[Federal Register Volume 87, Number 147 (Tuesday, August 2, 2022)]
[Notices]
[Pages 47218-47220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16507]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0101]


Duniel Tejeda: 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 Duniel Tejeda 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 Duniel Tejeda 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. Duniel Tejeda was 
given notice of the proposed permanent debarment and was given an 
opportunity to request a hearing to show why he should not be debarred. 
As of April 20, 2022 (30 days after receipt of the notice), Mr. Tejeda 
had not responded. Mr. Tejeda'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 August 2, 2022.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement (ELEM-4029), Office of Strategic Planning and Operational 
Policy, Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at 
[email protected].

I. Background

    Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) 
requires debarment of an individual from

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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 under the FD&C Act. On January 20, 2022, 
Mr. Duniel Tejeda 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 accepted his plea of guilty and 
entered judgment against him for one count of conspiracy to commit mail 
and wire fraud in violation of 18 U.S.C. 1349.
    As contained in the indictment, entered into the docket on February 
24, 2021, and the Factual Proffer in support of Mr. Tejeda's guilty 
plea, entered into the docket on October 26, 2021, both from his case, 
Mr. Tejeda was a project manager and study coordinator employed at 
Tellus Clinical Research, Inc. (``Tellus''). Tellus was a medical 
research clinic located in Miami, Florida that conducted clinical 
trials on behalf of pharmaceutical companies and other sponsors. Among 
the clinical research trials conducted by Tellus were two studies of an 
investigational drug intended to treat opioid dependency, sponsored by 
Sponsor 1 and managed by clinical research organization (CRO) 1 
(collectively, ``the opioid dependency trials''); two studies of an 
investigational drug intended to treat irritable bowel syndrome in 
female subjects, sponsored by Sponsor 2 and managed by CRO 2 
(collectively, ``the IBS trials''); and one study of an investigational 
injectable drug intended to treat diabetic nephropathy, sponsored by 
Sponsor 3 and managed by CRO 3 (``the diabetes trial''). In Mr. 
Tejeda's roles with Tellus, he conspired with others to defraud these 
sponsors and CROs responsible for initiating and overseeing these 
clinical trials. For the purpose of obtaining money by means of 
materially false and fraudulent pretenses, representations, and 
promises, Mr. Tejeda, along with his co-conspirators, caused false 
information to be entered in subject case histories to make it appear 
that subjects had, among other things, satisfied the eligibility 
criteria to participate in the studies, provided informed consent to 
participate in the studies, received proper physical examinations, 
received or had been administered the investigational drug that was the 
subject of each clinical trial, and received payments for visits to 
Tellus for the clinical trials, when in fact Mr. Tejeda knew that such 
events had not occurred. As an example of Mr. Tejeda's specific conduct 
to further this scheme, in one of the opioid dependency trials, Mr. 
Tejeda entered his initials in the case history documentation for one 
of the study subjects to represent falsely that he had administered 
multiple doses of the investigational drug to the subject as required 
by the study protocol, and that this drug administration was witnessed 
by one of Mr. Tejeda's co-conspirators. As Mr. Tejeda well knew, these 
representations were false because the study subject was not 
participating in the study, Mr. Tejeda did not dose them with the study 
medication, and the dosing was not witnessed by Mr. Tejeda's co-
conspirator.
    In another instance, in connection to one of the IBS trials, Mr. 
Tejeda wrote a check, endorsed by one of his co-conspirators, to a 
study participant for their purported participation in a study visit. 
As Mr. Tejeda well knew, the individual was not in fact participating 
in the study and had not received the check. Mr. Tejeda deposited that 
check in his own bank account. Further, as part of the IBS trials, 
study subjects were required to make daily phone calls to an ``e-
diary'' system (a toll-free number maintained by a third party) and 
report their personal experience with the study drug. Using the 
subjects' individual personal identification numbers, Mr. Tejeda, along 
with one or more of his co-conspirators, placed telephone calls to this 
e-diary system for the purposes of reporting fabricated data on behalf 
of purportedly legitimate study subjects.
    As a result of this conviction, FDA sent Mr. Tejeda by certified 
mail on March 1, 2022, a notice proposing to permanently debar him 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 Mr. Tejeda 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 under the FD&C Act. The proposal also offered Mr. Tejeda 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 his debarment. Mr. Tejeda received the proposal on March 21, 
2022. He 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 Mr. 
Tejeda 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, Mr. Tejeda 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 306(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 Mr. Tejeda 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 during his period of 
debarment Mr. Tejeda 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 application from 
Mr. Tejeda during his period of debarment, other than in connection 
with an audit under section 306 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 this Act [(21 U.S.C. 355, 360b, 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))).
    Any application by Mr. Tejeda for special termination of debarment 
under section 306(d)(4) of the FD&C Act should be identified with 
Docket No. FDA-2022-N-0101 and sent to the Dockets Management Staff 
(see ADDRESSES). The public availability of information in these 
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.


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    Dated: July 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16507 Filed 8-1-22; 8:45 am]
BILLING CODE 4164-01-P


