Information Collection

Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank

IC 182778 under ICR 200805-0925-001 · OMB 0925-0586.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0925-0586 can be found here:

Documents and Forms

Document Name Document Type
0459 FDA guidance.doc Other-Guidance document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance document			0459 FDA guidance.doc		No	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 8,452	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-8,452	8,452
Annual IC Time Burden (Hours)	-38,879	38,879
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.