Tuan Anh Tran: Final Debarment Order, 76583-76585 [2020-26250]
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TKELLEY on DSKBCP9HB2PROD with NOTICES
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) 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 regulation of any
drug product under the FD&C Act. On
June 27, 2017, Mr. Cadden was
convicted as defined in section 306(l)(1)
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the District of Massachusetts,
after a jury verdict, for one count of
racketeering in violation of 18 U.S.C.
1962(c), one count of racketeering
conspiracy in violation of 18 U.S.C.
1962(d), 52 counts of mail fraud in
violation of 18 U.S.C. 1341, and three
counts of introduction of misbranded
drugs into interstate commerce with the
intent to defraud and mislead-no
prescriptions in violation of 21 U.S.C.
353(b)(1), 331(a), and 333(a)(2).
As contained in counts 1–2, 4–39, 41–
56, 95, and 99–100 of the indictment,
filed on December 16, 2014, Mr. Cadden
was an owner and director of the New
England Compounding Center (NECC),
which held itself out as a compoundingonly pharmacy, and he served as
NECC’s president, head pharmacist, and
Manager of Record. In addition, Mr.
Cadden was an owner and director of
Medical Sales Management, Inc. (MSM),
and served as MSM’s Treasurer. MSM
provided sales and administrative
services to NECC for which MSM was
paid a service fee. MSM’s sales
representatives sold drugs on behalf of
NECC to customers throughout the
country. In those capacities, Mr. Cadden
instructed the MSM sales force to falsely
represent to customers that NECC was
providing the highest quality
compounded medications, when in fact
Mr. Cadden, among other things, failed
to properly sterilize drug products
consistent with applicable U.S.
Pharmacopeia standards, failed to test
purportedly sterile drugs, authorized the
shipping of drugs before test results
confirming their sterility were returned,
never notified customers of nonsterile
results, and compounded drugs with
expired ingredients. Additionally, Mr.
Cadden directed and authorized the
shipping and mailing, in interstate
commerce, of contaminated
methylprednisolone acetate to NECC
customers nationwide. Mr. Cadden also
caused drugs to be introduced and
delivered into interstate commerce
without the valid prescription of a
practitioner licensed by law to
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administer drugs, which act resulted in
the drugs being misbranded. Further,
Mr. Cadden defrauded the United States
by interfering with and obstructing the
lawful governmental functions of FDA
by claiming to be a pharmacy
dispensing drugs pursuant to valid,
patient-specific prescriptions. In fact,
NECC routinely dispensed drugs in bulk
without valid, patient-specific
prescriptions.
As a result of this conviction, FDA
sent Mr. Cadden, by certified mail on
June 2, 2020, a notice proposing to
permanently debar him 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)(B) of the FD&C Act, that Mr.
Cadden was convicted of felonies under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. The proposal also offered Mr.
Cadden an opportunity to request a
hearing, providing him 30 days from the
date of receipt of the letter in which to
file the request, and advised him 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. Mr.
Cadden received the proposal on June 9,
2020. Mr. Cadden did not request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and any
contentions concerning his 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)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Barry J.
Cadden, has been convicted of a felony
under Federal law for conduct
otherwise relating to the regulation of a
drug product under the FD&C Act.
As a result of the foregoing finding,
Barry J. Cadden, 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)(B) 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 Barry J.
Cadden, in any capacity during his
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 Mr.
Cadden provides services in any
capacity to a person with an approved
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76583
or pending drug product application
during his period of debarment, he 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 applications
from Mr. Cadden during his 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
section 306 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))).
Any application by Mr. Cadden for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2019–N–4248 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
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–26255 Filed 11–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1255]
Tuan Anh Tran: 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) debarring
Tuan Anh Tran for a period of 5 years
from importing or offering for import
any drug into the United States. FDA
bases this order on a finding that Mr.
Tran engaged in a pattern of importing
or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage
that is inconsistent with his personal or
household use) that are not designated
in an authorized electronic data
interchange system as products
SUMMARY:
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76584
Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
TKELLEY on DSKBCP9HB2PROD with NOTICES
regulated by FDA. Mr. Tran was given
notice of the proposed debarment and
an opportunity to request a hearing to
show why he should not be debarred.
As of September 14, 2020 (30 days after
receipt of the notice), Mr. Tran had not
responded. Mr. Trans’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable
November 30, 2020.
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:
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if FDA finds,
as required by section 306(b)(3)(D) of
the FD&C Act, that the individual has
engaged in a pattern of importing or
offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage
that is inconsistent with personal or
household use by the importer), and the
shipments are not designated in an
entry in an authorized electronic data
exchange system as products regulated
by FDA.
After an investigation, FDA
discovered that Mr. Tran has engaged in
numerous instances of importing or
offering for import misbranded drugs;
all the parcels containing the
misbranded drugs serving as the basis
for this action were intercepted by FDA
at the John F. Kennedy International
Mail Facility and were addressed to Mr.
Tran at one of two addresses connected
to him.
On or about April 12, 2019, Mr. Tran
offered for import three parcels. The
product contained in the first parcel was
210 packets (pieces) of Kamagra
Sildenafil Oral Jelly and was a
misbranded drug because the product
was a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label. The product was refused
entry on May 17, 2019. The product
contained in the second parcel was 245
packets (pieces) of Kamagra Sildenafil
VerDate Sep<11>2014
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Oral Jelly and was a misbranded drug
because the product was a prescription
drug product that failed to contain the
‘‘Rx-only’’ symbol on its label. The
product was refused entry on May 17,
2019. The product contained in the
third parcel was 245 packets (pieces) of
Kamagra Sildenafil Oral Jelly and was a
misbranded drug because the product
was a prescription drug product that
failed to contain the ‘‘Rx-only’’ symbol
on its label. The product was refused
entry on May 17, 2019.
On or about September 13, 2019, Mr.
Tran offered for import four parcels. The
product contained in the first parcel was
312 Kamagra Sildenafil Citrate
Chewable Tablets and was a misbranded
drug because it was a prescription drug
product that failed to contain the ‘‘Rxonly’’ symbol on its label. The product
was refused entry on October 22, 2019.
The product contained in the second
parcel was 312 Kamagra Sildenafil
Citrate Chewable Tablets and was a
misbranded drug because it was a
prescription drug product that failed to
contain the ‘‘Rx-only’’ symbol on its
label. The product was refused entry on
October 22, 2019. The product
contained in the third parcel was 196
packets (pieces) of Kamagra Sildenafil
Citrate Jelly and was a misbranded drug
because it was a prescription drug
product that failed to contain the ‘‘Rxonly’’ symbol on its label. The product
was refused entry on October 22, 2019.
The product contained in the fourth
parcel was 231 packets (pieces) of
Kamagra Sildenafil Citrate Jelly and was
a misbranded drug because it was a
prescription drug product that failed to
contain the ‘‘Rx-only’’ symbol on its
label. The product was refused entry on
October 22, 2019.
On or about September 26, 2019, Mr.
Tran offered for import a parcel that was
intercepted and processed by FDA. The
product contained in the parcel was 196
packets (pieces) of Kamagra Sildenafil
Oral Jelly and was a misbranded drug
because it was a prescription drug
product that failed to contain the ‘‘Rxonly’’ symbol on its label. The product
was refused entry on October 29, 2019.
Because of this pattern of importing or
offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage
that is inconsistent with his personal or
household use) that are not designated
in an authorized electronic data
interchange system as products
regulated by FDA, in accordance with
section 306(b)(3)(D) of the FD&C Act,
FDA sent Mr. Tran, by certified mail on
August 7, 2020, a notice proposing to
debar him for 5 years from importing or
offering for import any drug into the
United States.
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In proposing a debarment period,
FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C
Act that it considered applicable to Mr.
Tran’s pattern of conduct and
concluded that his conduct warranted
the imposition of a 5-year period of
debarment.
The proposal informed Mr. Tran of
the proposed debarment and offered
him an opportunity to request a hearing,
providing him 30 days from the date of
receipt of the letter in which to file the
request, and advised him that failure to
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Mr.
Tran received the proposal and notice of
opportunity for a hearing on August 15,
2020. Mr. Tran failed to request a
hearing within the timeframe prescribed
by regulation and, therefore, has waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Tuan Anh
Tran has engaged in a pattern of
importing or offering for import
misbranded drugs (i.e., in an amount,
frequency, or dosage that is inconsistent
with his personal or household use) that
are not designated in an authorized
electronic data interchange system as
products regulated by FDA. FDA finds
that this pattern of conduct should be
accorded a debarment of 5 years as
provided by section 306(c)(2)(A)(iii) of
the FD&C Act.
As a result of the foregoing finding,
Mr. Tran is debarred for 5 years from
importing or offering for import any
drug into the United States, effective
(see DATES). Pursuant to section 301(cc)
of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the
United States of any drug or controlled
substance by, with the assistance of, or
at the direction of Mr. Tran is a
prohibited act.
Any application by Mr. Tran for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2020–
N–1255 and sent to the Dockets
Management Staff (see ADDRESSES). The
public availability of information in
these submissions is governed by 21
CFR 10.20(j).
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
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Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
website address for the FACA database
is https://www.facadatabase.gov/.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–26247 Filed 11–27–20; 8:45 am]
BILLING CODE 4165–15–P
[FR Doc. 2020–26250 Filed 11–27–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Recharter for the National Advisory
Council on Nurse Education and
Practice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, HHS
is hereby giving notice that the National
Advisory Council on Nurse Education
and Practice (NACNEP) has been
rechartered. The effective date of the
recharter is November 30, 2020.
FOR FURTHER INFORMATION CONTACT:
Camillus Ezeike, Ph.D., JD, LLM, RN,
PMP, Designated Federal Officer,
Bureau of Health Workforce, Division of
Nursing and Public Health, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–2866; or
BHWNACNEP@hrsa.gov.
SUPPLEMENTARY INFORMATION: NACNEP
provides advice and recommendations
to the Secretary of HHS (‘‘Secretary’’)
and Congress on policy matters and the
preparation of general regulations
concerning activities under Title VIII of
the Public Health Service (PHS) Act,
including the range of issues relating to
the nurse workforce, education, and
practice improvement. NACNEP also
prepares and submits an annual report
to the Secretary and Congress describing
its activities, including NACNEP’s
findings and recommendations
concerning activities under Title VIII, as
required by the PHS Act.
The recharter of NACNEP was
approved on November 30, 2020, which
will also stand as the filing date. The
recharter of NACNEP gives
authorization for the Council to operate
until November 30, 2022.
A copy of the NACNEP charter is
available on the NACNEP website at
https://www.hrsa.gov/advisorycommittees/nursing/about.html. A copy
of the charter can also be obtained by
accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
TKELLEY on DSKBCP9HB2PROD with NOTICES
SUMMARY:
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Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Rural Health
Care Coordination Program OMB No.
0906–0024—Reinstate With Changes
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on the proposed data
collection projects of the Paperwork
Reduction Act of 1995, HRSA
announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than January 29, 2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Health Care Coordination Program
OMB No. 0906–0024—Reinstate with
Changes.
Abstract: The Rural Health Care
Coordination Program (Care
Coordination Program) is authorized
under Section 330A(e) of the Public
Health Service Act (42 U.S.C. 254(e)), as
SUMMARY:
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76585
amended, to ‘‘improve access and
quality of care through the application
of care coordination strategies with the
focus areas of collaboration, leadership
and workforce, improved outcomes, and
sustainability in rural communities.’’
This authority permits HRSA’s Federal
Office of Rural Health Policy to support
rural health consortiums/networks
aiming to achieve the overall goals of
improving access, delivery, and quality
of care through the application of care
coordination strategies in rural
communities.
This ICR was discontinued in January
2020. HRSA is requesting a
reinstatement with changes as it was
decided to re-compete this pilot
program.
The proposed Rural Health Care
Coordination Program draft measures
for information collection reflect
changes to the Clinical Measures
section, which was previously in
section eight and now currently in
section six. The Clinical Measures
Section now expands previous project
focus from three chronic diseases (i.e.
Type 2 diabetes, Congestive Heart
Failure, and Chronic Obstructive
Pulmonary Disease) to an inclusive list
of clinical measures in order to reflect
a patient’s overall health and well-being
as well as the organization’s overall
improved outcomes for the project.
Proposed revisions also include
measures to examine key elements cited
for a successful rural care coordination
program: (1) Collaboration, (2)
leadership and workforce, (3) improved
outcomes, and (4) sustainability.
1. Collaboration—Utilizing a
collaborative approach to coordinate
and deliver health care services through
a consortium, in which member
organizations actively engage in
integrated, coordinated, patientcentered delivery of health care
services.
2. Leadership and Workforce—
Developing and strengthening a highly
skilled care coordination workforce to
respond to vulnerable populations’
unmet needs within the rural
communities.
3. Improved Outcomes—Expanding
access and improving care quality and
delivery, and health outcomes through
evidence-based model and/or promising
practices tailored to meet the local
populations’ needs.
4. Sustainability—Developing and
strengthening care coordination
program’s financial sustainability by
establishing effective revenue sources
such as expanded service
reimbursement, resource sharing, and/or
contributions from partners at the
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]]>Agencies
[Federal Register Volume 85, Number 230 (Monday, November 30, 2020)]
[Notices]
[Pages 76583-76585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26250]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1255]
Tuan Anh Tran: 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) debarring
Tuan Anh Tran for a period of 5 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Mr. Tran engaged in a pattern of importing or offering for
import misbranded drugs (i.e., in an amount, frequency, or dosage that
is inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products
[[Page 76584]]
regulated by FDA. Mr. Tran was given notice of the proposed debarment
and an opportunity to request a hearing to show why he should not be
debarred. As of September 14, 2020 (30 days after receipt of the
notice), Mr. Tran had not responded. Mr. Trans's failure to respond and
request a hearing constitutes a waiver of his right to a hearing
concerning this matter.
DATES: This order is applicable November 30, 2020.
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:
I. Background
Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D))
permits debarment of an individual from importing or offering for
import any drug into the United States if FDA finds, as required by
section 306(b)(3)(D) of the FD&C Act, that the individual has engaged
in a pattern of importing or offering for import misbranded drugs
(i.e., in an amount, frequency, or dosage that is inconsistent with
personal or household use by the importer), and the shipments are not
designated in an entry in an authorized electronic data exchange system
as products regulated by FDA.
After an investigation, FDA discovered that Mr. Tran has engaged in
numerous instances of importing or offering for import misbranded
drugs; all the parcels containing the misbranded drugs serving as the
basis for this action were intercepted by FDA at the John F. Kennedy
International Mail Facility and were addressed to Mr. Tran at one of
two addresses connected to him.
On or about April 12, 2019, Mr. Tran offered for import three
parcels. The product contained in the first parcel was 210 packets
(pieces) of Kamagra Sildenafil Oral Jelly and was a misbranded drug
because the product was a prescription drug product that failed to
contain the ``Rx-only'' symbol on its label. The product was refused
entry on May 17, 2019. The product contained in the second parcel was
245 packets (pieces) of Kamagra Sildenafil Oral Jelly and was a
misbranded drug because the product was a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on May 17, 2019. The product contained in the third
parcel was 245 packets (pieces) of Kamagra Sildenafil Oral Jelly and
was a misbranded drug because the product was a prescription drug
product that failed to contain the ``Rx-only'' symbol on its label. The
product was refused entry on May 17, 2019.
On or about September 13, 2019, Mr. Tran offered for import four
parcels. The product contained in the first parcel was 312 Kamagra
Sildenafil Citrate Chewable Tablets and was a misbranded drug because
it was a prescription drug product that failed to contain the ``Rx-
only'' symbol on its label. The product was refused entry on October
22, 2019. The product contained in the second parcel was 312 Kamagra
Sildenafil Citrate Chewable Tablets and was a misbranded drug because
it was a prescription drug product that failed to contain the ``Rx-
only'' symbol on its label. The product was refused entry on October
22, 2019. The product contained in the third parcel was 196 packets
(pieces) of Kamagra Sildenafil Citrate Jelly and was a misbranded drug
because it was a prescription drug product that failed to contain the
``Rx-only'' symbol on its label. The product was refused entry on
October 22, 2019. The product contained in the fourth parcel was 231
packets (pieces) of Kamagra Sildenafil Citrate Jelly and was a
misbranded drug because it was a prescription drug product that failed
to contain the ``Rx-only'' symbol on its label. The product was refused
entry on October 22, 2019.
On or about September 26, 2019, Mr. Tran offered for import a
parcel that was intercepted and processed by FDA. The product contained
in the parcel was 196 packets (pieces) of Kamagra Sildenafil Oral Jelly
and was a misbranded drug because it was a prescription drug product
that failed to contain the ``Rx-only'' symbol on its label. The product
was refused entry on October 29, 2019.
Because of this pattern of importing or offering for import
misbranded drugs (i.e., in an amount, frequency, or dosage that is
inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA, in accordance with section 306(b)(3)(D) of
the FD&C Act, FDA sent Mr. Tran, by certified mail on August 7, 2020, a
notice proposing to debar him for 5 years from importing or offering
for import any drug into the United States.
In proposing a debarment period, FDA weighed the considerations set
forth in section 306(c)(3) of the FD&C Act that it considered
applicable to Mr. Tran's pattern of conduct and concluded that his
conduct warranted the imposition of a 5-year period of debarment.
The proposal informed Mr. Tran of the proposed debarment and
offered him an opportunity to request a hearing, providing him 30 days
from the date of receipt of the letter in which to file the request,
and advised him that failure to request a hearing constituted a waiver
of the opportunity for a hearing and of any contentions concerning this
action. Mr. Tran received the proposal and notice of opportunity for a
hearing on August 15, 2020. Mr. Tran failed to request a hearing within
the timeframe prescribed by regulation and, therefore, has waived his
opportunity for a hearing and waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. Tuan
Anh Tran has engaged in a pattern of importing or offering for import
misbranded drugs (i.e., in an amount, frequency, or dosage that is
inconsistent with his personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. FDA finds that this pattern of conduct
should be accorded a debarment of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Tran is debarred for 5
years from importing or offering for import any drug into the United
States, effective (see DATES). Pursuant to section 301(cc) of the FD&C
Act (21 U.S.C. 331(cc)), the importing or offering for import into the
United States of any drug or controlled substance by, with the
assistance of, or at the direction of Mr. Tran is a prohibited act.
Any application by Mr. Tran for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-1255 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20(j).
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
[[Page 76585]]
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, 240-402-
7500.
Dated: November 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26250 Filed 11-27-20; 8:45 am]
BILLING CODE 4164-01-P
