Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3881 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; 340B Drug Pricing Program; 

Initiation of the Administrative Dispute 

Resolution Process 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 14, 

2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

340B Drug Pricing Program; Initiation of 

the Administrative Dispute Resolution 

Process, OMB No. 0906-xxxx—New. 

Abstract: Section 602 of Public Law 

102–585, the Veterans Health Care Act 

of 1992, created the 340B Drug Pricing 

Program in section 340B of the Public 

Health Service (PHS) Act. Eligible 

covered entity types are defined in 

section 340B(a)(4) of the PHS Act, as 

amended. Section 340B(a)(1) of the PHS 

Act instructs HHS to enter into 

pharmaceutical pricing agreements with 

manufacturers of covered outpatient 

drugs. Under section 1927(a)(5)(A) of 

the Social Security Act, a manufacturer 

must enter into an agreement with the 

Secretary that complies with section 

340B of the PHS Act to receive 

payments from Medicaid or Medicare 

Part B for the manufacturer’s covered 

outpatient drugs. When a manufacturer 

signs a pharmaceutical pricing 

agreement, it agrees that the prices 

charged for covered outpatient drugs to 

covered entities will not exceed 

statutorily defined 340B ceiling prices. 

Such prices are based on quarterly 

pricing reports that manufacturers must 

provide to the Secretary, which are 

calculated and verified by HRSA. 

Section 340B(d)(3) to the PHS Act 

requires HHS to promulgate regulations 

establishing and implementing a 

binding 340B Administrative Dispute 

Resolution (ADR) process for certain 

disputes arising under the 340B Drug 

Pricing Program. Pursuant to the statute, 

the 340B ADR process is intended to 

resolve (1) claims by covered entities 

that they have been overcharged for 

covered outpatient drugs by 

manufacturers and (2) claims by 

manufacturers, after a manufacturer has 

conducted an audit as authorized by 

section 340B(a)(5)(C) of the PHS Act, 

that a covered entity has violated the 

prohibition on diversion or duplicate 

discounts. 

On April 19, 2024, HRSA published 

the 340B Drug Pricing Program; 

Administrative Dispute Resolution 

Regulation Final Rule (340B ADR Final 

Rule) (89 FR 28,643 (Apr. 19, 2024) (to 

be codified at 42 CFR part 10)). The 

340B ADR Final Rule provides the 

requirements for filing a 340B ADR 

claim. The 340B ADR Final Rule 

requires the submission of a 340B ADR 

claim within 3 years of the date of the 

alleged violation and specifies that it is 

a remedy open to all manufacturers and 

covered entities that participate in the 

340B Drug Pricing Program. To initiate 

the 340B ADR process, a petitioner will 

email HRSA’s Office of Pharmacy 

Affairs’ (OPA) designated mailbox with 

its 340B ID or Labeler code and contact 

information, the 340B ID or Labeler 

code and contact information of the 

opposing party, and a brief description 

of the claim. Once a petition is filed, 

OPA reviews the petition to make sure 

the claim meets the requirements for the 

340B ADR process, including whether: 

(1) the claim alleges a violation of an 

overcharge, duplicate discount, or 

diversion; (2) the claim has been filed 

within 3 years of the alleged violation; 

and (3) the petitioner has engaged in 

good faith efforts to resolve the claim. 

Both the petitioner and opposing party 

will be required to upload certain 

documentation to a secure 340B ADR 

workspace in the 340B OPA Information 

System to substantiate the claim. After 

an initial review of the claim and any 

supporting documentation, OPA staff 

will determine whether the 

requirements for filing a claim have 

been met, and if the claim is deemed 

complete, OPA will notify the parties. If 

the claim is deemed complete and all 

filing requirements are met, the claim 

will be assigned to a 340B ADR Panel. 

If the claim does not meet the filing 

requirements, the claim will not move 

forward for a 340B ADR Panel’s review. 

Specific details concerning the 340B 

ADR Panel and requirements for filing 

a claim are outlined in the 340B ADR 

Final Rule and can be reviewed at 

https://www.hrsa.gov/opa/340badministrative-dispute-resolution. 

This information collection request is 

limited to the initiation of the 340B 

ADR process and the uploading of the 

related documents. Filing a claim 

though the 340B ADR process is a 

remedy open to all manufacturers and 

covered entities that participate in the 

340B Drug Pricing Program, which can 

constitute a standardized federal 

information collection. Once the claim 

is assigned to a 340B ADR Panel for 

review, these subsequent steps, which 

encompass the 340B ADR process itself 

and ensuing correspondence with the 

parties involved in the process, are 

exempt from Paperwork Reduction Act 

requirements, pursuant to the 

Paperwork Reduction Act exception 

listed at 44 U.S.C. 3518(c), which 

exempts administrative actions or 

investigations involving an agency 

against specific individuals or entities. 

The only substantive change to the 

information collection request for this 

30-day notice is that HRSA adjusted the 

estimated number of respondents based 

on the number of ADR requests received 

thus far. HRSA increased the estimate 

from 10 requests to 15 over the next 

three years. 

A 60-day notice published in the 

Federal Register on August 7, 2024, 89 

FR 64468 and 64469. HRSA received 

five public comments. 

Three commenters representing 

pharmaceutical manufacturers 

explained that HRSA’s estimate of 2.5 

hours per response underestimates the 

significant burden manufacturers incur 

to access the ADR process. Some 

manufacturers noted that under the 

statute a manufacturer can only access 

the ADR process after it has completed 

an audit of a covered entity and argued 

HRSA’s manufacturer audit guidelines 

impose significant burdens on 

manufacturers’ ability to audit. HRSA 

notes that manufacturer audits of 


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3882 Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 

covered entities are a separate, preexisting process and are not subject to 

this information request. This 

information collection request is limited 

specifically to the initiation of the 340B 

ADR process under the 2024 340B ADR 

Final Rule and the uploading of the 

related documents at the initial phase of 

the 340B ADR process. 

One commenter requested that HRSA 

require manufacturers to present 

specific types of documentation and 

evidence to initiate a dispute. Another 

commenter requested that HRSA specify 

what ‘‘sufficient documentation’’ 

consists of for submitting an ADR claim. 

Under the 340B ADR Final Rule, 

petitioners have discretion regarding the 

documentation they submit as part of 

their initial submission to support their 

claims. 

Other comments discussed elements 

of the ADR Final Rule, including 

defining what good faith efforts entail, 

how child site eligibility relates to 

diversion and what the definition of an 

overcharge should include, that are 

outside of the scope of this information 

collection request. After detailed 

analysis of the comments received, 

HRSA plans to maintain the burden 

hours as proposed in the 60-day notice. 

Need and Proposed Use of the 

Information: HRSA is requesting 

approval for the initiation of the 340B 

ADR process and uploading of the 

related documents outlined in the 340B 

ADR Final Rule. The 340B ADR process 

is conducted pursuant to the 

requirements under section 340B(d)(3) 

of the PHS Act, which requires the 

establishment and implementation of 

the 340B ADR process for certain 

disputes arising under the 340B Drug 

Pricing Program. HRSA uses the 

information gathered in the 340B ADR 

initiation process to determine if the 

claim submitted meets the statutory 

requirements for filing a 340B claim and 

accessing the 340B ADR process. 

Likely Respondents: Covered entities 

(or their membership organizations or 

associations) and manufacturers. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

340B Claim Submission ....................................................... 15 1 15 2.5 37.5 

Total .............................................................................. 15 ........................ 15 ........................ 37.5 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2025–00831 Filed 1–14–25; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on the National Health Service 

Corps 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Council on the National 

Health Service Corps (NACNHSC) will 

hold public meetings for the 2025 

calendar year (CY). Information about 

NACNHSC, agendas, and materials for 

these meetings can be found on the 

NACNHSC website at: https://

www.hrsa.gov/advisory-committees/ 

national-health-service-corps. 

DATES: NACNHSC meetings will be held 

on March 18, 2025, 10:00 a.m. Eastern 

Time (ET)–4:30 p.m. ET and March 19, 

2025, 10 a.m. ET–3:30 p.m. ET; June 24, 

2025, 9 a.m. ET–4:30 p.m. ET and June 

25, 2025, 8:30 a.m. ET–2 p.m. ET; and 

November 18, 2025, 10 a.m. ET–4:30 

p.m. ET and November 19, 2025, 10 a.m. 

ET–3:30 p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or video 

conference. For updates on how the 

meeting will be held, visit the 

NACNHSC website 30 business days 

before the date of the meeting, where 

instructions for joining meetings either 

in-person or remotely will also be 

posted. In-person NACNHSC meetings 

will be held at 5600 Fishers Lane, 

Rockville, Maryland 20857. For meeting 

information updates, go to the 

NACNHSC website meeting page at: 

https://www.hrsa.gov/advisorycommittees/national-health-servicecorps/meetings. 

FOR FURTHER INFORMATION CONTACT: 

Diane Fabiyi-King, Designated Federal 

Official, Division of National Health 

Service Corps, HRSA, 5600 Fishers 

Lane, Rockville, Maryland 20857; 

NHSCAdvisoryCouncil@hrsa.gov or 

(301) 443–3609. 

SUPPLEMENTARY INFORMATION: 

NACNHSC provides advice and 

recommendations to the Secretary of 

Health and Human Services on policy, 

program development, and other 

matters of significance concerning the 

activities under subpart II, part D of title 

III of the Public Health Service Act. 

NACNHSC members are experts in the 

issues that communities with a shortage 

of primary care professionals face in 

meeting their healthcare needs. 

Since priorities dictate meeting times, 

be advised that start times, end times, 

and agenda items are subject to change. 

For CY 2025 meetings, agenda items 

may include, but are not limited to: the 

identification of NHSC priorities for 

future program issues and concerns; 

proposed policy changes by using the 

varying levels of expertise represented 

on NACNHSC to advise on specific 

program areas; updates from clinician 

workforce experts; and education and 

practice improvement in the training 

development of primary care clinicians. 

More general items may include 

presentations and discussions on the 


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