[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64725-64726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18508]


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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, 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 Pub. L. 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) has developed a dispute 
resolution process for manufacturers and covered entities as well as 
manufacturer guidelines for audit of covered entities.
    Audit Guidelines: A manufacturer will be 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 must notify 
the covered entity in writing when it believes the covered entity has 
violated the provisions of 340B. If the problem cannot be resolved, the 
manufacturer must then submit an audit work plan describing the audit 
and evidence in support of the reasonable cause standard to the HRSA 
OPA for review. The office 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 the HRSA 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.
    Dispute Resolution Guidelines: Because of the potential for 
disputes involving covered entities and participating drug 
manufacturers, the HRSA OPA has developed an informal dispute 
resolution process which can be used if an entity or manufacturer is 
believed to be in violation of section 340B. Prior to filing a request 
for resolution of a dispute with the HRSA OPA, the parties must 
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 the HRSA 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.
    The estimates of annualized burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                    Number of     Responses per       Total         Hours per      Total burden
     Reporting requirement         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
----------------------------------------------------------------------------------------------------------------
                                               Dispute Resolution
----------------------------------------------------------------------------------------------------------------
Mediation Request..............               2               4               8             10                80
Rebuttal.......................               2               1               2             16                32
                                --------------------------------------------------------------------------------
    Total Reporting............               8  ..............              14  ...............             129
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                                            Recordkeeping Requirement
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Dispute Records................              10               1              10               .5               5
                                --------------------------------------------------------------------------------
    Total Recordkeeping........              10  ..............  ..............  ...............              5
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* Prepared by the manufacturer.


[[Page 64726]]

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
John Kraemer, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC 
20503.

    Dated: October 26, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-18508 Filed 11-2-06; 8:45 am]
BILLING CODE 4165-15-P