[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.71]

[Page 118-119]
 
                        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 B--Applications
 
Sec. 314.71  Procedures for submission of a supplement to an approved application.

    (a) Only the applicant may submit a supplement to an application.
    (b) All procedures and actions that apply to an application under 
Sec. 314.50 also apply to supplements, except that

[[Page 119]]

the information required in the supplement is limited to that needed to 
support the change. A supplement is required to contain an archival copy 
and a review copy that include an application form and appropriate 
technical sections, samples, and labeling; except that a supplement for 
a change other than a change in labeling is required also to contain a 
field copy.
    (c) All procedures and actions that apply to applications under this 
part, including actions by applicants and the Food and Drug 
Administration, also apply to supplements.

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 58 
FR 47352, Sept. 8, 1993; 67 FR 9586, Mar. 4, 2002]