John Seil Lee: Final Debarment Order, 44907-44908 [2020-16062]
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44907
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section; activity
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response 2
Total hours
Total ......................................
........................
........................
........................
........................
....................................
4,883
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The calculation for 20 minutes uses 0.333 hour.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
base our estimate of the number of
respondents in table 1 on registrations,
process filings, and reports received.
The hours per response reporting
estimates are based on our experience
with similar programs and information
received from industry. The reporting
burden for §§ 108.25(d) and 108.35(d)
and (e) is minimal because notification
of spoilage, process deviation, or
contamination of product in distribution
occurs less than once a year. Most firms
discover these problems before the
product is distributed and, therefore, are
not required to report the occurrence.
We estimate that we will receive one
report annually under §§ 108.25(d) and
108.35(d) and (e). The report is expected
to take 4 hours per response, for a total
of 4 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
108, 113, and 114 ................................................................
10,392
1
10,392
250
2,598,000
jbell on DSKJLSW7X2PROD with NOTICES
1 here
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of 10,392
recordkeepers in table 2 on the number
of registered firms, excluding firms that
were inactive or out of business, yet still
registered. We estimate that 10,392
firms will each expend approximately
250 hours per year to fully satisfy the
recordkeeping requirements in parts
108, 113 and 114, for a total of 2,598,000
hours.
Finally, our regulations require that
processors mark thermally processed
low-acid foods in hermetically sealed
containers (§ 113.60(c)) and acidified
foods (§ 114.80(b)) with an identifying
code to permit lots to be traced after
distribution. No burden has been
estimated for the third-party disclosure
requirements in §§ 113.60(c) and
114.80(b) because the coding process is
done as a usual and customary part of
normal business activities. Coding is a
business practice in foods for liability
purposes, inventory control, and
process control in the event of a
problem. Under 5 CFR 1320.3(b)(2), the
time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities.
Dated: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16037 Filed 7–23–20; 8:45 am]
BILLING CODE 4164–01–P
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20:45 Jul 23, 2020
Jkt 250001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5969]
John Seil Lee: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring John
Seil Lee for a period of 10 years from
importing or offering for import any
drug into the United States. FDA bases
this order on a finding that Mr. Lee was
convicted of one felony count under
Federal law for conspiracy to import
merchandise contrary to law and to
defraud the United States and of one
felony count under Federal law for
importing merchandise contrary to law.
The factual basis supporting both of Mr.
Lee’s convictions, as described below, is
conduct relating to the importation into
the United States of a drug or controlled
substance. Mr. Lee 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 March 15, 2020 (30 days after
receipt of the notice), Mr. Lee had not
responded. Mr. Lee’s failure to respond
and request a hearing constitutes a
waiver of his right to a hearing
concerning this matter.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
DATES:
This order is applicable July 24,
2020.
Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa (ELEM–4029), Division
of Enforcement, 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 debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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 August 20, 2019, Mr. Lee was
convicted, as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S.
District Court for the Central District of
California, when the court accepted his
plea of guilty and entered judgment
against him for the felony offenses of
conspiracy to commit offense or to
defraud the United States in violation of
18 U.S.C. 371 and smuggling goods into
E:\FR\FM\24JYN1.SGM
24JYN1
jbell on DSKJLSW7X2PROD with NOTICES
44908
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
the United States; principals in
violation of 18 U.S.C. 545 and 2(b).
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein. The
factual basis for these convictions is as
follows: As contained in count 1 of the
information in Mr. Lee’s case, filed on
January 7, 2019, to which Mr. Lee
pleaded guilty, between 2011 and 2017
Mr. Lee owned, controlled, and
operated four businesses for the purpose
of manufacturing and distributing male
sexual enhancement pills that he
marketed as herbal remedies but that
contained undisclosed tadalafil, a
prescription drug product. Until
February 22, 2017, Mr. Lee conspired
with others to import bulk tadalafil,
with labeling that was false and
misleading, from suppliers in China
contrary to law. Mr. Lee had his Chinese
suppliers ship the bulk tadalafil under
false labeling to commercial mailboxes
that he controlled in New Jersey and
Pennsylvania. Mr. Lee then had the
commercial mailbox companies that
received the Chinese shipment
repackage the tadalafil shipments and
forward them to mailboxes Mr. Lee
controlled in California. After receiving
the bulk tadalafil in California, Mr. Lee
caused it to be manufactured into at
least 5 and a half million pills that he
sold to distributors across the United
States. The pills Mr. Lee manufactured
contained levels of tadalafil
significantly higher than the levels in
FDA-approved prescription drugs such
as Cialis. Mr. Lee sold at least $11
million worth of these pills to
distributors in packages with labeling
that did not disclose the presence of
tadalafil. When, as on a number of
occasions, FDA announced that a brand
of pills sold by one of Mr. Lee
companies contained undeclared
tadalafil, he would establish a new
company and/or begin manufacturing
identical pills with different brand
names in an effort to evade FDA
regulators.
As contained in count 2 of the
information in Mr. Lee’s case, to which
Mr. Lee pleaded guilty, on or about
February 9, 2017, Mr. Lee fraudulently
and knowingly, and contrary to law,
imported two parcels of the bulk drug
tadalafil with labeling that was false and
misleading as to the parcels’ contents,
labels that did not contain accurate
statements of the quantity of the
contents in terms of weight, measure,
and numerical count, and labeling that
did not bear adequate directions for use,
contrary to sections 301(a) and
502(a)(1), (b), and (f) of the FD&C Act
(21 U.S.C. 331(a), 352(a)(1), (b), and (f)).
VerDate Sep<11>2014
20:45 Jul 23, 2020
Jkt 250001
As a result of these convictions, FDA
sent Mr. Lee, by certified mail on
February 10, 2020, a notice proposing to
debar him for a 10-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. Lee’s felony conviction for one
felony count under Federal law for
conspiracy to import merchandise
contrary to law and to defraud the
United States was for conduct relating
to the importation into the United States
of any drug or controlled substance
because he conspired to illegally import
bulk tadalafil and repackage it into pills
that he resold across the United States.
The proposal was also based on a
finding under section 306(b)(3)(C) of the
FD&C Act that Mr. Lee’s felony
conviction for one felony count under
Federal law for importing merchandise
contrary to law was for conduct relating
to the importation into the United States
of any drug or controlled substance
because he also fraudulently and
knowingly imported two parcels of bulk
drug tadalafil into the United States
contrary to sections 301(a) and
502(a)(1), (b), and (f) of the FD&C Act.
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.
Lee’s offenses, and concluded that these
felony offenses warrant the imposition
of a 10-year period of debarment.
The proposal informed Mr. Lee of the
proposed debarment and offered Mr.
Lee 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.
Lee received the proposal and notice of
opportunity for a hearing on February
14, 2020. Mr. Lee 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. John Seil
Lee has been convicted of two felony
counts under Federal law for conduct
relating to the importation into the
United States of any drug or controlled
substance. FDA finds that each offense
should be accorded a debarment period
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
of 5 years as provided by section
306(c)(2)(A)(iii) of the FD&C Act. Under
section 306(c)(2)(A) of the FD&C Act, in
the case of a person debarred for
multiple offenses, FDA may determine
whether the periods of debarment shall
run concurrently or consecutively. FDA
has concluded that the 5-year period of
debarment for each of the two offenses
for which Mr. Lee was convicted will
run consecutively, resulting in a total
debarment period of 10 years.
As a result of the foregoing finding,
Mr. Lee is debarred for a period of 10
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, 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. Lee is a
prohibited act.
Any application by Mr. Lee for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2019–
N–5969 and sent to the Dockets
Management Staff (see ADDRESSSES).
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.
Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16062 Filed 7–23–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3277]
Revocation of Authorization of
Emergency Use of an In Vitro
Diagnostic Device for Detection and/or
Diagnosis of Zika Virus
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorization (EUA) (the Authorization)
issued to Chembio Diagnostic Systems,
Inc. (‘‘Chembio’’) for the DPP Zika IgM
Assay System. FDA revoked this
Authorization on June 3, 2020, under
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44907-44908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16062]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5969]
John Seil Lee: 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) debarring
John Seil Lee for a period of 10 years from importing or offering for
import any drug into the United States. FDA bases this order on a
finding that Mr. Lee was convicted of one felony count under Federal
law for conspiracy to import merchandise contrary to law and to defraud
the United States and of one felony count under Federal law for
importing merchandise contrary to law. The factual basis supporting
both of Mr. Lee's convictions, as described below, is conduct relating
to the importation into the United States of a drug or controlled
substance. Mr. Lee 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 March 15, 2020 (30 days after receipt of the notice),
Mr. Lee had not responded. Mr. Lee'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 July 24, 2020.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029), Division
of Enforcement, 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
[email protected].
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 August 20, 2019, Mr. Lee was convicted, as defined in section
306(l)(1)(A) of the FD&C Act, in the U.S. District Court for the
Central District of California, when the court accepted his plea of
guilty and entered judgment against him for the felony offenses of
conspiracy to commit offense or to defraud the United States in
violation of 18 U.S.C. 371 and smuggling goods into
[[Page 44908]]
the United States; principals in violation of 18 U.S.C. 545 and 2(b).
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein. The factual basis for these convictions
is as follows: As contained in count 1 of the information in Mr. Lee's
case, filed on January 7, 2019, to which Mr. Lee pleaded guilty,
between 2011 and 2017 Mr. Lee owned, controlled, and operated four
businesses for the purpose of manufacturing and distributing male
sexual enhancement pills that he marketed as herbal remedies but that
contained undisclosed tadalafil, a prescription drug product. Until
February 22, 2017, Mr. Lee conspired with others to import bulk
tadalafil, with labeling that was false and misleading, from suppliers
in China contrary to law. Mr. Lee had his Chinese suppliers ship the
bulk tadalafil under false labeling to commercial mailboxes that he
controlled in New Jersey and Pennsylvania. Mr. Lee then had the
commercial mailbox companies that received the Chinese shipment
repackage the tadalafil shipments and forward them to mailboxes Mr. Lee
controlled in California. After receiving the bulk tadalafil in
California, Mr. Lee caused it to be manufactured into at least 5 and a
half million pills that he sold to distributors across the United
States. The pills Mr. Lee manufactured contained levels of tadalafil
significantly higher than the levels in FDA-approved prescription drugs
such as Cialis. Mr. Lee sold at least $11 million worth of these pills
to distributors in packages with labeling that did not disclose the
presence of tadalafil. When, as on a number of occasions, FDA announced
that a brand of pills sold by one of Mr. Lee companies contained
undeclared tadalafil, he would establish a new company and/or begin
manufacturing identical pills with different brand names in an effort
to evade FDA regulators.
As contained in count 2 of the information in Mr. Lee's case, to
which Mr. Lee pleaded guilty, on or about February 9, 2017, Mr. Lee
fraudulently and knowingly, and contrary to law, imported two parcels
of the bulk drug tadalafil with labeling that was false and misleading
as to the parcels' contents, labels that did not contain accurate
statements of the quantity of the contents in terms of weight, measure,
and numerical count, and labeling that did not bear adequate directions
for use, contrary to sections 301(a) and 502(a)(1), (b), and (f) of the
FD&C Act (21 U.S.C. 331(a), 352(a)(1), (b), and (f)).
As a result of these convictions, FDA sent Mr. Lee, by certified
mail on February 10, 2020, a notice proposing to debar him for a 10-
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. Lee's felony conviction for one
felony count under Federal law for conspiracy to import merchandise
contrary to law and to defraud the United States was for conduct
relating to the importation into the United States of any drug or
controlled substance because he conspired to illegally import bulk
tadalafil and repackage it into pills that he resold across the United
States. The proposal was also based on a finding under section
306(b)(3)(C) of the FD&C Act that Mr. Lee's felony conviction for one
felony count under Federal law for importing merchandise contrary to
law was for conduct relating to the importation into the United States
of any drug or controlled substance because he also fraudulently and
knowingly imported two parcels of bulk drug tadalafil into the United
States contrary to sections 301(a) and 502(a)(1), (b), and (f) of the
FD&C Act.
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. Lee's offenses, and concluded that these felony
offenses warrant the imposition of a 10-year period of debarment.
The proposal informed Mr. Lee of the proposed debarment and offered
Mr. Lee 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. Lee received the proposal and notice of opportunity for a
hearing on February 14, 2020. Mr. Lee 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. John
Seil Lee has been convicted of two felony counts under Federal law for
conduct relating to the importation into the United States of any drug
or controlled substance. FDA finds that each offense should be accorded
a debarment period of 5 years as provided by section 306(c)(2)(A)(iii)
of the FD&C Act. Under section 306(c)(2)(A) of the FD&C Act, in the
case of a person debarred for multiple offenses, FDA may determine
whether the periods of debarment shall run concurrently or
consecutively. FDA has concluded that the 5-year period of debarment
for each of the two offenses for which Mr. Lee was convicted will run
consecutively, resulting in a total debarment period of 10 years.
As a result of the foregoing finding, Mr. Lee is debarred for a
period of 10 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, 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. Lee is a prohibited act.
Any application by Mr. Lee for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-5969 and sent to the Dockets Management Staff (see
ADDRESSSES). 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.
Dated: July 17, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16062 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P
