Information Collection

.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting

IC 10389 under ICR 202407-0990-001 · OMB 0990-0260.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
45 CFR part 46_0990-0260_10 May 2018.pdf	Other-cfr
45 CFR part 46_0990-0260_10 May 2018.pdf	Other-cfr

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

.103(b)(5), .113 [Pre-2018 Requirements]/.108(a)(4), .113 [2018 Requirements] - Incident Reporting, Suspension or Termination of IRB approval Reporting

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 45 CFR 46

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-cfr			45 CFR part 46_0990-0260_10 May 2018.pdf		No		Paper Only

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 5,200

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 25 %

table that charts list of burden
	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-5,200	5,200
Annual IC Time Burden (Hours)	-5,200	5,200
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
No associated records found

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