[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: 21CFR60.1]
[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. 60.1 Scope.
(a) This part sets forth procedures and requirements for the Food
and Drug Administration's review of applications for the extension of
the term of certain patents under 35 U.S.C. 156. Patent term restoration
is available for certain patents related to drug products (as defined in
35 U.S.C. 156(f)(2)), and to medical devices, food additives, or color
additives subject to regulation under the Federal Food, Drug, and
Cosmetic Act or the Public Health Service Act. Food and Drug
Administration actions in this area include:
(1) Assisting the United States Patent and Trademark Office in
determining eligibility for patent term restoration;
(2) Determining the length of a product's regulatory review period;
(3) If petitioned, reviewing and ruling on due diligence challenges
to the Food and Drug Administration's regulatory review period
determinations; and
(4) Conducting hearings to review initial Food and Drug
Administration findings on due diligence challenges.
(b) References in this part to the Code of Federal Regulations are
to chapter I of title 21, unless otherwise noted.
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992]
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