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⚠️ Notice: This information collection may be referencing outdated material.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 Form FDA 3454--certification.doc 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 301

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	Form FDA 3454--certification.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 902	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	902	-98	1,000
Annual IC Time Burden (Hours)	902	-4,098	5,000
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.