Certification--54.4(a)(1) and (a)(2)--Form FDA 3454

Financial Disclosure by Clinical Investigators

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0396 can be found here:

Documents and Forms

Document Name Document Type
Form 3454 Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form
3454 FDA Form 3454 FDA 3454_0910-0396 exp 2019.pdf Form

Information Collection (IC) Details

IC Title:	Certification--54.4(a)(1) and (a)(2)--Form FDA 3454	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 54.4

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3454	FDA Form 3454	FDA 3454_0910-0396 exp 2019.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: 1,050	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 10 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,050	50	1,000
Annual IC Time Burden (Hours)	1,050	50	1,000
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.