Requirements for Quality Factors -- PER Exemption

Infant Formula Requirements

OMB: 0910-0256

IC ID: 212196

Information Collection (IC) Details

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Requirements for Quality Factors -- PER Exemption
 
No Modified
 
Mandatory
 
21 CFR 106.96(g)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction Form FDA 3978 Infant Formula Tracking System 0256 IFTRACK II Wireframes v4.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1 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 34 0 0 0 0 34
Annual IC Time Burden (Hours) 408 0 0 0 0 408
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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