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OMB Control No: 0938-1485	ICR Reference No: 202608-0938-007
Status: Received in OIRA	Previous ICR Reference No: 202511-0938-002
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: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 08/13/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2028
Responses	70,000	10,400
Time Burden (Hours)	462,000	83,200
Cost Burden (Dollars)	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: US Code: 42 USC 1860D 14B(b)(1)(B) Name of Law: Social Security Act

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV82	Proposed rulemaking	91 FR 43842	07/16/2026

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 43842	07/16/2026
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Voluntary 340B Repository Data Element Reporting Requirements

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Adjustment in Estimate
Annual Number of Responses	70,000	10,400	45,600	14,000
Annual Time Burden (Hours)	462,000	83,200	364,800	14,000
Annual Cost Burden (Dollars)	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: The purpose of this collection of information collection request is for the Centers for Medicare & Medicaid Services (CMS) to collect information to implement the Medicare Part D Drug Inflation Rebate Program pursuant to the proposed policies in the Calendar Year (CY) 2027 Physician Fee Schedule rule (“CY 2027 PFS proposed rule”) (CMS-1848-P, RIN 0938-AV82). With adjustments of 14,000 responses and 14,000 hours, we estimate an increase of 45,600 responses and 364,800 hours.

Annual Cost to Federal Government: $1,277,346

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

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