BE Supplements/Amendments - ODG

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

OMB: 0910-0616

IC ID: 214358

Documents and Forms
Information Collection (IC) Details

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BE Supplements/Amendments - ODG
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 Guidance.pdf Yes No Paper Only

Health Consumer Health and Safety


698 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 -698 0 0 698
Annual IC Time Burden (Hours) 0 0 -524 0 0 524
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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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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