---
kind: "section"
citation: "21 C.F.R. § 312.10"
title: "21"
number: "312.10"
heading: "Waivers."
url: "https://uscodex.org/cfr/21/312.10"
---

# §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
  - (3) **Other information justifying a waiver.**
- (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;
  - (2) The sponsor's proposed alternative satisfies the requirement; or
  - (3) **The applicant's submission otherwise justifies a waiver.**

## Notes

### 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]