[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: 21CFR314.72]

[Page 119-120]
 
                        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. 314.72  Change in ownership of an application.

    (a) An applicant may transfer ownership of its application. At the 
time of transfer the new and former owners are

[[Page 120]]

required to submit information to the Food and Drug Administration as 
follows:
    (1) The former owner shall submit a letter or other document that 
states that all rights to the application have been transferred to the 
new owner.
    (2) The new owner shall submit an application form signed by the new 
owner and a letter or other document containing the following:
    (i) The new owner's commitment to agreements, promises, and 
conditions made by the former owner and contained in the application;
    (ii) The date that the change in ownership is effective; and
    (iii) Either a statement that the new owner has a complete copy of 
the approved application, including supplements and records that are 
required to be kept under Sec. 314.81, or a request for a copy of the 
application from FDA's files. FDA will provide a copy of the application 
to the new owner under the fee schedule in Sec. 20.42 of FDA's public 
information regulations.
    (b) The new owner shall advise FDA about any change in the 
conditions in the approved application under Sec. 314.70, except the new 
owner may advise FDA in the next annual report about a change in the 
drug product's label or labeling to change the product's brand or the 
name of its manufacturer, packer, or distributor.

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

[50 FR 7493, Feb. 22, 1985; 50 FR 14212, Apr. 11, 1985, as amended at 50 
FR 21238, May 23, 1985]