[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR60.34]

[Page 322-323]
 
                        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.  60.34  FDA action on petitions.

    (a) Within 90 days after FDA receives a petition filed under Sec.  
60.30(a), the agency will either deny the petition under paragraph (b) 
or (c) of this section or investigate and determine under Sec.  60.36 
whether the applicant acted with due diligence during the regulatory 
review period. FDA will publish its due diligence determination in the 
Federal Register, notify PTO of the due diligence determination in 
writing, and send copies of the notice

[[Page 323]]

to PTO, the applicant, and the petitioner.
    (b) FDA may deny a due diligence petition without considering the 
merits of the petition if:
    (1) The petition is not filed in accordance with Sec.  60.30;
    (2) The petition is not filed in accordance with Sec.  10.20;
    (3) The petition does not contain the information required by Sec.  
10.30;
    (4) The petition fails to contain information or allegations upon 
which it may reasonably be determined that the applicant did not act 
with due diligence during the applicable regulatory review period; or
    (5) The petition fails to allege a sufficient total amount of time 
during which the applicant did not exercise due diligence such that, 
even if the petition were granted, the petition would not affect the 
maximum patent extension the applicant sought in the application.