---
kind: "section"
citation: "21 C.F.R. § 316.52"
title: "21"
number: "316.52"
heading: "Availability for public disclosure of data and information in requests and applications."
url: "https://uscodex.org/cfr/21/316.52"
---

# §316.52. Availability for public disclosure of data and information in requests and applications.

- (a) FDA will not publicly disclose the existence of a request for orphan-drug designation under [section 526](/cfr/21/526.md) of the act prior to final FDA action on the request unless the existence of the request has been previously publicly disclosed or acknowledged.
- (b) Whether or not the existence of a pending request for designation has been publicly disclosed or acknowledged, no data or information in the request are available for public disclosure prior to final FDA action on the request.
- (c) Upon final FDA action on a request for designation, FDA will determine the public availability of data and information in the request in accordance with [part 20](/cfr/21/part20.md) and [§ 314.430](/cfr/21/314.430.md) of this chapter and other applicable statutes and regulations.
- (d) In accordance with [§ 316.28](/cfr/21/316.28.md), FDA will make a cumulative list of all orphan drug designations available to the public and update such list monthly.
- (e) FDA will not publicly disclose the existence of a pending marketing application for a designated orphan drug for the use for which the drug was designated unless the existence of the application has been previously publicly disclosed or acknowledged.
- (f) FDA will determine the public availability of data and information contained in pending and approved marketing applications for a designated orphan drug for the use for which the drug was designated in accordance with [part 20](/cfr/21/part20.md) and [§ 314.430](/cfr/21/314.430.md) of this chapter and other applicable statutes and regulations.

## Notes

### Authority

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

### Source

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