[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.2]

[Page 344-345]
 
                        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:

[[Page 345]]

    (1) Facilitate determinations of patent term restoration eligibility 
and regulatory review period length, and
    (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.