---
kind: "section"
citation: "21 C.F.R. § 316.2"
title: "21"
number: "316.2"
heading: "Purpose."
url: "https://uscodex.org/cfr/21/316.2"
---

# §316.2. Purpose.


The purpose of this part is to establish standards and procedures for determining eligibility for the benefits provided for in section 2 of the Orphan Drug Act, including written recommendations for investigations of orphan drugs, a 7-year period of exclusive marketing, and treatment use of investigational orphan drugs. This part is also intended to satisfy Congress' requirements that FDA promulgate procedures for the implementation of sections [525(a)](/cfr/21/525.md?p=a) and [526(a)](/cfr/21/526.md?p=a) of the act.


## Notes

### Authority

Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.

### Source

Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.