OMB control number

Financial Disclosure by Clinical Investigators

OMB 0910-0396 · HHS/FDA.

OMB 0910-0396

The collection require sponsors of any drug, biologic or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.

The latest form for Financial Disclosure by Clinical Investigators expires 2028-07-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 3454 Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form
Form 3455 Disclosure--54.4(a)(3)--Form FDA 3455 Form
0396_Supporting Statement_2025.docx Supporting Statement A
Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form
Recordkeeping--54.6
54.4(b)--Clinical Investigators Third Party Disclosure
Disclosure--54.4(a)(3)--Form FDA 3455 Form

All Historical Document Collections

202504-0910-011	Extension without change of a currently approved collection	2025-05-05
202110-0910-010 Approved without change	Extension without change of a currently approved collection	2022-03-31
201901-0910-004 Approved without change	Extension without change of a currently approved collection	2019-03-14
201510-0910-002 Approved with change	Extension without change of a currently approved collection	2015-11-06
201207-0910-012 Approved with change	Extension without change of a currently approved collection	2012-07-27
200904-0910-010 Approved with change	Extension without change of a currently approved collection	2009-04-28
200602-0910-004 Approved without change	Extension without change of a currently approved collection	2006-02-16
200301-0910-001 Approved without change	Reinstatement with change of a previously approved collection	2003-01-02
200207-0910-001 Withdrawn	Reinstatement without change of a previously approved collection	2002-07-08
199901-0910-003 Approved without change	New collection (Request for a new OMB Control Number)	1999-01-15

OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form 3454

CERTIFICATION: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORS

Fillable Fileable

Form

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.