[Federal Register Volume 74, Number 247 (Monday, December 28, 2009)]
[Notices]
[Pages 68628-68629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, e-mail 
[email protected] or call the HRSA Reports Clearance Office on (301) 
443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 
0915-0176)--[Extension]

    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 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.
    The annual estimate of burden is as follows:

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                                                                   Number of       Responses per                         Hours per        Total burden
                          Instrument                              respondents       respondent      Total responses       response            hours
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                                                                         Audits
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Audit Notification of Entity.................................                 2                 1                 2                4                   8
Audit Work Plan..............................................                 1                 1                 1                8                   8
Audit Report.................................................                 1                 1                 1                1                   1
Entity Response..............................................                 0                 0                 0                0                   0
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                                                                   Dispute Resolution
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Dispute Resolution Request...................................                 2                 4                 8               10                  80
Rebuttal.....................................................                 2                 1                 2               16                  32
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                                                               Record Keeping Requirement
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Dispute Records..............................................                10                 1                10                 .5                 5
                                                              ------------------------------------------------------------------------------------------
    Total Recordkeeping......................................                10  ................  ................  .................                 5
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[[Page 68629]]

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: December 18, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-30606 Filed 12-24-09; 8:45 am]
BILLING CODE 4165-15-P