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

Protection of Human Subjects: Common Rule (56 FR 28001)

Documents and Forms

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

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: Modified

Obligation to Respond: Mandatory

CFR Citation: 45 CFR 46

Information Collection 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

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 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	5,200	-230,780	235,980
Annual IC Time Burden (Hours)	5,200	-230,780	235,980
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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.