[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: 21CFR60.32]
[Page 322]
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. 60.32 Applicant response to petition.
(a) The applicant shall file with FDA a written response to the
petition no later than 30 days after the applicant's receipt of a copy
of the petition.
(b) The applicant's response may present additional facts and
circumstances to address the assertions in the petition, but shall be
limited to the issue of whether the applicant acted with due diligence
during the regulatory review period. The applicant's response may
include documents that were not in the original patent extension
application.
(c) If the applicant does not respond to the petition, FDA will
decide the matter on the basis of the information submitted in the
patent term restoration application, due diligence petition, and FDA
records.
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