[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20664-20665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3615]


Martin Valdes: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
permanently debarring Martin Valdes, M.D., 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 Dr. Valdes 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. Dr. Valdes was given 
notice of the proposed permanent debarment and an opportunity to 
request a hearing to show why he should not be debarred. As of January 
7, 2023 (30 days after receipt of the notice), Dr. Valdes had not 
responded. Dr. Valdes's failure to respond and request a hearing within 
the prescribed timeframe constitutes a waiver of his right to a hearing 
concerning this action.

DATES: This order is applicable March 25, 2024.

ADDRESSES: Any application by Dr. Valdes for special termination of 
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 
335a(d)(4)) may be submitted at any time 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

     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-3615. Received applications 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, 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. 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://

[[Page 20665]]

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: Jaime Espinosa, Division of Compliance 
and Enforcement, Office of Policy, Compliance, and Enforcement, Office 
of Regulatory Affairs, Food and Drug Administration, 240-402-8743, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the FD&C Act requires debarment of an 
individual from providing services in any capacity to a person that has 
an approved or pending drug product application 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 of 
development or approval, of any drug product. On August 18, 2023, Dr. 
Valdes was convicted as defined in section 306(l)(1) of the FD&C Act, 
in the U.S. District Court for the Southern District of Florida-Miami 
Division, when the court entered judgment against him, after a jury 
trial, for one count of False Statements in violation of 18 U.S.C. 
1001(a)(2).
    The underlying facts supporting the conviction are as follows: As 
contained in the Indictment, entered into the docket on February 24, 
2021, and as contained in the Acceptance of Responsibility signed by 
Dr. Valdes and entered into the docket on July 31, 2023, Dr. Valdes was 
a Florida licensed medical doctor. From in or about September 2013 and 
continuing through in or about May 2016, Dr. Valdes was the principal 
investigator responsible for conducting clinical research trials at 
Tellus Clinical Research, Inc. (Tellus). Tellus was a medical research 
clinic located in Miami, Florida, that conducted clinical trials on 
behalf of pharmaceutical company sponsors. Among the clinical research 
trials conducted by Tellus were two studies of an investigational drug 
intended to treat irritable bowel syndrome in subjects (collectively, 
IBS trials). On or about April 6, 2016, Dr. Valdes was interviewed by 
an FDA investigator. During that interview, Dr. Valdes knowingly and 
willfully made a false statement and/or representation; namely, that 
Dr. Valdes personally performed a physical examination on each subject 
of the IBS trials for which his signature appeared on the subject's 
case history form, when in fact he had not conducted such a physical 
examination on each subject.
    As a result of this conviction, FDA sent Dr. Valdes by certified 
mail on December 4, 2023, a notice proposing to debar him permanently 
from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal was based on 
a finding, under section 306(a)(2)(A) of the FD&C Act, that Dr. Valdes 
was convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the development or 
approval, including the process of development or approval, of any drug 
product. The proposal also offered Dr. Valdes an opportunity to request 
a hearing, providing him 30 days from the date of receipt of the letter 
in which to file the request, and advised him that failure to request a 
hearing constituted an election not to use the opportunity for a 
hearing and a waiver of any contentions concerning this action. Dr. 
Valdes received the proposal on December 8, 2023. Dr. Valdes did not 
request a hearing within the timeframe prescribed by regulation and 
has, therefore, waived his opportunity for a hearing and any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(a)(2)(A) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Dr. 
Valdes has been convicted of a felony under Federal law for conduct 
relating to the development or approval, including the process of 
development or approval, of any drug product under the FD&C Act.
    As a result of the foregoing finding, Dr. Valdes is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, effective (see DATES) 
(see sections 306(a)(2)(A) and (c)(2)(A)(ii) of the FD&C Act). Any 
person with an approved or pending drug product application who 
knowingly employs or retains as a consultant or contractor, or 
otherwise uses the services of Dr. Valdes in any capacity during his 
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 Dr. Valdes provides 
services in any capacity to a person with an approved or pending drug 
product application during his period of debarment, 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 
application from Dr. Valdes during his period of debarment, other than 
in connection with an audit under section 306(c)(1)(B) of the FD&C Act. 
Note that, for purposes of sections 306 and 307 of the FD&C Act, a 
``drug product'' is defined as a drug subject to regulation under 
section 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) 
(section 201(dd) of the FD&C Act (21 U.S.C. 321(dd)).

    Dated: March 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06242 Filed 3-22-24; 8:45 am]
BILLING CODE 4164-01-P