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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
ADN Modification--520(m)(6)(C) of the FD&C Act
Modified
5
500
0
Other-Guidance
ADN Notification--520(m)(6)(A)(iii) of the FD&C Act
Modified
1
100
0
Other-Guidance
Exemption from Profit Prohibition Information--520(m)(6)(A)(i) and (ii) of the FD&C Act
Modified
3
150
0
Other-Guidance
Pediatric Subpopulation and Patient Information--515A(a)(2) of the FD&C Act
Modified
6
600
0
Other-Guidance
Request for Determination of Eligibility Criteria--613(b) of FDASIA
New
2
20
0
Other-Guidance
Total burden requested under this ICR:
17
1370
0
To view an IC, click on IC Title
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