Disclosure - FDAA-Section 417 - Immediate Notification

Reporting and Recordkeeping Requirements for Reportable Food

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0643 can be found here:

Documents and Forms

Document Name Document Type
0643 Guidance Instrument.pdf www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm Other-Guidance - Questions and Answe

Information Collection (IC) Details

IC Title:	Disclosure - FDAA-Section 417 - Immediate Notification	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance - Questions and Answers			0643 Guidance Instrument.pdf	http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,200	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,200	0	1,200
Annual IC Time Burden (Hours)	2,880	2,160	720
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.