Regulatory Open Forum

Hello

I have a basic question regarding filling Form 3602A. So in Section I I fill in the company information. In Section II I fill information regarding each affiliate. With regards to Section III is where my problem arisis.

Scenario--- The company is headquartered in Belgium and has 3 affiliates. I'm trying to get the SBD for the affiliate in the US. The names of the companies are slightly different in Belgium and the USA (xyz nv in Belgium and xyz Inc. in the USA). xyz Inc. is the one that will be filing all the approvals and notifications and hence this is the one for which SBD is required. 

Questions--- (1) xyz Inc.  would have to file as a foreign business headquartered outside the US and use From 3602A, correct?
                     (2) Name of business requiring MDUFA Small Business Status in Section I would be xyz inc. The affiliates in Section II would include                           xyz inc. correct?

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Anjali Nair
Los Angeles, CA
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Hi Anjali,
While the US affiliate will be submitting the files and "owning" the premarket submissions, you are correct that you still need use Form 3602A since you have a "Business Headquartered Outside the United States."  To answer your questions:
1) Yes!
2) It is my understanding that XYZ NZ should be the business listed as the business applying and XYZ INC. should be one of the affiliates. The SBD number you get should cover the affiliates as well (since combined, their income should all be under $100M/annually). 
3) You just need one Section II with all the affiliates and just need one stamped page (by the NTA in Belgium). I've never tried to have it stamped by one of the affiliate countries but that might be a good question to ask FDA.  A quick call to DICE should be able to answer this (301-796-7100). I have a client in Belgium and that was a hard country to get that stamp!  

Best regards, 
Allison

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Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com/regulatoryaf
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Original Message:
Sent: 19-Jun-2019 17:56
From: Anjali Nair
Subject: Small Business Determination

Hello

I have a basic question regarding filling Form 3602A. So in Section I I fill in the company information. In Section II I fill information regarding each affiliate. With regards to Section III is where my problem arisis.

Scenario--- The company is headquartered in Belgium and has 3 affiliates. I'm trying to get the SBD for the affiliate in the US. The names of the companies are slightly different in Belgium and the USA (xyz nv in Belgium and xyz Inc. in the USA). xyz Inc. is the one that will be filing all the approvals and notifications and hence this is the one for which SBD is required.

Questions--- (1) xyz Inc.  would have to file as a foreign business headquartered outside the US and use From 3602A, correct?
                     (2) Name of business requiring MDUFA Small Business Status in Section I would be xyz inc. The affiliates in Section II would include                           xyz inc. correct?

                     (3) Is there going to be just one section II with all the affiliates and 3 different Section III pages signed and stamped by the 3 affiliates                                                                                                                           OR
                     Should there be 3 different Form3602A, (all three with the same Section I information) with one affiliate mentioned in the Section II of                        each form and the corresponding NTA's sign and stamp on the Section III of each form?

Thank you

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Anjali Nair
Los Angeles, CA
------------------------------

That was very helpful! Thank you, Allison!

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------

Original Message:
Sent: 20-Jun-2019 12:41
From: Allison Komiyama
Subject: Small Business Determination

Hi Anjali,
While the US affiliate will be submitting the files and "owning" the premarket submissions, you are correct that you still need use Form 3602A since you have a "Business Headquartered Outside the United States."  To answer your questions:
1) Yes!
2) It is my understanding that XYZ NZ should be the business listed as the business applying and XYZ INC. should be one of the affiliates. The SBD number you get should cover the affiliates as well (since combined, their income should all be under $100M/annually).
3) You just need one Section II with all the affiliates and just need one stamped page (by the NTA in Belgium). I've never tried to have it stamped by one of the affiliate countries but that might be a good question to ask FDA.  A quick call to DICE should be able to answer this (301-796-7100). I have a client in Belgium and that was a hard country to get that stamp!

Best regards,
Allison

------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com/regulatoryaf

Original Message:
Sent: 19-Jun-2019 17:56
From: Anjali Nair
Subject: Small Business Determination

Hello

I have a basic question regarding filling Form 3602A. So in Section I I fill in the company information. In Section II I fill information regarding each affiliate. With regards to Section III is where my problem arisis.

Scenario--- The company is headquartered in Belgium and has 3 affiliates. I'm trying to get the SBD for the affiliate in the US. The names of the companies are slightly different in Belgium and the USA (xyz nv in Belgium and xyz Inc. in the USA). xyz Inc. is the one that will be filing all the approvals and notifications and hence this is the one for which SBD is required.

Questions--- (1) xyz Inc.  would have to file as a foreign business headquartered outside the US and use From 3602A, correct?
                     (2) Name of business requiring MDUFA Small Business Status in Section I would be xyz inc. The affiliates in Section II would include                           xyz inc. correct?

                     (3) Is there going to be just one section II with all the affiliates and 3 different Section III pages signed and stamped by the 3 affiliates                                                                                                                           OR
                     Should there be 3 different Form3602A, (all three with the same Section I information) with one affiliate mentioned in the Section II of                        each form and the corresponding NTA's sign and stamp on the Section III of each form?

Thank you

------------------------------
Anjali Nair
Los Angeles, CA
------------------------------