§ 516.145 Content and format of a request for addition to the index.

(a) A requestor may request addition of a new animal drug to the index only after the new animal drug has been granted eligibility for indexing. (b) A requestor shall submit two copies of a dated request signed by the authorized contact for addition of a new animal drug to the index that contains the following: (1) A copy of FDA's determination of eligibility issued under § 516.137; (2) A copy of FDA's written determination that the proposed qualified expert panel meets the selection criteria provided for in § 516.141(b); (3) A written report that meets the requirements of § 516.143; (4) A proposed index entry that contains the information described in § 516.157; (5) Proposed labeling, including representative labeling proposed to be used for Type B and Type C medicated feeds if the drug is intended for use in the manufacture of medicated feeds; (6) Anticipated annual distribution of the new animal drug, in terms of the total quantity of active ingredient, after indexing; (7) A written commitment to manufacture the new animal drug and animal feeds bearing or containing such new animal drug according to current good manufacturing practices; (8) A written commitment to label, distribute, and promote the new animal drug only in accordance with the index entry; (9) The name and address of the contact person or permanent-resident U.S. agent; and (10) A draft Freedom of Information summary which includes the following information: (i) A general information section that contains the name and address of the requestor and a description of the drug, route of administration, indications, and recommended dosage. (ii) A list of the names and affiliations of the members of the qualified expert panel, not including their addresses or other contact information. (iii) A summary of the findings of the qualified expert panel concerning the target animal safety and effectiveness of the drug. (iv) Citations of all publicly-available literature considered by the qualified expert panel. (v) For an early life stage of a food-producing minor species animal, a human food safety summary. (c) Upon specific request by FDA, the requestor shall submit the information described in § 516.141 that it submitted to the qualified expert panel. Any such information not in English should be accompanied by an English translation.