---
kind: "section"
citation: "21 C.F.R. § 312.130"
title: "21"
number: "312.130"
heading: "Availability for public disclosure of data and information in an IND."
url: "https://uscodex.org/cfr/21/312.130"
---

# §312.130. Availability for public disclosure of data and information in an IND.

- (a) The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.
- (b) The availability for public disclosure of all data and information in an investigational new drug application for a new drug will be handled in accordance with the provisions established in [§ 314.430](/cfr/21/314.430.md) for the confidentiality of data and information in applications submitted in [part 314](/cfr/21/part314.md). The availability for public disclosure of all data and information in an investigational new drug application for a biological product will be governed by the provisions of §§ [601.50](/cfr/21/601.50.md) and [601.51](/cfr/21/601.51.md).
- (c) Notwithstanding the provisions of [§ 314.430](/cfr/21/314.430.md), FDA shall disclose upon request to an individual to whom an investigational new drug has been given a copy of any IND safety report relating to the use in the individual.
- (d) The availability of information required to be publicly disclosed for investigations involving an exception from informed consent under [§ 50.24](/cfr/21/50.24.md) of this chapter will be handled as follows: Persons wishing to request the publicly disclosable information in the IND that was required to be filed in Docket Number 95S-0158 in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, shall submit a request under the Freedom of Information Act.

## Notes

### Amendments

[52 FR 8831, Mar. 19, 1987. Redesignated at 53 FR 41523, Oct. 21, 1988, as amended at 61 FR 51530, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999; 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.

### Source

Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

### Amendments

[52 FR 8831, Mar. 19, 1987. Redesignated at 53 FR 41523, Oct. 21, 1988, as amended at 61 FR 51530, Oct. 2, 1996; 64 FR 401, Jan. 5, 1999; 68 FR 24879, May 9, 2003; 88 FR 45065, July 14, 2023]