340B Rebate Model Pilot Program Manufacturer Data Fields (Example)
ICR Details
Reginfo record details
202606-0906-001
Received in OIRA
HHS/HRSA
340B Rebate Model Pilot Program Application, Implementation, and Evaluation
New collection (Request for a new OMB Control Number)
No
Regular
06/16/2026
table that charts list comparision
Requested
Previously Approved
36 Months From Approved
793,091
0
3,965,092
0
0
0
HRSAâs Office of Pharmacy Affairs (OPA) intends to introduce a revised 340B Rebate Model Pilot Program (Pilot) as a mechanism for qualifying drug manufacturers, who wish to participate, to effectuate the 340B ceiling price on a limited set of drugs sold to covered entities using rebates. OPA plans to publish a Federal Register Notice to notify 340B stakeholders of criteria and standards for implementation of the Pilot. This ICR includes the collection of Pilot plans from drug manufacturers, the collection of purchase data reports from drug manufacturers for OPAâs monitoring of the Pilot and for overall 340B Program surveillance and program integrity monitoring, and the collection of data submitted by covered entities to manufacturers to request rebates.
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.
Manufacturers: 340B Program Rebate Model Pilot Program Plan Submission & Monthly Purchase Reports