OMB control number
Investigational New Drug Regulations
OMB 0910-0014 · HHS/FDA.
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 can be found here.
Document Name |
|---|
Form |
Form and Instruction |
Justification for No Material/Nonsubstantive Change |
Supporting Statement A |
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
0014 83C to add 0893 burden - Right To Try.docx
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form FDA 1571 | Investigational New Drug Application | Fillable Fileable | Form |
| Form Form FDA 1572 | Statement of Investigator | Fillable Fileable | Form |
| Form FDA 1571 | Investigator e-Form screenshots | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.