Device - Mandatory Newly Registered Trials

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⚠️ Notice: This information collection may be referencing outdated material.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
Form 1 Device - Mandatory Newly Registered Trials Form and Instruction
1 Registration Data Entry Attachment 3 Registration Data Entry.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Device - Mandatory Newly Registered Trials	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

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	1	Registration Data Entry	Attachment 3 Registration Data Entry.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 500	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-4,000	4,000
Annual IC Time Burden (Hours)	-8,000	8,000
Annual IC Cost Burden (Dollars)	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.