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 New
 
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) NEW_Guidance_8-2017.docx Yes No Printable Only

Health Consumer Health and Safety

 

26 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 26 0 26 0 0 0
Annual IC Time Burden (Hours) 4,680 0 4,680 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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