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 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice (OGCP) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiologic Health (CDRH) 
Office of Regulatory Affairs (ORA) 
 
August 2020 
   
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 
 
Additional copies are available from: 
 
Office of Good Clinical Practice  
Office of Clinical Policy and Programs  
Food and Drug Administration  
10903 New Hampshire Avenue, WO32-5103  
Silver Spring, MD 20993-0002  
(Tel) 301-796-8340  
(FAX) 301-847-8640 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Good Clinical Practice (OGCP) 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiologic Health (CDRH) 
Office of Regulatory Affairs (ORA) 
 
August 2020 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 3 
A.  Definitions ..................................................................................................... 3 
B.  How do the Centers intend to identify whether someone has: failed to submit 
required clinical trial registration and/or results information to the 
ClinicalTrials.gov data bank; submitted false or misleading information to the data 
bank; or failed to submit or knowingly submitted a false certification to FDA?....... 4 
 
C.  Under what circumstances may a Center decide to seek civil money penalties?........ 5 
 
D.  What procedures apply when a Center seeks civil money penalties?....................... 7 
 
E.  What civil money penalty amounts may be assessed?...................................................... 8 
 
  Contains Nonbinding Recommendations 
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank  
 
Guidance for Responsible Parties, Submitters of Certain 
Applications and Submissions to FDA, and FDA Staff1 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  This guidance does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of 
the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the 
appropriate FDA staff responsible for implementing this guidance.  If you cannot identify the appropriate 
FDA staff, call the appropriate number listed on the second title page of this guidance. 
 
 
 
 
I.  INTRODUCTION  
 
This guidance document is intended to describe the current thinking of FDAs Center for 
Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research 
(CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, Center or 
collectively, the Centers), regarding civil money penalties under section 303(f)(3) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act).2  That section authorizes FDA to 
assess civil money penalties against responsible parties and/or submitters of certain 
applications and submissions to FDA regarding drug products, biological products, and 
device products (hereafter, submitters) who violate applicable FD&C Act prohibitions 
relating to requirements under section 402(j) of the Public Health Service Act (PHS 
Act),3 including its implementing regulations in 42 CFR part 11, to submit clinical trial 
registration and/or results information to the ClinicalTrials.gov data bank and/or certain 
certifications to FDA.  
 
The guidance document addresses the following questions: 
 
  How do the Centers intend to 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, or whether submitters 
                                                 
1 This guidance has been prepared by the Office of Good Clinical Practice in cooperation with FDAs Center for 
Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological 
Health, and Office of Regulatory Affairs. 
2 21 U.S.C. 333(f)(3). 
3 42 U.S.C. 282(j). 
  1  Contains Nonbinding Recommendations 
have failed to submit to FDA the certification required by section 402(j)(5)(B) of the PHS 
Act4 or knowingly submitted a false certification to FDA? 
  Under what circumstances may a Center decide to seek civil money penalties against a 
responsible party or submitter? 
  What procedures apply when a Center seeks civil money penalties? 
  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) submitting false or misleading information to the data bank, (3) failing to 
submit the required certification to FDA, or (4) knowingly submitting a false 
certification to FDA? 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
 
II.  BACKGROUND 
 
Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) 
amended section 402(j) of the PHS Act5 to require that a responsible party submit 
clinical trial registration and results information to the ClinicalTrials.gov data bank for 
certain applicable clinical trials.  The section also requires a submitter to certify to FDA 
that all requirements of section 402(j) have been met when submitting certain applications 
and submissions to FDA regarding drug products, biological products, and device 
products.  FDAAA also directed the Secretary of Health and Human Services (Secretary) 
to promulgate regulations expanding the requirements for submission of clinical trial 
registration and results information for certain applicable clinical trials to the 
ClinicalTrials.gov data bank.  On September 21, 2016, the National Institutes of Health 
(NIH) and the Department of Health and Human Services published the Final Rule for 
Clinical Trials Registration and Results Information Submission, 81 Fed. Reg. 64,982 
(Sept. 21, 2016),6 which implements the provisions of section 402(j) of the PHS Act by 
clarifying and expanding the clinical trial registration and results information 
requirements.  The regulations are codified at 42 CFR part 11 and were effective January 
18, 2017, with a compliance date of April 18, 2017.   
 
FDAAA also amended the FD&C Act to add section 301(jj),7 which includes the 
following prohibited acts:  
 
1.  Failing to submit or knowingly submitting a false certification to FDA under 
section 402(j)(5)(B) of the PHS Act;  
                                                 
4 42 U.S.C. 282(j)(5)(B). 
5 42 U.S.C. 282(j). 
6 https://www.regulations.gov/document?D=NIH-2011-0003-0907. 
7 21 U.S.C. 331(jj). 
  2  Contains Nonbinding Recommendations 
 
2.  Failing to submit required clinical trial information under section 402(j) of the 
PHS Act; and  
 
3.  Submitting clinical trial information under section 402(j) to the 
ClinicalTrials.gov data bank that is false or misleading under 402(j)(5)(D).   
 
FDAAA further amended section 303(f)(3) of the FD&C Act8 to authorize FDA to assess 
civil money penalties against a person that commits these prohibited acts.  The maximum 
penalty amounts and factors considered when seeking civil money penalties are discussed 
in Section III.E. 
 
 
III.  DISCUSSION     
 
A.  Definitions 
 
 
The Centers intend to use the following definitions in implementing the FD&C Acts civil 
money penalty provisions relating to the submission of registration and results information 
to the ClinicalTrials.gov data bank and certain certifications to FDA. 
 
1.   Civil money penalty or civil monetary penalty:  The terms civil money 
penalty and civil monetary penalty are used interchangeably and mean 
a monetary penalty assessed under section 303(f)(3) of the FD&C Act9 for 
prohibited acts (found in section 301(jj) of the FD&C Act10) relating to the 
submission of clinical trial registration and results information to the 
ClinicalTrials.gov data bank and certain certifications to FDA. 
 
2.   Applicable clinical trial:  The term applicable clinical trial refers to an 
applicable device clinical trial or an applicable drug clinical trial as 
defined in 42 CFR 11.10(a).   
 
3.   Responsible party:  The term responsible party means the individual or 
entity required to submit clinical trial information for an applicable clinical 
trial, as defined in 42 CFR 11.10(a). 
 
4.  Clinical trial information:  The term clinical trial information means the 
clinical trial registration and/or results information required to be submitted 
to the ClinicalTrials.gov data bank for an applicable clinical trial, as 
defined in 42 CFR 11.10(a). 
 
                                                 
8 21 U.S.C. 333(f)(3). 
9 21 U.S.C. 333(f)(3). 
10 21 U.S.C. 331(jj). 
  3  Contains Nonbinding Recommendations 
5.  Certification to FDA:  The phrase certification to FDA means the 
certification required under section 402(j)(5)(B) of the PHS Act11 that must 
accompany an application or submission under sections 505, 510(k), 515, and 
520(m) of the FD&C Act12 and section 351 of the PHS Act.13  Form FDA 
3674 is used to certify that all applicable requirements of section 402(j) of the 
PHS Act, including its implementing regulations in 42 CFR part 11, have 
been met for all of the applicable clinical trials included in, relied upon, or 
otherwise referred to in the application or submission.14 
 
6.  Submitter: The term submitter means the individual or entity that submits 
certain applications and submissions to FDA regarding drug products, 
biological products, and device products and who provides a certification to 
FDA under section 402(j)(5)(B) of the PHS Act.15  In some cases, the 
submitter may be someone other than the responsible party for an applicable 
clinical trial identified in the certification. 
 
 
B.  How do the Centers intend to identify whether someone has:  failed to 
submit required clinical trial registration and/or results information to the 
ClinicalTrials.gov data bank; submitted false or misleading information to 
the data bank; or failed to submit or knowingly submitted a false 
certification to FDA? 
 
 
The Centers generally intend to identify violations of the FD&C Acts requirements 
relating to the ClinicalTrials.gov data bank through evidence collected during 
inspections conducted as part of FDAs Bioresearch Monitoring Program (BIMO).  
How FDA will collect information to assess compliance with these requirements is 
described in FDAs Bioresearch Monitoring Compliance Program for Sponsors, 
Contract Research Organizations and Monitors.16   
 
In general, the Centers may also identify violations based on the evaluation of 
complaints received by the Agency. The Centers intend to handle complaints in 
accordance with their existing processes for handling complaints about potential 
violations of FDA requirements.  In evaluating complaints, the Centers may 
review any public and non-public information available to FDA, including, but 
not limited to, information submitted to the ClinicalTrials.gov data bank and to 
FDA.   
 
 
 
                                                 
11 42 U.S.C. 282(j)(5)(B). 
12 21 U.S.C. 355, 360(k), 360e, 360j(m). 
13 42 U.S.C. 262. 
14  See Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device 
Applications/Submissions, available at 
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM562439.pdf.   
15 42 U.S.C. 282(j)(5)(B). 
16 See FDA Compliance Program 7348.810 Sponsors, Contract Research Organizations and Monitors. 
  4  Contains Nonbinding Recommendations 
 
 
 
C.  Under what circumstances may a Center decide to seek civil money penalties? 
 
When a Center believes that a responsible party for an applicable clinical trial may have 
committed a prohibited act under section 301(jj) of the FD&C Act17 by failing to comply 
with the PHS Acts clinical trial registration and results information submission 
requirements, including the regulations found in 42 CFR part 11, the Center generally 
intends to send the responsible party a Preliminary Notice of Noncompliance (Pre-Notice) 
Letter, which describes the potential violation and requests that the responsible party take any 
necessary actions to address the potential violation within 30 calendar days after receiving the 
letter.  The Centers also generally intend to send a Pre-Notice Letter to submitters who may 
have violated FDAAAs certification requirements in section 402(j)(5)(B) of the PHS 
Act.18  Pre-Notice Letters notify the recipient that, beginning 30 calendar days after the date 
a Pre-Notice Letter is received, FDA will conduct a further review and assessment of the 
clinical trial information submitted to ClinicalTrials.gov and any other relevant 
information available to FDA and that failure to comply with the requirements relating to 
applicable clinical trials may result in further FDA regulatory action, including the 
issuance of a Notice of Noncompliance, civil money penalties, injunction, and/or criminal 
prosecution.   
 
As discussed above, the Centers intend to identify potential violations of the FD&C Acts 
requirements relating to the ClinicalTrials.gov data bank in part through evidence 
collected during inspections conducted as part of FDAs BIMO program.19  Generally, 
FDAs BIMO activities are associated with the submission of a research or marketing 
application or are a part of the Agencys investigation of a complaint.  When evaluating 
potential violations identified during these activities, FDA intends to utilize a risk-based 
approach to determine the situations in which Pre-Notice Letters will be issued, consistent 
with FDAs public health mission and how the Agency approaches its other compliance 
programs.  In applying this risk-based approach to evaluating potential violations of the 
FD&C Acts requirements relating to the ClinicalTrials.gov data bank, the Centers intend 
to focus their enforcement and regulatory attention in the following areas: 
 
  Responsible parties who have failed to submit required clinical trial registration 
and/or results information under section 402(j) of the PHS Act, including its 
implementing regulations in 42 CFR part 11, for 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.  
Examples may include, but are not limited to, applicable clinical trials of a drug 
                                                 
17 21 U.S.C. 331(jj). 
18 42 U.S.C. 282(j)(5)(B). 
19 Because investigators may not be able to assess whether required clinical trial information has been submitted to 
the ClinicalTrials.gov databank at the time of an inspection, FDA does not intend to include on Forms FDA 483 any 
observations regarding potential violations of requirements 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 the Establishment Inspection Report and provided to the relevant Center for further evaluation. 
  5  Contains Nonbinding Recommendations 
product, biological product, or device product that has not previously been 
approved, licensed, or cleared by FDA and is intended to treat a serious and/or life-
threatening disease or condition and applicable clinical trials involving vulnerable 
populations (such as pediatrics), rare diseases, or emergency research conducted 
without informed consent under 21 CFR 50.24.  
 
  Responsible parties or submitters who have had a pattern of previous 
noncompliance with the requirements to submit clinical trial information and/or 
certifications under section 402(j) of the PHS Act, including its implementing 
regulations in 42 CFR part 11. 
 
  Applicable clinical trials for which noncompliance with the requirements under 
section 402(j) of the PHS Act, including its implementing regulations in 42 CFR 
part 11, exists in conjunction with noncompliance with other statutory and/or 
regulatory requirements pertaining to the conduct of the trial, for example the 
failure to retain clinical trial records or the failure to obtain informed consent. 
 
Pre-Notice Letters will be sent by certified mail, registered mail, mail delivery service, or 
personal delivery to the responsible party for the applicable clinical trial at the address 
specified in the ClinicalTrials.gov Protocol Registration and Results System (PRS), or to 
the submitter at the address specified in the FDA application/submission.  If a Center 
cannot reach the entity or its agent at the address to which the Pre-Notice Letter is sent, 
the Center intends to attempt to reach the entity or its agent through other means, for 
example, through other addresses otherwise identified by the Center in applications or 
submissions provided to the Agency.  Pre-Notice Letters will include an FDA contact to 
whom a response may be submitted and who can address any questions or concerns of the 
responsible party/submitter. 
 
After a Pre-Notice Letter has been received and the 30 calendar day period for any 
necessary action has passed, the Center intends to review the information submitted to 
the ClinicalTrials.gov data bank for that applicable clinical trial, the 
application/submission in FDA files, and/or any other information available to the 
Agency, to determine whether a violation exists.  If the Center determines that a 
responsible party failed to submit any required clinical trial information to the 
ClinicalTrials.gov data bank and/or submitted information that is false or misleading in 
any particular, the Agency will issue the responsible party a Notice of Noncompliance 
under section 402(j)(5)(C)(ii) of the PHS Act.20  If the Center determines that a submitter 
failed to submit the required certification to FDA or knowingly submitted a false 
certification, the Agency intends to issue a Notice of Noncompliance to the submitter.  A 
Notice of Noncompliance will notify the recipient of the Centers determination and give 
the recipient an opportunity to remedy noncompliance not later than 30 calendar days after 
the notification.  FDA intends to post the Notice of Noncompliance on the Agencys 
                                                 
20 42 U.S.C. 282(j)(5)(C)(ii).  The Secretary delegated to the Commissioner of Food and Drugs the authority to issue 
Notices of Noncompliance under this section. See https:/www.gpo.gov/fdsys/pkg/FR-2012-09-26/pdf/2012-
23598.pdf. 
  6  Contains Nonbinding Recommendations 
website and to transmit the Notice of Noncompliance to NIH so it can include the notice 
regarding noncompliance required under section 402(j)(5)(E) of the PHS Act21 in the 
ClinicalTrials.gov data bank.  
 
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.  If a responsible party or submitter does not remedy 
noncompliance within 30 calendar days after receiving a Notice of Noncompliance, the 
Center generally intends to seek civil money penalties, taking into account the type of 
noncompliance and the circumstances associated with the lack of remediation.  
 
D.  What procedures apply when a Center seeks civil money penalties? 
 
FDA regulations governing civil monetary penalty proceedings are found at 21 CFR part 
17.  Civil money penalty actions are initiated when the Center with principal jurisdiction over 
the matter involved files a Complaint with FDAs Division of Dockets Management and 
serves the Complaint on the respondent (in this case, the responsible party or submitter).  
The Complaint will be signed by the FDA Office of Chief Counsel attorney for the Center 
and include allegations of liability against the respondent, the violations that are the basis 
for the alleged liability, the reasons that the respondent is responsible for the violations, and 
the amount of penalties and assessments that the Center is seeking.  Additionally, the 
Complaint will include instructions for filing an Answer to request a hearing and will warn 
that failure to file an Answer within 30 days of service of the Complaint will result in the 
imposition of the proposed amount of penalties and assessments, as provided in 21 CFR 
17.11.22     
 
Upon being served, the respondent generally responds by: (1) either paying the penalty 
sought in the Complaint; or (2) filing an Answer with the Division of Dockets Management 
and contesting some or all of the Centers allegations.23   
 
If a respondent chooses to contest the matter, it must file an Answer to the Complaint 
within 30 days after the date of service of the Complaint.24 The Answer must admit or 
deny each of the allegations made in the Complaint, and include any and all defenses to the 
action and all reasons or explanations why the penalty and assessment should be less than 
the amount requested in the Complaint.25 If the respondent files an Answer within the time 
prescribed, the respondent is entitled to a hearing according to the procedures established 
in FDAs regulations governing civil money penalty proceedings, codified in 21 CFR part 
17. 
 
                                                 
21 42 U.S.C. 282(j)(5)(E). 
22 21 CFR 17.5. 
23 21 CFR 17.9. 
24 21 CFR 17.9. 
25 21 CFR 17.9. 
  7  Contains Nonbinding Recommendations 
After submitting an Answer, a respondent and its representatives may engage in 
settlement discussions with the Center regarding the civil money penalty.26  Respondents 
may present relevant mitigating factors or arguments for the Center to consider reducing 
the penalty amount.  The parties may at any time before a decision on appeal agree to 
settle all or part of the matter.  After the respondent pays any agreed-upon penalty 
amount and the parties sign a settlement agreement that is filed in the docket for the 
matter, the case will be completely or partially resolved as designated by the settlement 
agreement.27     
 
Cases that are not settled will be decided by a presiding officer,28 either after an 
administrative hearing or after a party files a motion for summary decision pursuant to 21 
CFR 17.17 and briefing is completed.  Upon request, for appropriate cause, the presiding 
officer may expedite the schedule for various aspects of the hearing. 
 
In advance of a hearing, parties are required to exchange exhibits and written 
testimony.29    Parties can choose to rest after the exchange of exhibits and written 
testimony, or request an opportunity to cross-examine the opposing party at an oral 
hearing and/or submit legal briefs.  After resting, or after an oral hearing and/or further 
briefing, the presiding officer will render an initial decision based on the administrative 
record.  The initial decision shall contain findings of fact, conclusions of law, and the 
amount of any penalties and assessments imposed.30   
 
Under section 303(f)(6) of the FD&C Act,31 after the presiding officer renders an initial 
decision, either party can appeal to the Department of Health and Human Services (HHS) 
Departmental Appeals Board (DAB).32  The respondent may appeal an adverse DAB 
decision to the U.S. Court of Appeals for the District of Columbia or any other circuit in 
which the respondent resides or transacts business.   
 
E.   What civil money penalty amounts may be assessed?  
 
Civil money penalties may be assessed under section 301(jj) of the FD&C Act33 for (1) 
failing to submit required clinical trial registration and/or results information to the 
ClinicalTrials.gov data bank, (2) submitting false or misleading information to the 
ClinicalTrials.gov data bank, (3) failing to submit the required certification to FDA, or 
(4) knowingly submitting a false certification to FDA.   
 
                                                 
26 21 CFR 17.15(b). 
27 21 CFR 17.15(b). 
28 The regulations define presiding officer to mean an administrative law judge qualified under 5 U.S.C. 3105.  
21 CFR 17.3(c). 
29 21 CFR 17.25 and 17.37. 
30 21 CFR 17.45. 
31 21 U.S.C. 333(f)(6). 
32 21 CFR 17.47. 
33 21 U.S.C. 331(jj). 
  8  Contains Nonbinding Recommendations 
The statutory maximum penalties under section 303(f)(3)(A) of the FD&C Act34 for 
committing these prohibited acts are not more than $10,000 for all violations adjudicated 
in a single proceeding and, if a violation is not corrected within 30 days following 
notification of such violation, section 303(f)(3)(B) of the FD&C Act35 provides for an 
additional civil money penalty of not more than $10,000 for each day that the violation 
continues after such period until the violation is corrected.36 
 
Pursuant to section 303(f)(5)(B) of the FD&C Act,37 in determining the amount of civil 
money penalty under the relevant statutory limits, the following factors are considered:  
the nature, circumstances, extent, and gravity of the violation(s) and, with respect to the 
violator, ability to pay, effect on ability to continue to do business, any history of prior 
such violations, the degree of culpability and such other matters as justice may require.   
 
                                                 
34 21 U.S.C. 333(f)(3)(A). 
35 21 U.S.C. 333(f)(3)(B). 
36 The civil money penalty amounts listed in this guidance reflect the amounts listed in the statute.  These amounts 
are updated annually to reflect inflation, as required by the Federal Civil Penalties Inflation Adjustment Act of 1990 
(Pub. L. No. 101-410, 104 Stat. 890 (1990) (codified as amended at 28 U.S.C. 2461 note 2(a)), as amended by the 
Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of the Bipartisan Budget Act 
of 2015, Pub. L. No. 114-74, November 2, 2015).  For the most up-to-date amounts, please see 45 CFR 102.3. 
37 21 U.S.C. 333(f)(5)(B). 
  9