[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]
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