Information Collection

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

IC 5669 under ICR 202608-0910-010 · OMB 0910-0014.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form Form FDA 1572 Statement of Investigator CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form
Form Form FDA 1572 Statement of Investigator CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form
Form FDA 1571 Investigator e-Form screenshots CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form and Instruction
Form FDA 1571 Investigator e-Form screenshots CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form and Instruction
Form FDA 1571 Investigational New Drug Application CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form
Form FDA 1571 Investigational New Drug Application: PROPOSED REVISIONS SEPT. 2026 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form and Instruction
Form FDA 1571 Investigational New Drug Application: CURRENTLY APPROVED VERSION CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Form and 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: PROPOSED REVISIONS Form FDA 1571 Revisions SEP 26.pdf	Form and Instruction
FDA 1571 Investigational New Drug Application: CURRENTLY APPROVED FDA-1571_AcroForm_Sec_05-21-2026.pdf	Form and Instruction

Information Collection (IC) Details

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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: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.1-312.10

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	Form FDA 1572	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 1571	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 1571	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 1571	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

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 %

table that charts list of burden
	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

table that charts IC Documents
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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