Information Collection

312.32(c)(1)(ii) and (c)(1)(iii); IND Safety Reports

IC 194532 under ICR 201610-0910-008 · OMB 0910-0672.

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Information Collection (IC) Details

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IC Title:	312.32(c)(1)(ii) and (c)(1)(iii); IND Safety Reports	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.32(c)(1)(ii) 21 CFR 312.32(c)(1)(iii)

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: 237	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	1,148	548	600
Annual IC Time Burden (Hours)	13,776	6,576	7,200
Annual IC Cost Burden (Dollars)	0	-250	250

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