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

Investigational New Drug Regulations

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

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: Unchanged

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: Consumer Health and Safety

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: 99 %

	Approved	Previously Approved
Annual Number of Responses for this IC	12,563	12,563
Annual IC Time Burden (Hours)	413,715	413,715
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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