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

1

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 FDA’s 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 FDA’s 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).
Contains Nonbinding Recommendations

2

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, FDA’s guidance documents do not establish legally enforceable responsibilities. 

Instead, guidances describe the Agency’s 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).
Contains Nonbinding Recommendations

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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 Act’s 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).
Contains Nonbinding Recommendations

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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 Act’s requirements 

relating to the ClinicalTrials.gov data bank through evidence collected during 

inspections conducted as part of FDA’s Bioresearch Monitoring Program (BIMO). 

How FDA will collect information to assess compliance with these requirements is 

described in FDA’s 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.
Contains Nonbinding Recommendations

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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 Act’s 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 FDAAA’s 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 Act’s

requirements relating to the ClinicalTrials.gov data bank in part through evidence 

collected during inspections conducted as part of FDA’s BIMO program.

19 Generally, 

FDA’s BIMO activities are associated with the submission of a research or marketing 

application or are a part of the Agency’s 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 FDA’s 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 Act’s 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.
Contains Nonbinding Recommendations

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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 lifethreatening 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 Center’s 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 Agency’s

 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.
Contains Nonbinding Recommendations

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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 FDA’s 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 Center’s 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 FDA’s 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.
Contains Nonbinding Recommendations

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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).
Contains Nonbinding Recommendations

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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).