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Generic Drug User Fees
Generic Drug User Fee Program
OMB: 0910-0727
IC ID: 204809
OMB.report
HHS/FDA
OMB 0910-0727
ICR 202310-0910-004
IC 204809
( )
Documents and Forms
Document Name
Document Type
GDUFA Cover Sheet.pdf
Other-E-form Screenshot
GFI GDUFA II.pdf
Other-Agency Guidance
FDA 3794 GDUFA Cover Sheet (e-form screenshot)
Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf
Form
Form FDA 3794 GDUFA Cover Sheet Instructions.pdf
userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref=
Instruction
GDUFA Performance Goals and Program Enhancements 2023-2027.pdf
Other-GDUFA Performance Goals
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Generic Drug User Fees
Agency IC Tracking Number:
CDER
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Required to Obtain or Retain Benefits
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-E-form Screenshot
GDUFA Cover Sheet.pdf
Yes
Yes
Fillable Fileable
Other-Agency Guidance
GFI GDUFA II.pdf
Yes
Yes
Fillable Fileable
Form
FDA 3794
GDUFA Cover Sheet (e-form screenshot)
Form FDA 3794 GDUFA Cover Sheet Screenshot.pdf
Yes
Yes
Fillable Fileable
Instruction
Form FDA 3794 GDUFA Cover Sheet Instructions.pdf
https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp?legalsel=2&ref=
Yes
Yes
Fillable Fileable
Other-GDUFA Performance Goals
GDUFA Performance Goals and Program Enhancements 2023-2027.pdf
Yes
Yes
Fillable Fileable
Federal Enterprise Architecture Business Reference Module
Line of Business:
Health
Subfunction:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
500
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
3,808
0
0
0
0
3,808
Annual IC Time Burden (Hours)
1,904
0
0
0
0
1,904
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.