Notice2025-14955
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB No. 0915-0327-Revision
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Published
August 7, 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
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<title>Federal Register, Volume 90 Issue 150 (Thursday, August 7, 2025)</title>
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[Federal Register Volume 90, Number 150 (Thursday, August 7, 2025)]
[Notices]
[Pages 38167-38169]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14955]
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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:
Enrollment and Re-Certification of Entities in the 340B Drug Pricing
Program, OMB No. 0915-0327--Revision
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), 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 October 6,
2025.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#dcacbdacb9aeabb3aeb79cb4aeafbdf2bbb3aa"><span class="__cf_email__" data-cfemail="6b1b0a1b0e191c0419002b0319180a450c041d">[email protected]</span></a> or by mail to the
HRSA Information Collection Clearance Officer, Room 14NWH04, 5600
Fishers Lane, Rockville, MD 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#95e5f4e5f0e7e2fae7fed5fde7e6f4bbf2fae3"><span class="__cf_email__" data-cfemail="0c7c6d7c697e7b637e674c647e7f6d226b637a">[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 information collection request title
for reference.
Information Collection Request Title: Enrollment and Re-
Certification of Entities in the 340B Drug Pricing Program, OMB No.
0915-0327--Revision.
Abstract: Section 602 of Public Law 102-585, the Veterans Health
Care Act of 1992, enacted section 340B of the Public Health Service
(PHS) Act, which instructs HHS to enter into a Pharmaceutical Pricing
Agreement (PPA) with manufacturers of covered outpatient drugs.
Manufacturers are also required by section 1927(a)(5)(A) of the Social
Security Act to enter into agreements with the Secretary of HHS
(Secretary) that comply with section 340B of the PHS Act if they
participate in the Medicaid Drug Rebate Program. When a drug
manufacturer signs a PPA, it is opting into the 340B Drug Pricing
Program (340B Program), and it agrees to the statutory requirement that
prices charged for covered outpatient drugs to covered entities will
not exceed statutorily defined 340B ceiling prices. When an eligible
covered entity voluntarily decides to enroll and participate in the
340B Program, it accepts responsibility for ensuring compliance with
all provisions of the 340B Program, including all associated costs.
Covered entities that choose to participate in the 340B Program must
comply with the requirements of section 340B(a)(5) of the PHS Act.
Section 340B(a)(5)(A) of the PHS Act prohibits a covered entity from
accepting a discount for a drug that would also generate a Medicaid
rebate. Further, section 340B(a)(5)(B) of the PHS Act prohibits a
covered entity from reselling or otherwise transferring a discounted
drug to a person who is not a patient of the covered entity.
Need and Proposed Use of the Information: To ensure the ongoing
responsibility to administer the 340B Program while maintaining
efficiency, transparency, and integrity, HRSA developed a process of
registration for covered entities to enable it to address specific
statutory mandates. Specifically, section 340B(a)(9) of the PHS Act
requires HRSA to notify manufacturers of the identities of covered
entities and of their status pertaining to certification and annual
recertification in the 340B Program pursuant to section 340B(a)(7) and
the establishment of a mechanism to prevent duplicate discounts as
outlined at section 340B(a)(5)(A)(ii) of the PHS Act.
In addition, section 340B(a)(1) of the PHS Act requires each
participating manufacturer to enter into an agreement with the
Secretary to offer covered outpatient drugs to 340B covered entities.
Finally, section 340B(d)(1)(B)(i) of the PHS Act requires the
development of a system to enable the Secretary to verify the accuracy
of ceiling prices calculated by manufacturers under subsection (a)(1)
and charged to covered entities.
HRSA is requesting approval for existing information collections.
HRSA notes that the previously approved collections are mostly
unchanged, except some forms have been revised to increase program
efficiency and integrity. Below are descriptions of each form and any
resulting revisions that are captured in both the registration and
pricing component of the 340B Office of Pharmacy Affairs Information
System (OPAIS).
Enrollment/Registration/Recertification
To enroll and certify the eligibility of federally funded grantees
and other safety net health care providers, HRSA requires covered
entities to submit administrative information (e.g., shipping and
billing arrangements, Medicaid participation), certifying information
(e.g., Medicare Cost Report information, documentation supporting the
hospital's selected classification), and attestation from appropriate
grantee-level or entity-level authorizing officials and primary
contacts. To maintain accurate records, HRSA requests entities submit
modifications to any administrative information that they submitted
when initially enrolling into the Program. Covered entities
participating in the 340B Program have an ongoing responsibility to
immediately notify HRSA in the event of any change in eligibility for
the 340B Program. Covered entities must comply with the statutory
mandates of the Program and, at least annually, they need to certify
the accuracy of the information provided and continued maintenance of
their eligibility.
Registration and annual recertification information is entered into
the 340B OPAIS by covered entities and verified by HRSA staff according
to 340B Program requirements. The following forms are being revised:
(1) 340B Registration, Recertification and Change Requests for
Shipping Address: HRSA is providing additional clarification for
covered entities to complete the shipping address section in 340B OPAIS
to improve transparency and assist in determining the exact shipping
address location and relationship to the covered entity. The
[[Page 38168]]
information collected will help determine whether the shipping address
is a pharmacy, health care delivery site, or other receiving location.
The information collected will also help determine if the location
should be listed as a shipping address or potentially registered
separately in OPAIS as a contract pharmacy or covered entity. Reviewing
shipping addresses has become difficult and inefficient for both the
covered entity and HRSA because it can involve sending the task back to
the covered entity, sometimes multiple times, before HRSA can
appropriately act on the task. The burden will not be significantly
affected since the requested language facilitates a more efficient
review with fewer exchanges between the covered entity and HRSA.
(2) 340B Registration and Recertification for Sexually Transmitted
Disease (STD) and Tuberculosis (TB) Grantees: HRSA is requesting that
STD and TB grantees provide supporting documentation to demonstrate
340B eligibility pursuant to section 340B(a)(4)(K) of the PHS Act
during initial registration as well as during recertification if
requested to ensure compliance. The requested documentation will
include a copy of the federal grant notice of award that identifies the
grantor, grant number, period of funding, and recipient information. If
the entity is a subgrantee then they will also need to provide a copy
of the executed written subrecipient agreement that includes the name
and address of the recipient and subrecipient, the grant and notice of
funding opportunity number, and the terms and conditions of support.
This new requirement streamlines the verification process and enhances
program integrity for STD and TB entity types. This requirement will
slightly increase the burden on covered entities since eligible covered
entities should already have this documentation readily available prior
to registering and recertifying for the 340B Program.
(3) 340B Program Registrations, Recertifications, and Change
Requests for Family Planning: HRSA is requesting to collect the time
period that assistance was received for Family Planning covered
entities. The addition of these fields is consistent with information
collected from Ryan White, STD, and TB entities at registration and
recertification and will support HRSA's ability to verify a Family
Planning covered entity's eligibility in the 340B Program as outlined
in section 340B(a)(4)(C) of the PHS Act. This collection of time period
information is a minor addition that will not significantly affect the
burden on covered entities, as the time period when assistance was
received is a readily available data point for Family Planning covered
entities.
(4) 340B Recertification and Change Requests for Street Address:
HRSA is providing additional clarification for covered entities that
revise their street address in 340B OPAIS to assist in determining
continued eligibility as outlined in section 340B(a)(4) of the PHS Act.
OPAIS will prompt the covered entity to state if they are still
receiving federal funding that makes them eligible for the 340B Program
and/or if the service remains open at the old address. The answers to
these questions will help determine the next appropriate action taken
by the covered entity and HRSA. The collection of this information will
not increase the burden on covered entities because it provides
increased transparency and facilitates a more efficient review with
fewer exchanges between the covered entity and HRSA.
(5) 340B Program Registrations, Recertifications, and Change
Requests for Urban Indian and Tribal Contract/Compact with IHS
(FQHC628) Covered Entities: HRSA is requesting the Tribal Agreement
number in OPAIS for registrations and recertifications for Urban Indian
and FQHC638 covered entities. This helps increase program integrity by
providing information that can be used to verify the eligibility of a
specific grant for a specific entity. This collection of information is
not expected to significantly increase burden as this information is
readily available to covered entities on the agreements they have with
their granting organization.
(6) 340B Program Registrations, Recertifications, and Change
Requests for Hospitals: HRSA is revising a hospital qualification field
in OPAIS from the language ``File Date'' to ``Date/Time Prepared'' to
match Centers for Medicare & Medicaid Services (CMS) language on
Worksheet S of a hospital's most recently filed Medicare Cost Report
(MCR). This eliminates confusion for covered entities and clarifies
what HRSA considers the ``file date.'' This update will not change the
burden on covered entities.
(7) 340B Program Registrations, Recertifications, and Change
Requests for Hospitals: HRSA is revising a hospital qualification field
in OPAIS from the language ``Medicare Provider Number'' to ``CMS
Certification Number'' to match CMS language on Worksheet S of the
hospital's most recently filed MCR. This provides consistency with CMS
language as they no longer use the term ``Medicare Provider Number.''
This update does not impact burden on covered entities as there is no
action needed to be taken on the covered entities' part for this change
to occur.
(8) 340B Program Registrations for Hospitals: HRSA is clarifying
Worksheet S instructions for hospitals to include a copy of their
signed, dated, and electronically encrypted Worksheet S from the latest
filed MCR. This language will be updated on the initial registration
instructions as well as in the actual registration. This updated
language clarifies the exact documentation required for submission
which results in fewer exchanges with covered entities. This update
does not impact burden on covered entities.
(9) 340B Program Registrations for Hospitals: HRSA is revising an
instructional update and clarifying the registration form language for
trial balance and cost center information to clarify that entities
should submit a trial balance that clearly indicates unique and
separate reimbursable outpatient costs and charges for each service
being registered. This update will not change the burden on covered
entities as there is no new or revised collection requirement.
Contract Pharmacy Certification
There are no changes being made to Contract Pharmacy Certification
from prior submissions. There is no change in burden on the covered
entities.
PPA and Addendum
There are no changes being made to PPA and Addendum from prior
submissions. There is no change in burden on the manufacturers.
Pricing Data Submission, Validation, and Dissemination
There are no changes being made to Pricing Data Submission,
Validation, and Dissemination from prior submissions. There is no
change in burden on the manufacturers.
Likely Respondents: Drug manufacturers and 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
[[Page 38169]]
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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Hospital Enrollment, Additions & Recertifications
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340B Program Registrations & 172 1 172 2.00 344
Certifications for Hospitals *.
Certifications to Enroll 1,036 6 6,216 0.50 3,108
Hospital Outpatient Facilities
*..............................
Hospital Annual Recertifications 2,699 13 35,087 0.25 8,772
*..............................
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Registrations and Recertifications for Covered Entities Other Than Hospitals
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340B Registrations for Community 350 3 1,050 1.00 1,050
Health Centers *...............
340B Registrations for STD/TB 341 1 341 1.25 426
Clinics **.....................
340B Registrations for Various 177 1 177 1.25 177
Other Eligible Entity Types ***
Community Health Center Annual 1,840 7 12,880 0.25 3,220
Recertifications *.............
STD and TB Annual 6,412 1 6,412 0.25 1,603
Recertifications *.............
Annual Recertification for 3,407 1 3,407 0.25 852
entities other than Hospitals,
Community Health Centers, and
STD/TB Clinics *...............
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Contracted Pharmacy Services Registration & Recertifications
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Contracted Pharmacy Services 4,376 11 48,136 1.00 48,136
Registration...................
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Other Information Collections
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Submission of Administrative 24,829 1 24,829 0.25 6,207
Changes for any Covered Entity
*..............................
Submission of Administrative 471 1 471 0.50 236
Changes for any Manufacturer...
PPA and Addendum................ 73 1 73 1.00 73
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Total....................... 46,183 .............. 133,251 .............. 74,204
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* Minor revisions to the language on the forms since the last OMB submission, but burden has not been impacted.
** Average Burden was increased from 1 to 1.25, compared to the prior version of this package.
*** Average Burden was increased from 1 to 1.25, compared to the prior version of this package. This is due to
an additional field being added for Family Planning covered entities.
**** Total Burden Hours are rounded up to the nearest whole number.
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. 2025-14955 Filed 8-6-25; 8:45 am]
BILLING CODE 4165-15-P
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