[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.86]

[Page 90]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
    Subpart E--Drugs Intended to Treat Life-threatening and Severely-
                         debilitating Illnesses
 
Sec. 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.