Procedure Simplification

Presented By Ms. Shikha Jain Date Venue - Presentation on D-U-N-S Number & FEI Number

BACKGROUNDSelf identification of generic drug facilities, Sites and organizations:In GDUFA 2012, FDAs requirement of submission of Self identification information by human generic drug facilities, Sites and organizations is listed.

On July 9, 2012 GDUFA was designed;To speed the delivery of safe and effective generic drugs to the public and,To reduce costs to industry.

BACKGROUNDFDA is establishing a new system for electronic self-identification of generic industry facilities and organization.

Therefore, entities that are required to register and list (under section 510 of Federal Food, drug And cosmetic Act or section 351 of the Public Health Service Act) are required to Self-identify with GDUFA.

Once self identification procedure has been completed, FDA will determine facility fees that is required to be paid annually.

Who is required to Self Identify

Information required for Self identification

Part ID-U-N-S Number

backgroundThe federal government requires that all applicants for federal grants and cooperative agreements have a D-U-N-S Number.The federal government will use D-U-N-S Number to identify related organizations that are receiving funding under grants and cooperative agreements

INTRODUCTIONIn 1962, Dun & Bradstreet established business identification database in the form of D-U-N-S Number: 9 digit identification numberD - DataU - UniversalN - NumberingS - System

D-U-N-S may be issued with or without dashes for readability: XX-XXX-XXXX OR XXXXXXXXX

INTRODUCTIOND-U-N-S Number is D&Bs copyrighted proprietary means identifying business entities on a location specific basis.

Specific for each site.Each distinct physical location of an entity (i.e. branch, division and headquarter) would be assigned a different D-U-N-S Number.

FDAs recommendationFDA will require D-U-N-S Number for both the facility and the registrant owner of the facility if both are at different locations.

D-U-N-S Number is required to uniquely identify registrant owner and each physical location of the business entity of the registrant.

D-U-N-S Number serves as useful resource for FDA in identifying and verifying certain business information submitted by a user.

Why do you need a D-U-N-S Number

What do I need to get my D-U-N-S Number

Part IIFEI Number

FEI numberFEI number a unique identifier designated by FDA to assign, monitor and track inspections of regulated firms.F FacilityE Establishment I Identifier

FEI numberFDA assigns only one FEI number to separate buildings:If they are in close proximity.If the activities conducted in each building are closely related to the same business enterprise, Are under the supervision of same local managementAre capable of being inspected by FDA during a single inspection.

How to obtain FEI number

What do I need to get my FEI Number