.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research

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

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	.109(d) [Pre-2018 and 2018 Requirements] – Written notification of IRB approval or disapproval of research	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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 6,000	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	150,000	147,000	3,000
Annual IC Time Burden (Hours)	75,000	72,750	2,250
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.