Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
511.1(a)(3) - Recordkeeping for laboratory research New 474 474 0
511.1(b)(3) - Recordkeeping for clinical investigations New 1238 1238 0
511.1(b)(4) NCIE for clinical investigations Modified 1238 1238 0 Form and Instruction 3458
511.1(b)(5) Data submission for use of edible food products New 70 560 0
511.1(b)(6) Information required in order to determine if there are grounds for terminating exemption New 2 2 0
511.1(b)(7)(ii) - Recordkeeping sponsor New 1238 4333 0
511.1(b)(8) (ii) Report of significant hazards New 15 30 0
511.1(b)(8)(i) - Recordkeeping of investigator reports New 1238 4333 0
511.1(b)(9) Import for clinical investigation New 15 120 0
Total burden requested under this ICR: 5528 12328 0  
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