Establishment+Registration+FAQ

[16-Dec 2009]

Subject:
No Change SPL

Question:
If I send a No Change SPL to eList, will it automatically validate against DUNS numbers, addresses, or other fields that have had validation rules applied recently?

Answer:
The submission of a No Change Notification SPL does not revalidate the previous ER SPL.

If there is an error or a change, the sponsor (registrant) should send the entire Establishment Registration SPL document.

Reference(s) :
//Question to SPL@fda.hhs.gov//

[11-Nov 2008]

Subject:
Changes to Establishment Registration Data

Question:
If I have a change to the only one of my establishments, can I delete the rest of the establshments from the ER SPL (since they have no changed information)?

Answer:
//Make the change to the Establishment information being modified. Leave in the other Establishments. If they are removed, their information will be deleted from the Establishment Registry.//

Reference(s) :
//DIA Meeting Oct 29-30.//

[11-Nov 2008]

Subject:
API Registration and Application Number

Question:
What application number, if any, do I add?

Answer:
//Include the Drug Master File ID number when available.//

Reference(s) :
//DIA Meeting Oct 29-30.//

[24-Nov 2008]

//Subject://
//Repackager and Establishment Registration Data//

//Question://
//I am a repacker (repackager). If I do not know the DUNS number for an establishment, what do I enter?//

//Answer://
//Include the NDC Product Code -- the first two sections of the NDC -- in the Source NDC Product Code field.//

//Reference(s) ://
//DIA Meeting Oct 29-30.//

[08-Dec 2008]

//Subject://
//US Agent and DUNS Number//

//Question://
//Does a US Agent have to get a DUNS number? Does a US Agent use the DUNS number of their company?//

//Answer://
//The DUNS Number is assigned to the company or organization. The US Agent is an individual doing business as (d/b/a) that company or organization.//

//Reference(s) ://
//DIA Meeting Oct 29-30.//

[08-Dec 2008]

//Subject://
//Paper Notification of Establishment Registration//

//Question://
//Will the sponsor receive any kind of paper notification that the FDA received an Establishment Registration?//

//Answer://
//The current expectation is that the FDA website will have the listing, and that a paper notification will not be sent to the sponsor.//

//Reference(s) ://
//DIA Meeting Oct 29-30.//