Information Collection

503B Initial drug product reports

IC 224059 under ICR 201911-0910-001 · OMB 0910-0827.

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Information Collection (IC) Details

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IC Title:	503B Initial drug product reports	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

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: 75	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	77	-12,024	12,101
Annual IC Time Burden (Hours)	153	-24,048	24,201
Annual IC Cost Burden (Dollars)	1,552,936	1,552,936	0

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