[Federal Register Volume 90, Number 158 (Tuesday, August 19, 2025)]
[Notices]
[Pages 40369-40370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-15787]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0709]
Doyal Kalita: 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
Doyal Kalita 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 that Mr. Kalita was convicted of two felony counts under
Federal law. The factual basis supporting Mr. Kalita's conviction, as
described below, is conduct relating to the importation into the United
States of a drug or controlled substance. Mr. Kalita 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 June 26, 2025 (30
days after receipt of the notice), Mr. Kalita had not responded. Mr.
Kalita'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 August 19, 2025.
ADDRESSES: Any application by Mr. Kalita 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 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-
2025-N-0709. 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, 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 October 9, 2024, Mr. Kalita was convicted as defined in section
306(l)(1) of the FD&C Act (21 U.S.C. 335a(l)(1)), in the U.S. District
Court for the District of Massachusetts, when the court accepted his
plea of guilty and entered
[[Page 40370]]
judgment against him for the offenses of one felony count of Conspiracy
to Import Schedule II and Schedule IV Controlled Substances in
violation of 21 U.S.C. 963 and one felony count of Money Laundering
Conspiracy in violation of 18 U.S.C. 1956(h). The underlying facts
supporting the conviction are as follows: As contained in the
Information and Plea Agreement from his case, Mr. Kalita along with
others devised a drug scheme where he and his co-conspirators would
process drug transactions for India based pharmacies who marketed their
illegal drugs through the internet. By at least March of 2020, Mr.
Kalita expanded his drug scheme to include actual shipment of drugs
from India to customers in the United States. The drugs he processed
through the scheme included erectile dysfunction drugs, Schedule II
controlled substances such as Adderall and hydrocodone, and Schedule IV
controlled substances such as zolpidem, phentermine, diazepam,
alprazolam, Tramadol, and carisoprodol.
Mr. Kalita concealed the nature of the drug sales by using merchant
payment accounts for travel entities and he created fake travel records
to convince the merchant account providers. Specifically, Mr. Kalita
and/or his conspirators, would create fake travel itineraries for his
customers who purchased his unapproved illegally imported drugs. These
actions were done to cover up Mr. Kalita's and his co-conspirators
illegal sales of imported misbranded drugs and controlled substances.
FDA sent Mr. Kalita, by certified mail, on May 16, 2025, 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. Kalita's
felony conviction under Federal law for conspiracy to import Schedule
II and Schedule IV controlled substances in violation of 21 U.S.C. 963
and one felony count of money laundering conspiracy in violation of 18
U.S.C. 1956(h), was for conduct relating to the importation of any drug
or controlled substance into the United States because Mr. Kalita
illegally imported and introduced misbranded prescription drug products
and controlled substances into interstate commerce and laundered the
revenues for such importation and introduction for himself and others.
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. Kalita's offenses and concluded that the offenses
warranted the imposition of a 10-year period of debarment.
The proposal informed Mr. Kalita 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. Kalita received the proposal and notice of opportunity for
a hearing on May 27, 2025. Mr. Kalita 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, Office of Inspections
and Investigations, under section 306(b)(3)(C) of the FD&C Act, under
authority delegated to the Director, Division of Enforcement, finds
that Mr. Doyal Kalita has been convicted of two 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. Kalita 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. Kalita is a prohibited act.
Dated: August 14, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-15787 Filed 8-18-25; 8:45 am]
BILLING CODE 4164-01-P