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Drug and Biologic - Mandatory
Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
OMB: 0925-0586
IC ID: 6153
OMB.report
HHS/NIH
OMB 0925-0586
ICR 200901-0925-002
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⚠️ Notice: This information collection may be referencing outdated material.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
Form 2
Drug and Biologic - Mandatory
Form and Instruction
2 survey
ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf
Form and Instruction
1 survey
ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf
Form and Instruction
ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf
ClinicalTrials
IC Document
ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf
ClinicalTrials
IC Document
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Drug and Biologic - Mandatory
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
Form and Instruction
2
survey
ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf
Yes
Yes
Paper Only
Form and Instruction
1
survey
ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf
Yes
Yes
Paper 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:
3,000
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
3,000
-500
0
0
0
3,500
Annual IC Time Burden (Hours)
21,000
-3,500
0
0
0
24,500
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
ClinicalTrials
ClinicalTrials.gov _Basic Results_ Data Element Definitions.pdf
12/19/2008
ClinicalTrials
ClinicalTrials.gov_Protocol Registry_ Data Element Definitions.pdf
12/19/2008
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.