasts. 

Dated: August 21, 2023. 

J.W. Noggle, 

Captain, U.S. Coast Guard, Captain of the 

Port Columbia River. 

[FR Doc. 2023–18917 Filed 8–31–23; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 3 

RIN 2900–AR25 

Presumptive Service Connection for 

Respiratory Conditions Due to 

Exposure to Fine Particulate Matter 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: This rulemaking adopts as 

final, with changes, an interim final rule 

that amended the Department of 

Veterans Affairs (VA) adjudication 

regulations governing presumptive 

service connection based on presumed 

exposures to fine particulate matter. The 

amendment was necessary to provide 

health care, services, and benefits to 

Gulf War Veterans who were exposed to 

fine particulate matter associated with 

deployment to the Southwest Asia 

theater of operations, as well as 

Afghanistan, Syria, Djibouti, and 

Uzbekistan. The amendment eased the 

evidentiary burden of Gulf War Veterans 

who file claims with VA for asthma, 

rhinitis, and sinusitis, to include 

rhinosinusitis. 

DATES: 

Effective date: This rule is effective 

October 31, 2023. 

Applicability date: The provisions of 

this final rule shall apply to all 

applications for benefits that are 

received by VA on or after the effective 

date of this final rule or that are pending 

before VA, the United States Court of 

Appeals for Veterans Claims, or the 

United States Court of Appeals for the 

Federal Circuit on the effective date of 

this final rule. 

FOR FURTHER INFORMATION CONTACT: Jane 

Allen, Policy Analyst; Robert Parks, 

Chief, Part 3 Regulations Staff (211), 

Compensation Service (21C), Veterans 

Benefits Administration, Department of 

Veterans Affairs, 810 Vermont Avenue 


lotter on DSK11XQN23PROD with RULES1