[Federal Register Volume 65, Number 109 (Tuesday, June 6, 2000)]
[Notices]
[Pages 35948-35949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14215]


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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 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 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, 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 the use of automated collection techniques or other forms of 
information technology.

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.

[[Page 35949]]

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 audits 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 these 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 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 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:
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              16               0
Dispute Resolution:
Mediation Request...............               5               1               5               8              40
Rebuttal........................               2               1               2              16              32
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    Total.......................               9             1.2              11             8.1             89
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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..............................................              10               .5                5
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    The total burden is 94 hours.
    Send comments to Susan G. Queen, HRSA Reports Clearance Officer, 
Room 14-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments should be received within 60 days of this notice.

    Dated: June 1, 2000.
James J. Corrigan,
Associate Administrator for Management and Program Support.
[FR Doc. 00-14215 Filed 6-5-00; 8:45 am]
BILLING CODE 4160-15-P