TITLE 9 - ANIMALS AND ANIMAL PRODUCTS

CHAPTER I - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE

SUBCHAPTER E - VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS

PART 124 - PATENT TERM RESTORATION

subpart d - DUE DILIGENCE PETITIONS

124.30 - Filing, format, and content of petitions.

  (a) Any interested person may file a petition with APHIS, no later than 180 days after the publication of a regulatory review period determination under 124.21, alleging that a license applicant did not act with due diligence in seeking APHIS approval of the product during the regulatory review period.

  (b) The petition must be filed with APHIS under the docket number of the Federal Register notice of the agency's regulatory review period determination. The petition must contain any additional information required by this subpart.

  (c) The petition must allege that the applicant failed to act with due diligence sometime during the regulatory review period and must set forth sufficient facts to merit an investigation by APHIS of whether the applicant acted with due diligence.

  (d) The petition must contain a certification that the petitioner has served a true and complete copy of the petition on interested parties by certified or registered mail (return receipt requested) or by personal delivery.