Information Collection

CBER/CDER Form FDA 3500

IC 216796 under ICR 202603-0910-005 · OMB 0910-0291.

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Information Collection (IC) Details

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IC Title:	CBER/CDER Form FDA 3500	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 1271 21 CFR 310 21 CFR 314 21 CFR 329 21 CFR 600

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3500				Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 58,711	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 20 %

	Requested	Previously Approved
Annual Number of Responses for this IC	58,711	58,711
Annual IC Time Burden (Hours)	38,749	38,749
Annual IC Cost Burden (Dollars)	0	0

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