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OMB Control No: 0938-0578	ICR Reference No: 202606-0938-019
Status: Active	Previous ICR Reference No: 202304-0938-029
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: [Medicaid] Medicaid Drug Rebate Program - Manufacturers and Supporting Regulation at 42 CFR 447.534 (CMS-367)
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: 08/12/2026
	Date Received in OIRA: 06/29/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2029	36 Months From Approved	08/31/2026
Responses	16,160	0	15,742
Time Burden (Hours)	606,932	0	591,042
Cost Burden (Dollars)	0	0	0

Abstract: Section 1927 of the Social Security Act (the Act) requires drug labelers to enter into and have in effect a rebate agreement with the Federal government for States to receive funding for drugs dispensed to Medicaid recipients. In order for payment to be made under Medicaid, the drug labeler must complete and sign a drug rebate agreement and fill in the information on the related documents. The drug manufacturer must also supply information within 30 days after the end of each calendar quarter and month on the average manufacturer price of the drugs. Under the Medicaid program, states may provide coverage of prescribed drugs as an optional service under section 1905(a)(12) of the Social Security Act (the Act). Section 1903(a) of the Act provides for federal financial participation (FFP) in state expenditures for these drugs. Section 1927 of the Act governs the Medicaid Drug Rebate (MDR) Program and payment for covered outpatient drugs (CODs), which are defined in section 1927(k)(2) of the Act. In general, for payment to be made available under section 1903(a) of the Act for CODs, manufacturers must enter into a National rebate agreement (agreement) as set forth in section 1927(a) of the Act. Section 1927 of the Act provides specific requirements for rebate agreements, drug pricing submission and confidentiality requirements, the formulas for calculating rebate payments, and requirements for states for CODs.

Authorizing Statute(s): Statute at Large: 19 Stat. 1927

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 2503 Name of Law: Patient Protection and Affordable Care Act
PL: Pub.L. 111 - 226 202 Name of Law: Education Jobs and Medicaid Assistance Act

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 59835	12/22/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 38715	06/26/2026
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
DDR Monthly Pricing Data (CMS-367b)	CMS-367b
DDR Product Data (CMS-367c)	CMS-367c
DDR Quarterly Pricing Data (CMS-367a)	CMS-376a
Quarterly VBP-MBP Data (CMS-367e)	CMS-367e
Supplemental Data Sheet (CMS-367d)	CMS-367d

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	16,160	15,742	418
Annual Time Burden (Hours)	606,932	591,042	15,890
Annual Cost Burden (Dollars)	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: No

Burden Reduction Due to:

Short Statement: In this 202526 iteration we are proposing to revise CMS-367c (Product Data). Using current data, we also have revised the number of respondents reporting drug information to CMS from 818 to 840; an increase of 22 participating labelers in the MDRP. Given that there are more respondents, the change has increased our total time and cost estimates. Our cost estimates have also increased by using more up to date wage figures. We are not proposing changes to any of our per response time estimates or to the frequency of reporting. Overall, we estimate an increase of 418 responses and 15,890 hours.

Annual Cost to Federal Government: $2,000,000

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]? Yes

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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