[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR314.99] [Page 137] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents Subpart C--Abbreviated Applications Sec. 314.99 Other responsibilities of an applicant of an abbreviated application. (a) An applicant shall comply with the requirements of Sec. 314.65 regarding withdrawal by the applicant of an unapproved abbreviated application and Sec. 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 Secs. 314.92 through 314.99. The applicant shall comply with the requirements for a waiver under Sec. 314.90.