Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process, 64468-64469 [2024-17380]
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Federal Register / Vol. 89, No. 152 / Wednesday, August 7, 2024 / Notices
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
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
paperwork@hrsa.gov 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 paperwork@
hrsa.gov 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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:07 Aug 06, 2024
Jkt 262001
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
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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/340badministrative-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
E:\FR\FM\07AUN1.SGM
07AUN1
64469
Federal Register / Vol. 89, No. 152 / Wednesday, August 7, 2024 / Notices
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
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
340B Claim Submission .......................................................
10
1
10
2.5
25
Total ..............................................................................
10
........................
10
........................
25
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2024–17408 Filed 8–6–24; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Center of Biomedical
Research Excellence—COBRE (P20) Phase-2
Applications.
Date: November 21–22, 2024.
Time: 10:00 a.m. to 6:00 p.m.
VerDate Sep<11>2014
17:07 Aug 06, 2024
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of General Medical
Sciences, Natcher Building, 45 Center Drive,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Person: Manas Chattopadhyay,
Ph.D., Scientific Review Officer, Office of
Scientific Review, National Institute of
General Medical Sciences, National Institutes
of Health, 45 Center Drive, Room 3AN12N,
Bethesda, Maryland 20892, 301–827–5320,
manasc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: August 1, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4165–15–P
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
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:
Jkt 262001
National Institutes of Health
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Frm 00069
Fmt 4703
Sfmt 4703
Dated: August 1, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–17376 Filed 8–6–24; 8:45 am]
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
PO 00000
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group; Kidney, Urologic and
Hematologic Diseases D Study Section.
Date: October 15–17, 2024.
Time: 5:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NIDDK
Democracy II, Suite 7000A, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Jason D. Hoffert, Ph.D.,
Scientific Review Officer, National Institute
of Diabetes and Digestive and Kidney,
National Institute of Health, 6707 Democracy
Boulevard, Rm. 7343, Bethesda, MD 20817,
301–496–9010, hoffertj@niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[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]
[[Page 64468]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
340B Claim Submission........... 10 1 10 2.5 25
-------------------------------------------------------------------------------
Total....................... 10 .............. 10 .............. 25
----------------------------------------------------------------------------------------------------------------
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
