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Investigational New Drug Sponsors: Interviews
Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act
OMB: 0910-0863
IC ID: 233950
OMB.report
HHS/FDA
OMB 0910-0863
ICR 201811-0910-001
IC 233950
( )
Documents and Forms
Document Name
Document Type
Survey Instrument.docx
Other-Survey
Interview Script.docx
Other-Script
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Investigational New Drug Sponsors: Interviews
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
New
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Survey
Survey Instrument.docx
Yes
Yes
Fillable Fileable
Other-Script
Interview Script.docx
Yes
No
Paper Only
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Health Care Services
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
450
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
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
450
0
450
0
0
0
Annual IC Time Burden (Hours)
675
0
675
0
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.