---
kind: "section"
citation: "21 C.F.R. § 316.50"
title: "21"
number: "316.50"
heading: "Guidance documents."
url: "https://uscodex.org/cfr/21/316.50"
---

# §316.50. Guidance documents.


FDA's Office of Orphan Products Development will maintain and make publicly available a list of guidance documents that apply to the regulations in this part. The list is maintained on the Internet and is published annually in the Federal Register. A request for a copy of the list should be directed to the Office of Orphan Products Development, Food and Drug Administration, Bldg. 32, rm. 5271, 10903 New Hampshire Ave., Silver Spring, MD 20993.


## Notes

### Amendments

[78 FR 35135, June 12, 2013]

### Authority

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

### Source

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

### Amendments

[78 FR 35135, June 12, 2013]