[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.44]
[Page 323]
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.
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