[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Pages 64468-64469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17380]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: 340B Drug 
Pricing Program; Initiation of the Administrative Dispute Resolution 
Process

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR) to the Office of Management and Budget (OMB). Prior to 
submitting the ICR to OMB, HRSA seeks comments from the public 
regarding the burden estimate, below, or any other aspect of the ICR.

DATES: Comments on this ICR should be received no later than October 7, 
2024.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N39, 5600 Fishers 
Lane, Rockville, Maryland, 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project, email [email protected] or call Joella Roland, the 
HRSA Information Collection Clearance Officer, at (301) 443-3983.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    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. The Secretary of HHS 
(Secretary) has delegated the authority to administer the 340B Drug 
Pricing Program to the HRSA Administrator, who has further delegated 
authority to the Office of Pharmacy Affairs (OPA), within HRSA, which 
oversees the 340B Drug Pricing Program. 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 28643 (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 OPA's 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, OPA will dismiss the claim. 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.
    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 and manufacturers and 
organizations representing these groups.
    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

[[Page 64469]]

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. To 
estimate the burden to initiate the 340B ADR process, HRSA reviewed the 
amount of petitions received under a prior 340B ADR process and 
estimated the amount of time it took petitioners to initiate the 340B 
ADR process up until the claim was assigned to a 340B ADR Panel for 
review. 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...........              10               1              10             2.5              25
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    Total.......................              10  ..............              10  ..............              25
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    HRSA specifically requests comments on: (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-17380 Filed 8-6-24; 8:45 am]
BILLING CODE 4165-15-P