[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87785-87787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     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.
     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-
2023-N-2080. 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 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 (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 www.ExpressPCT.com, 
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 www.ExpressPCT.com. 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 
www.ExpressPCT.com, 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]
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