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Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

IC 6305 under ICR 201907-0910-010 · OMB 0910-0582.

Documents and Forms
Document Name
Document Type
Other-Guidance: Guidance on Informed
Information Collection (IC) Details

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Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 812.2

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable 0582_Guidance_2019.pdf Yes No Fillable Printable

Health Consumer Health and Safety

 

700 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 700 0 0 0 0 700
Annual IC Time Burden (Hours) 2,800 0 0 0 0 2,800
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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