Applications, amendments, resubmissions using form FDA 3674

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

OMB: 0910-0616

IC ID: 183054

Documents and Forms
Information Collection (IC) Details

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Applications, amendments, resubmissions using form FDA 3674
No Modified

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3674 Certificate of Compliance Under 42 U.S.C. 282(j)(5)(B), with Requirements of Data Bank FDA 3674.pdf Yes Yes Fillable Fileable Signable
Other-Guidance 0616 guidance.pdf Yes Yes Printable Only

Health Consumer Health and Safety


17,409 0
Private Sector Businesses or other for-profits, Not-for-profit institutions
   80 %

  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 17,409 0 0 15,359 0 2,050
Annual IC Time Burden (Hours) 5,976 0 0 5,464 0 512
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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