---
kind: "section"
citation: "21 C.F.R. § 516.145"
title: "21"
number: "516.145"
heading: "Content and format of a request for addition to the index."
url: "https://uscodex.org/cfr/21/516.145"
---

# §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](/cfr/21/516.137.md);
  - (2) A copy of FDA's written determination that the proposed qualified expert panel meets the selection criteria provided for in [§ 516.141(b)](/cfr/21/516.141.md?p=b);
  - (3) A written report that meets the requirements of [§ 516.143](/cfr/21/516.143.md);
  - (4) A proposed index entry that contains the information described in [§ 516.157](/cfr/21/516.157.md);
  - (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](/cfr/21/516.141.md) that it submitted to the qualified expert panel. Any such information not in English should be accompanied by an English translation.

## Notes

### Source

Source: 72 FR 69121, Dec. 6, 2007, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

### Source

Source: 72 FR 41017, July 26, 2007, unless otherwise noted.