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:
(1)
An explanation why the sponsor's compliance with the requirement is unnecessary or cannot be achieved;
(2)
A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
(b)
FDA may grant a waiver if it finds that the sponsor's noncompliance would not pose a significant and unreasonable risk to human subjects of the investigation and that one of the following is met:
(1)
The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;