Information Collection

CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies

IC 189332 under ICR 201503-0910-002 · OMB 0910-0014.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0014 can be found here:

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Information Collection (IC) Details

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IC Title:	CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 312.110-312.145

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: 1,463	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	12,572	11,997	575
Annual IC Time Burden (Hours)	414,003	395,603	18,400
Annual IC Cost Burden (Dollars)	0	0	0

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