---
kind: "section"
citation: "21 C.F.R. § 516.137"
title: "21"
number: "516.137"
heading: "Notification of decision regarding eligibility for indexing."
url: "https://uscodex.org/cfr/21/516.137"
---

# §516.137. Notification of decision regarding eligibility for indexing.

- (a) Within 90 days after the filing of a request for a determination of eligibility for indexing based on § [516.129(c)(7)(i)](/cfr/21/516.129.md?p=c-7-i), or [180](/cfr/21/180.md) days for a request based on [§ 516.129(c)(7)(ii)](/cfr/21/516.129.md?p=c-7-ii), FDA shall grant or deny the request, and notify the requestor of FDA's decision in writing.
- (b) If FDA denies the request, FDA shall provide due notice and an opportunity for an informal conference as described in [§ 516.123](/cfr/21/516.123.md) regarding its decision. A decision of FDA to deny a request for determination of eligibility for indexing 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.