Information Collection

Drug and Biologic - Voluntary

IC 185103 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⚠️ Notice: This information collection may be referencing outdated material.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 Drug and Biologic - Voluntary	Form and Instruction
1 registration ClinicalTrials.gov - Registration Data Entry Screen Shots.pdf	Form and Instruction
2 results ClinicalTrials gov - Results Reporting 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:

Drug and Biologic - Voluntary

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

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	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 6,000

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	Program Change Due to New Statute	Previously Approved
Annual Number of Responses for this IC	48,000	4,800	43,200
Annual IC Time Burden (Hours)	96,000	9,600	86,400
Annual IC Cost Burden (Dollars)	0	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.