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.

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:

A copy of FDA's determination of eligibility issued under § 516.137;

A copy of FDA's written determination that the proposed qualified expert panel meets the selection criteria provided for in § 516.141(b);

A written report that meets the requirements of § 516.143;

A proposed index entry that contains the information described in § 516.157;

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;

Anticipated annual distribution of the new animal drug, in terms of the total quantity of active ingredient, after indexing;

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;

A written commitment to label, distribute, and promote the new animal drug only in accordance with the index entry;

The name and address of the contact person or permanent-resident U.S. agent; and

A draft Freedom of Information summary which includes the following information:

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.

A list of the names and affiliations of the members of the qualified expert panel, not including their addresses or other contact information.

A summary of the findings of the qualified expert panel concerning the target animal safety and effectiveness of the drug.

Citations of all publicly-available literature considered by the qualified expert panel.

For an early life stage of a food-producing minor species animal, a human food safety summary.

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.