[Federal Register Volume 84, Number 173 (Friday, September 6, 2019)]
[Notices]
[Pages 46959-46960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19244]


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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, the Paperwork Reduction Act of 
1995, HRSA has submitted an Information Collection Request (ICR) to the 
Office of Management and Budget (OMB) for review and approval. Comments 
submitted during the first public review of this ICR will be provided 
to OMB. OMB will accept further comments from the public during the 
review and approval period.

DATES: Comments on this ICR must be received no later than October 7, 
2019.

ADDRESSES: Submit your comments, including the ICR title, to the desk 
officer for HRSA, either by email to [email protected] or by 
fax to (202) 395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    Information Collection Request Title: Drug Pricing Program 
Reporting Requirements (OMB No. 0915-0176)--[Extension].
    Abstract: Section 602 of Public Law 102-585, the Veterans Health 
Care Act of 1992, enacted section 340B of the Public Health Service Act 
(PHS Act ``Limitation on Prices of Drugs Purchased by Covered 
Entities''), which 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 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 defined 340B 
ceiling prices, which are based on quarterly pricing data reported by 
manufacturers to the Centers for Medicare & Medicaid Services. 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 by procedures established 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 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

[[Page 46960]]

entities. Prior to filing a request for resolution of a dispute with 
OPA, the parties involved 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 in 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.
    A 60-day notice was published in the Federal Register on June 18, 
2019, vol. 84, No. 117; pp. 28308-09. There was one public comment 
received. The comment received addressed a policy issue that is beyond 
the scope of this information collection request; therefore, HRSA will 
not be addressing the comment in this notice.
    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:
    Good faith Resolution \1\...              10               1              10              60             600
    Audit Notification to Entity              14               1              14               6              84
     \1\........................
    Audit Workplan \1\..........              45               1              45              12             540
    Audit Report \1\............              14               1              14              12             168
    Entity Response.............              14               1              14              12             168
Dispute Resolution:
    Mediation Request...........              10               4              40              15             600
    Rebuttal....................              10               1              10              28             280
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        Total...................             117  ..............             147  ..............           2,440
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\1\ Prepared by the manufacturer.
* Since the first public review of the ICR, HRSA has received several audit work plans from manufacturers. HRSA
  has decided to update its proposed burden hours to reflect the increase in submissions.


                                              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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Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-19244 Filed 9-5-19; 8:45 am]
 BILLING CODE 4165-15-P