Efficacy Supplements/Resubmissions (BLA Only)

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

OMB: 0910-0616

IC ID: 214355

Documents and Forms
Information Collection (IC) Details

View Information Collection (IC)

Efficacy Supplements/Resubmissions (BLA Only) CBER
 
No New
 
Mandatory
 

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

Health Consumer Health and Safety

 

25 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 25 0 0 25 0 0
Annual IC Time Burden (Hours) 19 0 0 19 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.

© 2024 OMB.report | Privacy Policy