Information Collection

Investigational New Drug Applications: Annual Reporting DRUGS (CDER)

IC 263232 under ICR 202311-0910-007 · OMB 0910-0924.

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Information Collection (IC) Details

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IC Title:	Investigational New Drug Applications: Annual Reporting DRUGS (CDER)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.33 - DRUGS

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: 2,877	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
Annual Number of Responses for this IC	9,736	9,736
Annual IC Time Burden (Hours)	3,855,456	3,855,456
Annual IC Cost Burden (Dollars)	0	0

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