Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs

Except as provided in paragraph (3), any person may file with the Secretary an application for conditional approval of— a new animal drug not intended for a minor use or minor species— The applicant shall submit to the Secretary as part of an application for the conditional approval of a new animal drug— A person may not file an application under paragraph (1) if— Within 180 days after the filing of an application pursuant to subsection (a), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either— If the Secretary finds, after giving the applicant notice and an opportunity for an informal hearing, that— A conditional approval under this section is effective for a 1-year period and is thereafter renewable by the Secretary annually for up to 4 additional 1-year terms. A conditional approval shall be in effect for no more than 5 years from the date of approval under subsection (b)(1) or (c) of this section unless extended as provided for in subsection (h) of this section. The following shall also apply: A conditional approval shall be deemed renewed at the end of the 1-year period, or at the end of a 90-day extension that the Secretary may, at the Secretary’s discretion, grant by letter in order to complete review of the renewal request, unless the Secretary determines before the expiration of the 1-year period or the 90-day extension that— the request fails to contain sufficient information to show that— For purposes of this section, with respect to an application described in subparagraph (A), the term “date of approval” shall mean the later of— The Secretary shall, after due notice and opportunity for an informal hearing to the applicant, issue an order withdrawing conditional approval of an application filed pursuant to subsection (a) if the Secretary finds that— The label and labeling of a new animal drug with a conditional approval under this section shall for the conditionally approved use— A conditionally approved new animal drug application may not be amended or supplemented to add indications for use. 180 days prior to the termination date established under subsection (d) of this section, an applicant shall have submitted all the information necessary to support a complete new animal drug application in accordance with section 360b(b)(1) of this title or the conditional approval issued under this section is no longer in effect. Following review of this information, the Secretary shall either— The decision of the Secretary under subsection (c), (d), or (e) of this section refusing or withdrawing conditional approval of an application shall constitute final agency action subject to judicial review. In this section and section 360ccc–1 of this title, the term “transgenic animal” means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal; Provided that the term “transgenic animal” does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding. The Secretary—