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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Reporting- FDAAA, section 512A(a)(2)-Description of Any Pediatric Subpopulation That Suffers From Disease That The Device is Intended to Treat Diagnose or Cure.
Modified
5
500
0
Other-Guidance - Questions and Answers
Reporting-FDAAA, Section 520(m)(6)( C ) - Petition Requirements for HDE Holders Seeking to Modify ADN
Modified
5
500
0
Other-Guidance: HDE Holders- Questions and Answers
Reporting-FDAAA, Section 520(m)(6)(A)(ii)- Assignment of Annual distribution Number ( ADN) for Devices Indicated For Pediatric Patients
Modified
3
150
0
Other-Guidance: HDE-Questions and Answers
Reporting: FDAAA Section 520(m)(6)(A)(iii)- Immediate Notification to The Agency by HDE Holders if ADN Number is Exceed During the calendar Year.
Modified
1
100
0
Other-Buidance: HDE Holders- Questions and Answers
Total burden requested under this ICR:
14
1250
0
To view an IC, click on IC Title
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