[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.99]

[Page 133-134]
 
                        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.

[[Page 134]]

    (b) An applicant may ask FDA to waive under this section any 
requirement that applies to the applicant under Sec. Sec.  314.92 
through 314.99. The applicant shall comply with the requirements for a 
waiver under Sec.  314.90.