Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)

Forms and Documents

Document	Type	Status	Availability
Form CMS-10849 Negotiation Data Elements ICR Form	Form and Instruction	New	Repair queued
Form CMS-10849 Statutory Written Counteroffer ICR Form	Form and Instruction	Modified	Repair queued
CMS 10849 IPAY 2027 NDE Process ICR SSA.docx	Supporting Statement A	Uploaded 2024-11-25	Repair queued
IPAY 2027 30-day NDE Process ICR_Crosswalk 60day to 30day.docx	Supplementary Document	Uploaded 2024-11-22	Missing upstream
IPAY 2027 60-day NDE Process ICR_Crosswalk.docx	Supplementary Document	Uploaded 2024-11-22	Repair queued
IPAY 2027 NDE Process ICR 60-day Comment Summary and Responses .docx	Supplementary Document	Uploaded 2024-11-22	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
272617	Negotiation Data Elements ICR Form	Form and Instruction	New
261204	Statutory Written Counteroffer ICR Form	Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1452	ICR Reference No: 202411-0938-010
Status: Received in OIRA	Previous ICR Reference No: 202307-0938-009
Agency/Subagency: HHS/CMS	Agency Tracking No: CM
Title: Drug Price Negotiation Process 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: 11/25/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2025
Responses	355	10
Time Burden (Hours)	23,764	2,043
Cost Burden (Dollars)	0	0

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Abstract: Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price Negotiation Program (the “Negotiation Program”), codified in sections 1191 through 1198 of the Social Security Act (“the Act”). Section 1193(a)(1) of the Act establishes that CMS will negotiate an MFP with “the manufacturer” of the selected drug. In section 1191(c)(1) of the Act, the Negotiation Program statute adopts the definition of manufacturer established in section 1847A(c)(6)(A) of the Act. To the extent that more than one entity meets the statutory definition of manufacturer for a selected drug for purposes of initial price applicability year 2026. The statute provides that, after receiving CMS’ written initial offer for a selected drug, the Primary Manufacturer may, in accordance with section 1194(b)(2)(C) of the Act, submit an optional written counteroffer (if CMS’ written initial offer is not accepted by the Primary Manufacturer) that must be submitted no later than 30 days after the date of receipt of the written initial offer. If the Primary Manufacturer chooses to develop and submit a written counteroffer to CMS’ written initial offer during the drug price negotiation process for initial price applicability year 2026, the Primary Manufacturer must submit the Counteroffer Form.

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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

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 54824	07/02/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 92940	11/25/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Negotiation Data Elements ICR Form	CMS-10849	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
Statutory Written Counteroffer ICR Form	CMS-10849	Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form

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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	355	10	0	5	340	0
Annual Time Burden (Hours)	23,764	2,043	0	1,021	20,700	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: No

Burden Reduction Due to:

Short Statement: Burden has increased due to the merger of the "Written Counteroffer" (CMS-10849) ICR and the "Negotiation Data Elements" (CMS-10847) ICR into this existing ICR package for the Drug Price Negotiation Process that was developed to streamline the review process for the pharmaceutical industry and other interested parties when reviewing Paperwork Reduction Act (PRA) renewals for this notice.

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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

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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: 11/25/2024

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