[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Notices]
[Pages 44977-44978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22423]


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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 and Revision--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 Drug Pricing 
Program 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 to the HRSA Office of Drug Pricing Program for 
review. The manufacturer will submit copies of the audit report to the 
HRSA Office of Drug Pricing Program 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. As a result of public comment on the draft audit guidelines, 
one of the requirements has changed. The manufacturer is no longer 
required to submit a request for an audit of a covered entity to the 
HRSA Office of Drug Pricing Program. Instead, the manufacturer must 
notify the covered entity in writing when it believes the covered 
entity has violated the provisions of section 340B.
    Dispute resolution guidelines: Because of the potential for 
disputes involving covered entities and participating drug 
manufacturers, the HRSA Office of Drug Pricing Program 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 Office of 
Drug Pricing Program, 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 Office of Drug Pricing Program. 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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                                                               Responses                                Total   
             Reporting requirement                Number of       per         Total        Hours/       burden  
                                                 respondents   respondent   responses     response      hours   
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Audits:                                                                                                         
    Audit Notification of Entity \1\...........            2          1.0            2          4.0            8
    Audit Workplan \1\.........................            1          1.0            1          8.0            8
    Audit Report \1\...........................            1          1.0            1          1.0            1
    Entity Response............................            0          0.0            0         16.0            0

[[Page 44978]]

                                                                                                                
Dispute resolution:                                                                                             
    Mediation Request..........................            5          1.0            5            8           40
    Rebuttal...................................            2          1.0            2           16           32
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      Total....................................            9          1.2           11          8.1          89 
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\1\ Prepared by the manufacturers.                                                                              


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                                                                           No. 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: 
Laura Oliven, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, D.C. 
20503.

    Dated: August 19, 1997.
Jane Harrison,
Acting Director, Divison of Policy Review and Coordination.
[FR Doc. 97-22423 Filed 8-22-97; 8:45 am]
BILLING CODE 4160-15-P