103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent

Protection of Human Subjects: Common Rule (56 FR 28003)

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0990-0260 can be found here:

Documents and Forms

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

Information Collection (IC) Details

IC Title:	103(b)(4), .109(d)IRB Actions, .116 and .117 Informed Consent	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

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: Health Care Services

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: Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 5 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	235,980	-210,354	446,334
Annual IC Time Burden (Hours)	235,980	-869,854	1,105,834
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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