[Federal Register Volume 74, Number 182 (Tuesday, September 22, 2009)]
[Notices]
[Page 48269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22811]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Public Law 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, e-mail <a href="/cdn-cgi/l/email-protection#b8c8d9c8ddcacfd7cad3f8d0cacbd996dfd7ce"><span class="__cf_email__" data-cfemail="8fffeeffeafdf8e0fde4cfe7fdfceea1e8e0f9">[email protected]</span></a> or 
call the HRSA Reports Clearance Officer on (301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency; (b) the accuracy of the agency's estimate of the burden of 
the proposed collection of information; (c) ways to enhance the 
quality, utility, and clarity of the information to be collected; and 
(d) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques or other forms of information technology.

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       Total         Hours per     Total  burden
           Instrument               respondents     respondent       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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                                            Recordkeeping Requirement
----------------------------------------------------------------------------------------------------------------
Dispute Records.................              10               1              10              .5               5
Total Recordkeeping.............              10  ..............  ..............  ..............               5
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    E-mail comments to <a href="/cdn-cgi/l/email-protection#3646574653444159445d765e44455718515940"><span class="__cf_email__" data-cfemail="691908190c1b1e061b0229011b1a08470e061f">[email protected]</span></a> or mail the HRSA Reports 
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857. Written comments should be received within 60 days 
of this notice.

    Dated: September 15, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-22811 Filed 9-21-09; 8:45 am]
BILLING CODE 4165-15-P


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