Quality Facility Attestation; Forms FDA 3942a and 3942b

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food and Food for Animals

OMB: 0910-0751

IC ID: 248149

Information Collection (IC) Details

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Quality Facility Attestation; Forms FDA 3942a and 3942b
No Unchanged
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 0 0 19,127
Annual IC Time Burden (Hours) 9,564 0 0 0 0 9,564
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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