[IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
ICR 202604-0938-003 · OMB 0938-0921 · Received in OIRA
[IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
Revision of a currently approved collection
No
Regular
04/07/2026
Requested
Previously Approved
36 Months From Approved
02/28/2029
4,500
3,000
49,500
38,500
0
0
Section 1847A of the Social Security Act requires that the Medicare Part B payment amounts for covered drugs and biologicals not paid on a cost or prospective payment basis be based upon manufacturersâ average sales price data submitted quarterly to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR part 414, subpart J.
Our proposed changes account for additional burden for a secretary/administrative assistant to follow up with fee recipients and monitor certification amendments. We also identified that we should account for new burden and include legal/compliance review. We also revised our Bona Fide Service Fee Certification form.
Overall, this iteration proposes to add 1,500 responses and 11,000 hours.
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 CMS-10110 Bona Fide Service Fee Certification Form
CMS-10110_Supporting_Statement_A_(2026 version_24).docx
PRA Comment Response.pdf
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)