Notice2023-17481
Ildiko M. Knoll: Final Debarment Order
Primary source
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Published
August 15, 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 (FD&C Act) debarring Ildiko M. Knoll 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 Ms. Knoll engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Ms. Knoll was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of May 29, 2023 (30 days after receipt of the notice), Ms. Knoll had not responded. Ms. Knoll's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Full Text
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<title>Federal Register, Volume 88 Issue 156 (Tuesday, August 15, 2023)</title>
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[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55461-55463]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17481]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0250]
Ildiko M. Knoll: 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
Ildiko M. Knoll 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 Ms. Knoll engaged in a pattern of importing or offering
for import misbranded drugs (i.e., in an amount, frequency, or dosage
that is inconsistent with personal or household use) that are not
designated in an authorized electronic data interchange system as
products regulated by FDA. Ms. Knoll was given notice of the proposed
debarment and was given an opportunity to request a hearing to show why
she should not be debarred. As of May 29, 2023 (30 days after receipt
of the notice), Ms. Knoll had not responded. Ms. Knoll's failure to
respond and request a hearing constitutes a waiver of her right to a
hearing concerning this matter.
DATES: This order is applicable August 15, 2023.
ADDRESSES: Any application by Ms. Knoll for termination of debarment
[[Page 55462]]
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-0250. 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.
<bullet> 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. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' 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, 240-402-
7500. 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, 240-402-8743, or
<a href="/cdn-cgi/l/email-protection#82e6e7e0e3f0efe7ecf6f1c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="d6b2b3b4b7a4bbb3b8a2a596b0b2b7f8bebea5f8b1b9a0">[email protected]</span></a>.
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)(D) of the
FD&C Act, that the individual has engaged in a pattern of importing or
offering for import (i.e., in an amount, frequency, or dosage that is
inconsistent with personal or household use) misbranded drugs that are
not designated in an authorized electronic data interchange system as
products regulated by FDA.
After an investigation, FDA discovered that Ms. Knoll had engaged
in numerous instances of importing or offering for import misbranded
drugs. Specifically, between November 24, 2021, and November 29, 2022,
Ms. Knoll imported or offered for import 100 parcels containing a total
of 100 products (18,435 pieces, 9,495 tablets) that contained tadalafil
and sildenafil. FDA determined that these products were misbranded
drugs because their labeling lacked adequate directions for use, as
required by section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)),
and/or they were prescription drugs and their labels failed to bear the
symbol ``Rx only,'' as required by section 503(b)(4)(A) of the FD&C Act
(21 U.S.C. 353(b)(4)(A)). All the parcels containing the misbranded
drugs serving as the basis for this action were intercepted by FDA at
the John F. Kennedy International Mail Facility and were addressed to
Ms. Knoll at an address connected to her.
As a result of this pattern of importing or offering for import
(i.e. in an amount, frequency, or dosage that is inconsistent with
personal or household use) misbranded drugs that are not designated in
an authorized electronic data interchange system as products regulated
by FDA, in accordance with section 306(b)(3)(D) of the FD&C Act, FDA
sent Ms. Knoll, by United Parcel Service on April 27, 2023, a notice
proposing to debar her for a 5-year period from importing or offering
for import any drug into the United States. The attachment to that
notice contained a table listing all the parcels intercepted by FDA
that contained the misbranded drugs serving as a basis for this action.
Among other pieces of information, that table contained the submission
date of the entry, the product contained in the package, the quantity
of the product, and the product violation FDA found for each entry.
That attachment is posted to the docket and can be accessed by the
public at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 Ms. Knoll's pattern of
conduct and concluded that her conduct warranted the imposition of a 5-
year period of debarment. The proposal informed Ms. Knoll of the
proposed debarment and offered her an opportunity to request a hearing,
providing 30 days from the date of receipt of the letter in which to
file the request, and advised her that failure to request a hearing
constituted a waiver of the opportunity for a hearing and of any
contentions concerning this action. Ms. Knoll received the proposal and
notice of opportunity for a hearing on April 29, 2023. Ms. Knoll failed
to request a hearing within the timeframe prescribed by regulation and
has, therefore, waived her opportunity for a hearing and waived any
contentions concerning her debarment (21 CFR part 12).
[[Page 55463]]
II. Findings and Order
Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(3)(D) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Ms. Knoll
has engaged in a pattern of importing or offering for import (i.e. in
an amount, frequency, or dosage that is inconsistent with personal or
household use) misbranded drugs that are not designated in an
authorized electronic data interchange system as products regulated by
FDA. FDA finds that this pattern of conduct 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, Ms. Knoll 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 Ms. Knoll is a prohibited act.
Dated: August 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17481 Filed 8-14-23; 8:45 am]
BILLING CODE 4164-01-P
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