Clinical Amendments to Marketing Applications - CDER and CBER

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

OMB: 0910-0616

IC ID: 199617

Information Collection (IC) Details

View Information Collection (IC)

Clinical Amendments to Marketing Applications - CDER and CBER
No Removed

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 FINAL GUIDANCE 0616 12-19-14.pdf Yes No Paper Only

Health Consumer Health and Safety


1,067 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 0 0 -1,067 0 0 1,067
Annual IC Time Burden (Hours) 0 0 -800 0 0 800
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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