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Fast track designation and premeeting packages
Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review
OMB: 0910-0389
IC ID: 6040
OMB.report
HHS/FDA
OMB 0910-0389
ICR 201802-0910-005
IC 6040
( )
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:
Fast track designation and premeeting packages
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 356(C) (To search for a specific CFR, visit the
Code of Federal Regulations.
)
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:
1
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
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
0
0
-114
0
115
Annual IC Time Burden (Hours)
1
0
0
-6,899
0
6,900
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.