Information Collection

320.31(d); Bioavailability and Bioequivalence Safety Reports

IC 194531 under ICR 201610-0910-008 · OMB 0910-0672.

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Information Collection (IC) Details

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IC Title:	320.31(d); Bioavailability and Bioequivalence Safety Reports	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 320.31(d)

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: 14	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	196	-4	200
Annual IC Time Burden (Hours)	2,744	-56	2,800
Annual IC Cost Burden (Dollars)	0	-950	950

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