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:
0938-1485
ICR Reference No:
202511-0938-002
Status:
Active
Previous ICR Reference No:
202507-0938-024
Agency/Subagency:
HHS/CMS
Agency Tracking No:
CM-CPC
Title:
[IRA Collection] Medicare Prescription Drug Inflation Rebate Program: Sections 11101 and 11102 of the Inflation Reduction Act (IRA) (CMS-10930)
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 without change
Conclusion Date:
12/23/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/21/2025
Terms of Clearance:
Prior to the re-submission of the information collection “Medicare Prescription Drug Inflation Rebate Program: Sections 11101 and 11102 of the Inflation Reduction Act (IRA) (CMS-10930)” 0938-1485), the agency will assess its respondent burden, utility, and if the collection is duplicative with other collections in HHS for implementing the 340B and other drug programs. This assessment will be guided by the principles and priorities set forth in the Executive Order 14192 title "Unleashing Prosperity Through Deregulation" (January 21, 2025) https://www.whitehouse.gov/presidential-actions/2025/01/unleashing-prosperity-through-deregulation/. The assessment will inform and be integrated in the agency’s next extension or revision of this information collection.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2028
36 Months From Approved
Responses
10,400
0
0
Time Burden (Hours)
83,200
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The purpose of this ICR is for the Centers for Medicare & Medicaid Services (CMS) to collect information to implement the Medicare Part D Drug Inflation Rebate Program as proposed in CY 2026 Physician Fee Schedule (PFS) proposed rule. Specifically, section 1860D 14B(b)(1)(B) of the Act requires that beginning with plan year 2026, CMS shall exclude from the total number of units for a Part D rebatable drug, with respect to an applicable period, those units for which a manufacturer provides a discount under the 340B Program. In the CY 2026 PFS proposed rule, CMS proposed to establish a 340B repository to receive voluntary submissions from covered entities of certain data elements from Part D 340B claims to allow CMS to assess such data for use in identifying units of Part D rebatable drugs for which a manufacturer provides a discount under the 340B Program in a future applicable period. CMS proposed to allow covered entities to submit data on units of Part D rebatable drugs for which a manufacturer provides a discount under the 340B Program beginning in 2026 to begin testing the usability of the 340B repository. This ICR will enable CMS to collect information to implement this voluntary collection.
Authorizing Statute(s):
PL:
Pub.L. 117 - 169 11101 and 11102
Name of Law: inflation Reduction Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0938-AV50
Final or interim final rulemaking
90 FR 49266
11/05/2025
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
90 FR 32352
07/16/2025
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 49266
11/05/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Voluntary 340B Repository Data Element Reporting Requirements
CMS-10930
340B Repository Data Elements Reporting Example 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
10,400
0
0
10,400
0
0
Annual Time Burden (Hours)
83,200
0
0
83,200
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:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new collection that is associated with our CY 2026 Physician Fee Schedule (PFS) final rule. The rule establishes a 340B repository to receive voluntary submissions from covered entities. Overall it sets out a burden of 10,400 responses (2,600 covered entities x 4 quarterly responses) and 83,200 total hours.
Annual Cost to Federal Government:
$1,124,418
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:
Mitch Bryman 410 786-5258 Mitch.Bryman@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:
11/21/2025
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