[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.10]

[Page 53-54]
 
                        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 A_General Provisions
 
Sec.  312.10  Waivers.

    (a) A sponsor may request FDA to waive applicable requirement under 
this part. A waiver request may be submitted either in an IND or in an 
information amendment to an IND. In an emergency, a request may be made 
by telephone or other rapid communication means. A waiver request is 
required to contain at least one of the following:
    (1) An explanation why the sponsor's compliance with the requirement 
is unnecessary or cannot be achieved;
    (2) A description of an alternative submission or course of action 
that satisfies the purpose of the requirement; or
    (3) Other information justifying a waiver.
    (b) FDA may grant a waiver if it finds that the sponsor's 
noncompliance would not pose a significant and unreasonable risk to 
human subjects of the investigation and that one of the following is 
met:

[[Page 54]]

    (1) The sponsor's compliance with the requirement is unnecessary for 
the agency to evaluate the application, or compliance cannot be 
achieved;
    (2) The sponsor's proposed alternative satisfies the requirement; or
    (3) The applicant's submission otherwise justifies a waiver.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 
FR 9585, Mar. 4, 2002]