Information Collection

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

IC 182778 under ICR 200803-0925-002 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
0459 FDA guidance.doc	Other-Guidance document

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: New

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of 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 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
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

table that charts IC Documents
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.