---
kind: "section"
citation: "42 C.F.R. § 11.40"
title: "42"
number: "11.40"
heading: "Who must submit clinical trial results information?"
url: "https://uscodex.org/cfr/42/11.40"
---

# §11.40. Who must submit clinical trial results information?


The responsible party for an applicable clinical trial specified in [§ 11.42](/cfr/42/11.42.md) must submit clinical trial results information for that clinical trial.


## Notes

### Authority

Authority: 42 U.S.C. 282(i); 42 U.S.C. 282(j); 5 U.S.C. 301; 42 U.S.C. 286(a); 42 U.S.C. 241(a); 42 U.S.C. 216(b).

### Source

Source: 81 FR 65138, Sept. 21, 2016, unless otherwise noted.