[Medicaid] Section 1115 Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428 (CMS-10341)

Forms and Documents

Document	Type	Status	Availability
Response to 30-day Comments (2025 version 2).pdf	Supplementary Document	Uploaded 2025-04-11	Available
Response to 30-day Comments (2025 version 2).pdf	Supplementary Document	Uploaded 2025-04-11	Repair queued
Justification for a Nonsubstantive Change (CMS-10341).pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2025-04-11	Available
Justification for a Nonsubstantive Change (CMS-10341).pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2025-04-11	Repair queued
CMS-10341. Supporting Statement A (1-31-25).docx	Supporting Statement A	Uploaded 2025-01-31	Available
CMS-10341. Supporting Statement A (1-31-25).docx	Supporting Statement A	Uploaded 2025-01-31	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
250574	Summative Report (431.424(c)(2)(v))		Unchanged
196284	Reporting Requirements (431.428(b)(2))		Unchanged
196283	Reporting Requirements (431.428(a)(1) - (11))		Unchanged
196282	Evaluation Requirements (431.424(e))		Unchanged
196281	Evaluation Requirements (431.424(d))		Unchanged
196280	Evaluation Requirements (431.424(c)(1)		Unchanged
196279	Monitoring and Compliance (431.420(b))		Unchanged
196278	Application Procedures (431.412(c))		Unchanged
196277	State Public Notice Process (431.412(a))		Unchanged
196276	Application Procedures (431.408(b)(1))		Unchanged
196275	State Public Notice Process (431.408(a)(1) and (a)(2)(i))		Unchanged

ICR Details

OMB Control No: 0938-1162	ICR Reference No: 202504-0938-013
Status: Active	Previous ICR Reference No: 202501-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: [Medicaid] Section 1115 Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428 (CMS-10341)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/15/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 04/11/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2028	03/31/2028	03/31/2028
Responses	403	0	403
Time Burden (Hours)	41,874	0	41,874
Cost Burden (Dollars)	0	0	0

---

Abstract: Section 10201(i) of the Affordable Care Act (ACA) added provisions under Section 1115 of the Social Security Act to require the Secretary to publish no later than 180 days after the enactment of this act, regulations that establish application requirements for demonstration projects. Under section 10201(i) of ACA the Secretary must establish a process for public notice and comment at the State level, and at the federal level after an application for a demonstration project is received by the Secretary. In addition, the Secretary must implement reporting requirements for States, establish a process for the periodic evaluation of demonstration projects and report annually to Congress on the implementation of previously approved demonstration projects. This collection would address the provisions required under Sections 10201(i) of the Affordable Care Act.

---

Authorizing Statute(s): PL: Pub.L. 111 - 148 10201 Name of Law: Amendments to the Social Security Act and Title II of this Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 148 10201 Name of Law: Amendments to the Social Security Act and Title II of this 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:
	89 FR 86340	10/30/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 8800	02/03/2025
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Application Procedures (431.408(b)(1))
Application Procedures (431.412(c))
Evaluation Requirements (431.424(c)(1)
Evaluation Requirements (431.424(d))
Evaluation Requirements (431.424(e))
Monitoring and Compliance (431.420(b))
Reporting Requirements (431.428(a)(1) - (11))
Reporting Requirements (431.428(b)(2))
State Public Notice Process (431.408(a)(1) and (a)(2)(i))
State Public Notice Process (431.412(a))
Summative Report (431.424(c)(2)(v))

---

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	403	403	0	0	0	0
Annual Time Burden (Hours)	41,874	41,874	0	0	0	0
Annual Cost Burden (Dollars)	0	0	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:

---

Annual Cost to Federal Government: $0

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

---

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: 04/11/2025

---