[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.