[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: 21CFR60.2]
[Page 317]
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
(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.
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