Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

Guidance for Reagents for Detection of Specific Novel Influenza A Viruses

OMB: 0910-0584

IC ID: 6307

Documents and Forms
Document Name
Document Type
Other-Guidance; Class II Special Con
Information Collection (IC) Details

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Guidance for Reagents for Detection of Specific Novel Influenza A Viruses
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 800.820.100 21 CFR 800.820.30

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance; Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses - Guidance for Industry and FDA Staff 0584_Guidance_2019.pdf Yes No Fillable Printable

Health Consumer Health and Safety

 

1 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 2 0 0 -18 0 20
Annual IC Time Burden (Hours) 30 0 0 -270 0 300
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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