Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Rules and Regulations 60333 

Employee means an ‘‘employee’’ as 

defined in 5 U.S.C. 2105 and an 

employee of the United States Postal 

Service or the Postal Regulatory 

Commission. 

Political appointment means an 

appointment by the President without 

Senate confirmation (except those 

appointed under 5 CFR 213.3102(c)); an 

appointment to a position compensated 

under the Executive Schedule (5 U.S.C. 

5312 through 5316); an appointment of 

a White House Fellow to be assigned as 

an assistant to a top-level Federal officer 

(5 CFR 213.3102(z)); a Schedule C 

appointment (5 CFR 213.3301, 

213.3302); a noncareer, limited term, or 

limited emergency Senior Executive 

Service appointment (5 CFR part 317, 

subpart F); an appointee to serve in a 

political capacity under agency-specific 

authority; and a provisional political 

appointment. 

§ 920.102 Positions covered by Fair 

Chance Act regulations. 

(a) Positions covered. This part 

applies to all positions in the 

competitive service, excepted service, 

and Senior Executive Service in an 

agency. 

(b) Exempt positions. For purposes of 

this part an exempt position is any 

position for which a hiring agency is 

required by statutory authority to make 

inquiries into an applicant’s criminal 

history prior to extending an offer of 

employment to the applicant. 

Subpart B—Timing of Inquiries 

Regarding Criminal History 

§ 920.201 Limitations on criminal history 

inquiries. 

(a) Applicability. An employee of an 

agency may not request, in oral or 

written form (including through the 

Declaration for Federal Employment 

(Office of Personnel Management 

Optional Form 306) or any similar 

successor form, the USAJOBS internet 

website, or any other electronic means) 

that an applicant for an appointment to 

a position in the civil service disclose 

criminal history record information 

regarding the applicant before the 

appointing authority extends a 

conditional offer to the applicant. This 

includes the following points in the 

recruitment and hiring process: 

(1) Initial application, through a job 

opportunity announcement on 

USAJOBS, or through any recruitment/ 

public notification such as on the 

agency’s website/social media, etc.; 

(2) After an agency receives an initial 

application through its back-end system, 

through shared service providers/ 

recruiters/contractors, or orally or via 

email and other forms of electronic 

notification; and 

(3) Prior to, during, or after a job 

interview. This prohibition applies to 

agency personnel, including when they 

act through shared service providers, 

contractors (acting on behalf of the 

agency) involved in the agency’s 

recruitment and hiring process, or 

automated systems (specific to the 

agency or governmentwide). 

(b) Exceptions for certain positions. 

(1) The prohibition under paragraph (a) 

of this section shall not apply with 

respect to an applicant for an 

appointment to a position: 

(i) Which is exempt in accordance 

with § 920.102(b); 

(ii) That requires a determination of 

eligibility for access to classified 

information; 

(iii) Has been designated as a sensitive 

position under the Position Designation 

System issued by OPM and the Office of 

Director of National Intelligence, which 

describes in greater detail agency 

requirements for designating positions 

that could bring about a material 

adverse effect on the national security; 

(iv) Is a dual-status military 

technician position in which an 

applicant or employee is subject to a 

determination of eligibility for 

acceptance or retention in the armed 

forces, in connection with concurrent 

military membership; or 

(v) Is a Federal law enforcement 

officer position meeting the definition 

in section 115(c) of title 18, U.S. Code. 

(2) The prohibition under paragraph 

(a) of this section shall not apply with 

respect to an applicant for a political 

appointment. 

(c) Notification to applicants. Each 

agency must publicize to applicants the 

prohibition described in paragraph (a) of 

this section in job opportunity 

announcements and on agency 

websites/portals for positions that do 

not require a posting on USAJOBS, such 

as excepted service positions, and in 

addition to information on where it has 

posted about its complaint intake 

process under as required by part 754 of 

this chapter. 

§ 920.202 Violations. 

(a) An agency employee may not 

request, orally or in writing, information 

about an applicant’s criminal history 

prior to making a conditional offer of 

employment to that applicant unless the 

position is exempted or excepted in 

accordance with § 920.201(b). 

(b) A violation (or prohibited action) 

as defined in paragraph (a) of this 

section occurs when agency personnel, 

shared service providers, or contractors 

(acting on behalf of the agency) involved 

in the agency’s recruitment and hiring 

process, either personally or through 

automated systems (specific to the 

agency or governmentwide), make oral 

or written requests prior to giving a 

conditional offer of employment— 

(1) In a job opportunity 

announcement on USAJOBS or in any 

recruitment/public notification such as 

on the agency’s website or social media; 

(2) In communications sent after an 

agency receives an initial application, 

through an agency’s talent acquisition 

system, shared service providers/ 

recruiters/contractors, orally or in 

writing (including via email and other 

forms of electronic notification); or 

(3) Prior to, during, or after a job 

interview or other applicant assessment. 

(c) When a prohibited request, 

announcement, or communication is 

publicly posted or simultaneously 

distributed to multiple applicants, it 

constitutes a single violation. 

(d) Any violation as defined in 

paragraph (a) of this section is subject to 

the complaint and penalty procedures 

in part 754 of this chapter. 

[FR Doc. 2023–18242 Filed 8–31–23; 8:45 am] 

BILLING CODE 6325–39–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2019–D–4212] 

Wholesale Distributor Verification 

Requirement for Saleable Returned 

Drug Product and Dispenser 

Verification Requirements When 

Investigating a Suspect or Illegitimate 

Product—Compliance Policies, 

Revision 1; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a 

guidance for industry entitled 

‘‘Wholesale Distributor Verification 

Requirement for Saleable Returned Drug 

Product and Dispenser Verification 

Requirements When Investigating a 

Suspect or Illegitimate Product— 

Compliance Policies, Revision 1.’’ This 

revised guidance explains that FDA 

intends to extend for an additional year 

(from November 27, 2023, to November 

27, 2024), the enforcement policies 


lotter on DSK11XQN23PROD with RULES1
60334 Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Rules and Regulations 

described in the guidance entitled 

‘‘Wholesale Distributor Verification 

Requirement for Saleable Returned Drug 

Product and Dispenser Verification 

Requirements When Investigating a 

Suspect or Illegitimate Product— 

Compliance Policies,’’ published in the 

Federal Register on October 23, 2020 

(the 2020 Compliance Policies). The 

2020 Compliance Policies relate to 

provisions in the Federal Food, Drug, 

and Cosmetic Act (FD&C Act), as added 

by the Drug Supply Chain Security Act 

(DSCSA), requiring wholesale 

distributors to verify the product 

identifier prior to further distributing 

saleable returned product and requiring 

dispensers to verify the product 

identifier for suspect or illegitimate 

product in the dispenser’s possession or 

control. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 1, 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– 

2019–D–4212 for ‘‘Wholesale 

Distributor Verification Requirement for 

Saleable Returned Drug Product and 

Dispenser Verification Requirements 

When Investigating a Suspect or 

Illegitimate Product—Compliance 

Policies.’’ 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 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Division of 

Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Venti, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, drugtrackandtrace@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 23, 2020, FDA published 

the 2020 Compliance Policies. FDA is 

announcing the availability of a 

guidance for industry entitled 

‘‘Wholesale Distributor Verification 

Requirement for Saleable Returned Drug 

Product and Dispenser Verification 

Requirements When Investigating a 

Suspect or Illegitimate Product— 

Compliance Policies, Revision 1’’, 

which extends the enforcement policies 

described in the 2020 Compliance 

Policies for an additional year, from 

November 27, 2023, until November 27, 

2024. As described in this revised 

guidance, FDA does not intend to take 

enforcement action, prior to November 

27, 2024, against wholesale distributors 

who do not verify the product identifier 

prior to further distributing saleable 

returned product, or against dispensers 

who do not verify the product identifier 

of the statutorily designated proportion 

of suspect or illegitimate product in the 

dispenser’s possession or control, as 

required under section 582 of the FD&C 

Act (21 U.S.C. 360eee–1), as added by 

the DSCSA (Title II of Pub. L. 113–54). 

This revised guidance is being issued 

consistent with FDA’s good guidance 

practices regulations (21 CFR 10.115). 

FDA is implementing this guidance 

without prior public comment because 

the Agency has determined that prior 

public participation is not feasible or 

appropriate (21 CFR 10.115(g)(2)). FDA 

made this determination because this 

guidance document provides 

information pertaining to statutory 

requirements that FDA had planned to 

begin enforcing as of November 27, 


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Federal Register / Vol. 88, No. 169 / Friday, September 1, 2023 / Rules and Regulations 60335 

2023, for wholesale distributors to verify 

the product identifier prior to further 

distributing saleable returned product 

under section 582(c)(4)(D) of the FD&C 

Act and for dispensers to verify the 

product identifier, including the 

standardized numerical identifier, for 

suspect or illegitimate product in the 

dispenser’s possession or control under 

section 582(d)(4)(A)(ii)(II) and 

(d)(4)(B)(iii) of the FD&C Act. It is 

important that FDA provide this 

information before that date. Although 

this guidance document is being 

implemented immediately, it remains 

subject to comment in accordance with 

the Agency’s good guidance practices 

(21 CFR 10.115(g)(3)). 

Beginning November 27, 2019, 

wholesale distributors were required, 

under section 582(c)(4)(D) of the FD&C 

Act, to verify the product identifier, 

including the standardized numerical 

identifier, on each sealed homogeneous 

case of saleable returned product, or, if 

such product is not in a sealed 

homogeneous case, on each package of 

saleable returned product, prior to 

further distributing such returned 

product. In the Federal Register 

published September 24, 2019 (84 FR 

50044), FDA issued a notice announcing 

the availability of the Wholesale 

Distributor Verification Requirement for 

Saleable Returned Drug Product— 

Compliance Policy guidance (2019 

Compliance Policy), which described a 

1-year enforcement policy with respect 

to this wholesale distributor 

requirement, until November 27, 2020. 

The Agency subsequently published the 

2020 Compliance Policies, which 

extended the enforcement policy in the 

2019 Compliance Policy with respect to 

this wholesale distributor requirement 

for 3 years, until November 27, 2023, 

and also included an enforcement 

policy until that same date with respect 

to the requirement for dispensers to 

verify the product identifier, including 

the standardized numerical identifier, 

for suspect or illegitimate product in the 

dispenser’s possession or control. 

Since the announcement of the 2020 

Compliance Policies, FDA has received 

additional comments and feedback from 

wholesale distributors, as well as other 

trading partners and stakeholders, 

expressing concern with industry-wide 

readiness for implementation of the 

verification of saleable returned product 

requirement for wholesale distributors 

and the challenges stakeholders face 

with developing interoperable, 

electronic systems to enable such 

verification and achieve interoperability 

between networks. Specifically, 

comments received point out continuing 

challenges posed by the large volume of 

saleable returned product, explaining 

that wholesale distributors still need 

more time to test verification systems 

using real-time volumes of saleable 

returned product with all trading 

partners involved, as opposed to using 

small-scale pilot test projects. Given all 

these concerns, FDA recognizes that 

some wholesale distributors may need 

additional time, beyond November 27, 

2023, before they can begin verifying 

returned products prior to resale or 

other further distribution as required by 

section 582(c)(4)(D) of the FD&C Act in 

an efficient, secure, and timely manner. 

Additionally, section 582 of the FD&C 

Act requires certain trading partners 

(manufacturers, repackagers, wholesale 

distributors, and dispensers) to 

exchange transaction information, 

transaction history, and a transaction 

statement when engaging in transactions 

involving certain prescription drugs. 

Section 581(27)(E) of the FD&C Act (21 

U.S.C. 360eee(27)(E)) requires that the 

transaction statement include a 

statement that the entity transferring 

ownership in a transaction had systems 

and processes in place to comply with 

verification requirements under section 

582 of the FD&C Act. This revised 

guidance also explains that, prior to 

November 27, 2024, FDA does not 

intend to take action against a wholesale 

distributor for providing a transaction 

statement to a subsequent purchaser of 

product on the basis that such 

wholesale distributor does not yet have 

systems and processes in place to 

comply with the saleable return 

verification requirements under section 

582(c)(4)(D) of the FD&C Act. The 

guidance explains the scope of the 

compliance policy in further detail. 

In addition to helping minimize 

possible disruptions in the distribution 

of certain prescription drugs in the 

United States, FDA believes that by 

extending the enforcement approach 

described in the 2020 Compliance 

Policies until November 27, 2024, 

wholesale distributors will be able to 

focus resources and efforts on the 

requirements for enhanced drug 

distribution security under section 

582(g) of the FD&C Act (as described 

below). Thus, instead of developing 

separate processes or infrastructures 

solely for the saleable return verification 

requirement, wholesale distributors can 

incorporate the saleable return 

verification requirements into the 

enhanced verification required under 

section 582(g) of the FD&C Act. 

Further, section 582 of the FD&C Act, 

as added by the DSCSA, also established 

the requirements that specify how 

dispensers must investigate suspect and 

illegitimate product. As part of the 

investigation, section 582(d)(4)(A)(ii)(II) 

of the FD&C Act requires dispensers to 

verify the product identifier, including 

the standardized numerical identifier, of 

at least three packages or 10 percent of 

such suspect product, whichever is 

greater, or all packages, if there are 

fewer than three, corresponds with the 

product identifier for such product in 

the dispenser’s possession or control. 

Section 582(d)(4)(B)(iii) of the FD&C Act 

requires dispensers to verify product as 

described in section 582(d)(4)(A)(ii), 

which includes the section 

582(d)(4)(A)(ii)(II) requirement, in 

response to a notification from FDA or 

a trading partner that the product is an 

illegitimate product. 

In response to comments received 

from stakeholders regarding dispenser 

readiness to meet these requirements, 

and to minimize possible disruptions in 

the distribution of affected prescription 

drugs in the United States, this guidance 

also announces that FDA does not 

intend to take action before November 

27, 2024, against dispensers who do not 

verify the product identifier of the 

statutorily designated proportion of 

suspect product as required by section 

582(d)(4)(A)(ii)(II) of the FD&C Act, and 

that part of section 582(d)(4)(B)(iii) of 

the FD&C Act that requires dispensers to 

perform the same verification activities 

of section 582(d)(4)(A)(ii)(II) when 

responding to a notification of 

illegitimate product from FDA or 

another trading partner. FDA believes 

that the 1-year extension under this 

guidance of the applicable 2020 

Compliance Policies will facilitate the 

ability of dispensers to ensure the 

systems and processes that are put into 

place to meet the enhanced drug 

distribution security requirements, 

which FDA will generally not enforce 

before November 27, 2024, will also 

fulfill the dispenser verification 

requirements under section 582(d)(4) of 

the FD&C Act. 

In the ‘‘Enhanced Drug Distribution 

Security Requirements Under Section 

582(g)(1) of the Federal Food, Drug, and 

Cosmetic Act—Compliance Policies’’ 

(Enhanced Drug Distribution Security 

Compliance Policies) (88 FR 58498), 

FDA announced a 1-year enforcement 

policy with respect to the enhanced 

drug distribution security requirements 

set to take effect on November 27, 2023. 

FDA chose to adopt this enforcement 

policy until November 27, 2024, 

because FDA was aware that some 

stakeholders were facing challenges 

with implementing the section 582(g) 

requirements and needed additional 

time to comply with these requirements. 

While FDA generally expects trading 

partners to have the systems and 


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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 


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