Euton M. Laing: Final Debarment Order, 44898-44899 [2020-16046]
Download as PDF
<![CDATA[
44898
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
ANNUAL BURDEN ESTIMATES
Average
burden
minutes per
response
Annual total
burden hours
Placement Authorization (Form P–1) ..............................................................
Authorization for Medical, Dental, and Mental Health Care (Form P–2) ........
Notice of Placement in a Restrictive Setting (Form P–4/4s) ...........................
Long Term Foster Care Placement Memo (Form P–5) ..................................
Intakes Placement Checklist (Form P–7) ........................................................
Care Provider Checklist for Transfers to an Influx Care Facility (Form P–8)
Medical Checklist for Transfers (Form P–9A) .................................................
Medical Checklist for Influx Transfers (Form P–9B) .......................................
Transfer Request (Form P–10) .......................................................................
Transfer Request and Tracking Form (Form P–11) ........................................
UAC Portal Capacity Report (Form P–12) ......................................................
Add New UAC (Form P–13) ............................................................................
Notice of Transfer to ICE Chief Counsel—Change of Address/Change of
Venue (Form P–14) .....................................................................................
206
206
15
30
16
206
206
206
206
206
206
50
377
377
68
4
4,343
11
29
11
39
39
365
1,390
1
1
20
15
15
15
5
10
45
10
5
15
1,294
1,294
340
30
17,372
567
498
378
6,026
1,339
6,266
17,375
206
39
10
1,339
Estimated Annual Burden Total ...............................................................
........................
........................
........................
54,117
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Authority: 6 U.S.C. 279; 8 U.S.C. 1232;
Flores v. Reno Settlement Agreement, No.
CV85–4544–RJK (C.D. Cal. 1996).
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–16043 Filed 7–23–20; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5439]
Euton M. Laing: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSKJLSW7X2PROD with NOTICES
Annual total
number of
responses per
respondent
Annual total
number of
respondents
Instrument
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Euton M.
Laing from providing services in any
capacity to a person that has an
SUMMARY:
VerDate Sep<11>2014
20:45 Jul 23, 2020
Jkt 250001
approved or pending drug product
application. FDA bases this order on a
finding that Dr. Laing was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Dr. Laing
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing to show
why he should not be debarred. As of
March 11, 2020 (30 days after receipt of
the notice), Dr. Laing had not
responded. Dr. Laing’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable July 24,
2020.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, debarments@fda.hhs.gov, or at
240–402–8743.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) 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
August 22, 2019, Dr. Laing was
convicted as defined in section 306(l)(1)
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the Western District of
Kentucky, after his plea of guilty, to one
count of conspiracy to distribute, with
intent to defraud and mislead,
misbranded drugs dispensed by Meds 2
Go, Inc in violation of sections 301(a)
and 503(b)(1) of the FD&C Act (21
U.S.C. 331(a) and 353(b)(1)) and 18
U.S.C. 2 and 371, and a second count of
conspiracy to distribute, with intent to
defraud and mislead, misbranded drugs
dispensed by Aracoma Drug Co. in
violation of sections 301(a) and
503(b)(1) of the FD&C Act and 18 U.S.C.
2 and 371.
The factual basis for this conviction is
as follows: As contained in the Plea
Agreement filed in his case on July 17,
2018, from 2010 through at least 2011,
Dr. Laing conspired with others to
provide prescription drugs to Rx
Limited internet customers that were
misbranded within the meaning of the
FD&C Act, because the drugs were
prescribed without a valid prescription
in violation of sections 301(a) and
503(b)(1) of the FD&C Act. The
prescriptions were not valid because
they were issued outside of the scope of
professional practice. Specifically, the
prescriptions were issued based on
limited medical questionnaires and
without face-to-face encounters. The
misbranded prescription drugs were
then dispensed by Aracoma Drug Co.
and Meds 2 Go, Inc. The misbranded
prescription drugs were sent to
customers in various locations.
As a result of this conviction, FDA
sent Dr. Laing by certified mail on
February 5, 2020, a notice proposing to
permanently debar him from providing
services in any capacity to a person that
E:\FR\FM\24JYN1.SGM
24JYN1
Federal Register / Vol. 85, No. 143 / Friday, July 24, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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 Dr.
Laing was convicted of felonies under
Federal law for conduct relating to the
regulation of a drug product under the
FD&C Act. The proposal also offered Dr.
Laing 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
an election not to use the opportunity
for a hearing and a waiver of any
contentions concerning this action. Dr.
Laing received the proposal on February
10, 2020. Dr. Laing did not request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Euton M.
Laing has been convicted of a felony
under Federal law for conduct
otherwise relating to the regulation of a
drug product under the FD&C Act.
As a result of the foregoing finding,
Euton M. Laing, is permanently
debarred from providing services in any
capacity to a person with an approved
or pending drug product application,
effective (see DATES) (see sections
306(a)(2)(B) and 306(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 the services of Euton M.
Laing, in any capacity during his
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 Dr.
Laing provides services in any capacity
to a person with an approved or
pending drug product application
during his period of debarment, he 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 applications
from Dr. Laing during his period of
debarment, other than in connection
with an audit under section 306 of the
FD&C Act. Note that, for purposes of
section 306 of the FD&C Act, a ‘‘drug
product’’ is defined as a drug subject to
regulation under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355,
360b, 382) or under section 351 of the
Public Health Service Act (42 U.S.C.
VerDate Sep<11>2014
20:45 Jul 23, 2020
Jkt 250001
262) (section 201(dd) of the FD&C Act
(21 U.S.C. 321(dd))).
Any application by Dr. Laing for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2019–N–5439 and sent to the
Dockets Management Staff (see
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions may
be seen in 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. 2020–16046 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–5923]
Paul J. Elmer: Final Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Paul
J. Elmer 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 Mr. Elmer was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Mr. Elmer
was given notice of the proposed
permanent debarment and was given an
opportunity to request a hearing to show
why he should not be debarred. As of
March 11, 2020 (30 days after receipt of
the notice), Mr. Elmer had not
responded. Mr. Elmer’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable July 24,
2020.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa (ELEM–4029) Division
of Enforcement, Office of Strategic
SUMMARY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
44899
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, or at 240–402–8743.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) 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
September 23, 2019, Mr. Elmer was
convicted as defined in section 306(l)(1)
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the Southern District of
Indiana to one count of conspiracy in
violation of 18 U.S.C. 371, three counts
of introduction of adulterated drugs into
interstate commerce in violation of 21
U.S.C. 331(a), 333(a)(1), and 351, and
six counts of adulterating drugs while
holding for sale after shipment in
interstate commerce in violation of 21
U.S.C. 331(k), 333(a)(1), and 351.
The factual basis for this conviction is
as follows: as contained in in counts 1
and 3–11 of the indictment, filed on
February 7, 2019, Mr. Elmer was the
president and owner of Pharmakon
Pharmaceuticals, Inc. (Pharmakon).
Pharmakon compounded sterile drugs
for public, private, and military
hospitals and medical centers located
throughout the United States. In that
capacity Mr. Elmer conspired to defraud
the United States by interfering with
and obstructing, through deceitful and
dishonest means, the lawful functions of
FDA and to commit an offense against
the United States by corruptly
influencing, obstructing, and impeding,
and endeavoring to influence, obstruct,
and impede, the due and proper
administration of the law under which
a pending proceeding was being had
before an agency of the United States,
specifically FDA inspections of
Pharmakon. Among other things, Mr.
Elmer and his co-conspirators provided
or directed others to provide false
statements, during three inspections and
in related correspondence, to FDA
regarding the practices at Pharmakon. In
addition, on three separate occasions
Mr. Elmer introduced and delivered for
introduction into interstate commerce,
and caused to be introduced and
delivered for introduction into interstate
commerce, adulterated drugs which
were adulterated because the drugs were
E:\FR\FM\24JYN1.SGM
24JYN1
]]>Agencies
[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44898-44899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16046]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5439]
Euton M. Laing: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Euton M. Laing 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 Dr. Laing was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Dr. Laing was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of March
11, 2020 (30 days after receipt of the notice), Dr. Laing had not
responded. Dr. Laing's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is applicable July 24, 2020.
ADDRESSES: Submit applications for special termination of debarment to
the Dockets Management Staff (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857, [email protected], or at 240-402-8743.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
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 August 22, 2019, Dr. Laing was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the Western
District of Kentucky, after his plea of guilty, to one count of
conspiracy to distribute, with intent to defraud and mislead,
misbranded drugs dispensed by Meds 2 Go, Inc in violation of sections
301(a) and 503(b)(1) of the FD&C Act (21 U.S.C. 331(a) and 353(b)(1))
and 18 U.S.C. 2 and 371, and a second count of conspiracy to
distribute, with intent to defraud and mislead, misbranded drugs
dispensed by Aracoma Drug Co. in violation of sections 301(a) and
503(b)(1) of the FD&C Act and 18 U.S.C. 2 and 371.
The factual basis for this conviction is as follows: As contained
in the Plea Agreement filed in his case on July 17, 2018, from 2010
through at least 2011, Dr. Laing conspired with others to provide
prescription drugs to Rx Limited internet customers that were
misbranded within the meaning of the FD&C Act, because the drugs were
prescribed without a valid prescription in violation of sections 301(a)
and 503(b)(1) of the FD&C Act. The prescriptions were not valid because
they were issued outside of the scope of professional practice.
Specifically, the prescriptions were issued based on limited medical
questionnaires and without face-to-face encounters. The misbranded
prescription drugs were then dispensed by Aracoma Drug Co. and Meds 2
Go, Inc. The misbranded prescription drugs were sent to customers in
various locations.
As a result of this conviction, FDA sent Dr. Laing by certified
mail on February 5, 2020, a notice proposing to permanently debar him
from providing services in any capacity to a person that
[[Page 44899]]
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
Dr. Laing was convicted of felonies under Federal law for conduct
relating to the regulation of a drug product under the FD&C Act. The
proposal also offered Dr. Laing 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 an election not to use the opportunity for a hearing and a
waiver of any contentions concerning this action. Dr. Laing received
the proposal on February 10, 2020. Dr. Laing did not request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived his opportunity for a hearing and 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(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Euton M.
Laing has been convicted of a felony under Federal law for conduct
otherwise relating to the regulation of a drug product under the FD&C
Act.
As a result of the foregoing finding, Euton M. Laing, is
permanently debarred from providing services in any capacity to a
person with an approved or pending drug product application, effective
(see DATES) (see sections 306(a)(2)(B) and 306(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 the services of Euton M. Laing, in any capacity during
his 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 Dr. Laing
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment, he
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 applications from Dr. Laing during his period of debarment, other
than in connection with an audit under section 306 of the FD&C Act.
Note that, for purposes of section 306 of the FD&C Act, a ``drug
product'' is defined as a drug subject to regulation under section 505,
512, or 802 of the FD&C 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))).
Any application by Dr. Laing for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2019-N-5439 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
Publicly available submissions may be seen in 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. 2020-16046 Filed 7-23-20; 8:45 am]
BILLING CODE 4164-01-P
