21 CFR 312.10 - Waivers.
(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain at least one of the following:
(2) A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
(3) Other information justifying a waiver.
(2) The sponsor's proposed alternative satisfies the requirement; or