Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10847)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10847 Negotiation Data Elements Form	Form and Instruction	New	Available
Form CMS-10847 General Public (individual and organization)	Form and Instruction	New	Repair queued
Form CMS-10847 Negotiation Data Elements Form	Form and Instruction	New	Available
Form CMS-10847 Primary Manufacturers	Form and Instruction	New	Repair queued
Final clean 60 Day Data Elements Comment Summary Responses.docx	Supplementary Document	Uploaded 2023-06-29	Repair queued
60 to 30 Day Data Elements Cross Walk_508 FINAL.pdf	Supplementary Document	Uploaded 2023-06-29	Repair queued
CMS-10847_Negotiation Data Elements Supporting Statement.docx	Supporting Statement A	Uploaded 2023-06-29	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
260900	General Public (individual and organization)	Form and Instruction	New	Negotiation Data Elements Form
260900	General Public (individual and organization)	Form and Instruction	New
260899	Primary Manufacturers	Form and Instruction	New	Negotiation Data Elements Form
260899	Primary Manufacturers	Form and Instruction	New

ICR Details

OMB Control No: 0938-1449	ICR Reference No: 202306-0938-013
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-CPC
Title: Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10847)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/03/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/30/2023
Terms of Clearance: Prior to the submission of the information collection request (ICR) for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation Reduction Act for the 2027 negotiation process, CMS will provide an analysis of the 2026 negotiation data submissions from manufactures including, but not limited to, a meta-analysis of data from sections C: Research and Development Costs and Recoupment and D: Current Unit Costs of Production and Distribution. Also, in its 2027 ICR submission, CMS will address how it made improvements to the agency’s ability to audit the manufacturers’ data and improvements to the data collection more broadly from its analysis of the 2026 negotiation data.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2024	36 Months From Approved
Responses	3,310	0	0
Time Burden (Hours)	17,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Centers for Medicare & Medicaid Services (CMS) is requesting review and approval of 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 10 qualifying Part D drugs for 2026, 15 Part D drugs for 2027, 15 Part B and Part D drugs in 2028, and 20 Part B and Part D drugs for 2029 and each following year.

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Authorizing Statute(s): PL: Pub.L. 117 - 169 1193 and 1194 Name of Law: Inflation Reduction Act
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 169 1193 and 1194 Name of Law: Inflation Reduction Act

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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:
	88 FR 16983	03/21/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 42722	06/30/2023
Did the Agency receive public comments on this ICR? Yes

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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
General Public (individual and organization)	CMS-10847	Negotiation Data Elements Form
Primary Manufacturers	CMS-10847	Negotiation Data Elements Form

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ICR Summary of Burden

table that charts list of burden

	Total Approved	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	3,310	0	3,310	0	0	0
Annual Time Burden (Hours)	17,000	0	17,000	0	0	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: No

Burden Reduction Due to:

Short Statement: This is a new information collection request.

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Annual Cost to Federal Government: $3,447,654

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: 06/30/2023

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