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[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3881-3882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00831]

[[Page 3881]]

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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.

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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 [email protected] 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/340b-administrative-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

[[Page 3882]]

covered entities are a separate, pre-existing 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
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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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340B Claim Submission...........              15               1              15             2.5            37.5
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    Total.......................              15  ..............              15  ..............            37.5
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-00831 Filed 1-14-25; 8:45 am]
BILLING CODE 4165-15-P
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