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Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank
OMB: 0925-0586
IC ID: 6153
OMB.report
HHS/NIH
OMB 0925-0586
ICR 200803-0925-002
IC 6153
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0925-0586 can be found here:
2023-02-08 - Extension without change of a currently approved collection
2020-01-28 - Extension without change of a currently approved collection
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:
Modified
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
Federal Enterprise Architecture Business Reference Module
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 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
10,664
0
0
-27,850
0
38,514
Annual IC Time Burden (Hours)
49,054
0
0
-128,111
0
177,165
Annual IC Cost Burden (Dollars)
0
0
0
0
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.