Section 314.99 - Other responsibilities of an applicant of an ANDA(a) An applicant must comply with the requirements of § 314.65 regarding withdrawal by the applicant of an unapproved ANDA and § 314.72 regarding a change in ownership of an ANDA.(b) An applicant may ask FDA to waive under this section any requirement that applies to the applicant under §§ 314.92 through 314.99 . The applicant must comply with the requirements for a waiver under § 314.90 . If FDA grants the applicant's waiver request with respect to a requirement under §§ 314.92 through 314.99 , the waived requirement will not constitute a basis for refusal to approve an ANDA under § 314.127 . 81 FR 69653 , Oct. 6, 2016