[Federal Register Volume 68, Number 108 (Thursday, June 5, 2003)]
[Notices]
[Pages 33728-33729]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14217]


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

Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 
0915-0176)--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.
    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 Pharmacy Affairs Branch (PAB) 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 PAB 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 PAB 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 PAB 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 PAB, 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 PAB. 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, but two disputes 
have reached the level where a committee review may be 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
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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

[[Page 33729]]

 
Entity Response.................               0               0               0               0               0
---------------------------------
                                               DISPUTE RESOLUTION
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Mediation Request...............               2               4               8              10              80
Rebuttal........................               2               1               2              16              32
                                 -----------------
      Total.....................               8             1.8              14             9.2            129
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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 134 hours.
    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 14-45, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of this 
notice.

    Dated: May 30, 2003.
Jane M. Harrison,
Director, Division of Policy Review and Coordination.
[FR Doc. 03-14217 Filed 6-4-03; 8:45 am]
BILLING CODE 4165-15-P