Maytee Lledo: Final Debarment Order

CourtFood And Drug Administration
Citation86 FR 66566
Publication Date23 November 2021
Record Number2021-25589
66566
Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Notices
address, at a minimum, options, best
practices, and identified standards to
prevent instances of balance billing;
steps that can be taken by State
legislatures, State insurance regulators,
State attorneys general, and other State
officials as appropriate, consistent with
current legal authorities regarding
consumer protection; and legislative
options for Congress to prevent balance
billing.
The GAPB Advisory Committee must
submit this report no later than 180 days
after the date of its first meeting.
A copy of the charter for the Advisory
Committee may be obtained by
submitting a written request to the
address specified in the
ADDRESSES
section of this notice.
B. Composition of the Advisory
Committee on Ground Ambulance and
Patient Billing
The GAPB Advisory Committee shall
consist of the following:
(i) The Secretary of Labor, or the
Secretary’s designee;
(ii) the Secretary of Health and
Human Services, or the Secretary’s
designee;
(iii) the Secretary of the Treasury, or
the Secretary’s designee;
(iv) One representative, to be
appointed jointly by the Secretaries, for
each of the following:
(I) Each relevant Federal agency, as
determined by the Secretaries;
(II) State insurance regulators;
(III) Health insurance providers;
(IV) Patient advocacy groups;
(V) Consumer advocacy groups;
(VI) State and local governments;
(VII) Physician specializing in
emergency, trauma, cardiac, or stroke;
(VIII) State Emergency Medical
Services Officials; and
(IX) Emergency medical technicians,
paramedics, and other emergency
medical services personnel.
(v) Three representatives, to be
appointed jointly by the Secretaries, to
represent the various segments of the
ground ambulance industry.
(vi) Up to an additional 2
representatives otherwise not described
in paragraphs (i) through (v), as
determined necessary and appropriate
by Secretaries.
III. Submissions of Nominations
The Secretaries are requesting
nominations for membership on the
GAPB Advisory Committee. The
Secretaries are also requesting
nominations for a member to serve as
the chairperson of the GAPB Advisory
Committee. The Secretaries will
consider qualified individuals who are
self-nominated or are nominated by
organizations representing affected
stakeholders when selecting those
representatives. The Secretaries will
make every effort to appoint members to
serve on the GAPB Advisory Committee
from among those candidates
determined to have the technical
expertise required to meet specific
statutory categories and Departmental
needs, and in a manner to ensure an
appropriate balance of membership.
Selection of committee membership will
be consistent with achieving the greatest
impact, scope, and credibility among
diverse stakeholders. The diversity in
such membership includes, but is not
limited to, race, gender, disability,
sexual orientation, and gender identity.
The Secretaries reserve discretion to
appoint members who were not
nominated in response to this notice to
serve on the GAPB Advisory Committee
if necessary to meet specific statutory
categories and Departmental needs in a
manner to ensure an appropriate
balance of membership.
Any interested person may nominate
one or more qualified individuals (self-
nominations will also be accepted).
Each nomination must include the
following information:
1. A letter of nomination that contains
contact information for both the
nominator and nominee (if not the
same).
2. A statement from the nominee that
he or she is willing to serve on the
GAPB Advisory Committee for its
duration and an explanation of interest
in serving on the GAPB Advisory
Committee. The nominee should also
indicate which category or categories he
or she is willing to represent. (For self-
nominations, this information may be
included in the nomination letter.)
3. A curriculum vitae that indicates
the nominee’s educational experience,
as well as relevant professional
experience.
4. Two letters of reference that
support the nominee’s qualifications for
participation on the GAPB Advisory
Committee. (For nominations other than
self-nominations, a nomination letter
that includes information supporting
the nominee’s qualifications may be
counted as one of the letters of
reference.)
To ensure that a nomination is
considered, the Departments must
receive all of the nomination
information specified in section III of
this notice by December 13, 2021.
Nominations should be emailed or
mailed to the appropriate address
specified in the
ADDRESSES
section of
this notice.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2021–25560 Filed 11–19–21; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0405]
Maytee Lledo: Final Debarment Order
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Maytee Lledo 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 Ms. Lledo was
convicted of a felony under Federal law
for conduct that relates to the
development or approval, including the
process for development or approval, of
any drug product under the FD&C Act.
Ms. Lledo was given notice of the
proposed permanent debarment and an
opportunity to request a hearing to show
why she should not be debarred within
the timeframe prescribed by regulation.
Ms. Lledo has not responded to the
notice. Ms. Lledo’s 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
November 23, 2021.
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 debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION
:
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66567
Federal Register / Vol. 86, No. 223 / Tuesday, November 23, 2021 / Notices
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 for
development or approval, of any drug
product under the FD&C Act. On April
16, 2021, in the U.S. District Court for
the Southern District of Florida, Miami
Division, a judgment of conviction was
entered against Ms. Maytee Lledo, after
her plea of guilty to one count of
Conspiracy to Commit Wire Fraud in
violation of 18 U.S.C. 1349, a felony
offense under Federal law.
The factual basis for this conviction is
as follows: As contained in the
Information, entered into the docket on
August 31, 2020, and the Factual Proffer
in Support of Ms. Lledo’s guilty plea,
entered into the docket on February 5,
2021, both from her case, Ms. Lledo was
a receptionist at Sacred Heart Medical
Office P.A., a private medical practice,
in Florida. That medical practice
primarily served a pediatric population.
From about September 2013 through
June 2016, Ms. Lledo and others
conspired to unlawfully enrich
themselves by making materially false
representations about clinical trials,
fabricating data and the participation of
subjects in those clinical trials,
concealing from FDA, sponsors, and
contract research organizations the fact
that the data and participation of
subjects had been fabricated, and
inducing sponsors and contract research
organizations to pay money for Ms.
Lledo and her co-conspirators’ own
benefit. Specifically, one of Ms. Lledo’s
co-conspirators entered into a contract
with a Contract Research Organization
(CRO) retained by a drug manufacturer
(Sponsor) to hire clinical investigators
and to manage clinical trials. Ms.
Lledo’s co-conspirator entered into a
contract with the CRO to conduct a
study at Unlimited Medical Research
site in return for payment. The study
was for an investigational drug intended
to treat pediatric asthma in children
between the ages of 4 and 11 years. Her
co-conspirators were responsible for
complying with the study protocol,
including administering study drug to
subjects in the study and preparing
written records, known as case histories,
which documented the participation of
subjects in the study.
Ms. Lledo participated in a scheme to
defraud the Sponsor by fabricating the
data and participation of subjects in the
clinical trial in a variety of ways. Ms.
Lledo and her co-conspirators falsified
medical records to portray persons as
legitimate study subjects when they
were not. In addition, her co-
conspirators made it appear as though
pediatric subjects made scheduled visits
to Unlimited Medical Research when
they had not; made it appear as though
subjects had taken the study drug as
required when they had not; and made
it appear that the study subjects had
received checks as payment when they
had not. In addition, study subjects
were required to make daily phone calls
to an ‘‘e-diary’’ system and report their
daily drug usage and experience with
the study drug. As part of the
conspiracy, Ms. Lledo placed thousands
of telephone calls to the e-diary system,
using falsely obtained PIN numbers to
access the system, for purposes of
reporting fabricated data on behalf of
purportedly legitimate study subjects.
Ms. Lledo entered this fabricated
information in the e-diary system for at
least 11 study subjects.
Based on this conviction, FDA sent
Ms. Lledo by certified mail on July 27,
2021, 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. Lledo 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 for development
or approval, of a drug product under the
FD&C Act. The proposal also offered
Ms. Lledo 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 file a timely request for a
hearing would constitute an election not
to use the opportunity for a hearing and
a waiver of any contentions concerning
this action. Ms. Lledo received the
proposal on August 2, 2021. 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. Lledo 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
a drug product under the FD&C Act.
As a result of the foregoing finding,
Ms. Lledo 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 in any capacity the services of Ms.
Lledo 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. Lledo 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). In addition, FDA will not
accept or review any abbreviated new
drug application from Ms. Lledo 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). 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))).
Any application by Ms. Lledo for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2021–N–0405 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.
Dated: November 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–25589 Filed 11–22–21; 8:45 am]
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