[Federal Register Volume 90, Number 48 (Thursday, March 13, 2025)]
[Notices]
[Pages 11986-11988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04028]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3359]
Harpreet Singh: 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
Harpreet Singh for a period of 10 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding Mr. Singh was convicted of multiple felony offenses, which
serve as the basis for this debarment, that are conspiracy to possess
with intent to distribute cathinone, tapentadol, tramadol, and
carisoprodol; one felony count under Federal law for fraudulent
importation and transportation of goods; one felony count under Federal
law for conspiracy to launder money; and one felony count under Federal
law for conspiracy to obstruct justice. The factual basis supporting
Mr. Singh's conviction, as described below, is conduct relating to the
importation into the United States of a drug or controlled substance.
Mr. Singh 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 November 20, 2024 (30 days after receipt of the notice), Mr.
Singh had not responded. Mr. Singh'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 March 13, 2025.
ADDRESSES: Any application by Mr. Singh for termination of debarment
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) 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
[[Page 11987]]
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-
2024-N-3359. 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 ``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, 240-402-
7500. Publicly available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of Field
Enforcement, Office of Field Regulatory Operations, Office of
Inspections and Investigations, 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 (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)(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 May 21, 2024, Mr. Singh was convicted as defined in section
306(l)(1) of the FD&C Act in the United States District Court for the
Eastern District of New York when the court accepted his plea of guilty
and entered judgment against him for multiple felony offenses that are
conspiracy to possess with intent to distribute cathinone, tapentadol,
tramadol, and carisoprodol, in violation of 21 U.S.C. 846 and
841(b)(1)(C); one felony count under Federal law for fraudulent
importation and transportation of goods in violation of 18 U.S.C. 545;
one felony count under Federal law for conspiracy to launder money in
violation of 18 U.S.C. 1956(a) and 1956(h); and one felony count under
Federal law for conspiracy to obstruct justice in violation of 18
U.S.C. 1512(c) and 1512(k). The underlying facts supporting the
conviction are as follows: as contained in the Information from his
case, between January 2017 and September 2019, Mr. Singh knowingly,
intentionally and with intent to defraud the United States, smuggled,
and clandestinely introduced and attempted to smuggle and clandestinely
introduced into the United States misbranded drugs, which should had
been invoiced, and made out and passed, and attempted to pass, through
the customhouse one or more false, forged and fraudulent invoices, and
other documents and papers; and knowingly, intentionally and
fraudulently imported and brought into the United States merchandise
contrary to law, and receive, conceal, buy, sell and facilitate the
transportation, concealment and sale of the misbranded drugs, knowing
that the drugs to have been imported and brought into the United States
contrary to law. In addition, Mr. Singh together with others, did
knowingly and intentionally conspire to distribute and possess with
intent to distribute one or more controlled substances that are
cathinone, a schedule I controlled substance; tapentadol, a schedule II
controlled substance; and tramadol and carisoprodol, schedule IV
controlled substances. Also, together with others, Mr. Singh knowingly
and intentionally conspired: (a) to conduct one or more financial
transactions affecting interstate and foreign commerce, to wit:
interstate and foreign transfers of funds and payments of Federal
Express bills, which transactions in fact involved the proceeds of
specified unlawful activity, to wit: the crimes charged in counts one
and two of the Information, knowing that the property involved in the
financial transactions represented the proceeds of some form of
unlawful activity, with the intent to promote the carrying on of
specified unlawful activity, in violation of 18 U.S.C.
1956(a)(1)(A)(i); and (b) to conduct one or more financial transactions
affecting interstate and foreign commerce, to wit: interstate and
foreign transfers of funds and payments of Federal Express bills, which
transactions in fact involved the proceeds of the crimes charged in
counts one and two of the Information, knowing that the property
involved in the financial transactions represented the proceeds of some
form of unlawful activity, and knowing that the transactions were
designed in whole and in part to conceal and disguise the nature,
location, source, ownership and control of the proceeds of specified
unlawful activity, in violation of 18 U.S.C. 1956(a)(1)(B)(i).
As further contained in the Information from Mr. Singh's case,
between approximately August 2019 and September 2019, Mr. Singh,
together with others, knowingly and intentionally conspired to
corruptly alter, destroy, mutilate and conceal records, documents and
other objects
[[Page 11988]]
with the intent to impair the objects' integrity and availability for
use in an official proceeding, to wit: a grand jury investigation in
the Eastern District of New York, in violation of 18 U.S.C. 1512(c)(1)
and 1512(k).
FDA sent Mr. Singh, by certified mail, on October 3, 2024, a notice
proposing to debar him for a 10-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. Singh's
felony convictions under Federal law for conspiracy to possess with
intent to distribute cathinone, tapentadol, tramadol, and carisoprodol,
fraudulent importation and transportation of goods, conspiracy to
launder money, and conspiracy to obstruct justice, was for conduct
relating to the importation of any drug or controlled substance into
the United States because Mr. Singh illegally imported and then
introduced misbranded drug products into interstate commerce. He then
laundered money gained from that illegal activity and conspired to
obstruct justice by destroying documents and other objects to prevent
their use in a criminal investigation.
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. Singh's offense and concluded that the offense
warranted the imposition of a 10-year period of debarment.
The proposal informed Mr. Singh 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. Singh received the proposal and notice of opportunity for a
hearing on October 21, 2024. Mr. Singh 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 Division of Field Enforcement Director, Office of
Inspections and Investigations, under section 306(b)(3)(C) of the FD&C
Act, under authority delegated to the Division of Field Enforcement
Director, finds that Mr. Harpreet Singh has been convicted of multiple
felonies under Federal law for conduct relating to the importation into
the United States of any drug or controlled substance. FDA finds that
the offenses should be accorded a debarment period of 10 years as
provided by section 306(c)(2)(A)(iii) of the FD&C Act.
As a result of the foregoing finding, Mr. Singh is debarred for a
period of 10 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. Singh is a prohibited act.
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04028 Filed 3-12-25; 8:45 am]
BILLING CODE 4164-01-P