---
kind: "section"
citation: "21 C.F.R. § 516.153"
title: "21"
number: "516.153"
heading: "Notification of decision regarding index listing."
url: "https://uscodex.org/cfr/21/516.153"
---

# §516.153. Notification of decision regarding index listing.

- (a) Within 180 days after the filing of a request for addition of a new animal drug to the index, FDA shall grant or deny the request and notify the requestor of FDA's decision in writing.
- (b) If FDA denies the request for addition of a new animal drug to the index, FDA shall provide due notice and an opportunity for an informal conference as described in [§ 516.123](/cfr/21/516.123.md). A decision of FDA to deny a request to index a new animal drug following an informal conference shall constitute final agency action subject to judicial review.

## 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.