Notice2026-03833
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-NEW
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
February 26, 2026
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
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<title>Federal Register, Volume 91 Issue 38 (Thursday, February 26, 2026)</title>
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[Federal Register Volume 91, Number 38 (Thursday, February 26, 2026)]
[Notices]
[Pages 9632-9633]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-03833]
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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
Rebate Model Pilot Program Application, Implementation, and Evaluation,
OMB Number 0906-NEW
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
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), 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 April 27,
2026.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#a6d6c7d6c3d4d1c9d4cde6ced4d5c788c1c9d0"><span class="__cf_email__" data-cfemail="7606170613040119041d361e04051758111900">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 13N82, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed collection or to obtain a copy of the information collection
plans and draft instruments, email <a href="/cdn-cgi/l/email-protection#3f4f5e4f5a4d48504d547f574d4c5e11585049"><span class="__cf_email__" data-cfemail="502031203522273f223b10382223317e373f26">[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-XXXX.
Abstract: HRSA's Office of Pharmacy Affairs (OPA) is considering a
potential 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, and is requesting information from
340B stakeholders and others as described in a Request for Information
(91 FR, 7287) issued on February 17, 2026.\1\ This ICR includes the
collection of proposed rebate model plans from qualifying drug
manufacturers, the collection of reports from drug manufacturers
approved for participation to allow OPA to evaluate the Pilot Program
and enhance 340B Program integrity and compliance monitoring, and the
collection of data submitted by covered entities to participating drug
manufacturers to request a rebate in connection with a potential 340B
Rebate Model Pilot Program.
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\1\ Request for Information (91 FR, 7287) issued on February 17,
2026, available at <a href="https://www.federalregister.gov/documents/2026/02/17/2026-03042/request-for-information-340b-rebate-model-pilot-program">https://www.federalregister.gov/documents/2026/02/17/2026-03042/request-for-information-340b-rebate-model-pilot-program</a>.
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Need and Proposed Use of the Information: This new proposed
information collection request will replace an emergency clearance ICR,
OMB No: 0906-0111 (Reference No: 202508-0906-002),\2\ which HRSA
discontinued. The scope of the potential 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 years 2026 and 2027.\3\
This information collection request includes the collection of proposed
rebate model plans from qualifying drug manufacturers, the ongoing
collection of sales data from drug manufacturers to allow OPA to
evaluate the pilot program and enhance 340B Program integrity and
compliance monitoring, and the collection of data submitted by covered
entities to manufacturers to request a rebate in connection with a
potential 340B Rebate Model Pilot Program.
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\2\ 340B Rebate Model Pilot Program Application, Implementation,
and Evaluation (0906-0111) available at <a href="https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202508-0906-002">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202508-0906-002</a>.
\3\ The Fact Sheets for Negotiated Prices for Applicability
Years 2026 and 2027 includes the list of Primary Manufacturers with
selected drugs, available at <a href="https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf">https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf</a> and <a href="https://www.cms.gov/files/document/fact-sheet-negotiated-prices-ipay-2027.pdf">https://www.cms.gov/files/document/fact-sheet-negotiated-prices-ipay-2027.pdf</a> respectively.
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Collection of Drug Manufacturer Applications: OPA anticipates
evaluating and approving manufacturer plans for participation in a
potential 340B Rebate Model Pilot Program based on requirements
published by OPA in future guidance.
Collection of Reporting Data from Manufacturers: In a potential
340B Rebate Model Pilot Program, manufacturers will be required to
[[Page 9633]]
submit data to the 340B Prime Vendor monthly to evaluate program
integrity and to provide greater transparency in the 340B Program.
Monthly data submissions will enhance 340B Program compliance
monitoring and reduce lag time in assessing 340B Program metrics. The
monthly data will also support the ongoing assessment of any 340B
Rebate Model Pilot Program.
Collection of Data Submitted by Covered Entities to Manufacturers:
In a potential 340B Rebate Model Pilot Program, covered entities will
be required to provide specific data to participating manufacturers for
the manufacturers to provide rebates to effectuate the 340B price on
the entities' covered outpatient drug purchases. OPA expects that
specific requirements that detail the type and frequency of such
submittals will be defined in future guidance to include claims level
data elements for 340B-eligible dispenses. OPA expects that data
submitted by covered entities to manufacturers will be comparable to
data already being collected and maintained by covered entities through
existing third-party vendor relationships or data that is already being
provided to manufacturers with respect to certain contract pharmacy
policies, in-house pharmacy claims requests, and data elements provided
for claims with drugs dispensed under the Medicare Drug Price
Negotiation Program. Therefore, the burden associated with a potential
340B Rebate Model Pilot Program data requests may not be significant.
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 60-day comment period in the Request for Information).
Likely Respondents: Pharmaceutical manufacturers and covered
entities.
Burden Statement: Burden in the context of this information
collection 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, if necessary, 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 and were analyzed based on implementation
of a potential 340B Rebate Model Pilot Program compared to current data
collection practices in the market.
Total Estimated Annualized Burden Hours
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Number of Average burden
Name Number of responses per Total per response Total burden
respondents * respondent responses (in hours) hours
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340B Rebate Model Pilot Program 13 1 13 8 104
Plan Submission................
Manufacturer monthly purchase 13 12 156 2 312
reports........................
Covered Entities reporting 14,600 52 759,200 5 3,796,000
claims data to third party
platform.......................
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Total....................... 14,613 .............. 759,369 .............. 3,796,416
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* Potentially 13 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 14,613.
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. 2026-03833 Filed 2-25-26; 8:45 am]
BILLING CODE 4165-15-P
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