Angela Maria Giron: Final Debarment Order, 35836-35838 [2024-09528]
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Federal Register / Vol. 89, No. 86 / Thursday, May 2, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
improve it. To help inform our thinking
as we begin the process of further
updating the guidance, we invite
comment on the following questions:
1. What are some alternative strategies
for providing data that would support
approval of heritable IGAs in animals?
a. How can a developer demonstrate
the durability of a heritable IGA over
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is difficult or not possible?
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approval requirements for multiple
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approval?
2. What areas of current good
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production of heritable IGAs in animals
do you believe need clarification
through the publication of additional
guidance?
3. Are there process improvements
(e.g., combining steps of the approval
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Recommended Process for Completing
Pre-approval Assessments for IGAs in
Animals, of the guidance) that you
believe would make the approval
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This level 1 draft guidance is being
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does not establish any rights for any
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approach if it satisfies the requirements
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Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
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information in 21 CFR part 58 have been
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information in 21 CFR part 207 have
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VerDate Sep<11>2014
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number 0910–0045; the collections of
information in 21 CFR part 211 have
been approved under OMB control
number 0910–0139; the collections of
information in 21 CFR part 511 have
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number 0910–0117; the collections of
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number 0910–0284; and the collections
of information in 21 CFR 558.6(a)(4)
have been approved under OMB control
number 0910–0363.
III. Electronic Access
Persons with access to the internet
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guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: April 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09279 Filed 5–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5018]
Angela Maria Giron: 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 Angela Maria Giron, M.D.
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 Dr.
Giron 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. Dr. Giron was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of February 16, 2024 (30
days after receipt of the notice), Dr.
Giron has not responded. Dr. Giron’s
failure to respond and request a hearing
constitutes a waiver of Dr. Giron’s right
to a hearing concerning this matter.
DATES: This order is applicable May 2,
2024.
SUMMARY:
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Any application by Dr.
Giron 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 at any time as follows:
ADDRESSES:
Electronic Submissions
• 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.
• 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
• 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 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–2023–N–
5018. 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.
• 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
E:\FR\FM\02MYN1.SGM
02MYN1
Federal Register / Vol. 89, No. 86 / Thursday, May 2, 2024 / Notices
‘‘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. 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:
khammond on DSKJM1Z7X2PROD with NOTICES
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 of
development or approval, of any drug
product. On September 11, 2023, Dr.
Giron was convicted as defined in
section 306(l)(1) of the FD&C Act in the
United States 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 defraud the United States in violation
of 18 U.S.C. 371. The underlying facts
supporting the conviction are as
follows: As contained in the Information
and the Factual Proffer in Support of
Guilty Plea, from Dr. Giron’s case, she
was a licensed physician and served as
a clinical investigator at AMB Research
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Center, Inc. (AMB), a medical clinic
located in Miami, Florida. AMB
conducted clinical trials of new drugs
for pharmaceutical companies and other
sponsors. AMB entered into a Clinical
Trial Agreement with a Clinical
Research Organization (CRO) that
managed and oversaw a clinical trial
designed to evaluate the safety and
efficacy of an investigational drug
intended to treat persons with
Clostridium difficile-associated diarrhea
(CDAD clinical trial) on behalf of a
sponsor (a pharmaceutical company).
Dr. Giron agreed to serve as the clinical
investigator, also known as the principal
investigator, for the CDAD clinical trial
at AMB and signed the Form FDA 1572,
Statement of Investigator, for the CDAD
clinical trial. By signing the Form FDA
1572, she knew that as the clinical
investigator she was required to, among
other things, (1) conduct the CDAD
clinical trial according to the study
protocol and in compliance with all
applicable Federal regulations; (2)
personally conduct and supervise the
CDAD clinical trial; (3) obtain informed
consent from the subjects; and (4)
comply with the clinical trial protocol
and applicable Federal regulations
relating to obtaining informed consent
and the informed consent process.
As the CDAD principal investigator,
Dr. Giron was also responsible for
complying with all requirements
regarding the eligibility of subjects in
accordance with the protocol;
dispensing study medication; collecting
and reporting data; reporting adverse
events; and ensuring that all employees
working on the study met those same
obligations. Dr. Giron was also required
to prepare and maintain case histories
which were records relating to the
CDAD clinical trial. These case histories
for each subject participating in the
CDAD clinical trial included informed
consent forms and medical records,
drug dispensation records, and records
of all observations and other data
pertinent to the CDAD clinical trial.
For purposes of obtaining money from
the Sponsor and/or CRO, Dr. Giron,
along with her co-conspirators, created
false and fraudulent study records. For
example, electronic case record files
(eCRFs) falsely represented that the
subjects completed the informed
consent form (ICF) process, which
required Dr. Giron to review the ICF
with each subject and personally obtain
the subject’s written informed consent.
In truth and fact, Dr. Giron did not
obtain written informed consent for any
of the 22 subjects enrolled in the CDAD
clinical trial. Dr. Giron knew that the
study subjects did not participate in the
CDAD clinical trial in accordance with
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35837
the study protocol and applicable
Federal regulations.
In addition, along with her coconspirators, Dr. Giron falsified data of
enrolled subjects in the CDAD clinical
trial. For example, Dr. Giron did not
conduct the required clinical
investigator assessments at the second,
third and fifth visits. She also knew that
falsified and fraudulent information was
submitted in case report forms and
eCRFs falsely representing she had
completed those required assessments
according to the protocol. Furthermore,
Dr. Giron also knew that false
information and data was submitted in
the case report forms and eCRFs
representing that the subjects had
satisfied eligibility criteria to participate
in the CDAD clinical trial, received and
taken the study medication, and
completed the required documents and
journals.
After an on-site audit of AMB by the
Sponsor in April 2017, the Sponsor
notified the FDA in writing of potential
scientific misconduct by AMB. The
Institutional Review Board for the
CDAD clinical trial sent AMB a copy of
the Sponsor’s notification to FDA. Dr.
Giron, along with a co-conspirator,
signed a letter entitled ‘‘Site response to
the Notification of Potential Scientific
Misconduct.’’ At the time of signing that
response letter Dr. Giron knew that it
contained materially false and
fraudulent representations including
that (1) she was present for all subjects’
informed consent and gave each subject
the time to understand, read, and
resolve any questions prior to signing
the informed consent form; (2) AMB
took special care with ICF signatures
and the ICF process to ensure that
subjects understood the study and its
risks and could make an informed
decision whether to participate; (3) all
participating subjects had completed the
study treatment and follow up visits;
and (4) she and AMB site staff acted in
accordance with the study protocol to
the best of their knowledge. Dr. Giron
received $58,119.60 in proceeds for the
CDAD clinical trial. AMB received more
than $250,000 for the CDAD clinical
trial.
As a result of this conviction, FDA
sent Dr. Giron, by certified mail, on
January 10, 2024, 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), that Dr. Giron was
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
E:\FR\FM\02MYN1.SGM
02MYN1
khammond on DSKJM1Z7X2PROD with NOTICES
35838
Federal Register / Vol. 89, No. 86 / Thursday, May 2, 2024 / Notices
product. The proposal informed Dr.
Giron of the proposed debarment and
offered her 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
a waiver of the opportunity for a hearing
and of any contentions concerning this
action. Dr. Giron received the proposal
and notice of opportunity for a hearing
on January 17, 2024. Dr. Giron failed to
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and waived any contentions
concerning her debarment (21 CFR part
12).
Dated: April 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
II. Findings and Order
HHS.
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 Angela Maria
Giron, M.D. 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.
As a result of the foregoing finding,
Dr. Giron 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,
(335a(c)(2)(A)(ii))). 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 Dr. Giron 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 Dr.
Giron 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 Dr. Giron during her 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 the FD&C 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))).
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[FR Doc. 2024–09528 Filed 5–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA–2024–N–1464]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
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
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 reporting and
recordkeeping requirements of our
regulations concerning new animal
drugs for investigational use.
DATES: Either electronic or written
comments on the collection of
information must be submitted by July
1, 2024.
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
July 1, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
SUMMARY:
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
PO 00000
Frm 00066
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Sfmt 4703
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
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
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–
2024–N–1464 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; New
Animal Drugs for Investigational Use.’’
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
E:\FR\FM\02MYN1.SGM
02MYN1
]]>Agencies
[Federal Register Volume 89, Number 86 (Thursday, May 2, 2024)]
[Notices]
[Pages 35836-35838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09528]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-5018]
Angela Maria Giron: 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 Angela Maria Giron, M.D. 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 Dr. Giron 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. Dr. Giron was given notice of the
proposed debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. As of February 16, 2024 (30 days
after receipt of the notice), Dr. Giron has not responded. Dr. Giron's
failure to respond and request a hearing constitutes a waiver of Dr.
Giron's right to a hearing concerning this matter.
DATES: This order is applicable May 2, 2024.
ADDRESSES: Any application by Dr. Giron 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 at any time as follows:
Electronic Submissions
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.
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
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 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-
2023-N-5018. 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.
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
[[Page 35837]]
``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. 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 of
development or approval, of any drug product. On September 11, 2023,
Dr. Giron was convicted as defined in section 306(l)(1) of the FD&C Act
in the United States 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 defraud the
United States in violation of 18 U.S.C. 371. The underlying facts
supporting the conviction are as follows: As contained in the
Information and the Factual Proffer in Support of Guilty Plea, from Dr.
Giron's case, she was a licensed physician and served as a clinical
investigator at AMB Research Center, Inc. (AMB), a medical clinic
located in Miami, Florida. AMB conducted clinical trials of new drugs
for pharmaceutical companies and other sponsors. AMB entered into a
Clinical Trial Agreement with a Clinical Research Organization (CRO)
that managed and oversaw a clinical trial designed to evaluate the
safety and efficacy of an investigational drug intended to treat
persons with Clostridium difficile-associated diarrhea (CDAD clinical
trial) on behalf of a sponsor (a pharmaceutical company). Dr. Giron
agreed to serve as the clinical investigator, also known as the
principal investigator, for the CDAD clinical trial at AMB and signed
the Form FDA 1572, Statement of Investigator, for the CDAD clinical
trial. By signing the Form FDA 1572, she knew that as the clinical
investigator she was required to, among other things, (1) conduct the
CDAD clinical trial according to the study protocol and in compliance
with all applicable Federal regulations; (2) personally conduct and
supervise the CDAD clinical trial; (3) obtain informed consent from the
subjects; and (4) comply with the clinical trial protocol and
applicable Federal regulations relating to obtaining informed consent
and the informed consent process.
As the CDAD principal investigator, Dr. Giron was also responsible
for complying with all requirements regarding the eligibility of
subjects in accordance with the protocol; dispensing study medication;
collecting and reporting data; reporting adverse events; and ensuring
that all employees working on the study met those same obligations. Dr.
Giron was also required to prepare and maintain case histories which
were records relating to the CDAD clinical trial. These case histories
for each subject participating in the CDAD clinical trial included
informed consent forms and medical records, drug dispensation records,
and records of all observations and other data pertinent to the CDAD
clinical trial.
For purposes of obtaining money from the Sponsor and/or CRO, Dr.
Giron, along with her co-conspirators, created false and fraudulent
study records. For example, electronic case record files (eCRFs)
falsely represented that the subjects completed the informed consent
form (ICF) process, which required Dr. Giron to review the ICF with
each subject and personally obtain the subject's written informed
consent. In truth and fact, Dr. Giron did not obtain written informed
consent for any of the 22 subjects enrolled in the CDAD clinical trial.
Dr. Giron knew that the study subjects did not participate in the CDAD
clinical trial in accordance with the study protocol and applicable
Federal regulations.
In addition, along with her co-conspirators, Dr. Giron falsified
data of enrolled subjects in the CDAD clinical trial. For example, Dr.
Giron did not conduct the required clinical investigator assessments at
the second, third and fifth visits. She also knew that falsified and
fraudulent information was submitted in case report forms and eCRFs
falsely representing she had completed those required assessments
according to the protocol. Furthermore, Dr. Giron also knew that false
information and data was submitted in the case report forms and eCRFs
representing that the subjects had satisfied eligibility criteria to
participate in the CDAD clinical trial, received and taken the study
medication, and completed the required documents and journals.
After an on-site audit of AMB by the Sponsor in April 2017, the
Sponsor notified the FDA in writing of potential scientific misconduct
by AMB. The Institutional Review Board for the CDAD clinical trial sent
AMB a copy of the Sponsor's notification to FDA. Dr. Giron, along with
a co-conspirator, signed a letter entitled ``Site response to the
Notification of Potential Scientific Misconduct.'' At the time of
signing that response letter Dr. Giron knew that it contained
materially false and fraudulent representations including that (1) she
was present for all subjects' informed consent and gave each subject
the time to understand, read, and resolve any questions prior to
signing the informed consent form; (2) AMB took special care with ICF
signatures and the ICF process to ensure that subjects understood the
study and its risks and could make an informed decision whether to
participate; (3) all participating subjects had completed the study
treatment and follow up visits; and (4) she and AMB site staff acted in
accordance with the study protocol to the best of their knowledge. Dr.
Giron received $58,119.60 in proceeds for the CDAD clinical trial. AMB
received more than $250,000 for the CDAD clinical trial.
As a result of this conviction, FDA sent Dr. Giron, by certified
mail, on January 10, 2024, 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), that Dr. Giron was 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
[[Page 35838]]
product. The proposal informed Dr. Giron of the proposed debarment and
offered her 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 a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Dr. Giron received the proposal and notice of opportunity for a
hearing on January 17, 2024. Dr. Giron failed to request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and waived 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 Angela
Maria Giron, M.D. 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.
As a result of the foregoing finding, Dr. Giron 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,
(335a(c)(2)(A)(ii))). 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 Dr. Giron
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 Dr. Giron
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 Dr. Giron during her 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 the FD&C 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 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09528 Filed 5-1-24; 8:45 am]
BILLING CODE 4164-01-P
