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  1. Generic Drug User Fee Amendments

GDUFA Cover Sheet Clarifications: Facility

 

 
 
1.    What is an FDA Establishment Identification number?
An FDA Establishment Identification (FEI) number is a unique identifier issued by FDA to track inspections of the regulated establishment or facility. FEI numbers are also used to track GDUFA facility fee payments. Please note that an FEI number is different from a Central File Number and Federal Tax Identification Number. If you have questions about your assigned FEI numbers, please contact the appropriate FDA district office (for domestic firms) or email FDAGDUFAFEIRequest@fda.hhs.gov (for foreign firms).
 
2.    What is a Central File Number?
A Central File Number (CFN) is also issued by FDA. CFN has been phased out; it is no longer used for inspection purposes.
 
3.    What is an Employer Identification Number?
An Employer Identification Number (EIN), also known as a Federal Tax Identification Number, is a nine-digit number issued by the United States Government to uniquely identify an organization as a business entity. All U.S. organizations must have an EIN to conduct business with the U.S. Government. To obtain an EIN, you may navigate to the Internal Revenue Service website and search for “Employer Identification Number”. If you are a foreign organization, please obtain a DUNS Number prior to initiating the GDUFA Cover Sheet registration process.
 
4.    What is a DUNS number, and how do I obtain one?
Dun & Bradstreet (D&B) is a common source of commercial information on businesses. D&B assigns and maintains a database of Data Universal Numbering System (DUNS) numbers, which serve as unique identifiers of business entities globally. Upon application, each business entity is assigned a distinct site-specific 9-digit DUNS number. A DUNS number for an entity is a useful resource for FDA in identifying and verifying certain business information for that entity. The DUNS number is required for foreign organizations to register in the User Fee System. To obtain a DUNS number, please visit http://www.dnb.com. 
 
5.    What is a United States Federal Fiscal Year?
The United Stated federal fiscal year is the accounting period for the federal government, which begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2013 begins on October 1, 2012 and ends on September 30, 2013.