Information Collection

Clinical Protocol Amendments (IND) - CDER and CBER

IC 183055 under ICR 201801-0910-004 · OMB 0910-0616.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0616 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Guidance.pdf	Other-Guidance
FDA 3674 Certification of Compliance Form_3674.pdf	Form

IC Title:

Clinical Protocol Amendments (IND) - CDER and CBER

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			Guidance.pdf		Yes	No	Paper Only
Form	FDA 3674	Certification of Compliance	Form_3674.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 15,741

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 70 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	15,741	1,413	14,328
Annual IC Time Burden (Hours)	3,935	353	3,582
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
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.