E9-19381. 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: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program [NEW]

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 Pricing 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)(9) to notify manufacturers of the identities of covered entities and the mandate of section 340B(a)(5)(A)(ii) to establish a mechanism to ensure against duplicate discounts and the ongoing responsibility to administer the 340B Drug Pricing Program while maintaining efficiency, transparency and integrity, the HRSA Office of Pharmacy Affairs (OPA) developed a process of registration of covered entities to enable it to address those mandates.

Enrollment/Registration

To enroll and certify the eligible federally funded grantees and other safety net health care providers, OPA requires entities to submit administrative information (e.g., shipping and billing arrangements, Medicaid participation), certifying information and signatures from appropriate grantee level or entity level authorizing officials and State/local government representatives. The purpose of this registration information is to determine eligibility for the 340B program. This information is received and verified according to 340B requirements and entered into the 340B database. Accurate records are critical to implementation of the 340B legislation especially to prevent diversion and duplicate discounts. To maintain accurate records, the OPA requests entities to submit modifications to any administrative information that they submitted when initially enrolling into the program. The burden requirement for these processes is minimal.

Contract Pharmacy Self-Certification

In order to ensure that drug manufacturers and drug wholesalers recognize contract pharmacy arrangements, covered entities that elect to utilize a contract pharmacy are required to submit to OPA a self-certification form similar to the registration form that they have signed an agreement with the contract pharmacy.

The Estimates of annualized burden are as follows:

Reporting requirement	Number of respondents	Responses per respondent	Total responses	Hours per response	Total burden hours
DSH & Children's Hospital Enrollment, Additions & Recertifications
340B Program Registrations & Certifications for Disproportionate Share Hospitals	70	1	70	.25	17.5
340B Program Registrations & Certifications for Children's Hospitals	80	1	80	.25	20
Certifications to Enroll DSH & Children's Hospitals Outpatient facilities to 340B Program	180	1	180	.083	14.94
DSH & Children's Hospitals' Annual Recertification	937	1	937	.5	468.5
Registration for Entities Other Than Hospitals & Recertifications
340B Registration Form (Family Planning, STD, TB, and others)	170	1	170	.083	14.11
Family Planning Annual Recertification	85	47	3995	.083	331.59
STD & TB Annual Recertification	111	11	1221	.083	101.34
Other Entity Annual Recertification for entities other than DSHs, FP, STD or TB entities	400	10	4000	.083	332
Submission of Administrative Changes for any entity	460	1	460	.083	38.18
Contracted Pharmacy Services Registration & Recertifications
Contracted Pharmacy Services Registration	2000	1	2000	.083	166
Total	* 4493		13,313		1504.16
* The total number of respondents may be overestimated since we are unable to avoid duplication of respondents who submit information to the OPA over the course of participation in the 340B Drug Pricing Program, via the initial registration process to any updates/modifications and enrolling contract pharmacies, if applicable, to the recertification process.

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 e-mail to [e-mail] or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”

Dated: August 5, 2009.

Alexandra Huttinger,

Director, Division of Policy Review and Coordination.