Clinical Protocol Amendments (IND) - CDER and CBER

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

OMB: 0910-0616

IC ID: 183055

Documents and Forms
Information Collection (IC) Details

View Information Collection (IC)

Clinical Protocol Amendments (IND) - CDER and CBER
 
No Removed
 
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_3674.pdf Yes Yes Fillable Fileable Signable
Other-Guidance Guidance.pdf Yes No Paper Only

Health Consumer Health and Safety

 

15,741 0
   
Private Sector Not-for-profit institutions, Businesses or other for-profits
 
   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 0 0 -15,741 0 0 15,741
Annual IC Time Burden (Hours) 0 0 -3,935 0 0 3,935
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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