View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1452
ICR Reference No:
202511-0938-003
Status:
Active
Previous ICR Reference No:
202411-0938-010
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM
Title:
Drug Price Negotiation for Initial Price Applicability Year 2028 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
OIRA Conclusion Action:
Approved with change
Conclusion Date:
01/09/2026
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/24/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2028
36 Months From Approved
01/31/2026
Responses
405
0
355
Time Burden (Hours)
47,620
0
23,764
Cost Burden (Dollars)
0
0
0
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). Both forms will be used for negotiation and renegotiation of selected drugs for initial price applicability year 2028.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 1193 through 1194
Name of Law: The Inflation Reduction Act of 2022
PL:
Pub.L. 117 - 169 1191 through 1198
Name of Law: The Inflation Reduction Act of 2022
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 27869
06/30/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 52955
11/24/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Counteroffer ICR Form
CMS-10849
Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
Negotiation Data Elements ICR Form - Selected Drugs for Negotiation
CMS-10849
Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
Negotiation Data Elements ICR Form - Selected Drugs for Renegotiation
CMS-10849
Negotiation Data Elements ICR Form and Drug Price Negotiation Process ICR Form
ICR Summary 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
405
355
0
50
0
0
Annual Time Burden (Hours)
47,620
23,764
0
23,856
0
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
CMS has revised the burden estimates and cost to the federal government upwards to account for use of this ICR package to meet the statutory requirement for initial price applicability year 2028 to renegotiate the MFP for selected drugs because additional manufacturers and the public will use the Forms to submit information to CMS and the federal government will need to prepare and review additional information related to the Forms.
Annual Cost to Federal Government:
$3,565,788
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
Agency Contact:
Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov
Common Form ICR:
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:
(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:
11/24/2025
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