Notice2024-03020
Ross Lucien: Final Debarment Order
Primary source
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Published
February 14, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ross Lucien 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. Lucien was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Lucien's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lucien was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of December 20, 2023 (30 days after receipt of the notice), Mr. Lucien had not responded. Mr. Lucien's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 89 Issue 31 (Wednesday, February 14, 2024)</title>
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[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11298-11299]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03020]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2180]
Ross Lucien: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Ross Lucien 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. Lucien was convicted of one felony count under Federal
law for conspiracy to smuggle goods into the United States. The factual
basis supporting Mr. Lucien's conviction, as described below, is
conduct relating to the importation into the United States of a drug or
controlled substance. Mr. Lucien was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
he should not be debarred. As of December 20, 2023 (30 days after
receipt of the notice), Mr. Lucien had not responded. Mr. Lucien'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 February 14, 2024.
ADDRESSES: Any application by Mr. Lucien for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted as follows:
Electronic Submissions
[ssquf] Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. An application
submitted electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
[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-
2023-N-2180. Received applications will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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, 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 <a href="/cdn-cgi/l/email-protection#14707176756679717a6067547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="15717077746778707b6166557371743b7d7d663b727a63">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(D) of the FD&C Act 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)(C) of the
FD&C Act, that the individual has been convicted of a felony for
conduct relating to the importation into the United States of any drug
or controlled substance.
On February 23, 2023, Mr. Lucien was convicted, as defined in
section 306(l)(1) of FD&C Act, in the United States District Court for
Western District of Michigan, when the court entered judgment against
him for the offense of conspiracy to smuggle goods into the United
States in violation of 18 U.S.C. 371 and 545. FDA's finding that
debarment is appropriate is based on the felony conviction referenced
herein.
The factual basis for this conviction is as follows: as contained
in the indictment and plea agreement in Mr. Lucien's case, both filed
on May 6, 2022, Mr. Lucien agreed to participate in a scheme to
receive, repackage, and reship misbranded prescription drugs purchased
by customers on the website <a href="http://www.ExpressPCT.com">www.ExpressPCT.com</a>, without a prescription,
and shipped to the United States from foreign countries. Mr. Lucien
received approximately 11 packages containing bulk quantities of
misbranded prescription drugs, all shipped mostly from India but also
from
[[Page 11299]]
other countries. Mr. Lucien then reshipped the misbranded prescription
drugs according to instructions he received from co-conspirators. In
exchange for Mr. Lucien's participation in the scheme, he received free
or discounted prescription drugs.
As a result of this conviction, FDA sent Mr. Lucien, by United
Parcel Service, on November 17, 2023, a notice proposing to debar him
for a 5-year period from importing or offering for import any drug into
the United States. The proposal was based on a finding under section
306(b)(3)(C) of the FD&C Act that Mr. Lucien's felony conviction under
Federal law for conspiracy to smuggle goods into the United States in
violation of 18 U.S.C. 371 and 545, was for conduct relating to the
importation into the United States of any drug or controlled substance
because he was involved in a scheme to illegally import and introduce
prescription drugs 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. Lucien's offense
and concluded that the offense warranted the imposition of a 5-year
period of debarment.
The proposal informed Mr. Lucien 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. Lucien received the proposal and notice of opportunity for
a hearing at his residence on November 20, 2023. Mr. Lucien failed to
request a hearing within the timeframe prescribed by regulation and
has, therefore, 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)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. Ross
Lucien has been convicted of a felony under Federal law for conduct
relating to the importation into the United States of any drug or
controlled substance. FDA finds that the offense should be accorded a
debarment period 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. Lucien is debarred for a
period of 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 by, with the assistance of,
or at the direction of Mr. Lucien is a prohibited act.
Dated: February 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03020 Filed 2-13-24; 8:45 am]
BILLING CODE 4164-01-P
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