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)
Modified
4
3
0
Humanitarian Use Devices; Notification of emergency use--814.124(a)
New
22
22
0
Information to Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements
Modified
5
360
0
Other-Guidance; Humanitarian Device Exemption (HDE) Program - Guidance for Industry and Food and Drug Administration Staff
Medical Devices; Humanitarian Use Devices - Recordkeeping
New
81
162
0
Medical Devices; Humanitarian Use Devices - Reporting
Modified
211
22037
0
Total burden requested under this ICR:
323
22584
0
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