[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.