Information Collection

FFDCA Sections 583 & 584 Reporting

IC 109945 under ICR 202202-0910-012 · OMB 0910-0251.

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Information Collection (IC) Details

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IC Title:	FFDCA Sections 583 & 584 Reporting	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 205

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: 2,410	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	Program Change Due to New Statute	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	5,850	550	5,300
Annual IC Time Burden (Hours)	8,782	5,690	3,092
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.