[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: 21CFR60.2]

[Page 322-323]
 
                        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 A--General Provisions
 
Sec. 60.2  Purpose.

    (a) The purpose of this part is to establish a thorough yet 
efficient process for the Food and Drug Administration review of patent 
term restoration applications. To achieve this purpose, the regulations 
are intended to:
    (1) Facilitate determinations of patent term restoration eligibility 
and regulatory review period length, and

[[Page 323]]

    (2) Ensure that parties interested in due diligence challenges will 
have an opportunity to participate in that process, including informal 
hearings.
    (b) The regulations are intended to complement those promulgated by 
the United States Patent and Trademark Office to implement those parts 
of the law which are under that agency's jurisdiction. These regulations 
shall be construed in light of these objectives.