Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Acceptance Checklist New 60 60 0 Other-Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo request under 21 U.S.C. 513(f)(2)(i) Modified 3 300 364 Other-Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo request under 21 U.S.C. 513(f)(2)(ii) Modified 57 10260 6914 Other-Guidance:De Novo Classification Process (Evaluation of Automatic Class III Designation)
Recommended Content Checklist New 60 60 0 Other-Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation)
Request for withdrawal Modified 5 50 5 Other-Guidance: De Novo Classification Process (Evaluation of Automatic Class III Designation)
Total burden requested under this ICR: 185 10730 7283  
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