[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
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.