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Agency Information Collection Activities: Proposed Collection: Comment Request

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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, e-mail or call the HRSA Reports Clearance Officer on (301) 443-1129.

Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (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: 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 Start Printed Page 65610responsibility 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.


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.


The purposes of recertification are to request that 340B covered entities annually certify program eligibility and confirm the accuracy of all information in the covered entity's 340B database record. Recertification is an electronic process that will require the covered entity to review the current database record and submit required edits (i.e., covered entity name and address changes, changes to 340B designated contact information, billing and shipping arrangements). The recertification process will pose a minimal burden to 340B covered entities.

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 requirementNumber of respondentsResponses per respondentTotal responsesHours per responseTotal burden hours
340B Program Registrations & Certifications for Disproportionate Share Hospitals70170.2517.5
340B Program Registrations & Certifications for Children's Hospitals80180.2520
Certifications to Enroll DSH & Children's Hospitals Outpatient facilities to 340B Program1801180.08314.94
DSH & Children's Hospitals' Annual Recertification9371937.5468.5
340B Registration Form (Family Planning, STD, TB, and others)1701170.08314.11
Family Planning Annual Recertification85473995.083331.59
STD & TB Annual Recertification111111221.083101.34
Other Entity Annual Recertification for entities other than DSHs, FP, STD or TB entities400104000.083332
Submission of Administrative Changes for any entity4601460.08338.18
Contracted Pharmacy Services Registration200012000.083166
TOTAL* 449313,3131504.16
* 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.

E-mail comments to or mail the 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.

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Dated: October 28, 2008.

Alexandra Huttinger,

Director, Division of Policy Review and Coordination.

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[FR Doc. E8-26271 Filed 11-3-08; 8:45 am]