[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.44]

[Page 328]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 60--PATENT TERM RESTORATION--Table of Contents
 
                    Subpart E--Due Diligence Hearings
 
Sec. 60.44  Hearing procedures.

    The due diligence hearing shall be conducted in accordance with this 
part, supplemented by the nonconflicting procedures in part 16. During 
the due diligence hearing, the applicant and the petitioner shall enjoy 
all the rights and privileges accorded a person requesting a hearing 
under part 16. The standard of due diligence set forth in Sec. 60.36 
will apply in the due diligence hearing. The party requesting the due 
diligence hearing shall have the burden of proof at the hearing.