Information Collection

Foreign Clinical Studies Not Conducted Under an IND - 312.120

IC 184501 under ICR 201306-0910-008 · OMB 0910-0622.

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IC Title:

Foreign Clinical Studies Not Conducted Under an IND - 312.120

Agency IC Tracking Number:

19758

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 312.120(b)

Information Collection Instruments:

table that charts list of 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: 237

Number of Respondents for Small Entity: 0

Affected Public: Federal Government

Percentage of Respondents Reporting Electronically: 75 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	1,185	1,185
Annual IC Time Burden (Hours)	37,920	37,920
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.