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[Federal Register Volume 62, Number 45 (Friday, March 7, 1997)]
[Notices]
[Pages 10574-10575]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5560]

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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 of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Health Resources and Services 
Administration (HRSA) will publish periodic summaries of proposed 
projects being developed for submission to 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, 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, including whether the information shall have practical 
utility; (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.

[[Page 10575]]

Proposed Project

    Drug Pricing Program Reporting Requirements (OMB No. 0915-0176)--
Extension, No Change--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 and/or audits involving 
covered entities and participating drug manufacturers; the HRSA Office 
of Drug Pricing Program has developed an informal 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 
submit a request for an audit of a covered entity to the HRSA Office of 
Drug Pricing Program. 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.
    Dispute resolution guidelines: Because of the potential for audit 
and other disputes involving covered entities and participating drug 
manufacturers, the HRSA Office of Drug Pricing Program 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 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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                                     Number of     Responses per       Total                       Total burden 
      Reporting requirement         respondents     respondent       responses    Hours/response       hours    
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Audits:                                                                                                         
    Audit request \1\...........               2               1               2               4               8
    Audit workplan \1\..........               1               1               1               8               8
    Audit report \1\............               1               1               1               1               1
    Entity response.............               1               1               1              16              16
Dispute resolution:                                                                                             
    Mediation request...........               5               1               5               8              40
    Rebuttal....................               2               1               2              16              32
                                 -------------------------------------------------------------------------------
        Total...................              10             1.2              12            8.75             105
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\1\ Prepared by the manufacturer.                                                                               

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                                                      Number of             Hours of                            
           Recordkeeping requirement                recordkeepers         recordkeeping         Total burden    
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Dispute records...............................                     8                    .5                     4
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    Send comments to Patricia Royston, HRSA Reports Clearance Officer, 
Room 14-36, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments should be received within 60 days of this notice.

    Dated: February 26, 1997.
J. Henry Montes,
Director, Office of Policy and Information Coordination.
[FR Doc. 97-5560 Filed 3-6-97; 8:45 am]
BILLING CODE 4160-15-P
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