Page:United States Statutes at Large Volume 102 Part 4.djvu/1003

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PUBLIC LAW 100-670—NOV. 16, 1988

102 STAT. 3973

of administration, the dosage form, or the strength of the new animal drug is different and the application is filed pursuant to the approval of a petition filed under paragraph (3), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require; "(E) information to show that the new animal drug is bioequivalent to the approved new animal drug, except that if the application is filed pursuant to the approval of a petition filed under paragraph (3) for the purposes described in subparagraph (B) or (C), information to show that the active ingredients of the new euiimal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling; "(F) information to show that the labeling proposed for the new animal drug is the same as the labeling approved for the approved new animal drug except for changes required because of differences approved under a petition filed under paragraph (3), because of a different withdrawal period, or because the new animal drug and the approved new animal drug are produced or distributed by different manufacturers; "(G) the items specified in clauses (B) through (F) of subsection (b)(1); "(H) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the approved new animal drug or which claims a use for such approved new animal drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection OaXD or (c)(3)— "(i) that such patent information has not been filed, "(ii) that such patent has expired, "(iii) of the date on which such patent will expire, or "(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new animed drug for which the application is filed; and "(I) if with respect to the approved new animal drug information was filed under subsection (b)(1) or (c)(3) for a method of use patent which does not claim a use for which the applicant is seeking approval of an application under subsection (c)(2), a statement that the method of use patent does not claim such a use. The Secretary may not require that an abbreviated application contain information in addition to that required by subparagraphs (A) through (H). "(2)(A) An applicant who makes a certification described in paragraph (IXGXiv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— "(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and "(ii) the holder of the approved application under subsection (c)(1) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice.

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