[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31947-31949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11869]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the Health Resources and Services Administration 
(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 should be received no later than June 20, 
2016.

ADDRESSES: Submit your comments, including the Information Collection 
Request 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 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 information request collection title 
for reference.

Information Collection Request Title: 340B Drug Pricing Program 
Reporting Requirements OMB No. 0915-0176--[Revision]

    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.'' Section 340B provides that a manufacturer who participates 
in Medicaid must sign a Pharmaceutical Pricing Agreement with

[[Page 31948]]

the Secretary of Health and Human Services in which the manufacturer 
agrees to charge enrolled covered entities a price for covered 
outpatient drugs that will not exceed an amount determined under a 
statutory formula. Covered entities who choose to participate in the 
section 340B Drug Pricing Program must comply with the requirements of 
340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered 
entity from requesting Medicaid reimbursement from a drug that has been 
discounted under the 340B Program. 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 entity.
    Section 340B(a)(5)(C) of the PHS Act permits the Secretary 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 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 complete, 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 Health and Human Services (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, 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).
    The revision to this package includes additional background 
information on the dispute resolution process and clarifies the need 
and proposed use of information regarding the manufacturer audit 
guidelines and the informal dispute resolution process.
    HHS has reviewed all comments submitted in response to the 
publication of a 60-day Federal Register notice requesting comments on 
this ICR. Comments submitted included requests for standardized 
reporting forms. Commenters also expressed concern that burden hours 
were significantly understated. HHS agrees that the burdens associated 
with this ICR may have been understated. Adjusted burden estimates are 
included in this 30-day notice. Finally, HHS appreciates the comments 
received regarding the development of a formal dispute resolution 
process. HHS is in the process of developing a regulation to establish 
and implement a binding administrative dispute resolution process 
pursuant to section 340(d)(3) of the PHS Act. Some of the comments 
received regarding the audit process are beyond the scope of this 
notice, and as such, HHS will not be addressing them in this notice.
    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 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 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. In addition, 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 section 340B 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. 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. 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

[[Page 31949]]

 
Audit Workplan \1\..............              40               1              18              12             216
Audit Report \1\................               8               1               8              12              96
Entity Response.................               8               1               8              12              96
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                                               Dispute Resolution
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Dispute Request.................              10               4              40              15             600
Rebuttal........................              10               1              10              28             280
    Total.......................              96  ..............             104  ..............            1948
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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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Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-11869 Filed 5-19-16; 8:45 am]
 BILLING CODE 4165-15-P