Information Collection

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

IC 6153 under ICR 200711-0910-004 · OMB 0910-0459.

Documents and Forms

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

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

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: 5,332

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	Previously Approved
Annual Number of Responses for this IC	10,664	-27,850	38,514
Annual IC Time Burden (Hours)	49,054	-128,111	177,165
Annual IC Cost Burden (Dollars)	0	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.