[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: 21CFR60.30]

[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. 60.30  Filing, format, and content of petitions.


    (a) Any person may file a petition with FDA, no later than 180 days 
after the publication of a regulatory review period determination under 
Sec. 60.20, that challenges FDA's determination by alleging that the 
applicant for patent term restoration did not act with due diligence in 
seeking FDA approval of the product during the regulatory review period.
    (b) The petition shall be filed in accordance with Sec. 10.20, under 
the docket number of the Federal Register notice of the agency's 
regulatory review period determination, and shall be in the format 
specified in Sec. 10.30. The petition shall contain the information 
specified in Sec. 10.30 and any additional information required by this 
subpart. If any provision of Sec. 10.20 or Sec. 10.30 is inconsistent 
with any provision of this part, FDA will consider the petition in 
accordance with this part.
    (c) The petition shall claim that the applicant did not act with due 
diligence during some part of the regulatory review period and shall set 
forth sufficient facts, including dates if possible, to merit an 
investigation by FDA of whether the applicant acted with due diligence.
    (d) The petition shall contain a certification that the petitioner 
has served a true and complete copy of the petition upon the applicant 
by certified or registered mail (return receipt requested) or by 
personal delivery.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0233)