21 CFR 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.