View Information Collection (IC)
View Information Collection (IC)

View Information Collection (IC)

Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver CTP
 
No Modified
 
Mandatory
 
21 CFR 1114.5 21 CFR 1114.9 21 CFR 1114.13 21 CFR 1114.17 21 CFR 1114.41 21 CFR 1114.45 21 CFR 1114.49 21 CFR 1114.15

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 4057 Yes Yes Fillable Fileable Signable
Form and Instruction FDA 4057a Yes Yes Fillable Fileable Signable
Form and Instruction FDA 4057b Yes Yes Fillable Fileable
Other-Validator Tool Screenshots Yes Yes Printable Only
Form and Instruction FDA Web Form 4057 Yes Yes Fillable Fileable Signable
Form and Instruction FDA Web Form 4057a Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

215 10
   
Private Sector Businesses or other for-profits
 
   93 %

  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 1,276 0 24 1,061 0 191
Annual IC Time Burden (Hours) 382,828 0 17 369,104 0 13,707
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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