Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds

Documents and Forms

Document Name Document Type
completeresponseguidance.pdf Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			completeresponseguidance.pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 127	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	180	16	164
Annual IC Time Burden (Hours)	51,120	4,544	46,576
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

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