Clinical Amendments to Marketing Applications

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions

OMB: 0910-0616

IC ID: 214353

Information Collection (IC) Details

View Information Collection (IC)

Clinical Amendments to Marketing Applications CBER
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 3674 Certification of Compliance FORM FDA 3674 12-19-14.pdf Yes Yes Fillable Fileable Signable
Other-Guidance FINAL GUIDANCE 0616 12-19-14.pdf Yes No Paper Only

Health Consumer Health and Safety

 

1 0
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   70 %

  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 0 0 1 0 0
Annual IC Time Burden (Hours) 1 0 0 1 0 0
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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