Maytee Lledo: Final Debarment Order, 66566-66567 [2021-25589]
Download as PDF
<![CDATA[
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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:09 Nov 22, 2021
Jkt 256001
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 (selfnominations 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 selfnominations, 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),
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
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.
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:
SUMMARY:
E:\FR\FM\23NON1.SGM
23NON1
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
18:09 Nov 22, 2021
Jkt 256001
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 coconspirators 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
PO 00000
Frm 00053
Fmt 4703
Sfmt 9990
66567
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]
BILLING CODE 4164–01–P
E:\FR\FM\23NON1.SGM
23NON1
]]>Agencies
[Federal Register Volume 86, Number 223 (Tuesday, November 23, 2021)]
[Notices]
[Pages 66566-66567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25589]
-----------------------------------------------------------------------
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
[email protected].
SUPPLEMENTARY INFORMATION:
[[Page 66567]]
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]
BILLING CODE 4164-01-P
