Information Collection

Recordkeeping - AER records under 314.80 (marketing applications)

IC 188678 under ICR 202405-0910-001 · OMB 0910-0230.

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Information Collection (IC) Details

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IC Title:	Recordkeeping - AER records under 314.80 (marketing applications)	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.80(j)

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: 841	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,525,625	867,385	658,240
Annual IC Time Burden (Hours)	24,410,000	13,878,160	10,531,840
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.