Supplements and other changes to an approved abbreviated application

Abbreviated New Drug Applications and 505(b)(2) Applications

OMB: 0910-0786

IC ID: 214795

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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Supplements and other changes to an approved abbreviated application CDER
 
No Removed
 
Mandatory
 
21 CFR 314.97(c)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Health Care Services

 

16 0
   
Private Sector Businesses or other for-profits
 
   75 %

  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 0 0 0 0
Annual IC Time Burden (Hours) 0 0 0 0 0 0
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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