[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79915-79917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection; 
Public Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995), the Health Resources and Services 
Administration (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 February 
22, 2016.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 10C-16, 5600 Fishers 
Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of

[[Page 79916]]

the data collection plans and draft instruments, email 
[email protected] or call 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: 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 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 the HRSA 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, should attempt in good faith to resolve the dispute. 
All parties involved in the dispute must maintain written documentation 
as evidence of a good faith attempt to resolve the dispute. If the 
dispute is not resolved and dispute resolution is desired, a party must 
submit 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 expected 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.
    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 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. 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 in 
order 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 
Information Collection Request 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              40             400
    Audit Notification to Entity              10               1              10               4              40
     \1\........................
    Audit Workplan \1\..........              40               1              18               8             144

[[Page 79917]]

 
    Audit Report \1\............               8               1               8               8              64
    Entity Response.............               8               1               8               8              64
DISPUTE RESOLUTION:
    Dispute Request.............              10               4              40              10             400
    Rebuttal....................              10               1              10              16             160
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        Total...................              96  ..............             104  ..............            1272
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\1\ Prepared by the manufacturer.


                          Recordkeeping Burden
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                                   Number of       Hours of      Total
   Recordkeeping requirement     recordkeepers  recordkeeping    burden
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Dispute Records................           50            0.5           25
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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.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-32171 Filed 12-22-15; 8:45 am]
BILLING CODE 4165-15-P