Drug and Biologic - Voluntary

Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)

⚠️ Notice: This information collection may be referencing outdated material.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
CT Screen Shot -Welcome Page.pdf Other-Screen Shots
CT Screen Shot - First Data Entry Page.pdf Other-Screen Shots
ClinicalTrials gov Data Element Definition - DRAFT _2-5-08_.pdf ClinicalTrials gov Data Element Definition - DRAFT _2-5-08_ IC Document

Information Collection (IC) Details

IC Title:	Drug and Biologic - Voluntary	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Screen Shots			CT Screen Shot -Welcome Page.pdf		Yes	Yes	Paper Only
Other-Screen Shots			CT Screen Shot - First Data Entry Page.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5,400	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
Annual Number of Responses for this IC	43,200	43,200
Annual IC Time Burden (Hours)	86,400	86,400
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
ClinicalTrials gov Data Element Definition - DRAFT _2-5-08_	ClinicalTrials gov Data Element Definition - DRAFT _2-5-08_.pdf	05/08/2008

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.