Notice2025-17641
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 340B Rebate Model Pilot Program Application, Implementation, and Evaluation, OMB Number 0906-0111-Extension
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 12, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
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), described below, 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.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 175 (Friday, September 12, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 175 (Friday, September 12, 2025)]
[Notices]
[Pages 44197-44199]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-17641]
-----------------------------------------------------------------------
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
Rebate Model Pilot Program Application, Implementation, and Evaluation,
OMB Number 0906-0111--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection
[[Page 44198]]
projects of the Paperwork Reduction Act of 1995, HRSA announces plans
to submit an Information Collection Request (ICR), described below, 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 November
12, 2025.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#8cfcedfce9fefbe3fee7cce4feffeda2ebe3fa"><span class="__cf_email__" data-cfemail="1666776673646179647d567e64657738717960">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 14NWH04, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email <a href="/cdn-cgi/l/email-protection#3646574653444159445d765e44455718515940"><span class="__cf_email__" data-cfemail="5b2b3a2b3e292c3429301b3329283a753c342d">[email protected]</span></a> or call Samantha Miller,
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 Rebate Model Pilot
Program Application, Implementation, and Evaluation, OMB No. 0906-
0111--Extension.
Abstract: HRSA's Office of Pharmacy Affairs (OPA) is introducing a
340B Rebate Model Pilot Program as a voluntary mechanism for qualifying
drug manufacturers to effectuate the 340B ceiling price on select drugs
to covered entities, as outlined in a Federal Register Notice (90 FR
38165; herein referred to as the ``Notice'') issued on August 7, 2025.
This information collection request includes the collection of 340B
Rebate Model Pilot Program plans from drug manufacturers, the
collection of reports from drug manufacturers for OPA's evaluation of
the pilot program and for overall 340B Program surveillance, and the
collection of data submitted by covered entities to manufacturers to
request a rebate.
Need and Proposed Use of the Information: The scope of the 340B
Rebate Model Pilot Program will be limited to manufacturers with
Medicare Drug Price Negotiation Program Agreements with the Centers for
Medicare & Medicaid Services' for the initial price applicability year
2026.\1\ Once selected plans are approved in accordance with the
Notice, manufacturers may then begin to effectuate the 340B rebate
starting January 1, 2026. This information collection request includes
the collection of 340B Rebate Model Pilot Program plans from drug
manufacturers, the collection of sales data from drug manufacturers for
OPA's evaluation of the pilot program and for overall 340B Program
surveillance, and the collection of data submitted by covered entities
to manufacturers to request a rebate.
---------------------------------------------------------------------------
\1\ The Fact Sheet for Negotiated Prices for Applicability Year
2026 includes the list of Primary Manufacturers with selected drugs,
available at <a href="https://www.cms.gov/files/document/fact-sheetnegotiated-prices-initial-price-applicability-year2026.pdf">https://www.cms.gov/files/document/fact-sheetnegotiated-prices-initial-price-applicability-year2026.pdf</a>.
---------------------------------------------------------------------------
Collection of Drug Manufacturer Applications: OPA will evaluate and
approve plans for participation in the 340B Rebate Pilot Program based
on the elements required in the Notice (90 FR 38166-67).
Collection of Reporting Data from Manufacturers: Manufacturers will
be required to submit data to the 340B Prime Vendor on a monthly basis
to ensure program integrity and to provide transparency in the 340B
Program. Monthly submissions will provide better data for tracking 340B
data and reduce lag time in assessing Program metrics. The data
submitted is also being collected to support the assessment of the 340B
Rebate Model Pilot Program.
Collection of Data Submitted by Covered Entities to Manufacturers:
Covered entities are required to provide specific data to participating
manufacturers in order for the manufacturers to provide rebates to
effectuate the 340B discount on the entities' covered outpatient drug
purchases. Specific requirements that detail the type of and frequency
of such submittals can be found in the Notice (FR 38166). The data
collected will be kept private to the extent permitted by the law.
HRSA received an emergency clearance from OMB on August 26, 2025.
The emergency clearance will ensure that the agency will collect drug
manufacturer applications by September 15, 2025. This 60-day Federal
Register Notice will allow HRSA to fully consider all public comments
on its burden statement. HRSA has taken all practicable steps to
consult with the public to minimize burden (including a 30-day comment
period in the Notice).
Likely Respondents: Pharmaceutical manufacturers and 340B covered
entities.
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total
Name respondents * responses per responses response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
340B Program Rebate Model Pilot Program 9 1 9 8 72
Plan Submission.........................
Monthly purchase reports................. 9 12 108 2 216
Covered Entities reporting claims data to 14,600 52 759,200 2 1,518,400
third party platform....................
----------------------------------------------------------------------
Total................................ 14,609 .............. 759,317 ........... 1,518,688
----------------------------------------------------------------------------------------------------------------
* The same nine manufacturers will submit Plans and Monthly Purchase Reports (first two rows, above), while the
14,600 Covered Entities will submit Claims Data (third row, above). Therefore, the total number of respondents
is 14,609.
[[Page 44199]]
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. 2025-17641 Filed 9-11-25; 8:45 am]
BILLING CODE 4165-15-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 12, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.