---
kind: "section"
citation: "21 C.F.R. § 312.31"
title: "21"
number: "312.31"
heading: "Information amendments."
url: "https://uscodex.org/cfr/21/312.31"
---

# §312.31. Information amendments.

- (a) **Requirement for information amendment.** A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a protocol amendment, IND safety reports, or annual report. Examples of information requiring an information amendment include:
  - (1) New toxicology, chemistry, or other technical information; or
  - (2) **A report regarding the discontinuance of a clinical investigation.**
- (b) **Content and format of an information amendment.** An information amendment is required to bear prominent identification of its contents (e.g., “Information Amendment: Chemistry, Manufacturing, and Control”, “Information Amendment: Pharmacology-Toxicology”, “Information Amendment: Clinical”), and to contain the following:
  - (1) **A statement of the nature and purpose of the amendment.**
  - (2) **An organized submission of the data in a format appropriate for scientific review.**
  - (3) If the sponsor desires FDA to comment on an information amendment, a request for such comment.
- (c) **When submitted.** Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than every 30 days.

## Notes

### Amendments

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988; 67 FR 9585, Mar. 4, 2002]

### 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, as amended at 52 FR 23031, June 17, 1987; 53 FR 1918, Jan. 25, 1988; 67 FR 9585, Mar. 4, 2002]