[Federal Register Volume 88, Number 118 (Wednesday, June 21, 2023)]
[Notices]
[Pages 40275-40276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13135]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2687]


Daylen Diaz: 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 Daylen Diaz 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 Daylen Diaz 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. Daylen Diaz was given 
notice of the proposed permanent debarment and was given an opportunity 
to request a hearing to show why she should not be debarred. As of 
February 26, 2023 (30 days after receipt of the notice), Ms. Diaz had 
not responded. Ms. Diaz' failure to respond and request a hearing 
within the prescribed timeframe constitutes a waiver of her right to a 
hearing concerning this action.

DATES: This order is applicable June 21, 2023.

ADDRESSES: Any application by Daylen Diaz 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 as follows:

Electronic Submissions

    [ssquf] 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.
    [ssquf] 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

    [ssquf] 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.
    [ssquf] 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-
2022-N-2687. 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.
    [ssquf] 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 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: Jaime Espinosa, Division of Compliance 
and Enforcement, Office of Policy, Compliance, and Enforcement, Office 
of Regulatory Affairs, Food and Drug Administration, 240-402-8743, or 
[email protected].

SUPPLEMENTARY INFORMATION:

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 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 October 18, 2022, Ms. Diaz 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 her plea of guilty and entered judgment against her for 
one count of conspiracy to commit mail fraud and wire fraud in 
violation of 18 U.S.C. 1349.
    The factual basis for this conviction is as follows: As contained 
in the Information, entered into the docket on March 16, 2021, and the 
Factual Proffer in support of Ms. Diaz' guilty plea, entered into the 
docket on August 8, 2022, both from her case, Ms. Diaz was a research 
assistant and assistant study coordinator employed at Tellus Clinical 
Research, Inc. (Tellus). Tellus was a medical research clinic that 
conducted clinical trials on behalf of pharmaceutical company sponsors. 
Sponsor 1 was a drug manufacturer that developed drugs for commercial 
distribution in the United States. Contract Research Organization 1 
(CRO 1) was an organization that hired clinical investigators and 
managed clinical trials for sponsors. On or about December 23, 2013, 
CRO 1 entered into a contract with Tellus and one of Ms.

[[Page 40276]]

Diaz' co-conspirators in which Tellus and Ms. Diaz' co-conspirator 
agreed to serve as study site and clinical investigator, respectively, 
for a clinical trial initiated by sponsor 1 (IBS study 1) designed to 
evaluate a drug intended to treat irritable bowel syndrome in female 
patients. On or about September 5, 2014, CRO 1 entered into a contract 
to conduct a second clinical trial initiated by sponsor 1 (IBS study 
2), which evaluated the same drug in the same population over the 
course of 52 weeks. Sponsor 2 was a drug manufacturer that developed 
drugs for commercial distribution in the United States. On or about 
January 5, 2015, sponsor 2 entered into a contract with Tellus and one 
of Ms. Diaz' co-conspirators in which they agreed to serve as study 
site and clinical investigator, respectively, for a clinical trial 
initiated by sponsor 2 (the diabetes study). The diabetes study was 
designed to evaluate the safety and efficacy of an experimental 
injectable drug intended to treat subjects with kidney damage from 
diabetes.
    Ms. Diaz served as an assistant study coordinator for IBS study 1, 
IBS study 2, and the diabetes study (collectively, the ``Studies''). As 
an assistant study coordinator for the Studies, Ms. Diaz was 
responsible for administering procedures to subjects in the Studies and 
preparing honest and accurate written records, including records known 
as ``case histories,'' describing the participation of subjects in the 
Studies. Ms. Diaz along with her 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 physical examinations, received or 
been administered the investigational drug for the Studies, and 
received payments for visits to Tellus when, in truth and in fact, and 
as Ms. Diaz well knew, such events had not occurred. For example, on or 
about April 6, 2015, Ms. Diaz initialed case history documentation for 
a study subject, K.L., falsely representing that K.L. was a study 
subject participating in IBS study 2, that K.L. visited Tellus, that 
Ms. Diaz obtained K.L.'s urine and blood for analysis as required by 
the protocol governing IBS study 2, that Ms. Diaz had performed an 
electrocardiogram on K.L., and that Ms. Diaz dispensed IBS study 2 
medication to K.L. In truth and in fact, Ms. Diaz knew that K.L. was 
not participating in IBS study 2 and these representations were false. 
In addition, Ms. Diaz knew that IBS study 2 subjects were required to 
make daily phone calls to an ``e-diary'' (a toll-free number maintained 
by a third party) and report their personal experience with the IBS 
study 2 drug. In furtherance of the conspiracy, Ms. Diaz along with her 
co-conspirators knowingly placed telephone calls to the e-diary system, 
using the subjects' individual PIN numbers, for purposes of reporting 
fabricated data on behalf of IBS study 2 subjects. Ms. Diaz along with 
her co-conspirators placed these fraudulent telephone calls on behalf 
of more than 10 subjects in IBS study 2.
    Ms. Diaz also participated in falsifying and fabricating data in 
connection with the diabetes study. For example, on May 13, 2015, Ms. 
Diaz initialed case history documentation for subject S.D., falsely 
representing that S.D. has visited Tellus, that Ms. Diaz trained S.D. 
on the appropriate handling of the investigational drug, and that S.D. 
self-administered the study drug by injection. In truth and in fact, 
Ms. Diaz knew that S.D. had not visited Tellus or received the study 
drug, and these representations were false. Ms. Diaz, along with her 
co-conspirators, also enrolled subjects in the diabetes study who did 
not meet the eligibility criteria or participate in the trial. Further, 
Ms. Diaz observed her co-conspirator dispense diabetes study medication 
into the garbage, but falsely represent in case history documentation 
that the medication had been administered to study subject S.D.
    As a result of this conviction, FDA sent Ms. Diaz by certified mail 
on January 20, 2023, a notice proposing to permanently debar her 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 Ms. Diaz 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 Ms. Diaz an 
opportunity to request a hearing, providing her 30 days from the date 
of receipt of the letter in which to file the request, and advised her 
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. Ms. Diaz received the proposal on January 27, 
2023. She did not request a hearing within the timeframe prescribed by 
regulation and has, therefore, waived her opportunity for a hearing and 
any contentions concerning her 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 Ms. Diaz 
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, Ms. Diaz 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 Ms. Diaz in any capacity during her 
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 Ms. Diaz provides services 
in any capacity to a person with an approved or pending drug product 
application during her period of debarment, she will be subject to 
civil money penalties (section 307(a)(7) of the FD&C Act (21 U.S.C. 
335b(a)(7))). In addition, FDA will not accept or review any 
abbreviated new drug application from Ms. Diaz during her period of 
debarment, other than in connection with an audit under section 306 of 
the FD&C Act (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 
335a(c)(1)(B))). Note that, for purposes of sections 306 and 307 of the 
FD&C Act (21 U.S.C. 335a and 335b), 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))).

    Dated: June 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13135 Filed 6-20-23; 8:45 am]
BILLING CODE 4164-01-P


