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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10849 Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form	Form and Instruction	New	Repair queued
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	Repair queued
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	Repair queued
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	Repair queued
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	Repair queued
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	Repair queued
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

Information collection document groups

IC ID	Collection	Type	Status	Form
280785	Negotiation Data Elements ICR Form - Temporary Floor for Small Biotech Drugs ICR Form	Form and Instruction	New	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
280785	Negotiation Data Elements ICR Form - Temporary Floor for Small Biotech Drugs ICR Form	Form and Instruction	New	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
278115	Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation	Form and Instruction	Modified	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
278115	Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation	Form and Instruction	Modified	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
272617	Negotiation Data Elements ICR Form - Selected Drugs for Negotiation	Form and Instruction	Modified	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
272617	Negotiation Data Elements ICR Form - Selected Drugs for Negotiation	Form and Instruction	Modified	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
261204	Counteroffer ICR Form	Form and Instruction	Modified	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
261204	Counteroffer ICR Form	Form and Instruction	Modified	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form

ICR Details

OMB Control No: 0938-1452	ICR Reference No: 202606-0938-003
Status: Historical Inactive	Previous ICR Reference No: 202511-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Drug Price Negotiation for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10849)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 07/29/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/16/2026
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2028	36 Months From Approved	01/31/2028
Responses	405	0	405
Time Burden (Hours)	47,620	0	47,620
Cost Burden (Dollars)	0	0	0

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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).

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV90	Proposed rulemaking	91 FR 36236	06/16/2026

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

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
Negotiation Data Elements ICR Form - Temporary Floor for Small Biotech Drugs ICR Form	CMS-10849	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form

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

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $1,058,693

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

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Common Form ICR:  No

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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: 06/16/2026

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