Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)

Forms and Documents

Document Name	Status
Form CMS-10849 Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation Form and Instruction	New
Form CMS-10849 Negotiation Data Elements ICR Form - Selected Drugs for Negotiation Form and Instruction	Modified
Form CMS-10849 Counteroffer ICR Form Form and Instruction	Modified
CMS-10849 Initial Price Applicability Year 2028 30-day Drug Price Negotiation ICR Supporting Statement A.docx Supporting Statement A	2025-11-24
clean IPAY 2027 NDE Process ICR 60 and 30-day Comment Summary and Responses FINAL.docx Supplementary Document	2025-01-06
IPAY 2027 30-day to final NDE Process ICR_Crosswalk FINAL.docx Supplementary Document	2025-01-06
IPAY 2027 30-day NDE Process ICR_Crosswalk 60day to 30day.docx Supplementary Document	2024-11-22
IPAY 2027 60-day NDE Process ICR_Crosswalk.docx Supplementary Document	2024-11-22
IPAY 2027 NDE Process ICR 60-day Comment Summary and Responses .docx Supplementary Document	2024-11-22

IC Document Collections

IC ID	Document Title	Status
278115	Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation Form and Instruction	New
272617	Negotiation Data Elements ICR Form - Selected Drugs for Negotiation Form and Instruction	Modified
261204	Counteroffer ICR Form Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1452	ICR Reference No: 202511-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202411-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 11/24/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2026
Responses	405	355
Time Burden (Hours)	47,620	23,764
Cost Burden (Dollars)	0	0

---

Abstract: 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). Both forms will be used for negotiation and renegotiation of selected drugs for initial price applicability year 2028.

---

Authorizing Statute(s): PL: Pub.L. 117 - 169 1191 through 1198 Name of Law: The Inflation Reduction Act of 2022
   PL: Pub.L. 117 - 169 1193 through 1194 Name of Law: The Inflation Reduction Act of 2022
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 27869	06/30/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52955	11/24/2025
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Counteroffer ICR Form	CMS-10849	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
Negotiation Data Elements ICR Form - Selected Drugs for Negotiation	CMS-10849	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation	CMS-10849	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form

---

ICR Summary of Burden

	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	405	355	0	50	0	0
Annual Time Burden (Hours)	47,620	23,764	0	23,856	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: CMS has revised the burden estimates and cost to the federal government upwards to account for use of this ICR package to meet the statutory requirement for initial price applicability year 2028 to renegotiate the MFP for selected drugs because additional manufacturers and the public will use the Forms to submit information to CMS and the federal government will need to prepare and review additional information related to the Forms.

---

Annual Cost to Federal Government: $1,547,166

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

---

Common Form ICR:  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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/24/2025

---