Notice2023-19672
Mayya Tatsene: Final Debarment Order
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 12, 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) 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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 175 (Tuesday, September 12, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Notices]
[Pages 62575-62577]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19672]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
<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 comments,
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
[[Page 62576]]
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-0579. 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. 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, at 240-402-8743,
or <a href="/cdn-cgi/l/email-protection#7a1e1f181b08171f140e093a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="4226272023302f272c3631022426236c2a2a316c252d34">[email protected]</span></a>.
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
[[Page 62577]]
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on September 12, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.