Information Collection

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

IC 252860 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⚠️ Notice: This information collection may be referencing outdated material.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 GenIC #74 (Revised): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials	Form
Form CMS-10398 #74 GenIC #74 (Revised): Coverage of Routine Patient Cost for Items & Services in Qualifying Clinical Trials	Form
CMS-10398 #74 Qualifying Clinical Trial Preprint (Attachment 3.1-A) Preprint Att. 3.1-A (2022 version 3).pdf	Form
CMS-10398 #74 Qualifying Clinical Trial Preprint (Attachment 3.1-A) Preprint Att. 3.1-A (2022 version 3).pdf	Form
CMS-10398 #74 Qualifying Clinical Trial Preprint (Attachment 3.1-B) Preprint Att. 3.1-B (2022 version 3).pdf	Form
CMS-10398 #74 Qualifying Clinical Trial Preprint (Attachment 3.1-B) Preprint Att. 3.1-B (2022 version 3).pdf	Form
HHS Qualifying Clinical Trial Attestation Form REVISED QUALIFYING CLINICAL TRIAL ATTESTATION FORM Clean 3.17.22 - 508.pdf	Form
HHS Qualifying Clinical Trial Attestation Form REVISED QUALIFYING CLINICAL TRIAL ATTESTATION FORM Clean 3.17.22 - 508.pdf	Form
#74 - Generic Supporting Statement (2022 version 7).docx Generic Supporting Statement	IC Document
#74 - Generic Supporting Statement (2022 version 7).docx Generic Supporting Statement	IC Document
SCRS Comment.pdf Public Comment	IC Document
SCRS Comment.pdf Public Comment	IC Document
Response to Comments.pdf Response to Public Comment	IC Document
Response to Comments.pdf Response to Public Comment	IC Document
Crosswalk - Qualifying Clinical Trials Attestation Form 03-29-2022.pdf Crosswalk: Qualifying Clinical Trial Attestation Form	IC Document
Crosswalk - Qualifying Clinical Trials Attestation Form 03-29-2022.pdf Crosswalk: Qualifying Clinical Trial Attestation Form	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

GenIC #74 (Revised): 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	Qualifying Clinical Trial Preprint (Attachment 3.1-A)	Preprint Att. 3.1-A (2022 version 3).pdf	Yes	Yes	Fillable Fileable
Form	CMS-10398 #74	Qualifying Clinical Trial Preprint (Attachment 3.1-B)	Preprint Att. 3.1-B (2022 version 3).pdf	Yes	Yes	Fillable Fileable
Form	n/a	HHS Qualifying Clinical Trial Attestation Form	REVISED QUALIFYING CLINICAL TRIAL ATTESTATION FORM Clean 3.17.22 - 508.pdf	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

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)	5	5
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 7).docx	04/13/2022
Public Comment	SCRS Comment.pdf	04/13/2022
Response to Public Comment	Response to Comments.pdf	04/13/2022
Crosswalk: Qualifying Clinical Trial Attestation Form	Crosswalk - Qualifying Clinical Trials Attestation Form 03-29-2022.pdf	04/13/2022

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