OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Investigational New Drug Regulations

OMB 0910-0014 ยท HHS/FDA.

OMB 0910-0014

This information collection supports FDA implementation of regulations regarding investigational new drug applications. Respondents to the information collection are those who undertake clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)). The regulations are intended to ensure adherence to procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's).

The latest form for Investigational New Drug Regulations expires 2026-09-30 and is listed under ICR 202509-0910-004.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 1571 Investigational New Drug ApplicationForm
Form FDA 1571 Investigator e-Form screenshotsForm and Instruction
Form Form FDA 1572 Statement of InvestigatorForm
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waiversForm
Form FDA 5023 Right to Try Annual SummaryForm and Instruction
Form FDA 5023 Right to try reporting requirementsForm and Instruction
0014 83C to add 0893 burden - Right To Try.docxJustification for No Material/Nonsubstantive Change
0014 83C to add 0893 burden - Right To Try.docx Justification for No Material/Nonsubstantive Change
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docxSupporting Statement A
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docxSupporting Statement A
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form and Instruction
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Instruction
Right to try reporting requirements Form and Instruction
Right to try reporting requirements Form and Instruction
CBER: IND Required Recordkeeping Information collection
CDER: IND Required Recordkeeping Information collection
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145) Other-Agency Guidance
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Information collection
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA Information collection
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Other-Agency Guidance Document
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Information collection
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides Information collection
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications Information collection
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA Information collection
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202509-0910-004 No material or nonsubstantive change to a currently approved collection 2025-12-02 Approved without change
202403-0910-001 No material or nonsubstantive change to a currently approved collection 2024-03-05 Approved without change
202308-0910-009 Revision of a currently approved collection 2023-08-09 Approved without change
202303-0910-008 No material or nonsubstantive change to a currently approved collection 2023-03-13 Approved without change
202209-0910-001 No material or nonsubstantive change to a currently approved collection 2022-09-07 Approved without change
202202-0910-009 Revision of a currently approved collection 2022-02-23 Approved without change
202103-0910-010 No material or nonsubstantive change to a currently approved collection 2021-03-12 Approved with change
202006-0910-003 No material or nonsubstantive change to a currently approved collection 2020-06-09 Approved without change
201907-0910-023 No material or nonsubstantive change to a currently approved collection 2019-07-25 Approved without change
201902-0910-003 Extension without change of a currently approved collection 2019-02-28 Approved without change
201802-0910-016 No material or nonsubstantive change to a currently approved collection 2018-02-28 Approved without change
201709-0910-004 No material or nonsubstantive change to a currently approved collection 2017-09-21 Approved without change
201503-0910-002 Extension without change of a currently approved collection 2015-03-11 Approved with change
201105-0910-011 Revision of a currently approved collection 2011-05-31 Approved with change
200905-0910-005 Extension without change of a currently approved collection 2009-05-28 Approved with change
200602-0910-005 Extension without change of a currently approved collection 2006-02-17 Approved with change
200211-0910-004 Extension without change of a currently approved collection 2002-11-27 Approved without change
199907-0910-007 Extension without change of a currently approved collection 1999-07-28 Approved without change
199610-0910-007 Reinstatement without change of a previously approved collection 1996-10-31 Approved without change
199509-0910-003 No material or nonsubstantive change to a currently approved collection 1995-09-30 Approved without change
199209-0910-003 Reinstatement with change of a previously approved collection 1992-09-14 Approved without change
198906-0910-007 No material or nonsubstantive change to a currently approved collection 1989-06-05 Approved with change
198801-0910-002 Reinstatement with change of a previously approved collection 1988-01-04 Approved without change
198705-0910-001 Revision of a currently approved collection 1987-05-05 Approved without change
198611-0910-001 Reinstatement with change of a previously approved collection 1986-11-06 Approved without change
198507-0910-006 Reinstatement with change of a previously approved collection 1985-07-24 Approved without change
198401-0910-003 Extension without change of a currently approved collection 1984-01-19 Approved without change
198303-0910-009 Extension without change of a currently approved collection 1983-03-07 Approved without change
198301-0910-002 Reinstatement with change of a previously approved collection 1983-01-12 Approved without change
198205-0910-004 Revision of a currently approved collection 1982-05-13 Approved without change
197710-0910-003 Extension without change of a currently approved collection 1977-10-27 Approved without change

OMB Details

CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form FDA 1571Investigational New Drug ApplicationFillable FileableForm
Form Form FDA 1572Statement of InvestigatorFillable FileableForm
Form FDA 1571Investigator e-Form screenshotsFillable FileableForm and instruction

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