[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: 21CFR60.36]
[Page 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 D_Due Diligence Petitions
Sec. 60.36 Standard of due diligence.
(a) In determining the due diligence of an applicant, FDA will
examine the facts and circumstances of the applicant's actions during
the regulatory review period to determine whether the applicant
exhibited that degree of attention, continuous directed effort, and
timeliness as may reasonably be expected from, and are ordinarily
exercised by, a person during a regulatory review period. FDA will take
into consideration all relevant factors, such as the amount of time
between the approval of an investigational exemption or research permit
and the commencement of a clinical investigation and the amount of time
required to conduct a clinical investigation.
(b) For purposes of this part, the actions of the marketing
applicant shall be imputed to the applicant for patent term restoration.
The actions of an agent, attorney, contractor, employee, licensee, or
predecessor in interest of the marketing applicant or applicant for
patent term restoration shall be imputed to the applicant for patent
term restoration.
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