[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: 21CFR314.90]

[Page 127]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                         Subpart B--Applications
 
Sec. 314.90  Waivers.

    (a) An applicant may ask the Food and Drug Administration to waive 
under this section any requirement that applies to the applicant under 
Secs. 314.50 through 314.81. An applicant may ask FDA to waive under 
Sec. 314.126(c) any criteria of an adequate and well-controlled study 
described in Sec. 314.126(b). A waiver request under this section is 
required to be submitted with supporting documentation in an 
application, or in an amendment or supplement to an application. The 
waiver request is required to contain one of the following:
    (1) An explanation why the applicant's compliance with the 
requirement is unnecessary or cannot be achieved;
    (2) A description of an alternative submission that satisfies the 
purpose of the requirement; or
    (3) Other information justifying a waiver.
    (b) FDA may grant a waiver if it finds one of the following:
    (1) The applicant's compliance with the requirement is unnecessary 
for the agency to evaluate the application or compliance cannot be 
achieved;
    (2) The applicant's alternative submission satisfies the 
requirement; or
    (3) The applicant's submission otherwise justifies a waiver.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0001)

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985]