This PDF is the current document as it appeared on Public Inspection on 07/19/2012 at 08:45 am.
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, email firstname.lastname@example.org or call the HRSA Reports Clearance Office on (301) 443-1984.
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 (OMB No. 0915-0327)—[Revision]
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 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.
In response to the statutory mandate of section 340B(a)(9) of the PHS Act 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.
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 Drug Pricing Program. This information is entered into the 340B database by entities and verified by OPA staff according to 340B Drug Pricing Program requirements. Accurate records are critical to implementation of the 340B Drug Pricing Program legislation, especially to prevent diversion and duplicate discounts. To maintain accurate records, 340B statute also requires that entities recertify eligibility annually and that they notify the program of updates to any administrative information that they submitted when initially enrolling into the program. The burden requirement is low for recertification and for submitting change requests.
Contract Pharmacy Self-Certification
In order to ensure that drug manufacturers and drug wholesalers recognize contract pharmacy arrangements, covered entities that elect to utilize one or more contract pharmacies are also required to submit general information about the arrangements and to certify that signed agreements are in place with those contract pharmacies.
Pharmaceutical Pricing Agreement
In accordance with the guidance found in the May 7, 1993, Federal Register, Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a Pharmaceutical Pricing Agreement (the “Agreement”) with the Secretary of Health and Human Services (the “Secretary”) in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the average manufacturer price (“AMP”) decreased by a rebate percentage.
The estimates of annualized burden are as follows:
|Reporting requirement||Number of respondents||Responses per respondent||Total responses||Hours per response||Total burden hours|
|HOSPITAL ENROLLMENT, ADDITIONS & RECERTIFICATIONS|
|340B Program Registrations & Certifications for Hospitals||546||1||546||2.0||1,092.0|
|Certifications to Enroll Hospital Outpatient Facilities||606||1||606||0.5||303.0|
|Hospital Annual Recertification||4,842||1||4,842||0.5||2,421.0|
|REGISTRATIONS AND RECERTIFICATIONS FOR ENTITIES OTHER THAN HOSPITALS|
|340B Registrations for Community Health Centers||253||1||253||1.0||253.0|
|340B Registrations for Family Planning Programs, STD/TB Clinics and Various Other Eligible Entity Types||353||1||353||1.0||353.0|
|Community Health Center Annual Recertification||4,507||1||4,507||0.5||2,253.5|
|Family Planning Annual Recertification||3,879||1||3,879||0.5||1,939.5|
|STD & TB Annual Recertification||2,754||1||2,754||0.5||1,377.0|
|Annual Recertification for entities other than Hospitals, Community Health Centers, Family Planning, STD or TB Clinics||1,174||1||1,174||0.5||587.0|
|CONTRACTED PHARMACY SERVICES REGISTRATIONS|
|Contracted Pharmacy Services Registration||2500||1||2500||1.0||2500.0|
|OTHER INFORMATION COLLECTIONS|
|Submission of Administrative Changes for any Covered Entity||2,500||1||2,500||0.5||1,250.0|
|Submission of Administrative Changes for any Manufacturer||350||1||350||0.5||175.0|
|Pharmaceutical Pricing Agreement||200||1||200||1.0||200.0|
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 OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.”
Dated: July 16, 2012.
Deputy Director, Office of Management.
[FR Doc. 2012-17777 Filed 7-19-12; 8:45 am]
BILLING CODE 4165-15-P