Development of Comprehensive Monitoring Plan

Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0733 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE 0733 1-4-2016.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Development of Comprehensive Monitoring Plan	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 312 21 CFR 812

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE 0733 1-4-2016.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 88	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Previously Approved
Annual Number of Responses for this IC	132	132
Annual IC Time Burden (Hours)	528	528
Annual IC Cost Burden (Dollars)	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.