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Designation Requests
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 201412-0910-016
IC 6040
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0389 can be found here:
2018-02-13 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
GUIDANCE 0389 12-29-2014.pdf
Other-Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Designation Requests
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
Other-Guidance
GUIDANCE 0389 12-29-2014.pdf
Yes
No
Paper Only
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:
81
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
80 %
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
115
0
0
38
0
77
Annual IC Time Burden (Hours)
6,900
0
0
-800
0
7,700
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.