[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: 21CFR60.34]
[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 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
[[Page 323]]
not affect the maximum patent extension the applicant sought in the
application.
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