Information Collection

ONE-TIME Burden to review and implement new requirements

IC 183803 under ICR 202211-0910-012 · OMB 0910-0560.

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Information Collection (IC) Details

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IC Title:	ONE-TIME Burden to review and implement new requirements	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1 Subpart S secs.1.1300-1.1465

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 570,977	Number of Respondents for Small Entity: 1,897

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Program Change Due to New Statute	Previously Approved
Annual Number of Responses for this IC	900,979	882,004	18,975
Annual IC Time Burden (Hours)	8,289,635	8,204,247	85,388
Annual IC Cost Burden (Dollars)	0	0	0

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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.