View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0915-0327	ICR Reference No: 201604-0915-002
Status: Historical Active	Previous ICR Reference No: 201504-0915-001
Agency/Subagency: HHS/HSA	Agency Tracking No: 20345
Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program and Collection of Manufacturer Data to Verify 340B Drug Pricing Program Ceiling Price Calculations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/23/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/03/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	09/30/2018
Responses	56,705	0	52,591
Time Burden (Hours)	27,594	0	27,054
Cost Burden (Dollars)	0	0	0

Abstract: Section 602 of Public Law 102–585, the Veterans Health Care Act of 1992, enacted as Section 340B of the Public Health Service Act (PHS Act; ‘‘Limitation on Prices of Drugs Purchased by Covered Entities’’), provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a Pharmaceutical Pricing Agreement (PPA) 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 (‘‘ceiling price’’). A manufacturer subject to a PPA must offer all covered outpatient drugs at no more than the ceiling price to a covered entity listed in the 340B Program database. The manufacturer shall rely on the information in the 340B database to determine if the covered entity is participating in the 340B Program or for any notifications of changes to eligibility that may occur within a quarter. By signing the PPA, the manufacturer agrees to comply with all applicable statutory and regulatory requirements, including any changes that occur after execution of the PPA. Covered entities which choose to participate in the 340B 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. This revision to this package consists of the addition of a PPA Addendum. As part of HRSA’s oversight of the 340B Program, this Addendum to the Agreement will help to ensure that the requirements of the statute are met, including that manufacturers provide HRSA with their calculated prices for the pricing validation system, and the provision to offer covered entities drugs for purchase at or below the applicable ceiling price if such drugs are made available to any other purchaser at any price.

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	56,705	52,591	4,264	-150
Annual Time Burden (Hours)	27,594	27,054	840	-300
Annual Cost Burden (Dollars)	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The program has rearranged forms into different ICs. The number of forms or the forms themselves have not changed, just how they are presented in the ICs. This has increased or decreased burden hours in the ICs that have been modified, but the total burden hours or responses have not changed in amount.