Ross Lucien: Final Debarment Order, 11298-11299 [2024-03020]

Download as PDF 11298 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices drug application from Mr. Patel during his period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act. Note that, for purposes of sections 306 and 307 of the FD&C Act, a ‘‘drug product’’ is defined as a drug subject to regulation under section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382) or under section 351 of the Public Health Service Act (42 U.S.C. 262) (section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))). Dated: February 9, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–03036 Filed 2–13–24; 8:45 am] BILLING CODE 4164–01–P 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. 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: ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: Electronic Submissions D Federal eRulemaking Portal: https://www.regulations.gov. Follow the VerDate Sep<11>2014 17:50 Feb 13, 2024 Jkt 262001 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–2023–N– 2180. 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. 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 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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, 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 debarments@fda.hhs.gov. 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 www.ExpressPCT.com, 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 E:\FR\FM\14FEN1.SGM 14FEN1 Federal Register / Vol. 89, No. 31 / Wednesday, February 14, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:50 Feb 13, 2024 Jkt 262001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2022–E–2205; FDA– 2022–E–2206; FDA–2022–E–2207; FDA– 2022–E–2208; FDA–2022–E–2243; FDA– 2022–E–2244; and FDA–2022–E–2246] Determination of Regulatory Review Period for Purposes of Patent Extension; WINLEVI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WINLEVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product. SUMMARY: Anyone with knowledge that any of the dates as published (see SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic or written comments and ask for a redetermination by April 15, 2024. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 12, 2024. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. 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 April 15, 2024. Comments received by mail/hand delivery/courier (for written/ DATES: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 11299 paper submissions) will be considered timely if they are received on or before that date. 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 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 Nos. FDA– 2022–E–2205; FDA–2022–E–2206; FDA–2022–E–2207; FDA–2022–E–2208; FDA–2022–E–2243; FDA–2022–E–2244; and FDA–2022–E–2246 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; WINLEVI.’’ 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. E:\FR\FM\14FEN1.SGM 14FEN1

Agencies

[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11298-11299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03020]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 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-
2023-N-2180. 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.
    [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. 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, 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 [email protected].

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 www.ExpressPCT.com, 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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