Legal Status This site displays a prototype of a “Web 2.0” version of the daily
Federal Register. It is not an official legal edition of the Federal
Register, and does not replace the official print version or the official
electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal
Register documents. Each document posted on the site includes a link to the
corresponding official PDF file on govinfo.gov. This prototype edition of the
daily Federal Register on FederalRegister.gov will remain an unofficial
informational resource until the Administrative Committee of the Federal
Register (ACFR) issues a regulation granting it official legal status.
For complete information about, and access to, our official publications
and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on FederalRegister.gov with the objective of
establishing the XML-based Federal Register as an ACFR-sanctioned
publication in the future. While every effort has been made to ensure that
the material on FederalRegister.gov is accurately displayed, consistent with
the official SGML-based PDF version on govinfo.gov, those relying on it for
legal research should verify their results against an official edition of
the Federal Register. Until the ACFR grants it official status, the XML
rendition of the daily Federal Register on FederalRegister.gov does not
provide legal notice to the public or judicial notice to the courts.

Legal Status

Notice

Bernardo Garmendia; Denial of Hearing; Final Debarment Order

A Notice by the Food and Drug Administration on 03/14/2025

• 1.

1.

• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2023-N-4938 Document Citation 90 FR 12164 Document Number 2025-04117 Document Type Notice Pages 12164-12165
  (2 pages) Publication Date 03/14/2025 Published Content - Document Details

• PDF Official Content

  • View printed version (PDF) Official Content

• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2023-N-4938 Document Citation 90 FR 12164 Document Number 2025-04117 Document Type Notice Pages 12164-12165
  (2 pages) Publication Date 03/14/2025 Published Content - Document Details

• Document Dates Published Content - Document Dates Dates Text The order is applicable March 14, 2025. Published Content - Document Dates

• Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the
  headings within the legal text of Federal Register documents.
  This repetition of headings to form internal navigation links
  has no substantive legal effect.

  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • ADDRESSES:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION:
  • I. Background
  • II. Findings and Order Enhanced Content - Table of Contents

• Public Comments Enhanced Content - Public Comments Comments are no longer being accepted.
  See DATES for details.

Enhanced Content - Public Comments
- Regulations.gov Data Enhanced Content - Regulations.gov Data

FederalRegister.gov retrieves relevant information about this document
from Regulations.gov to provide users with additional context. This
information is not part of the official Federal Register document.

NOOH Proposal to Debar Bernardo Garmendia

Docket ID FDA-2023-N-4938 Supporting Documents No supporting documents available Enhanced Content - Regulations.gov Data

- Sharing Enhanced Content - Sharing Shorter Document URL https://www.federalregister.gov/d/2025-04117 Email Email this document to a friend Enhanced Content - Sharing

• Print Enhanced Content - Print
  • Print this document Enhanced Content - Print
• Document Statistics Enhanced Content - Document Statistics Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.

Page views 1,039
as of
04/06/2026 at 10:15 am EDT Enhanced Content - Document Statistics
- Other Formats Enhanced Content - Other Formats This document is also available in the following formats:

JSON Normalized attributes and metadata XML Original full text XML MODS Government Publishing Office metadata More information and documentation can be found in our developer tools pages.

Enhanced Content - Other Formats
- Public Inspection Public Inspection This PDF is FR Doc. 2025-04117 as it appeared on Public Inspection on
03/13/2025 at 8:45 am.

It was viewed
17
times while on Public Inspection.

If you are using public inspection listings for legal research, you
should verify the contents of the documents against a final, official
edition of the Federal Register. Only official editions of the
Federal Register provide legal notice of publication to the public and judicial notice
to the courts under 44 U.S.C. 1503 & 1507. Learn more here.

Public Inspection
Published Document: 2025-04117 (90 FR 12164) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings Document headings vary by document type but may contain
the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2023-N-4938]

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

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.
• 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:

• 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 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

• 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 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 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 ( printed 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: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.
  Docket: For access to the docket, 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 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

Published Document: 2025-04117 (90 FR 12164)