Payment of annual establishment fee

GFI: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0776

IC ID: 212974

Documents and Forms
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Document Type
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Information Collection (IC) Details

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Payment of annual establishment fee CDER
 
No Modified
 
Mandatory
 

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

Health Health Care Services

 

60 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 60 0 0 10 0 50
Annual IC Time Burden (Hours) 30 0 0 5 0 25
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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