Karis Copper Delong: Debarment Order, 11045-11046 [2017-03172]
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Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
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. The proposal
was received on October 31, 2016. Dr.
Brown did not request a hearing 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 Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(a)(2)(B) of the FD&C Act,
under authority delegated to him (Staff
Manual Guide 1410.35), finds that Dr.
Raymond Sean Brown has been
convicted of a felony under Federal law
for conduct relating to the regulation of
a drug product under the FD&C Act.
Section 306(c)(2)(A)(ii) of the FD&C Act
requires that Dr. Brown’s debarment be
permanent.
As a result of the foregoing finding,
Dr. Raymond Sean Brown is
permanently debarred from providing
services in any capacity to a person with
an approved or pending drug product
application under sections 505, 512, or
802 of the FD&C Act (21 U.S.C. 355,
360b, or 382), or under section 351 of
the Public Health Service Act (42 U.S.C.
262), effective (see DATES) (see section
201(dd), 306(c)(1)(B), and
306(c)(2)(A)(ii) of the FD&C Act (21
U.S.C. 321(dd), 335a(c)(1)(B), and
335a(c)(2)(A)(ii)). 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 Dr.
Brown, 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.
Brown 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. Brown during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Dr. Brown for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2016–N–2191 and sent to the
Division of Dockets Management (see
ADDRESSES). All such submissions are to
be filed in four copies. The public
VerDate Sep<11>2014
17:38 Feb 16, 2017
Jkt 241001
availability of information in these
submissions is governed by 21 CFR
10.20.
Publicly available submissions will be
placed in the docket, and will be
viewable at https://www.regulations.gov
or at the Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday.
Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
[FR Doc. 2017–03173 Filed 2–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1677]
Karis Copper Delong: 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) debarring Karis Copper
Delong for a period of 12 years 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. Delong
was convicted of four misdemeanor
counts under the FD&C Act for
introducing, delivering for introduction,
and causing the introduction and
delivery for introduction of a
misbranded drug into interstate
commerce, which relates to the
regulation of drug products under the
FD&C Act. In addition, FDA determined
that the type of conduct that served as
the basis for the conviction undermines
the process for the regulation of drugs.
Ms. Delong was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. Ms.
Delong failed to request a hearing. Ms.
Delong’s failure to request a hearing
constitutes a waiver of her right to a
hearing concerning this action.
DATES: This order is effective February
17, 2017.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
11045
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Division of Enforcement,
Office of Regulatory Affairs (ELEM–
4144), Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits debarment of an individual if
FDA finds that the individual has been
convicted of a misdemeanor under
federal law for conduct relating to the
regulation of drug products under the
FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On June 9, 2015, in the U.S. District
Court for the Eastern District of
Washington, judgment was entered
against Ms. Delong after she entered a
plea of guilty to four counts of shipment
of misbranded drugs in interstate
commerce, in violation of section 301(a)
of the FD&C Act (21 U.S.C. 331(a)),
which according to section 303(a)(1) of
the FD&C Act (21 U.S.C. 333(a)(1))
constitutes a misdemeanor.
FDA’s finding that debarment is
appropriate is based on the
misdemeanor convictions referenced
herein. The factual basis for these
convictions is as follows: Beginning as
early as April 2008, Ms. Delong assisted
Louis Daniel Smith and others in the
operation of Project Green Life (PGL).
PGL was a Nevada corporation with
physical operations at various locations
in Spokane, WA. PGL marketed and
sold various health-related products
over the Internet. PGL’s flagship product
was the Miracle Mineral Solution
(MMS), a mixture of sodium chlorite
and water.
Although Ms. Delong acted primarily
at the direction of Louis Daniel Smith,
she had access to PGL’s operations. On
various occasions, she handled shipping
for PGL, including the delivery of
packages containing MMS for shipment
in interstate commerce to PGL
customers nationwide and
internationally. Although at times PGL
marketed MMS as a water purification
product, Ms. Delong knew that MMS
was also used by consumers to treat
disease. At times, PGL provided
instructions to consumers that directed
consumers to mix MMS with a citric
acid solution and consume orally to
treat various diseases. Ms. Delong knew
that PGL provided such instructions to
consumers.
E:\FR\FM\17FEN1.SGM
17FEN1
11046
Federal Register / Vol. 82, No. 32 / Friday, February 17, 2017 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
At no time did Ms. Delong or anyone
else employed by PGL register their
MMS manufacturing facilities with FDA
as required under section 510 of the
FD&C Act (21 U.S.C. 360). In addition,
bottled MMS that PGL shipped to
consumers did not bear labeling that
bore the full place of business of the
manufacturer.
On or about November 1, 2010,
November 12, 2010, November 16, 2010,
and June 30, 2011, Ms. Delong or
another person involved with PGL,
delivered for introduction into interstate
commerce a number of packages
containing bottled MMS. These
packages contained MMS that Ms.
Delong knew was primarily intended as
a treatment for disease.
As a result of these convictions, FDA
sent Ms. Delong by certified mail on
October 12, 2016, a notice proposing to
debar her for 12 years 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(b)(2)(B)(i)(I) of the FD&C Act, that
Ms. Delong was convicted of
misdemeanors under Federal law for
conduct relating to the regulation of
drug products under the FD&C Act, and
that the type of conduct that served as
the basis for the conviction undermines
the process for the regulation of drugs.
The proposal offered Ms. Delong 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
request a hearing constituted a waiver of
the opportunity for a hearing and of any
contentions concerning this action. Ms.
Delong received the proposal on
October 20, 2016. Ms. Delong did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and has waived any contentions
concerning her debarment (21 CFR part
12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act, under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Karis Copper Delong has been
convicted of four misdemeanor counts
under federal law for conduct relating to
the regulation of drug products under
the FD&C Act, and that the type of
conduct that served as the basis for the
conviction undermines the process for
the regulation of drugs.
Based on consideration of the factors
under section 306(c)(3) of the FD&C Act,
VerDate Sep<11>2014
17:38 Feb 16, 2017
Jkt 241001
FDA finds that each offense be accorded
a debarment period of 3 years. Under
section 306(c)(2)(A) of the FD&C Act, in
the case of a person debarred for
multiple offenses, FDA shall determine
whether the periods of debarment shall
run concurrently or consecutively. FDA
has concluded that the 3-year period of
debarment for each of the four offenses
of conviction need to be served
consecutively, resulting in a total
debarment period of 12 years.
As a result of the foregoing finding,
Karis Copper Delong is debarred for a
period of 12 years from providing
services in any capacity to a person with
an approved or pending drug product
application under sections 505, 512, or
802 of the FD&C Act (21 U.S.C. 355,
360b, or 382), or under section 351 of
the Public Health Service Act (42 U.S.C.
262), effective (see DATES) (see sections
306(c)(1)(B), (c)(3), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B),
(c)(3), and 321(dd))). 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 Karis
Copper Delong, in any capacity during
Ms. Delong’s 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. Delong 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 applications submitted by or with
the assistance of Karis Copper Delong
during her period of debarment (section
306(c)(1)(B) of the FD&C Act).
Any application by Ms. Delong for
termination of debarment under section
306(d)(4) of the FD&C Act should be
identified with Docket No. FDA–2016–
N–1677 and sent to the Division of
Dockets Management (see ADDRESSES).
All such submissions are to be filed in
four copies. 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 Division of Dockets
Management (see ADDRESSES) between 9
a.m. and 4 p.m., Monday through
Friday.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
[FR Doc. 2017–03172 Filed 2–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Minority Health
Department of Health and
Human Services, Office of the Secretary,
Office of Minority Health.
ACTION: Notice of meeting.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (DHHS) is hereby giving notice
that the Advisory Committee on
Minority Health (ACMH) will hold a
meeting. This meeting will be open to
the public. Preregistration is required
for both public attendance and
comment. Any individual who wishes
to attend the meetings and/or
participate in the public comment
session should email OMH–ACMH@
hhs.gov.
SUMMARY:
The meeting will be held on
Thursday, March 23, 2017, from 9:00
a.m. to 5:00 p.m. and Friday, March 24,
2017, from 9:00 a.m. to 1:00 p.m.
ADDRESSES: The meeting will be held at
the 5600 Fishers Lane Building, Room
05N76, 5600 Fishers Lane, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Dr.
Minh Wendt, Designated Federal
Officer, ACMH; Tower Building, 1101
Wootton Parkway, Suite 600, Rockville,
Maryland 20852. Phone: 240–453–8222,
Fax: 240–453–8223; OMH–ACMH@
hhs.gov.
DATES:
In
accordance with Public Law 105–392,
the ACMH was established to provide
advice to the Deputy Assistant Secretary
for Minority Health in improving the
health of each racial and ethnic
minority group and on the development
of goals and specific program activities
of the Office of Minority Health.
Topics to be discussed during this
meeting will include strategies to
improve the health of racial and ethnic
minority populations through the
development of health policies and
programs that will help eliminate health
disparities, as well as other related
issues.
Public attendance at this meeting is
limited to space available. Individuals
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17FEN1.SGM
17FEN1
Agencies
[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11045-11046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1677]
Karis Copper Delong: 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 (the FD&C Act)
debarring Karis Copper Delong for a period of 12 years 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.
Delong was convicted of four misdemeanor counts under the FD&C Act for
introducing, delivering for introduction, and causing the introduction
and delivery for introduction of a misbranded drug into interstate
commerce, which relates to the regulation of drug products under the
FD&C Act. In addition, FDA determined that the type of conduct that
served as the basis for the conviction undermines the process for the
regulation of drugs. Ms. Delong was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Ms. Delong failed to request a hearing. Ms.
Delong's failure to request a hearing constitutes a waiver of her right
to a hearing concerning this action.
DATES: This order is effective February 17, 2017.
ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement,
Office of Regulatory Affairs (ELEM-4144), Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds
that the individual has been convicted of a misdemeanor under federal
law for conduct relating to the regulation of drug products under the
FD&C Act, and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
On June 9, 2015, in the U.S. District Court for the Eastern
District of Washington, judgment was entered against Ms. Delong after
she entered a plea of guilty to four counts of shipment of misbranded
drugs in interstate commerce, in violation of section 301(a) of the
FD&C Act (21 U.S.C. 331(a)), which according to section 303(a)(1) of
the FD&C Act (21 U.S.C. 333(a)(1)) constitutes a misdemeanor.
FDA's finding that debarment is appropriate is based on the
misdemeanor convictions referenced herein. The factual basis for these
convictions is as follows: Beginning as early as April 2008, Ms. Delong
assisted Louis Daniel Smith and others in the operation of Project
Green Life (PGL). PGL was a Nevada corporation with physical operations
at various locations in Spokane, WA. PGL marketed and sold various
health-related products over the Internet. PGL's flagship product was
the Miracle Mineral Solution (MMS), a mixture of sodium chlorite and
water.
Although Ms. Delong acted primarily at the direction of Louis
Daniel Smith, she had access to PGL's operations. On various occasions,
she handled shipping for PGL, including the delivery of packages
containing MMS for shipment in interstate commerce to PGL customers
nationwide and internationally. Although at times PGL marketed MMS as a
water purification product, Ms. Delong knew that MMS was also used by
consumers to treat disease. At times, PGL provided instructions to
consumers that directed consumers to mix MMS with a citric acid
solution and consume orally to treat various diseases. Ms. Delong knew
that PGL provided such instructions to consumers.
[[Page 11046]]
At no time did Ms. Delong or anyone else employed by PGL register
their MMS manufacturing facilities with FDA as required under section
510 of the FD&C Act (21 U.S.C. 360). In addition, bottled MMS that PGL
shipped to consumers did not bear labeling that bore the full place of
business of the manufacturer.
On or about November 1, 2010, November 12, 2010, November 16, 2010,
and June 30, 2011, Ms. Delong or another person involved with PGL,
delivered for introduction into interstate commerce a number of
packages containing bottled MMS. These packages contained MMS that Ms.
Delong knew was primarily intended as a treatment for disease.
As a result of these convictions, FDA sent Ms. Delong by certified
mail on October 12, 2016, a notice proposing to debar her for 12 years
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(b)(2)(B)(i)(I) of the FD&C Act, that Ms.
Delong was convicted of misdemeanors under Federal law for conduct
relating to the regulation of drug products under the FD&C Act, and
that the type of conduct that served as the basis for the conviction
undermines the process for the regulation of drugs.
The proposal offered Ms. Delong 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 request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Ms. Delong received the
proposal on October 20, 2016. Ms. Delong did not request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and has waived any contentions
concerning her debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section
306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the
Director (Staff Manual Guide 1410.35), finds that Karis Copper Delong
has been convicted of four misdemeanor counts under federal law for
conduct relating to the regulation of drug products under the FD&C Act,
and that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
Based on consideration of the factors under section 306(c)(3) of
the FD&C Act, FDA finds that each offense be accorded a debarment
period of 3 years. Under section 306(c)(2)(A) of the FD&C Act, in the
case of a person debarred for multiple offenses, FDA shall determine
whether the periods of debarment shall run concurrently or
consecutively. FDA has concluded that the 3-year period of debarment
for each of the four offenses of conviction need to be served
consecutively, resulting in a total debarment period of 12 years.
As a result of the foregoing finding, Karis Copper Delong is
debarred for a period of 12 years from providing services in any
capacity to a person with an approved or pending drug product
application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C.
355, 360b, or 382), or under section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B),
(c)(3), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(3),
and 321(dd))). 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 Karis Copper Delong, in
any capacity during Ms. Delong's 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. Delong 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 applications submitted by or with
the assistance of Karis Copper Delong during her period of debarment
(section 306(c)(1)(B) of the FD&C Act).
Any application by Ms. Delong for termination of debarment under
section 306(d)(4) of the FD&C Act should be identified with Docket No.
FDA-2016-N-1677 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. 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 Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of
Regulatory Affairs.
[FR Doc. 2017-03172 Filed 2-16-17; 8:45 am]
BILLING CODE 4164-01-P