[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: 21CFR60.30]
[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.
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR 9585, Mar. 4, 2002]
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