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
ICR 201604-0915-002 · OMB 0915-0327 · Historical Active
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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
Section 602 of Public Law 102â585, the Veterans Health Care Act of 1992, enacted as Section 340B of the Public Health Service Act (PHS Act; ââLimitation on Prices of Drugs Purchased by Covered Entitiesââ), 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 (ââceiling priceââ).
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 HRSAâs 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.
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.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Pharmaceutical Pricing Agreement Addendum