---
kind: "section"
citation: "21 C.F.R. § 516.12"
title: "21"
number: "516.12"
heading: "Purpose."
url: "https://uscodex.org/cfr/21/516.12"
---

# §516.12. Purpose.


This subpart establishes standards and procedures for determining eligibility for designation and the associated incentives and benefits described in [section 573](/cfr/21/573.md) of the act, including a 7-year period of exclusive marketing rights.


## Notes

### Authority

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

### Source

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