[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: 21CFR312.81]

[Page 88]
 
                        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. 312.81  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.

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