(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.
Effective Date Note: At 79 FR 33092, June 10, 2014, Sec. 600.90 was amended by removing the phrase ``licensed manufacturer'' or ``licensed manufacturer's'' each time it appears and by adding in its place the word ``applicant'' or ``applicant's'' respectively, effective June 10, 2015.