Information Collection

FFDCA Sections 583 & 584 Reporting

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

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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:

table that charts list of 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 %

table that charts list of burden
	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

Documents for IC

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