Negotiation Program Drug Selection for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10844)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
277593	Identification and Selection of Renegotiation-Eligible Drugs		Modified
271326	Biosimilar Delay		Modified
259843	Small Biotech Exception		Removed

ICR Details

OMB Control No: 0938-1443	ICR Reference No: 202611-0938-003
Status: PreApproved	Previous ICR Reference No: 202606-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Negotiation Program Drug Selection for Initial Price Applicability Year 20XX under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) - (CMS-10844)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Preapproved	Conclusion Date: 11/05/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/05/2026
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2029	36 Months From Approved	11/30/2028
Responses	46	0	65
Time Burden (Hours)	4,760	0	3,677
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 11001 and 11002 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	Final or interim final rulemaking

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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: 2

table that charts list of burden

IC Title	Form No.	Form Name
Biosimilar Delay	CMS-10844
Identification and Selection of Renegotiation-Eligible Drugs	CMS-10844
Small Biotech Exception	CMS-10844

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ICR Summary of Burden

table that charts list of burden

	Total Preapproved	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	46	65	0	-30	11	0
Annual Time Burden (Hours)	4,760	3,677	0	-292	1,375	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Collection burden has decreased due to the removed burden associated with a Small Biotech Exception. Additionally, for the Identification and Selection of Renegotiation-Eligible Drugs ICR Form, CMS included technical revisions. CMS replaced references to dates specific to a specific initial price applicability year and replaced the reference with terms language to reference the requirement in the final rule. These revisions did not impact the burden.

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Annual Cost to Federal Government: $255,447

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: 11/05/2026

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