[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: 21CFR314.71]

[Page 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 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.

(Collection of information requirements approved by the Office of 
Management and Budget under control number 0910-0001)

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