---
kind: "section"
citation: "21 C.F.R. § 312.86"
title: "21"
number: "312.86"
heading: "Focused FDA regulatory research."
url: "https://uscodex.org/cfr/21/312.86"
---

# §312.86. Focused FDA regulatory research.


At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation. When initiated, FDA will undertake such research efforts as a means for meeting a public health need in facilitating the development of therapies to treat life-threatening or severely debilitating illnesses.


## Notes

### 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.