Information Collection

CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA

IC 189319 under ICR 202509-0910-004 · OMB 0910-0014.

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Information Collection (IC) Details

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IC Title:	CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.40-312.48

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: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 154	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	Previously Approved
Annual Number of Responses for this IC	713	713
Annual IC Time Burden (Hours)	119,948	119,948
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.

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