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Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics

IC 229929 under ICR 202101-0910-011 · OMB 0910-0850.

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Other-Agency Guidance
Information Collection (IC) Details

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Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics CDRH
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0850- Agency Guidance Next Generating Sequencing Database.pdf Yes No Printable Only

Health Consumer Health and Safety

 

5 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 5 0 0 0 0 5
Annual IC Time Burden (Hours) 505 0 0 0 0 505
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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