[Federal Register Volume 71, Number 138 (Wednesday, July 19, 2006)]
[Notices]
[Pages 41028-41029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11440]


-----------------------------------------------------------------------

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 the Office of Management and Budget 
(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)--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 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 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 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 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 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.
    The estimates of annualized burden are as follows:

----------------------------------------------------------------------------------------------------------------
                                     Number of     Responses per       Total         Hours per     Total burden
      Reporting requirement         respondents     respondent       responses       response          hours
----------------------------------------------------------------------------------------------------------------
                                                     Audits
----------------------------------------------------------------------------------------------------------------
Audit Notification of Entity*...               2               1               2               4               8
Audit Work Plan.................               1               1               1               8               8

[[Page 41029]]

 
Audit Report....................               1               1               1               1               1
Entity Response.................               0               0               0               0               0
----------------------------------------------------------------------------------------------------------------
                                               Dispute Resolution
----------------------------------------------------------------------------------------------------------------
Mediation Request...............               2               4               8              10              80
Rebuttal........................               2               1               2              16              32
                                 -------------------------------------------------------------------------------
    Total Reporting.............               8  ..............              14  ..............             129
----------------------------------------------------------------------------------------------------------------
                                            Recordkeeping Requirement
----------------------------------------------------------------------------------------------------------------
Dispute Records.................              10               1              10              .5               5
                                 -------------------------------------------------------------------------------
    Total Recordkeeping.........              10  ..............  ..............  ..............               5
----------------------------------------------------------------------------------------------------------------
*Prepared by the manufacturer.

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of this 
notice.

    Dated: July 12, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. E6-11440 Filed 7-18-06; 8:45 am]
BILLING CODE 4165-15-P