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

Investigational New Drug Regulations

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0014 can be found here:

Documents and Forms

Document Name Document Type
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form
FDA-form-1571_r13_instructions_508_FINAL_CDERProposedEdits.pdf Instruction
FDA-form-1571_r13_instructions_508_FINAL_CDERProposedEdits.pdf Instruction
Form FDA 1572 Statement of Investigator FORM FDA 1572 Statement of Investigator.pdf Form
Form FDA 1572 Statement of Investigator FORM FDA 1572 Statement of Investigator.pdf Form
FDA 1571 Investigator e-Form screenshots 0014 Getting Started Page PRA Statement.pdf Form and Instruction
FDA 1571 Investigator e-Form screenshots 0014 Getting Started Page PRA Statement.pdf Form and Instruction
FDA 1571 Investigational New Drug Application FDA-1571 updates.pdf Form
FDA 1571 Investigational New Drug Application FDA-1571 updates.pdf Form

Information Collection (IC) Details

IC Title:	CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.1-312.10

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	Form FDA 1572	Statement of Investigator	FORM FDA 1572 Statement of Investigator.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 1571	Investigator e-Form screenshots	0014 Getting Started Page PRA Statement.pdf	Yes	Yes	Fillable Fileable
Form	FDA 1571	Investigational New Drug Application	FDA-1571 updates.pdf	Yes	Yes	Fillable Fileable
Instruction			FDA-form-1571_r13_instructions_508_FINAL_CDERProposedEdits.pdf	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 454	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Previously Approved
Annual Number of Responses for this IC	722	722
Annual IC Time Burden (Hours)	17,880	17,880
Annual IC Cost Burden (Dollars)	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.