[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR54.3]

[Page 297]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 54--FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS--Table of Contents
 
Sec. 54.3  Scope.

    The requirements in this part apply to any applicant who submits a 
marketing application for a human drug, biological product, or device 
and who submits covered clinical studies. The applicant is responsible 
for making the appropriate certification or disclosure statement where 
the applicant either contracted with one or more clinical investigators 
to conduct the studies or submitted studies conducted by others not 
under contract to the applicant.