Information Collection

Drugs and Biologics (Ongoing Trials)

IC 185099 under ICR 200901-0925-002 · 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⚠️ Notice: This information collection may be referencing outdated material.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
Form 2 Drugs and Biologics (Ongoing Trials)	Form and Instruction
2 results ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf	Form and Instruction
1 registration 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

IC Title:

Drugs and Biologics (Ongoing Trials)

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
Form and Instruction	2	results	ClinicalTrials gov - Results Reporting Data Entry Screen Shots.pdf		Yes	Yes	Paper Only
Form and Instruction	1	registration	ClinicalTrials.gov - Registration Data Entry Screen Shots.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: 7,000

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	28,000	28,000
Annual IC Time Burden (Hours)	56,000	56,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
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.