2023-19672. 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

• 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 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 [e-mail].

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 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.