Information Collection

Disclosure - FDAA-Section 417 - Immediate Notification

IC 189626 under ICR 202303-0910-024 · OMB 0910-0643.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

CFSAN

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

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 - 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 %

table that charts list of burden
	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

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.