Disclosure - FDAA-Section 417 - Immediate Notification

Reporting and Recordkeeping Requirements for Reportable Food

Documents and Forms

Document Name Document Type
Guidance for Industry_ Questions and Answers_0643.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-regarding 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			Guidance for Industry_ Questions and Answers_0643.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-regarding-reportable-food-registry-established-food	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 %

	Requested	Previously Approved
Annual Number of Responses for this IC	1,200	1,200
Annual IC Time Burden (Hours)	2,880	2,880
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.