# Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C. 282(j) ; or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D) — Federal civil penalty maximums — current inflation-adjusted amounts across agencies

For Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C. 282(j) ; or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D), agency is HHS; statutory authority is 333(f)(3)(A); maximum penalty is 15,107, recorded from its source on 2026-08-10.

- **Agency:** HHS _(our reading, not quoted from the source)_
- **Violation:** Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C. 282(j) ; or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D) _(verified: appears in the quote below)_
- **Statutory authority:** 333(f)(3)(A) _(verified: appears in the quote below)_
- **Maximum penalty:** 15,107 _(verified: appears in the quote below)_

## What the source says

> 333(f)(3)(A) | | FDA | Penalty for all violations adjudicated in a single proceeding for any person who violates <https://www.govinfo.gov/link/uscode/21/331> 21 U.S.C. 331(jj) by failing to submit the certification required by <https://www.govinfo.gov/link/uscode/42/282> 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under <https://www.govinfo.gov/link/uscode/42/282> 42 U.S.C. 282(j) ; or by submitting clinical trial information under <https://www.govinfo.gov/link/uscode/42/282> 42 U.S.C. 282(j) that is false or misleading in any particular under <https://www.govinfo.gov/link/uscode/42/282> 42 U.S.C. 282(j)(5)(D) | 2024 | 14,724 | 15,107

## Source

- https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3

Last verified: 2026-08-10. Review by: 2027-02-26.
Part of [Federal civil penalty maximums — current inflation-adjusted amounts across agencies](https://referencesource.org/federal-civil-penalty-maximums/).