OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Financial Disclosure by Clinical Investigators

OMB 0910-0396 ยท 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 is listed under ICR 202504-0910-011.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form 3454 CERTIFICATION: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORSForm
Form 3454 Certification--54.4(a)(1) and (a)(2)--Form FDA 3454Form
Form 3455 DISCLOSURE: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORSForm
Form 3455 Disclosure--54.4(a)(3)--Form FDA 3455Form
0396_Supporting Statement_2025.docxSupporting Statement A
0396_Supporting Statement_2025.docxSupporting Statement A
Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form
Certification--54.4(a)(1) and (a)(2)--Form FDA 3454 Form
Recordkeeping--54.6 Information collection
54.4(b)--Clinical Investigators Third Party Disclosure Information collection
Disclosure--54.4(a)(3)--Form FDA 3455 Form
Disclosure--54.4(a)(3)--Form FDA 3455 Form

All Historical Document Collections

Historical document collections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200207-0910-001 Reinstatement without change of a previously approved collection 2002-07-08 Withdrawn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

OMB Details

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

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form 3454CERTIFICATION: FINANCIAL INTERESTS AND ARRANGEMENTS OF CLINICAL INVESTIGATORSFillable FileableForm

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