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Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202307-0938-009 · OMB 0938-1452 · Received in OIRA

Forms and Documents
Document
Name
Status
Form and Instruction
 New
Supporting Statement A
2023-07-25
Supplementary Document
2023-07-25
Supplementary Document
2023-07-25
IC Document Collections
IC ID
Document
Title
Status
261204 New
ICR Details
202307-0938-009
Received in OIRA
HHS/CMS CM
Drug Price Negotiation Process under Sections 11001 and 11002 of the Inflation Reduction Act (CMS-10849) - (IRA)
New collection (Request for a new OMB Control Number)   No
Regular 07/25/2023
  Requested Previously Approved
36 Months From Approved
10 0
2,043 0
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 Sections 1191 through 1198 Name of Law: The Inflation Reduction Act
Not associated with rulemaking
  88 FR 23680 04/18/2023
88 FR 47880 07/25/2023
Yes
1
IC Title Form No. Form Name
Developing a counteroffer submission per selected drug CMS-10849 Counteroffer Form
  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 10 0 10 0 0 0
Annual Time Burden (Hours) 2,043 0 2,043 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new information collection request.
$296,102
No
    No
    No
No
No
No
No
Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov
  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.
07/25/2023