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Food and Drug Administration, HHS.
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for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Submit either electronic or written comments on the draft guidance by November 20, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2018-D-0787 for “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
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.
FDA 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 CDER, CBER, and CDRH (Center, or collectively Centers), regarding civil money penalties for responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, or device products (submitters) who violate applicable FD&C Act (21 U.S.C. 301 et seq.) prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)), including its implementing regulations in 42 CFR part 11, to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA. The draft guidance is intended to address several questions. First, how the Centers identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, and whether submitters have failed to submit the certification required by section 402(j)(5)(B) of the PHS Act (42 U.S.C. 282(j)(5)(B)) to FDA or knowingly submitted a false certification to FDA. Second, under what circumstances a Center may decide to seek civil money penalties against a responsible party or submitter. Third, what procedures apply when a Center seeks civil money penalties; and finally, what civil money penalty amounts may be assessed for: (1) Failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) knowingly submitting false or misleading clinical trial information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on civil money penalties relating to the ClinicalTrials.gov data bank. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: September 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20560 Filed 9-20-18; 8:45 am]
BILLING CODE 4164-01-P
63 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.