PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Certification of Compliance with 42 U.S.C. ยง 282(j)(5)(B)
New
4
3
0
Form
FDA 3674
Certification of Compliance with 42 USC 282(j)(5)(B)
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Unchanged
5
360
0
Other-Agency Guidance
Medical Devices; Humanitarian Use Devices
Unchanged
377
22542
0
Total burden requested under this ICR:
386
22905
0
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