Information Collection

#74 (New): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials

IC 251149 under ICR 202401-0938-016 · OMB 0938-1148.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-1148 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form CMS-10398 #74 #74 (New): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials	Form
Form CMS-10398 #74 #74 (New): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials	Form
CMS-10398 #74 Att. 3.1-A (Qualifying Clinical Trial Draft Preprint) Preprint Att. 3.1-A (2022 version 3).docx	Form
CMS-10398 #74 Att. 3.1-A (Qualifying Clinical Trial Draft Preprint) Preprint Att. 3.1-A (2022 version 3).docx	Form
CMS-10398 #74 Att. 3.1.-B (Qualifying Clinical Trial Draft Preprint) Preprint Att. 3.1-B (2022 version 3).docx	Form
CMS-10398 #74 Att. 3.1.-B (Qualifying Clinical Trial Draft Preprint) Preprint Att. 3.1-B (2022 version 3).docx	Form
Qualifying Clinical Trial Attestation Form 74 - QUALIFYING CLINICAL TRIAL ATTESTATION FORM CLEAN 8.17.21 I.pdf	Form and Instruction
Qualifying Clinical Trial Attestation Form 74 - QUALIFYING CLINICAL TRIAL ATTESTATION FORM CLEAN 8.17.21 I.pdf	Form and Instruction
74 - Generic Supporting Statement (2022 version 5).docx Generic Supporting Statement	IC Document
74 - Generic Supporting Statement (2022 version 5).docx Generic Supporting Statement	IC Document
84f2c322 - GenIC #74 Comment.pdf Public Comment	IC Document
84f2c322 - GenIC #74 Comment.pdf Public Comment	IC Document
Public Comments Received on GenIC #74.docx Response to Public Comment	IC Document
Public Comments Received on GenIC #74.docx Response to Public Comment	IC Document

IC Title:

#74 (New): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials

Agency IC Tracking Number:

CMCS

IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	CMS-10398 #74	Att. 3.1-A (Qualifying Clinical Trial Draft Preprint)	Preprint Att. 3.1-A (2022 version 3).docx	Yes	Yes	Fillable Fileable
Form	CMS-10398 #74	Att. 3.1.-B (Qualifying Clinical Trial Draft Preprint)	Preprint Att. 3.1-B (2022 version 3).docx	Yes	Yes	Fillable Fileable
Form and Instruction	N/A	Qualifying Clinical Trial Attestation Form	74 - QUALIFYING CLINICAL TRIAL ATTESTATION FORM CLEAN 8.17.21 I.pdf	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 56

Number of Respondents for Small Entity: 0

Affected Public: State, Local, and Tribal Governments

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Previously Approved
Annual Number of Responses for this IC	66	66
Annual IC Time Burden (Hours)	61	61
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Generic Supporting Statement	74 - Generic Supporting Statement (2022 version 5).docx	01/24/2022
Public Comment	84f2c322 - GenIC #74 Comment.pdf	01/24/2022
Response to Public Comment	Public Comments Received on GenIC #74.docx	01/24/2022

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.