Olga L. Torres: Final Debarment Order, 22043-22045 [2023-07670]
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
a. Name, address, and FEI number of
the sterilization facility.
b. Master File number in which the
referenced sterilization procedures are
described, with signed right of reference
from the Master File holder.
c. List of device(s) sterilized
(identified by manufacturer, trade name,
model number, and PMA number).
Upon receipt of a postapproval report
containing the above information, FDA
will notify the PMA holder of whether
the postapproval report is permitted as
an alternate submission under
§ 814.39(a) and (e). Additionally, FDA
will notify the PMA holder of whether
the PMA identified device(s) and
referenced Master File are eligible for
the sterilization provider’s participation
in the pilot. If the PMA is not eligible
for the sterilization provider’s
participation in the pilot program, FDA
will notify the PMA holder of the
reasons for rejection.
This Pilot Program does not otherwise
remove or replace any requirements,
such as, but not limited to,
recordkeeping and reporting
requirements under part 814 or part 820.
It is the manufacturer’s responsibility to
ensure compliance with applicable laws
and regulations administered by FDA.
During this voluntary Radiation Pilot
Program, CDRH staff intends to be
available to answer questions or
concerns that may arise. The Radiation
Pilot Program participants may
comment on and discuss their
experiences with the Center.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Paperwork Reduction Act of 1995
This notice refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
part 814, subparts A through E,
regarding premarket approval, have
been approved under OMB control
number 0910–0231. The collections of
information in part 820, regarding the
Quality System Regulation, have been
approved under OMB control number
0910–0073.
III. References
The following references are on
display at the Dockets Management Staff
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, and are available for viewing by
interested persons between 9 a.m. and 4
determined to be acceptable as described in this
pilot notice.
VerDate Sep<11>2014
19:25 Apr 11, 2023
Jkt 259001
p.m., Monday through Friday; they are
also available electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA, ‘‘FDA Executive Summary
Prepared for the November 6–7, 2019
meeting of the General Hospital and Personal
Use Devices Panel of the Medical Devices
Advisory Committee,’’ available at: https://
www.fda.gov/advisory-committees/advisorycommittee-calendar/november-6-7-2019general-hospital-and-personal-use-devicespanel-medical-devices-advisory-committee.
2. FDA, Sterilization for Medical Devices,
available at: https://www.fda.gov/medicaldevices/general-hospital-devices-andsupplies/ethylene-oxide-sterilizationmedical-devices.
3. FDA, PMA Supplements and
Amendments, available at: https://
www.fda.gov/medical-devices/premarketapproval-pma/pma-supplements-andamendments.
4. National Academies of Sciences,
Engineering, and Medicine. 2021.
Radioactive Sources: Applications and
Alternative Technologies. Washington, DC:
The National Academies Press. https://
doi.org/10.17226/26121.
5. FDA, ‘‘Statement on Concerns With
Medical Device Availability Due to Certain
Sterilization Facility Closures,’’ available at:
https://www.fda.gov/news-events/pressannouncements/statement-concernsmedical-device-availability-due-certainsterilization-facility-closures.
Dated: April 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07598 Filed 4–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2515]
Olga L. Torres: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Olga L.
Torres 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. Torres was convicted of
a felony under Federal law for conduct
relating to the development or approval,
including the process for development
SUMMARY:
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22043
or approval, of any drug product under
the FD&C Act. Ms. Torres 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
January 20, 2023 (30 days after receipt
of the notice), Ms. Torres had not
responded. Ms. Torres’ 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 April 12,
2023.
ADDRESSES: Any application by Olga L.
Torres 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
D 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.
D 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
D 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.
D 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–
2515. Received applications will be
placed in the docket and, except for
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ddrumheller on DSK120RN23PROD with NOTICES1
22044
Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
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.
D 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-201509-18/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.
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, at 240–402–8743, or
debarments@fda.hhs.gov.
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
VerDate Sep<11>2014
19:25 Apr 11, 2023
Jkt 259001
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
September 30, 2022, Ms. Olga L. Torres
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 obstruction of agency
proceeding in violation of 18 U.S.C.
1505.
The factual basis for this conviction is
as follows: as contained in the
information, entered into the docket on
October 28, 2021, and the Factual
Proffer in support of her guilty plea,
entered into the docket on January 13,
2022, Ms. Torres co-owned a business
called Unlimited Medical Research, LLC
(Unlimited Medical Research) that
conducted clinical trials on behalf of
pharmaceutical company sponsors. On
or around October 25, 2013, on behalf
of Unlimited Medical Research, Ms.
Torres signed a contract with a contract
research organization retained by a drug
manufacturer (Sponsor) to conduct a
clinical trial (Study) initiated by the
Sponsor. The clinical trial was designed
to study the safety and efficacy of an
investigational asthma medication in
children between the ages of 4 and 11
with persistent asthma. Dr. Yvelice
Villaman-Bencosme was a licensed
medical doctor who had been retained
by Unlimited Medical Research to serve
as the clinical investigator for the Study.
On or about February 6, 2017, Ms.
Torres learned that FDA investigators
intended to conduct a regulatory
inspection of Dr. Villaman-Bencosme in
her capacity as the clinical investigator
for the Study at Unlimited Medical
Research. Ms. Torres also learned that,
as part of the inspection, FDA
investigators would review records
prepared and maintained by Unlimited
Medical Research concerning the study.
The FDA regulatory inspection began on
or about February 6, 2017, and
continued until on or about April 28,
2017. In or around February 2017, as
part of the inspection, Ms. Torres was
interviewed by FDA investigators. On or
about February 24, 2017, while the
regulatory inspection remained ongoing,
Ms. Torres reviewed and signed an
affidavit which summarized her
interview. In that affidavit, Ms. Torres
made a number of false statements for
purposes of falsely portraying to FDA
investigators that the Study had been
conducted legitimately and honestly,
when in fact it had not. For example,
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Ms. Torres falsely represented in her
signed affidavit that subjects were seen
at Unlimited Medical Research and that
medical records prepared and
maintained by Unlimited Medical
Research, which had been provided to
the FDA investigators during the course
of the inspection, and which purported
to document the participation of
subjects in the Study, were accurate and
complete. In fact, Unlimited Medical
Research employees falsified case
histories to portray persons as legitimate
study subjects who attended scheduled
study visits at Unlimited Medical
Research, when in fact such persons
were not subjects participating in the
Study. Ms. Torres knew these
statements were dishonest and were
made with the specific intent to conceal
the truth about the Study from the FDA
investigators and thereby prevent FDA
from recommending further regulatory
enforcement action against Unlimited
Medical Research or its staff.
Based on this conviction, FDA sent
Ms. Torres by certified mail on
December 9, 2022, 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.
Torres 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 any drug product under
the FD&C Act. The proposal also offered
Ms. Torres 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.
Torres received the proposal on
December 21, 2022. 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. Torres 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.
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
As a result of the foregoing finding,
Ms. Torres is permanently debarred
from providing services in any capacity
to a person with an approved or
pending drug product application,
applicable as of the date of this order
(see DATES) (see section 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. Torres 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. Torres 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. Torres 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 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: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–07670 Filed 4–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0918]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ddrumheller on DSK120RN23PROD with NOTICES1
ACTION:
Notice.
19:25 Apr 11, 2023
Either electronic or written
comments on the collection of
information must be submitted by June
12, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 12, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment 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
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
SUMMARY:
VerDate Sep<11>2014
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection activity associated with
statutory and regulatory food labeling
requirements.
Jkt 259001
Submit written/paper submissions as
follows:
• 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 written/paper comments
submitted to the Dockets Management
PO 00000
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22045
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2023–N–0918 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Labeling Regulations.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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 a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments 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 comments. 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 comments 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-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, 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, 240–402–7500.
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]]>Agencies
[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22043-22045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2515]
Olga L. Torres: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Olga L. Torres 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. Torres 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. Ms. Torres 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
January 20, 2023 (30 days after receipt of the notice), Ms. Torres had
not responded. Ms. Torres' 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 April 12, 2023.
ADDRESSES: Any application by Olga L. Torres 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-2515. Received applications will be placed in the docket and,
except for
[[Page 22044]]
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. 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, at 240-402-8743,
or [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 for
development or approval, of any drug product under the FD&C Act. On
September 30, 2022, Ms. Olga L. Torres 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
obstruction of agency proceeding in violation of 18 U.S.C. 1505.
The factual basis for this conviction is as follows: as contained
in the information, entered into the docket on October 28, 2021, and
the Factual Proffer in support of her guilty plea, entered into the
docket on January 13, 2022, Ms. Torres co-owned a business called
Unlimited Medical Research, LLC (Unlimited Medical Research) that
conducted clinical trials on behalf of pharmaceutical company sponsors.
On or around October 25, 2013, on behalf of Unlimited Medical Research,
Ms. Torres signed a contract with a contract research organization
retained by a drug manufacturer (Sponsor) to conduct a clinical trial
(Study) initiated by the Sponsor. The clinical trial was designed to
study the safety and efficacy of an investigational asthma medication
in children between the ages of 4 and 11 with persistent asthma. Dr.
Yvelice Villaman-Bencosme was a licensed medical doctor who had been
retained by Unlimited Medical Research to serve as the clinical
investigator for the Study.
On or about February 6, 2017, Ms. Torres learned that FDA
investigators intended to conduct a regulatory inspection of Dr.
Villaman-Bencosme in her capacity as the clinical investigator for the
Study at Unlimited Medical Research. Ms. Torres also learned that, as
part of the inspection, FDA investigators would review records prepared
and maintained by Unlimited Medical Research concerning the study. The
FDA regulatory inspection began on or about February 6, 2017, and
continued until on or about April 28, 2017. In or around February 2017,
as part of the inspection, Ms. Torres was interviewed by FDA
investigators. On or about February 24, 2017, while the regulatory
inspection remained ongoing, Ms. Torres reviewed and signed an
affidavit which summarized her interview. In that affidavit, Ms. Torres
made a number of false statements for purposes of falsely portraying to
FDA investigators that the Study had been conducted legitimately and
honestly, when in fact it had not. For example, Ms. Torres falsely
represented in her signed affidavit that subjects were seen at
Unlimited Medical Research and that medical records prepared and
maintained by Unlimited Medical Research, which had been provided to
the FDA investigators during the course of the inspection, and which
purported to document the participation of subjects in the Study, were
accurate and complete. In fact, Unlimited Medical Research employees
falsified case histories to portray persons as legitimate study
subjects who attended scheduled study visits at Unlimited Medical
Research, when in fact such persons were not subjects participating in
the Study. Ms. Torres knew these statements were dishonest and were
made with the specific intent to conceal the truth about the Study from
the FDA investigators and thereby prevent FDA from recommending further
regulatory enforcement action against Unlimited Medical Research or its
staff.
Based on this conviction, FDA sent Ms. Torres by certified mail on
December 9, 2022, 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. Torres 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 any
drug product under the FD&C Act. The proposal also offered Ms. Torres
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. Torres received the proposal on December
21, 2022. 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.
Torres 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.
[[Page 22045]]
As a result of the foregoing finding, Ms. Torres is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, applicable as of the date
of this order (see DATES) (see section 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. Torres
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. Torres 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. Torres 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 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: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07670 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P
