United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2018_register executive 2018-09-21 article Notices D09002ee1c7e10c65 D09002ee1c7e10e07 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA." The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) regarding civil money penalties that may be assessed against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibitions relating to requirements, including implementing regulations, submitting registration and/or results information to the ClinicalTrials.gov data bank, and/or certain certifications to FDA. 83 FR 47926 https://www.govinfo.gov/app/details/FR-2018-09-21/2018-20560 2018-20560 fr21se18-63 4164-01-P Docket No. FDA-2018-D-0787 https://www.govinfo.gov/app/details/FR-2018-09-21/2018-20560 https://www.govinfo.gov/content/pkg/FR-2018-09-21/html/2018-20560.htm https://www.govinfo.gov/content/pkg/FR-2018-09-21/pdf/2018-20560.pdf 2 p. 47926 47927 83 FR 47926 Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration; Availability; Federal Register Vol. 83, Issue NOTICE 2018-20560 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-11-20 Docket No. FDA-2018-D-0787 4164-01-P 2018-20560 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA." The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) regarding civil money penalties that may be assessed against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products who violate applicable Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibitions relating to requirements, including implementing regulations, submitting registration and/or results information to the ClinicalTrials.gov data bank, and/or certain certifications to FDA.

Submit either electronic or written comments on the draft guidance by November 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Patrick McNeilly, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-2941. Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank , ClinicalTrials.gov https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 184 Office of the Federal Register, National Archives and Records Administration 2018-09-21 continuing daily deposited born digital 410 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-09-21 P0b002ee19cdda012 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21se18 https://www.govinfo.gov/app/details/FR-2018-09-21 https://www.govinfo.gov/content/pkg/FR-2018-09-21/pdf/FR-2018-09-21.pdf fdlp 47801 48200 DGPO 2018-09-21 2024-06-01 FR-2018-09-21 machine generated eng FR FR-2018-09-21 83 184