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Federal forms, ICRs, and supporting documents

Information Collection Request

Drug Price Negotiation for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10849)

ICR 202606-0938-003 · OMB 0938-1452 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form CMS-10849 Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form Form and Instruction New Available
Form CMS-10849 Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form Form and Instruction Modified Available
Form CMS-10849 Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form Form and Instruction Modified Available
Form CMS-10849 Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form Form and Instruction Modified Available
CMS-10849 Initial Price Applicability Year (20XX) 60-day Drug Price Negotiation ICR Supporting Statement.docx Supporting Statement A Uploaded 2026-06-16 Available
CMS-10849 Initial Price Applicability Year 2028 to Proposed 60-day Drug Price Negotiation ICR Crosswalk of Proposed Revisions_wo.docx Supplementary Document Uploaded 2026-06-05 Available
IC Document Collections
IC IDCollectionTypeStatusForm
280785 Negotiation Data Elements ICR Form - Temporary Floor for Small Biotech Drugs ICR Form Form and Instruction NewNegotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
278115 Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation Form and Instruction ModifiedNegotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
272617 Negotiation Data Elements ICR Form - Selected Drugs for Negotiation Form and Instruction ModifiedNegotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
261204 Counteroffer ICR Form Form and Instruction ModifiedNegotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
ICR Details
0938-1452 202606-0938-003
Received in OIRA 202511-0938-003
HHS/CMS CM
Drug Price Negotiation for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10849)
Revision of a currently approved collection   No
Regular 06/16/2026
  Requested Previously Approved
36 Months From Approved 01/31/2028
447 405
64,236 47,620
0 0
The Centers for Medicare & Medicaid Services (CMS) is requesting review and approval of a revision to an existing data collection related to the Inflation Reduction Act of 2022 (P.L. 117-169) (the Act). Sections 1193 and 1194 of the Act requires drug manufacturers to submit data to the Secretary of the Department of Health and Human Services, in a form and manner specified by the Secretary; information on the non-Federal average manufacturer price; and information that the Secretary requires to carry out the negotiation or renegotiation process. The Act establishes a Drug Price Negotiation Program for certain selected drugs covered under Medicare Part B and Part D. The Secretary is required to negotiate maximum fair prices (MFPs) with drug manufacturers for 15 Part B and Part D drugs in 2028, 20 Part B and Part D drugs for 2029 and each following year. The Secretary is required to renegotiate MFPs with drug manufacturers of selected drugs that are eligible and selected for renegotiation for 2028 and each following year. Additionally, this information collection request describes the information collection that may occur if the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS’ written initial offer for initial negotiation or renegotiation of the MFP, as applicable to a selected drug, during initial price applicability year 2028 under the Medicare Drug Price Negotiation Program (under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117-169), codified in sections 1191 through 1198 of the Social Security Act).
PL: Pub.L. 117 - 169 1193 through 1194 Name of Law: The Inflation Reduction Act of 2022
   PL: Pub.L. 117 - 169 1191 through 1198 Name of Law: The Inflation Reduction Act of 2022
  
None
0938-AV90 Proposed rulemaking 91 FR 36236 06/16/2026
No
  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 447 405 0 42 0 0
Annual Time Burden (Hours) 64,236 47,620 0 16,616 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
CMS has adjusted the burden due to the addition of new burden estimates for a Primary Manufacturer’s voluntary completion of the Temporary Floor for Small Biotech Drugs ICR Form. CMS is proposing the following substantives changes to the Negotiation Data Elements ICR Form that impact the burden of a Primary Manufacturer to respond to the ICR because CMS is requesting the additional following information. Burden has been adjusted accordingly.
$1,058,693
No
    No
    No
No
No
No
No
Stephan McKenzie 410 786-1943 [email protected]
  No
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.
06/16/2026