Agency Information Collection Activities: Proposed Collection: Comment Request

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

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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

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

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