[Federal Register Volume 77, Number 208 (Friday, October 26, 2012)]
[Notices]
[Pages 65392-65393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities; Proposed Collection; 
Comment Request

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 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 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, email [email protected] or 
call the HRSA Reports Clearance Officer at (301) 443-1984.
    HRSA 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.
    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 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 which 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 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 
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, 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 (Federal Register Final Notice, December 
12, 1996 (Vol. 61, No. 240, pp. 65406-65413)).
    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 Information Collection Request 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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Audit Notification to Entity \1\              10               1              10               4              40
Audit Workplan \1\..............               8               1               8               8              64
Audit Report \1\................               6               1               6               8              48
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  ..............             760
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\1\ Prepared by the manufacturer.

    Recordkeeping Burden:

[[Page 65393]]



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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 [email protected] or mail the 
HRSA Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857.
    Deadline: Comments on this Information Collection Request must be 
received within 60 days of this notice.

    Dated: October 22, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-26354 Filed 10-25-12; 8:45 am]
BILLING CODE 4165-15-P