[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Pages 28308-28310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request Information Request Title: 340B Drug Pricing Program 
Reporting Requirements, OMB Number 0915-0176--Extension

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 or any other aspect of the ICR.

DATES: Comments on this ICR must be received no later than August 19, 
2019.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 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 [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer, at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Drug Pricing Program 
Reporting Requirements OMB No. 0915-0176--[Extension].
    Abstract: Section 340B of the Public Health Service Act (PHS Act 
``Limitation on Prices of Drugs Purchased by Covered Entities'') 
instructs HHS to enter into a Pharmaceutical Pricing Agreement (PPA) 
with manufacturers of covered outpatient drugs. Manufacturers are 
required by section 1927(a)(5)(A) of the Social Security Act to enter 
into agreements with the Secretary of HHS to 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 defined 340B ceiling prices, which are based 
on quarterly pricing data reported by manufacturers to the Centers for 
Medicare & Medicaid Services (CMS). 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) prohibits a covered entity from accepting a discount for 
a drug that would also generate a Medicaid rebate. Further, section 
340B(a)(5)(B) prohibits a covered entity from reselling or otherwise 
transferring a discounted drug to a person who is not a patient of the 
covered entity.
    Section 340B(a)(5)(C) of the PHS Act permits the Secretary of HHS 
and manufacturers of a covered outpatient drug to conduct audits of 
covered entities in accordance with procedures established by the 
Secretary related to the number, duration, and scope of the audits. 
Manufacturers are permitted to conduct an audit only when there is 
reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) 
has occurred. The manufacturer notifies the covered entity in writing 
when it believes the covered entity has violated these provisions of 
the 340B Program. If the problem cannot be resolved, the manufacturer 
will then submit an audit work plan describing the audit and evidence 
in support of the reasonable cause standard to the HRSA, Healthcare 
Systems Bureau, Office of Pharmacy Affairs (OPA) for review. OPA will 
review the documentation to determine if reasonable cause exists. Once 
the audit is completed, the manufacturer will submit copies of the 
audit report to OPA for review and resolution of the findings, as 
appropriate. The manufacturer will also submit an informational copy of 
the audit report to the HHS Office of Inspector General (OIG).
    In response to the statutory mandate of section 340B(a)(5)(C) to 
permit the Secretary or manufacturers to conduct audits of covered 
entities and because of the potential for disputes involving covered 
entities and participating drug manufacturers, OPA developed an 
informal voluntary dispute resolution process for manufacturers and 
covered entities who, prior to filing a request for resolution of a 
dispute with OPA,

[[Page 28309]]

should attempt in good faith to resolve the dispute. All parties 
involved in the dispute should maintain written documentation as 
evidence of a good faith attempt to resolve the dispute. To request 
voluntary dispute resolution of an unresolved dispute, a party submits 
a written request for a review of the dispute to OPA. A committee 
appointed to review the documentation will send a letter to the party 
alleged to have committed a violation. The party will be asked to 
provide a response to or a rebuttal of the allegations.
    HRSA published a notice in 1996 and a policy release in 2011 on 
manufacturer audit guidelines and the informal dispute resolution 
process (61 FR 65406 (December 12, 1996) and ``Clarification of 
Manufacturer Audits of 340B Covered Entities,'' Release No. 2011-3).
    Need and Proposed Use of the Information: HRSA is proposing the 
collection of information related to the manufacturer audit guidelines. 
These guidelines contain the following reporting/notification elements:
    1. Manufacturers should notify the covered entity in writing when 
it believes a violation has occurred;
    2. manufacturers should submit documentation to OPA as evidence of 
good faith of attempts to resolve a dispute;
    3. manufacturers must submit an audit work plan to OPA;
    4. manufacturers should submit the audit report to the OPA and 
informational copies to the HHS OIG; and
    5. the covered entity should provide a written response to the 
audit report.
    This information is necessary to ensure the orderly conduct of 
manufacturer audits. Also, the informal dispute resolution process 
requires the participating manufacturer or covered entity requesting 
dispute resolution to provide OPA with a written request. The party 
alleged to have committed a 340B Program violation may provide a 
response or rebuttal to OPA. This information is necessary to ensure 
that the dispute will be resolved in a fair and equitable manner.
    Likely Respondents: Drug 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 during an audit. 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 for both covered entities and 
manufacturers. 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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                                                     Audits
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Good faith Resolution \1\.......              10               1              10              60             600
Audit Notification to Entity \1\              10               1              10               6              60
Audit Workplan \1\..............              43               1              43              12             516
Audit Report \1\................              14               1              14              12             168
Entity Response.................              14               1              14              12             168
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                                               Dispute Resolution
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Mediation Request...............              10               4              40              15             600
Rebuttal........................              10               1              10              28             280
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    Total.......................             111  ..............             120  ..............           2,392
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\1\ Prepared by the manufacturer.

    Recordkeeping Burden:

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                                                                  Number of         Hours of
                  Recordkeeping requirement                     recordkeepers    recordkeeping     Total burden
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Dispute Records..............................................              50                1               50
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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, Division of the Executive Secretariat.
[FR Doc. 2019-12894 Filed 6-17-19; 8:45 am]
BILLING CODE 4165-15-P