Answer: In the event of the sale of a business, a change in corporate control, or a change in the name of the notifying company, the company should be able to transfer an FCN to the successor organization simply by informing FDA of the change and providing authoritative documentation of the legal basis for the transfer.
A formal procedure to govern assignment or transfer transactions is not contemplated --probably because an FCN confers only a very short-term exclusivity, since anyone can file a similar notice that will become effective in 120 days. Rather, notice to the agency is all that is needed so that the agency can keep track of the extent of use of notified substances.
Nothing in the statute or proposed regulations provides that a notification can be assigned or transferred to a competitor. Certainly, a competitor can rely on the data the original filer has submitted to file its own FCN and prove the safety of the competing product if it can show that the characteristics of its product are the same. In short, there is so little incentive for the purchase of a notification that no special procedures exist -- or are likely to be established -- to facilitate purchases.
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