118 STAT. 893 PUBLIC LAW 108–282—AUG. 2, 2004 ‘‘(A) all information necessary to meet the requirements of section 512(b)(1) except section 512(b)(1)(A); ‘‘(B) full reports of investigations which have been made to show whether or not such drug is safe under section 512(d) (including, for an antimicrobial new animal drug, with respect to antimicrobial resistance) and there is a reasonable expecta tion of effectiveness for use; ‘‘(C) data for establishing a conditional dose; ‘‘(D) projections of expected need and the justification for that expectation based on the best information available; ‘‘(E) information regarding the quantity of drug expected to be distributed on an annual basis to meet the expected need; and ‘‘(F) a commitment that the applicant will conduct addi tional investigations to meet the requirements for the full dem onstration of effectiveness under section 512(d)(1)(E) within 5 years. ‘‘(3) A person may not file an application under paragraph (1) if— ‘‘(A) the application seeks conditional approval of a new animal drug that is contained in, or is a product of, a transgenic animal. ‘‘(B) the person has previously filed an application for condi tional approval under paragraph (1) for the same drug in the same dosage form for the same intended use whether or not subsequently conditionally approved by the Secretary under subsection (b), or ‘‘(C) the person obtained the application, or data or other information contained therein, directly or indirectly from the person who filed for conditional approval under paragraph (1) for the same drug in the same dosage form for the same intended use whether or not subsequently conditionally approved by the Secretary under subsection (b). ‘‘(b) 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— ‘‘(1) issue an order, effective for one year, conditionally approving the application if the Secretary finds that none of the grounds for denying conditional approval, specified in sub section (c) of this section applies and publish a Federal Register notice of the conditional approval, or ‘‘(2) give the applicant notice of an opportunity for an informal hearing on the question whether such application can be conditionally approved. ‘‘(c) If the Secretary finds, after giving the applicant notice and an opportunity for an informal hearing, that— ‘‘(1) any of the provisions of section 512(d)(1) (A) through (D) or (F) through (I) are applicable; ‘‘(2) the information submitted to the Secretary as part of the application and any other information before the Sec retary with respect to such drug, is insufficient to show that there is a reasonable expectation that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or ‘‘(3) another person has received approval under section 512 for the same drug in the same dosage form for the same Federal Register, publication. Deadline. Reports.
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