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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Humanitarian Device Exemption Applications (HDE) - Requirement to Include Readily Available Information Concerning Actual and Potential Uses of the Device
New
1
20
0
PMA Supplements - Requirement for Submission of All Changes That Affect Safety and Efficacy
New
10
40
0
Premarket Approval Applications (PMA) - Specifies Submission of Certain Information on Pediatric Subpopulations , if Readily Available, Concerning Potential Pediatric Uses
New
25
100
0
Procedures for Amending an Incomplete PMA or Resubmitting a Withdrawn PMA With any Information Concerning Potential Pediatric Uses
New
10
40
0
Total burden requested under this ICR:
46
200
0
To view an IC, click on IC Title