{"data":{"id":"us/21-cfr-312.86","jurisdiction":"us","citation":"21 CFR 312.86","heading":"Focused FDA regulatory research.","body":"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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 312—INVESTIGATIONAL NEW DRUG APPLICATION","Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"76c117c724bd15415608a5fdb6fcc150af8962794aa055f71c9abc82a7897532","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-312.85","next":"us/21-cfr-312.87"},"notice":"GroundRules: Original legal text. Not legal advice."}