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
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0915-0327 can be found here:
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 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.
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.
Form 1 Pharmaceutical Pricing Agreement Addendum
List of all ICR documents REVISED.docx
60-day FRN.pdf
Pharmaceutical Pricing Agreement Addendum