---
kind: "section"
citation: "21 C.F.R. § 312.81"
title: "21"
number: "312.81"
heading: "Scope."
url: "https://uscodex.org/cfr/21/312.81"
---

# §312.81. Scope.


This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.

- (a) **For purposes of this section, the term “life-threatening” means—**
  - (1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and
  - (2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.
- (b) For purposes of this section, the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity.
- (c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products.

## Notes

### Amendments

[53 FR 41523, Oct. 21, 1988, as amended at 64 FR 401, Jan. 5, 1999]

### Authority

Authority: 21 U.S.C. 351, 352, 353, 355, 371; 42 U.S.C. 262.

### Source

Source: 53 FR 41523, Oct. 21, 1988, unless otherwise noted.

### 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

[53 FR 41523, Oct. 21, 1988, as amended at 64 FR 401, Jan. 5, 1999]