[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: 21CFR60.36]

[Page 350]
 
                        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.