21 CFR § 312.86 - Focused FDA regulatory research.

---
identifier: "/us/cfr/t21/s312.86"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 312.86 - Focused FDA regulatory research."
title_number: 21
title_name: "Food and Drugs"
section_number: "312.86"
section_name: "Focused FDA regulatory research."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "312"
part_name: "INVESTIGATIONAL NEW DRUG APPLICATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262."
regulatory_source: "52 FR 8831, Mar. 19, 1987, unless otherwise noted."
cfr_part: "312"
---


# 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.