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Foreign Clinical Studies Not Conducted Under an IND - 312.120
Foreign Clinical Studies Not Conducted Under an IND
OMB: 0910-0622
IC ID: 184501
OMB.report
HHS/FDA
OMB 0910-0622
ICR 201306-0910-008
IC 184501
( )
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
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:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Federal Enterprise Architecture Business Reference Module
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 %
Approved
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
1,185
0
0
1,185
0
0
Annual IC Time Burden (Hours)
37,920
0
0
37,920
0
0
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.