1. (a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 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. (1) An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved,
   2. (2) A description of an alternative submission that satisfies the purpose of the requirement, or
   3. (3) Other information justifying a waiver.

2. (b) FDA may grant a waiver if it finds one of the following:

   1. (1) The applicant's compliance with the requirement is unnecessary or cannot be achieved,
   2. (2) The applicant's alternative submission satisfies the requirement, or
   3. (3) The applicant's submission otherwise justifies a waiver.

[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]