§312.10. Waivers.
21 C.F.R. § 312.10
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:
An explanation why the sponsor's compliance with the requirement is unnecessary or cannot be achieved;
A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
Other information justifying a waiver.
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:
The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;
The sponsor's proposed alternative satisfies the requirement; or
The applicant's submission otherwise justifies a waiver.
Notes, amendments, and revision history
Amendments
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9585, Mar. 4, 2002]
Authority
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
Source
Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.
Amendments
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9585, Mar. 4, 2002]