[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: 21CFR314.96]

[Page 136-137]
 
                        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. 314.96  Amendments to an unapproved abbreviated application.

    (a) Abbreviated new drug application. (1) An applicant may amend an 
abbreviated new drug application that is submitted under Sec. 314.94, 
but not yet approved, to revise existing information or provide 
additional information.
    (2) Submission of an amendment containing significant data or 
information constitutes an agreement between FDA and the applicant to 
extend the review period only for the time necessary to review the 
significant data or information and for no more than 180 days.
    (3) Submission of an amendment containing significant data or 
information to resolve deficiencies in the application as set forth in a 
not approvable letter issued under Sec. 314.120 constitutes an agreement 
between FDA and the applicant under section 505(j)(4)(A) of the act to 
extend the date by which the agency is required to reach a decision

[[Page 137]]

on the abbreviated new drug application only for the time necessary to 
review the significant data or information and for no more than 180 
days.
    (b) The applicant shall submit a field copy of each amendment to 
Sec. 314.94(a)(9). The applicant, other than a foreign applicant, shall 
include in its submission of each such amendment to FDA a statement 
certifying that a field copy of the amendment has been sent to the 
applicant's home FDA district office.

[57 FR 17983, Apr. 28, 1992, as amended at 58 FR 47352, Sept. 8, 1993; 
64 FR 401, Jan. 5, 1999]