Drug and Biologic - 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⚠️ Notice: This information collection may be referencing outdated material.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 Attachment 3 Drug and Biologic - Mandatory Newly registered Trials Form
Attachment 3 Registration Data Entry Attachment_3_Registration_Data_Entry[1].pdf Form

Information Collection (IC) Details

IC Title:	Drug and Biologic - Mandatory Newly registered Trials	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	Attachment 3	Registration Data Entry	Attachment_3_Registration_Data_Entry[1].pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 5,000	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	5,000	2,000	3,000
Annual IC Time Burden (Hours)	35,000	14,000	21,000
Annual IC Cost Burden (Dollars)	0	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.