Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
511.1(a)(3) - Recordkeeping for laboratory research Modified 545 545 0
511.1(b)(3) - Recordkeeping for clinical investigations Modified 1395 1395 0
511.1(b)(4) NCIE for clinical investigations Modified 1395 1395 607376 Instruction
Other-e-Submission screenshot
511.1(b)(5) Data submission for use of edible food products Modified 69 552 0
511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption Modified 2 2 0
511.1(b)(7)(ii) - Recordkeeping sponsor Modified 1395 4883 0
511.1(b)(8) (ii) Report of significant hazards Modified 15 30 0
511.1(b)(8)(i) - Recordkeeping of investigator reports Modified 1395 4883 0
511.1(b)(9) Import for clinical investigation Modified 15 120 0
Total burden requested under this ICR: 6226 13805 607376  
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