9 C.F.R. § 124.30 Filing, format, and content of petitions.
Title 9 - Animals and Animal Products
(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 (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.
Title 9: Animals and Animal Products
PART 124—PATENT TERM RESTORATION
Subpart D—Due Diligence Petitions
§ 124.30 Filing, format, and content of petitions.