CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > SUBPART C—Abbreviated Applications (§314.92 to §314.99) > 314.99—Other responsibilities of an applicant of an abbreviated application.

314.99—Other responsibilities of an applicant of an abbreviated application.

(a) An applicant shall comply with the requirements of § 314.65 regarding withdrawal by the applicant of an unapproved abbreviated application and § 314.72 regarding a change in ownership of an abbreviated application.
(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 shall comply with the requirements for a waiver under § 314.90.