E9-30606. Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail [e-mail] or call the HRSA Reports Clearance Office on [phone].

The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995:

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) developed a dispute resolution process for manufacturers and covered entities as well as manufacturer guidelines for audit of covered entities.

The annual estimate of burden is as follows:

Instrument	Number of respondents	Responses per respondent	Total responses	Hours per response	Total burden hours
Audits
Audit Notification of Entity	2	1	2	4	8
Audit Work Plan	1	1	1	8	8
Audit Report	1	1	1	1	1
Entity Response	0	0	0	0	0
Dispute Resolution
Dispute Resolution Request	2	4	8	10	80
Rebuttal	2	1	2	16	32
Record Keeping Requirement
Dispute Records	10	1	10	.5	5
Total Recordkeeping	10				5

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to [e-mail] or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”

Dated: December 18, 2009.

Alexandra Huttinger,

Director, Division of Policy Review and Coordination.