[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Notices]
[Pages 50028-50030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0787]


Civil Money Penalties Relating to the ClinicalTrials.gov Data 
Bank; Guidance for Responsible Parties, Submitters of Certain 
Applications and Submissions to the Food and Drug Administration, and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry and other responsible 
parties entitled ``Civil Money Penalties Relating to the 
ClinicalTrials.gov Data Bank; Guidance

[[Page 50029]]

for Responsible Parties, Submitters of Certain Applications and 
Submissions to FDA, and FDA Staff.'' The guidance provides the current 
thinking of FDA's medical product Centers--the Center for Drug 
Evaluation and Research, the Center for Biologics Evaluation and 
Research, and the Center for Devices and Radiological Health--regarding 
civil money penalties that may be assessed under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) for violations of the requirements to 
submit clinical trial registration and results information to the 
ClinicalTrials.gov data bank and certain certifications to FDA.

DATES: The announcement of the guidance is published in the Federal 
Register on August 17, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-0787 for ``Civil Money Penalties Relating to the 
ClinicalTrials.gov Data Bank; Guidance for Responsible Parties, 
Submitters of Certain Applications and Submissions to FDA, and FDA 
Staff.'' 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.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 guidance to the 
Office of Good Clinical Practice (OGCP), Office of Clinical Policy and 
Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5103, Silver Spring, MD 20993. Send one self-addressed adhesive 
label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Patrick McNeilly, Office of Good 
Clinical Practice, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-2941.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
other responsible parties entitled ``Civil Money Penalties Relating to 
the ClinicalTrials.gov Data Bank; Guidance for Responsible Parties, 
Submitters of Certain Applications and Submissions to FDA, and FDA 
Staff.'' The guidance provides the current thinking of FDA's Center for 
Drug Evaluation and Research, Center for Biologics Evaluation and 
Research, and Center for Devices and Radiological Health (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, and 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 clinical trial 
registration and results information to the ClinicalTrials.gov data 
bank and certain certifications to FDA.
    The guidance is intended to address several questions. First, the 
guidance addresses how the Centers may 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 to FDA or knowingly submitted a false 
certification to FDA. Second, the guidance addresses the circumstances 
under which a Center may decide to seek civil money penalties against a 
responsible party or submitter. Third,

[[Page 50030]]

the guidance addresses the procedures that apply when a Center seeks 
civil money penalties; and fourth, the guidance addresses the civil 
money penalty amounts that 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.
    In the Federal Register of September 21, 2018 (83 FR 47926), FDA 
announced the availability of the draft guidance. FDA received comments 
on the draft guidance and considered all comments in finalizing this 
guidance. FDA revised the guidance to clarify that FDA does not intend 
to include on its Lists of Inspectional Observations, Forms FDA 483, 
any inspectional observations regarding potential violations relating 
to the ClinicalTrials.gov data bank; however, information that is 
collected by an investigator regarding potential violations of such 
requirements will be included in an Establishment Inspection Report and 
provided to the relevant Center for further evaluation. The guidance 
has also been revised to make clear that, in determining whether to 
seek civil money penalties, FDA intends to take into consideration any 
corrective action taken by a responsible party or submitter after 
receiving a Notice of Noncompliance. The guidance further explains that 
FDA intends to post Notices of Noncompliance on its website and to 
transmit the Notices of Noncompliance to the National Institutes of 
Health (NIH), so NIH can include the notice regarding noncompliance 
required under section 402(j)(5)(E) of the PHS Act in the 
ClinicalTrials.gov data bank. The guidance also provides some limited 
examples of applicable clinical trials of products that potentially may 
pose a higher risk to human subjects or applicable clinical trials of 
products intended to address significant public health need. In 
addition, editorial changes were made to the guidance to improve 
clarity. The guidance announced in this notice finalizes the draft 
guidance dated September 21, 2018.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this guidance refers to previously approved collections of 
information. This collection of information is subject to review by OMB 
under the PRA. The collection of information referenced in this 
guidance is related to information required under section 402(j)(5)(B) 
of the PHS Act and has been approved under OMB control number 0910-
0616.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: August 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17909 Filed 8-14-20; 8:45 am]
BILLING CODE 4164-01-P


