[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12068-12069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03912]


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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

ACTION: Notice.

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SUMMARY: In compliance with section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and 
Services Administration (HRSA) will submit an Information Collection 
Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests 
submitted to OMB for review, email [email protected] or call the HRSA 
Reports Clearance Office at (301) 443-1984.
    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.'' Section 340B provides that a manufacturer who sells covered 
outpatient drugs to eligible entities must sign a pharmaceutical 
pricing agreement with the Secretary of Health and Human Services in 
which

[[Page 12069]]

the manufacturer agrees to charge a price for covered outpatient drugs 
that will not exceed an amount determined under a statutory formula. 
Covered entities which choose to participate in the section 340B drug 
discount program must comply with the requirements of 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 entity.
    In response to the statutory mandate of section 340B(a)(5)(C) to 
develop audit guidelines and because of the potential for disputes 
involving covered entities and participating drug manufacturers, the 
HRSA Office of Pharmacy Affairs (OPA) developed a dispute resolution 
process for manufacturers and covered entities as well as manufacturer 
guidelines for audit of 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.
    The annual estimate of burden is as follows:

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     Reporting/Notification          Number of     Responses per       Total          Hours/       Total burden
           requirement              respondents     respondent       responses       response          hours
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                                                     AUDITS
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Good Faith Resolution\1\........              10               1              10              40             400
Audit Notification of Entity \1\              10               1              10               4              40
Audit Workplan \1\..............               8               1               8              10              80
Audit Report \1\................               6               1               6              10              60
Entity Response.................               6               1               6               8              48
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                                               DISPUTE RESOLUTION
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Mediation Request...............              10               4              40              10             400
Rebuttal........................              10               1              10              16             160
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    TOTAL.......................              50  ..............              80  ..............            1188
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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              0.5               25
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ADDRESSES: Submit your comments to the desk officer for HRSA, either by 
email to [email protected] or by fax to 202-395-5806. Please 
direct all correspondence to the ``attention of the desk officer for 
HRSA.''
    Deadline: Comments on this ICR should be received within 30 days of 
this notice.

    Dated: February 13, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-03912 Filed 2-20-13; 8:45 am]
BILLING CODE 4165-15-P