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

ICR 202411-0938-010

OMB: 0938-1452

Federal Form Document

Forms and Documents
ICR Details
0938-1452 202411-0938-010
Received in OIRA 202307-0938-009
HHS/CMS CM
Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)
Revision of a currently approved collection   No
Regular 11/25/2024
  Requested Previously Approved
36 Months From Approved 09/30/2025
355 10
23,764 2,043
0 0

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.

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
  
None

Not associated with rulemaking

  89 FR 54824 07/02/2024
89 FR 92940 11/25/2024
Yes

  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
Yes
Miscellaneous Actions
No
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.

$1,547,166
No
    No
    No
No
No
No
No
Stephan McKenzie 410 786-1943 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
11/25/2024


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