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Federal forms, ICRs, and supporting documents

Information Collection

Quality Facility Attestation; Forms FDA 3942a and 3942b

IC 248149 under ICR 202107-0910-001 · OMB 0910-0751.

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

View Information Collection (IC)

Quality Facility Attestation; Forms FDA 3942a and 3942b
 
No New
 
Required to Obtain or Retain Benefits
 
21 CFR 117.201; 507.7

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance QualifiedFacilityGuidance2018.pdf https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

38,254 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 19,127 0 0 19,127 0 0
Annual IC Time Burden (Hours) 9,564 0 0 9,564 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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