83 FR 47926 - Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for Food and Drug Administration Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to the Food and Drug Administration;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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 184 (September 21, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA.'' The draft guidance provides the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for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.

[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47926-47927]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20560]


-----------------------------------------------------------------------

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Bank; Draft Guidance for Food and Drug Administration Staff, 
Responsible Parties, and Submitters of Certain Applications and 
Submissions to the Food and Drug Administration; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: 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the availability of a draft guidance for industry entitled ``Civil 
Money Penalties Relating to the ClinicalTrials.gov Data Bank; Draft 
Guidance for FDA Staff, Responsible Parties, and Submitters of Certain 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 The draft guidance provides the 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.

DATES: 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.

ADDRESSES: You may submit comments on any guidance 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; 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.
     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

[[Page 47927]]

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.thefederalregister.org/fdsys/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 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.

FOR FURTHER INFORMATION CONTACT: 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    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.

II. Electronic Access

    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