---
kind: "section"
citation: "21 C.F.R. § 516.52"
title: "21"
number: "516.52"
heading: "Availability for public disclosure of data and information in requests."
url: "https://uscodex.org/cfr/21/516.52"
---

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

- (a) FDA will not publicly disclose the existence of a request for MUMS-drug designation under [section 573](/cfr/21/573.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) Except as provided in [paragraph (d)](#d) of this section, upon final FDA action on a request for designation, the public availability of data and information in the request will be determined in accordance with [part 20](/cfr/21/part20.md) of this chapter and other applicable statutes and regulations.
- (d) In accordance with [§ 516.28](/cfr/21/516.28.md), FDA will make a cumulative list of all MUMS-drug designations available to the public and update such list periodically. In accordance with [§ 516.29](/cfr/21/516.29.md), FDA will give public notice of the termination of all MUMS-drug designations.

## Notes

### Authority

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

### Source

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