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

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

OMB: 0910-0616

IC ID: 183054

Documents and Forms
Document Name
Document Type
Other-Public Law
Other-guidance document
Information Collection (IC) Details

View Information Collection (IC)

Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Public Law FDAAA Title VIII-Public Law 110-85.pdf No No Paper Only
Other-guidance document 0616 guidance.htm No No Paper Only

Health Consumer Health and Safety

 

33,334 0
   
Private Sector Businesses or other for-profits, Not-for-profit institutions
 
   0 %

  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 33,334 0 0 0 0 33,334
Annual IC Time Burden (Hours) 8,334 0 0 0 0 8,334
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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