[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Notices]
[Pages 50997-50998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21256]


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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, 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 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 section 
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.
    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 section 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 exist. 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 a 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.
    To date, there have been no requests for audits, and no disputes 
have reached the level where a committee review was needed. As a 
result, the estimates of annualized hour burden for audits and disputes 
have been reduced to the level shown in the table below.

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                                     Number of     Responses per       Total          Hours/       Total burden
      Reporting requirement         respondents     respondent       responses       response          hours
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                                             Audits
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Audit Notification of Entity \1\               2               1               2               4               8
Audit Workplan \1\..............               1               1               1               8               8
Audit Report \1\................               1               1               1               1               1
Entity Response.................               0               0               0               0               0

[[Page 50998]]

 
                                       Dispute Resolution
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Mediation Request...............               5               1               5               8              40
Rebuttal........................               2               1               2              16              32
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    Total.......................               9               1               9              37             89
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\1\ Prepared by the manufacturer.


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                                 Number of       Hours of       Total
  Recordkeeping requirement    recordkeepers  recordkeeping     burden
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 Dispute records.............            10             .5             5
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    The total burden is 94 hours.
    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
John Morrall, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, D.C. 
20503.

    Dated: August 15, 2000.
James J. Corrigan,
Associate Administrator for Management and Program Support.
[FR Doc. 00-21256 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-15-P