[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR600.90]

[Page 20]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 600_BIOLOGICAL PRODUCTS: GENERAL--Table of Contents
 
               Subpart D_Reporting of Adverse Experiences
 
Sec.  600.90  Waivers.

    (a) A licensed manufacturer may ask the Food and Drug Administration 
to waive under this section any requirement that applies to the licensed 
manufacturer under Sec. Sec.  600.80 and 600.81. A waiver request under 
this section is required to be submitted with supporting documentation. 
The waiver request is required to contain one of the following:
    (1) An explanation why the licensed manufacturer'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 licensed manufacturer's compliance with the requirement is 
unnecessary or cannot be achieved,
    (2) The licensed manufacturer's alternative submission satisfies the 
requirement, or
    (3) The licensed manufacturer's submission otherwise justifies a 
waiver.