De Novo request under 21 U.S.C. 513(f)(2)(ii)

De Novo Classification Process (Evaluation of Automatic Class III Designation)

OMB: 0910-0844

IC ID: 227824

Documents and Forms
Document Name
Document Type
Other-Guidance:De Novo Classificatio
Information Collection (IC) Details

View Information Collection (IC)

De Novo request under 21 U.S.C. 513(f)(2)(ii)
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance:De Novo Classification Process (Evaluation of Automatic Class III Designation) 0844_Supporting Statement_2019.doc Yes No Printable Only

Health Consumer Health and Safety

 

57 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 57 0 0 31 0 26
Annual IC Time Burden (Hours) 10,260 0 0 5,580 0 4,680
Annual IC Cost Burden (Dollars) 6,914 0 0 6,914 0 0

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