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)
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
- 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
- Statutory authority
- 333(f)(3)(A) verified
- Maximum penalty
- 15,107 verified
Values marked our reading are our classification of what the source says — the source does not print them in those words. The quote below is the evidence for each one; judge it yourself.
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
— ecfr.gov, retrieved 2026-08-10
Source
- ecfr.govhttps://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3