Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions (CMS-10398)

Forms and Documents

Document Name	Status
CMS-10398 - Supporting Statement A (2021 version 3).docx Supporting Statement A	2021-03-19

IC Document Collections

IC ID	Document Title	Status
246350	GenIC Inventory Other-Inventory of Currently Approved GenICs	New

ICR Details

OMB Control No: 0938-1148	ICR Reference No: 202103-0938-018
Status: Received in OIRA	Previous ICR Reference No: 201712-0938-019
Agency/Subagency: HHS/CMS	Agency Tracking No: CMCS
Title: Generic Clearance for Medicaid and CHIP State Plan, Waiver, and Program Submissions (CMS-10398)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 03/23/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2021
Responses	6,720	6,720
Time Burden (Hours)	154,104	154,104
Cost Burden (Dollars)	0	0

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Abstract: The Center for Medicaid, CHIP, and Survey & Certification in CMS works in partnership with States to implement Medicaid and the Children's Health Insurance Program (CHIP), and the Social Security Act requires written plans between CMS and the State to implement these programs. The Affordable Care Act enacted comprehensive reform that requires modification of existing programs. In addition to the Medicaid and CHIP State plans, CMS also continues to work with States through other methods to further the goals of health reform, including program waivers and demonstrations and other technical assistance initiatives and reporting. This collection will provide streamlined submission forms for States to implement health reform initiatives in Medicaid and CHIP state plans, demonstrations, and waivers, including legislative requirements enacted by the Affordable Care Act.

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Authorizing Statute(s): Statute at Large: 21 Stat. 2101
   Statute at Large: 21 Stat. 1115
   Statute at Large: 19 Stat. 1901
   Statute at Large: 19 Stat. 1915
  

Citations for New Statutory Requirements: Statute at Large: 19 Stat. 1915
Statute at Large: 21 Stat. 2101
Statute at Large: 21 Stat. 1115
Statute at Large: 19 Stat. 1901

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 37456	06/22/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 14927	03/19/2021
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
GenIC Inventory

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ICR Summary of Burden

	Total Request	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	6,720	6,720	0	0	0	0
Annual Time Burden (Hours)	154,104	154,104	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:

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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

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Common Form ICR:  No

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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: 03/23/2021

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