Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
511.1(b)(3) - Recordkeeping for clinical investigations Removed 0 0 0
511.1(b)(5) Data submission for use of edible food products Removed 0 0 0
511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption Removed 0 0 0
511.1(b)(7)(ii) - Recordkeeping sponsor Removed 0 0 0
511.1(b)(8) (ii) Report of significant hazards Removed 0 0 0
511.1(b)(8)(i) - Recordkeeping of investigator reports Removed 0 0 0
511.1(b)(9) Import for clinical investigation Removed 0 0 0
Recordkeeping: NAD for Investigational Use Modified 5060 13060 0
Reporting: NAD for Investigational Use Modified 1663 2000 0 Instruction
Other-e-Submission screenshot
Total burden requested under this ICR: 6723 15060 0  
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