Exempt Infant Formula Production; GMP; Audits, Records & Records

Infant Formula Requirements

OMB: 0910-0256

IC ID: 235376

Information Collection (IC) Details

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Exempt Infant Formula Production; GMP; Audits, Records & Records
 
No Unchanged
 
Required to Obtain or Retain Benefits
 
21 CFR 107.50

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0811 Exempt IF Production Guidance 2019.pdf https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/ucm384451.htm Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

3 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 1,902 0 0 0 0 1,902
Annual IC Time Burden (Hours) 85,590 0 0 0 0 85,590
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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