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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
MDUFMA Small Business Qualification Certification (Form FDA 3602 and Form FDA 3602A))
Agency IC Tracking Number:
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
Form
Form FDA 3602
MDUFA Small Business Qualification and Certification (In the United States)
FDA 3602.pdf
No
Printable Only
Form
Form FDA 3602A
MDUFA Small Business Qualification and Certification (Outside of United States)
FDA 3602a.pdf
No
Printable Only
Other-Guidance
Medical Device User Fee Small Business Qualification Guidance.pdf
Yes
No
Printable Only
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:
4,500
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
90 %
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
4,500
0
0
-2,500
0
7,000
Annual IC Time Burden (Hours)
4,500
0
0
-2,500
0
7,000
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.