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