[Federal Register Volume 88, Number 156 (Tuesday, August 15, 2023)]
[Notices]
[Pages 55461-55463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

     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-0250. 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. 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: 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 Compliance 
and Enforcement, Office of Policy, Compliance, and Enforcement, Office 
of Regulatory Affairs, Food and Drug Administration, 240-402-8743, or 
[email protected].

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 https://www.regulations.gov. 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