Information Collection

BE Supplements/Amendments - ODG

IC 214358 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type
Form FDA 3674 BE Supplements/Amendments - ODG Form
Guidance.pdf Other-Guidance
FDA 3674 Certification of Compliance Form_3674.pdf Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	BE Supplements/Amendments - ODG	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 698	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 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	698	-291	989
Annual IC Time Burden (Hours)	524	-218	742
Annual IC Cost Burden (Dollars)	0	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.