Notice2023-27855
Jeremy Walenty: Final Debarment Order
Primary source
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Published
December 19, 2023
Effective
December 19, 2023
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 (the FD&C Act) debarring Jeremy Walenty 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. Walenty was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Walenty's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Walenty 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 October 15, 2023 (30 days after receipt of the notice), Mr. Walenty had not responded. Mr. Walenty'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 88 Issue 242 (Tuesday, December 19, 2023)</title>
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[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87785-87787]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27855]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2080]
Jeremy Walenty: 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 (the FD&C Act) debarring
Jeremy Walenty 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. Walenty was convicted of one felony count under
Federal law for conspiracy to smuggle goods into the United States. The
factual basis supporting Mr. Walenty's conviction, as described below,
is conduct relating to the importation into the United States of a drug
or controlled substance. Mr. Walenty 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 October 15, 2023 (30 days after
receipt of the notice), Mr. Walenty had not responded. Mr. Walenty's
failure to respond and request a hearing constitutes a waiver of his
right to a hearing concerning this matter.
DATES: This order is effective December 19, 2023.
ADDRESSES: Any application by Mr. Walenty for termination of debarment
[[Page 87786]]
under section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) may be
submitted as follows:
Electronic Submissions
<bullet> 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>.
<bullet> 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
<bullet> 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.
<bullet> 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-2080. 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 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#096d6c6b687b646c677d7a496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="3357565152415e565d4740735557521d5b5b401d545c45">[email protected]</span></a>.
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 the 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 24, 2023, Jeremy Walenty was convicted as defined in
section 306(l)(1) of the FD&C Act in the U.S. District Court for
Western District of Michigan when the court accepted his plea of guilty
and 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. The underlying facts supporting the conviction are as follows:
As contained in the indictment and plea agreement from Mr.
Walenty's case, filed on March 1, 2022, and July 15, 2022,
respectively, Brendon Gagne owned and operated <a href="http://www.ExpressPCT.com">www.ExpressPCT.com</a>,
which sold misbranded prescription drugs, obtained from overseas
suppliers, and sold to customers in the United States without requiring
a prescription. Mr. Walenty was recruited by Brendon Gagne to receive,
repackage, and reship the misbranded prescription drugs he received
from coconspirators outside of the United States that were purchased by
customers on the website <a href="http://www.ExpressPCT.com">www.ExpressPCT.com</a>. In Mr. Walenty's plea
agreement he acknowledged that he knew that receiving and reshipping
prescription drugs in this manner was illegal. Later on, Mr. Walenty
also began receiving bulk shipments of prescription drugs from
coconspirators in the U.S. which had originally been sent to these
coconspirators from overseas suppliers. Mr. Walenty then would use
these shipments to fulfill orders that customers had placed on
<a href="http://www.ExpressPCT.com">www.ExpressPCT.com</a>, without ever seeing a prescription from these
customers. In exchange for Mr. Walenty's participation in the scheme,
Mr. Walenty received monetary compensation.
As a result of this conviction, FDA sent Mr. Walenty, by certified
mail, on September 6, 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. Walenty'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. Walenty's offense
and concluded that the offense warranted the imposition of a 5 year
period of debarment.
The proposal informed Mr. Walenty 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. Walenty received the proposal and notice of opportunity for
a hearing on September 15, 2023. Mr. Walenty failed to request a
hearing within the timeframe prescribed by regulation and has,
therefore, waived his opportunity for a hearing and waived any
[[Page 87787]]
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 Jeremy
Walenty 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. Walenty 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. Walenty is a prohibited act.
Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27855 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P
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