Recordkeeping associated with 21 CFR parts 50 and 56

Protection of Human Subjects and Institutional Review Boards

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0130 can be found here:

Documents and Forms

Document Name Document Type

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

Information Collection (IC) Details

IC Title:	Recordkeeping associated with 21 CFR parts 50 and 56	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 50 21 CFR 56

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: 2,520	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: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	137,616	0	137,616
Annual IC Time Burden (Hours)	1,522,104	-104,655	1,626,759
Annual IC Cost Burden (Dollars)	0	-58,400,115	58,400,115

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.