[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Notices]
[Pages 62575-62577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19672]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0579]


Mayya Tatsene: 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) permanently 
debarring Mayya Tatsene from providing services in any capacity to a 
person that has an approved or pending drug product application. FDA 
bases this order on a finding that Ms. Tatsene was convicted of a 
felony under Federal law for conduct that relates to the regulation of 
any drug product under the FD&C Act. Ms. Tatsene was given notice of 
the proposed permanent debarment and was given an opportunity to 
request a hearing to show why she should not be debarred. As of July 8, 
2023 (more than 30 days after receipt of the notice, as prescribed by 
regulation), Ms. Tatsene has not responded to the notice. Ms. Tatsene's 
failure to respond and request a hearing within the prescribed 
timeframe constitutes a waiver of her right to a hearing concerning 
this action.

DATES: This order is applicable September 12, 2023.

ADDRESSES: Any application by Ms. Tatsene for special termination of 
debarment under section 306(d)(4) of the FD&C Act (21 U.S.C. 
335a(d)(4)) 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 comments, 
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential

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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-0579. 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 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(a)(2)(B) of the FD&C Act requires debarment of an 
individual from providing services in any capacity to a person that has 
an approved or pending drug product application if FDA finds that the 
individual has been convicted of a felony under Federal law for conduct 
relating to the regulation of any drug product under the FD&C Act.
    On January 10, 2023, Mayya Tatsene was convicted in the U. S. 
District Court for the Southern District of New York when the court 
entered judgment of conviction against her, after her plea of guilty, 
to one count of Conspiracy to Commit Wire Fraud in violation of 18 
U.S.C. 1349 and one count of Wire Fraud in violation of 18 U.S.C. 1343.
    The underlying facts supporting the conviction are contained in the 
Information, entered into the docket on May 29, 2019, and from the 
transcript of Ms. Tatsene's guilty plea hearing which occurred on May 
29, 2019. Ms. Tatsene was an employee of AMA Laboratories (AMA), a 
consumer product testing company in Rockland County, New York. At AMA, 
Ms. Tatsene was employed as the clinical laboratory director and, 
between 2005 and 2017, was in charge of the Repeat Insult Patch Test 
laboratory at AMA. AMA purported to test the safety and efficacy of 
cosmetics, sunscreens, and other products on specified numbers of 
volunteer panelists in exchange for fees paid by consumer products 
companies. The customers who engaged AMA to run these tests on their 
products used the results to determine whether those products were safe 
and effective. From at least in or about 2005, through in or about 
April 2017, Ms. Tatsene and AMA personnel defrauded AMA's customers in 
excess of $25 million by testing products on materially lower numbers 
of panelists than the numbers specified and paid for by AMA's 
customers. Ms. Tatsene and other AMA employees made materially false 
and misleading statements about the results of the tests to AMA's 
customers. Specifically, Ms. Tatsene and other AMA employees falsely 
represented to AMA's customers that AMA had tested the products on the 
number of panelists specified by the laboratory's customers. Ms. 
Tatsene and other AMA employees sent its customers laboratory results 
containing false information via interstate email and facsimile 
communications.
    Based on this conviction, FDA sent Ms. Tatsene by certified mail on 
May 25, 2023, a notice proposing to permanently debar her from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding, 
under section 306(a)(2)(B) of the FD&C Act, that Ms. Tatsene was 
convicted, as set forth in section 306(l)(1) of the FD&C Act, of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the FD&C Act. The proposal also offered Ms. Tatsene 
an opportunity to request a hearing, providing her 30 days from the 
date of receipt of the letter in which to file the request, and advised 
her that failure to file a timely request for a hearing would 
constitute an election not to use the opportunity for a hearing and a 
waiver of any contentions concerning this action. Ms. Tatsene received 
the proposal on June 8, 2023. She did not request a hearing within the 
timeframe prescribed by regulation and has, therefore, waived her 
opportunity for a hearing and any contentions concerning her debarment 
(21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Ms. 
Tatsene has been convicted of a felony under Federal law for conduct 
relating to the regulation of a drug product under the FD&C Act.
    As a result of the foregoing finding, Ms. Tatsene is permanently 
debarred from providing services in any capacity to a person with an 
approved or pending drug product application, effective (see DATES) 
(see section 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act. Any person 
with an approved or pending drug product application who knowingly 
employs or retains as a consultant or contractor, or otherwise uses in 
any capacity the services of Ms. Tatsene during her debarment, will be 
subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 
U.S.C. 335b(a)(6))). If Ms. Tatsene provides services in any capacity 
to a person with an approved or pending drug product application during 
her period of debarment, she will be subject to civil money penalties 
(section 307(a)(7) of the FD&C Act). In addition, FDA will not

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accept or review any abbreviated new drug application from Ms. Tatsene 
during her period of debarment, other than in connection with an audit 
under section 306 of the FD&C Act. Note that, for purposes of sections 
306 and 307 of the FD&C Act, a ``drug product'' is defined as a ``drug 
subject to regulation under section 505, 512, or 802 of this Act [(21 
U.S.C. 355, 360b, 382)] or under section 351 of the Public Health 
Service Act [(42 U.S.C. 262)]'' (section 201(dd) of the FD&C Act (21 
U.S.C. 321(dd))).

    Dated: September 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19672 Filed 9-11-23; 8:45 am]
BILLING CODE 4164-01-P