Notice2025-04117
Bernardo Garmendia; Denial of Hearing; Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 14, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Bernardo Garmendia, also known as Bernardo Germendia, (Garmendia) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Garmendia from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Garmendia was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA provided notice to Garmendia of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Garmendia submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 49 (Friday, March 14, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 49 (Friday, March 14, 2025)]
[Notices]
[Pages 12164-12165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04117]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4938]
Bernardo Garmendia; Denial of Hearing; Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is denying a
request for a hearing submitted by Bernardo Garmendia, also known as
Bernardo Germendia, (Garmendia) and is issuing an order under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring
Garmendia from providing services in any capacity to a person that has
an approved or pending drug product application. FDA bases this order
on a finding that Garmendia was convicted of a felony under Federal law
for conduct relating to the development or approval, including the
process for development or approval, of any drug product under the FD&C
Act. FDA provided notice to Garmendia of the proposed debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. Garmendia submitted a request for hearing but failed to
file with the Agency information and analyses sufficient to create a
basis for a hearing.
DATES: The order is applicable March 14, 2025.
ADDRESSES: Any application for termination of debarment by Garmendia
under section 306(d) of the FD&C Act (21 U.S.C. 335a(d)) (application)
may be submitted as follows:
Electronic Submissions
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> will be posted to the docket unchanged. Because
your application will be made public, you are solely responsible for
ensuring that your application 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 application,
that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit an application with confidential
information that you do not wish to be made available to the public,
submit the application 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:
<bullet> 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.
<bullet> For a written/paper application submitted to the Dockets
Management Staff, FDA will post your application, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All applications must include the Docket No. FDA-
2023-N-4938. An application will be placed in the docket and, unless
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit an application with
confidential information that you do not wish to be made publicly
available, submit your application 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 your application. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 application 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
[[Page 12165]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Karen Fikes, Office of Scientific
Integrity, Food and Drug Administration, 10903 New Hampshire Avenue,
Bldg. 1, Rm. 4232, Silver Spring, MD 20993, 301-796-9603.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(A) of the FD&C Act mandates permanent debarment
if FDA finds that the individual has been convicted of a felony under
Federal law for conduct relating to the development or approval,
including the process for development or approval, of any drug product.
On June 20, 2023, following a guilty plea, the U.S. District Court for
the Southern District of Florida-Miami Division entered a judgment
against Garmendia for one count of conspiracy to commit wire fraud in
violation of 18 U.S.C. 1349.
Garmendia's conviction is based upon conduct from on or about
September 2015 through on or about March 2018, committed in his
capacity at AMB Research Center, Inc. (AMB Research), a medical clinic
that conducted clinical trials of new drugs for pharmaceutical
companies and sponsors. Garmendia was co-owner of AMB Research and
served as vice president and back-up study coordinator. Garmendia and
his co-conspirators did willfully, that is, with the intent to further
the object of the conspiracy, and knowingly combine, conspire,
confederate, and agree with each other to commit wire fraud, that is:
to knowingly, and with the intent to defraud, devise and intend to
devise a scheme and artifice to defraud and to obtain money and
property by means of materially false and fraudulent pretenses,
representations, and promises, knowing that the pretenses,
representations, and promises were false and fraudulent when made, and,
for the purpose of executing the scheme and artifice, did transmit and
cause to be transmitted by means of wire communication and interstate
and foreign commerce, certain writings, signs, signals, pictures, and
sounds, in violation of 18 U.S.C. 1349.
Specifically, AMB Research entered into a clinical trial agreement
with a contract research organization to lead a pharmaceutical
company's clinical trial designed to evaluate the safety and efficacy
of an investigational drug intended to treat persons with Clostridium
difficile-associated diarrhea (CDAD clinical trial). Garmendia and his
co-conspirators conspired to unlawfully enrich themselves by, among
other things, securing contracts to conduct the CDAD clinical trial;
fabricating and falsifying documents, study data, and other items
related to the CDAD clinical trial to obtain payments and inflate the
payments due and owing to the conspirators under the clinical trial
agreement; receiving payment for the CDAD clinical trial by making
material false and fraudulent representations; and using the
fraudulently obtained funds for personal use and benefit, the use and
benefit of others, and to further the conspiracy. Garmendia's conduct
included direct involvement in falsifying and fabricating study
documents. In addition, Garmendia transported study documents to the
principal investigator for purposes of obtaining a signature for the
CDAD clinical trial at AMB Research. Garmendia received $80,027.44 in
proceeds from payments made to AMB Research for the CDAD clinical
trial.
Garmendia is subject to permanent debarment based on a finding by
the Office of Regulatory Affairs (ORA), under section 306(a)(2)(A) of
the FD&C Act, that he was convicted of a felony under Federal law for
conduct relating to the development or approval, including the process
for development or approval, of any drug product. By letter dated
January 8, 2024, ORA informed Garmendia of the proposal to permanently
debar him from providing services in any capacity to a person having an
approved or pending drug product application. The letter also offered
Garmendia an opportunity to request a hearing, providing 30 days from
the date of Garmendia's receipt of the letter in which to file the
request and 60 days from the date of Garmendia's receipt of the letter
to support any hearing request with information sufficient to justify a
hearing. In a letter dated February 6, 2024, Garmendia requested a
hearing. More than 60 days have passed from the date Garmendia received
ORA's letter, and Garmendia has not filed any additional information to
justify a hearing.
Under the authority delegated to him by the Commissioner of Food
and Drugs, the Director, Office of Scientific Integrity (OSI Director),
has considered Garmendia's request for a hearing. Hearings will be
granted upon a showing of a genuine and substantial issue of fact; not
on issues of policy or law, on mere allegations, denials, or general
descriptions of positions and contentions, or on data and information
insufficient to justify the factual determination urged, even if
accurate (see 21 CFR 12.24(b)). Garmendia has failed to present any
arguments or evidence raising a genuine and substantial issue of fact
to support his hearing request. Accordingly, the OSI Director denies
Garmendia's request for a hearing.
II. Findings and Order
Therefore, the OSI Director, under section 306(a)(2)(A) of the FD&C
Act and authority delegated to him by the Commissioner of Food and
Drugs, finds that Garmendia has been convicted of a felony under
Federal law for conduct relating to the development or approval,
including the process for development or approval, of any drug product.
As a result of the foregoing findings, Garmendia is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective March
14, 2025 (see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii) and 21 U.S.C.
321(dd)). Any person with an approved or pending drug product
application, who knowingly uses the services of Garmendia, in any
capacity during his period of debarment, will be subject to civil money
penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))).
If Garmendia, during his period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, he will be subject to civil money penalties (section
307(a)(7) of the FD&C Act). In addition, FDA will not accept or review
any abbreviated new drug applications submitted by or with the
assistance of Garmendia during his period of debarment (section
306(c)(1)(B) of the FD&C Act).
Dated: March 7, 2025.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2025-04117 Filed 3-13-25; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on March 14, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.