[Federal Register Volume 87, Number 2 (Tuesday, January 4, 2022)]
[Notices]
[Pages 225-226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0506]


William Kulakevich: 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 
William Kulakevich 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 Mr. Kulakevich was convicted of one felony count under 
Federal law for conspiracy to commit offenses against the United 
States. The factual basis supporting Mr. Kulakevich's conviction, as 
described below, is conduct relating to the importation into the United 
States of a drug or controlled substance. Mr. Kulakevich was given 
notice of the proposed debarment and was given an opportunity to 
request a hearing to show why he should not be debarred. As of 
September 16, 2021 (30 days after receipt of the notice), Mr. 
Kulakevich had not responded. Mr. Kulakevich's failure to respond and 
request a hearing constitutes a waiver of his right to a hearing 
concerning this matter.

DATES: This order is applicable January 4, 2022.

ADDRESSES: Submit applications for termination of debarment to the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement (ELEM-4029), Office of Strategic Planning and Operational 
Policy, Office of Regulatory Affairs, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at 
<a href="/cdn-cgi/l/email-protection#ee8a8b8c8f9c838b809a9dae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="096d6c6b687b646c677d7a496f6d682761617a276e667f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) 
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)(C) of the FD&C Act, that the individual has been 
convicted of a felony for conduct relating to the importation into the 
United States of any drug or controlled substance. On July 23, 2019, 
Mr. Kulakevich was convicted, as defined in section 306(l)(1) of FD&C 
Act, in the U.S. District Court for the Western District of 
Pennsylvania, when the court entered judgment against him for the 
offense of conspiracy to commit offenses against the United States, in 
violation of 18 U.S.C. 2 and 371.
    FDA's finding that debarment is appropriate is based on the felony 
conviction referenced herein. The factual basis for this conviction is 
as follows: As contained in the indictment in Mr. Kulakevich's case, 
filed August 22, 2017, to which he plead guilty, from on or about April 
2015, and continuing until May 2017, Mr. Kulakevich was the owner and a 
co-operator of a website, www.etizy.com, through which he sold and 
distributed a drug known as etizolam to consumers throughout the United 
States. Etizolam is a drug known as thienodiazepine, which is 
chemically similar to benzodiazepines and carries risks of dependency, 
toxicity, and the possibility of fatal overdose. Etizolam is not FDA-
approved in the United States. Mr. Kulakevich and his co-conspirator 
illegally bought etizolam from an overseas supplier in India, after 
which he arranged to have it smuggled into the United States through 
the use of multiple post office boxes controlled by him and his 
coconspirator. To avoid Federal regulators, Mr. Kulakevich used

[[Page 226]]

false and misleading labeling and generally misrepresented the nature 
of the products sold on his website. Mr. Kulakevich reshipped the 
misbranded etizolam to customers located in the United States.
    As a result of this conviction, FDA sent Mr. Kulakevich, by 
certified mail, on August 3, 2021, a notice proposing to debar him for 
a 5-year period from importing or offering for import any drug into the 
United States. The proposal was based on a finding under section 
306(b)(3)(C) of the FD&C Act that Mr. Kulakevich's felony conviction 
under Federal law for conspiracy to commit offenses against the United 
States, in violation of 18 U.S.C. 2 and 371, was for conduct relating 
to the importation into the United States of any drug or controlled 
substance because he illegally imported, relabeled, and then introduced 
unapproved etizolam products into interstate commerce. 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 Mr. 
Kulakevich's offense and concluded that the offense warranted the 
imposition of a 5-year period of debarment.
    The proposal informed Mr. Kulakevich of the proposed debarment and 
offered him an opportunity to request a hearing, providing him 30 days 
from the date of receipt of the letter in which to file the request, 
and advised him that failure to request a hearing constituted a waiver 
of the opportunity for a hearing and of any contentions concerning this 
action. Mr. Kulakevich received the proposal and notice of opportunity 
for a hearing on August 17, 2021. Mr. Kulakevich failed to request a 
hearing within the timeframe prescribed by regulation and has, 
therefore, waived his opportunity for a hearing and waived any 
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal 
Food Operations, under section 306(b)(3)(C) of the FD&C Act, under 
authority delegated to the Assistant Commissioner, finds that Mr. 
William Kulakevich has been convicted of a felony under Federal law for 
conduct relating to the importation into the United States of any drug 
or controlled substance. FDA finds that the offense 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, Mr. Kulakevich 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 or controlled substance 
by, with the assistance of, or at the direction of Mr. Kulakevich is a 
prohibited act.
    Any application by Mr. Kulakevich for termination of debarment 
under section 306(d)(1) of the FD&C Act should be identified with 
Docket No. FDA-2021-N-0506 and sent to the Dockets Management Staff 
(see ADDRESSES). The public availability of information in these 
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket and 
will be viewable at https://www.regulations.gov or at the Dockets 
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: December 28, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28479 Filed 1-3-22; 8:45 am]
BILLING CODE 4164-01-P


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