Early Warning Recall Voluntary

Electronic Submission of FDA Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0645 can be found here:

Documents and Forms

Document Name Document Type
Confidential 1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109 (2).pdf Other-system screenshot
Confidential 1005 Mandatory-Initial-Subview Questions Explanatory Notes-040109.doc Other-system screenshot
Confidential 1005_Mandatory-Initial-Part_3-Problem_Summary-040109.pdf Other-system screenshot

Information Collection (IC) Details

IC Title:	Early Warning Recall Voluntary	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-system screenshot	Confidential 1005_Mandatory-Initial-Part_4-Adulteration_Origination_Site-040109 (2).pdf	Yes	Yes	Paper Only
Other-system screenshot	Confidential 1005 Mandatory-Initial-Subview Questions Explanatory Notes-040109.doc	Yes	Yes	Paper Only
Other-system screenshot	Confidential 1005_Mandatory-Initial-Part_3-Problem_Summary-040109.pdf	Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 540	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	-540	540
Annual IC Time Burden (Hours)	-324	324
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.