Answer: In its proposed rules, FDA has outlined an operating plan for accepting notifications.
Under that plan, FDA is conducting initial reviews of FCNs to determine whether any basic information is missing, and will request additional information by telephone (confirmed by a letter). If the request is answered in a satisfactory way, within approximately two weeks, then FDA will issue a letter accepting the FCN.
In the event an FCN is accepted, the 120-day period continues to run from the original date of receipt. FDA has indicated its intent to decide on the acceptability of an FCN, and to provide the appropriate responsive letter within 30 days of receipt. Unhappily, since FDA is not required to issue the acceptance letters, our experience is that this 30-day timeframe has been followed loosely, with some acknowledgment letters issuing only a few weeks in advance of the effective date of the notification.
A filer can agree to let the review period start over in the case of unacceptable FCNs that cannot be corrected very quickly (again, within two weeks of FDA's request for additional information). If supplemental information cannot be provided quickly, the FCN will need to be withdrawn or FDA will send a letter refusing to accept the FCN. The submitter of an FCN also may choose to leave an FCN pending to draw a formal objection from FDA. This will set the stage for judicial review of FDA's decision.
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