---
kind: "section"
citation: "42 C.F.R. § 11.6"
title: "42"
number: "11.6"
heading: "What are the requirements for the submission of truthful information?"
url: "https://uscodex.org/cfr/42/11.6"
---

# §11.6. What are the requirements for the submission of truthful information?


The clinical trial information submitted by a responsible party under this part shall not be false or misleading in any particular. A responsible party who submits false and/or misleading information is subject to civil monetary penalties and/or other civil or criminal remedies available under U.S. law.


## 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.