Louis Daniel Smith: Debarment Order, 80077-80078 [2016-27417]
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Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
Dated: November 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27330 Filed 11–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1162]
Louis Daniel Smith: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The U.S. 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 Louis
Daniel Smith 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. Smith was convicted of
felonies under Federal law for conduct
relating to the development or approval,
including the process for development
or approval, of a drug product, or
otherwise relating to the regulation of a
drug product under the FD&C Act. Mr.
Smith was given notice of the proposed
permanent debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
Mr. Smith failed to respond. Mr. Smith’s
failure to respond constitutes a waiver
of his right to a hearing concerning this
action.
DATES: This order is effective November
15, 2016.
ADDRESSES: Submit applications for
special 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 Enforcement and Import
Operations, Office of Regulatory Affairs
(ELEM–4144), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
I. Background
Section 306(a)(2)(A) of the FD&C Act
(21 U.S.C. 335a(a)(2)(A)) requires
debarment of an individual if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the development or
approval, including the process for
VerDate Sep<11>2014
22:00 Nov 11, 2016
Jkt 241001
development or approval, of any drug
product. Section 306(a)(2)(B) of the
FD&C Act requires debarment of an
individual if FDA finds that the
individual has been convicted of a
felony under Federal law for conduct
otherwise relating to the regulation of
any drug product under the FD&C Act.
On October 27, 2015, the U.S. District
Court for the Eastern District of
Washington entered judgment against
Mr. Smith for one count of conspiracy,
in violation of 18 U.S.C. 371, three
counts of introducing misbranded drugs
into interstate commerce with intent to
defraud or mislead, in violation of
section 301(a) of the FD&C Act (21
U.S.C. 331(a)), which according to
section 303(a)(2) of the FD&C Act (21
U.S.C. 333(a)(2)) constitutes a felony,
and one count of smuggling in violation
of 18 U.S.C. 545.
The factual basis for this conviction is
as follows: Mr. Smith was a managing
member of PGL International, LLC
(PGL), and served as the director of
PGL’s operations. PGL is a Nevada
corporation, which marketed and sold
various health-related products,
including Miracle Mineral Solution
(MMS), a mixture of sodium chlorite
and water. Sodium chlorite is an
industrial chemical used as a pesticide
and for hydraulic fracking and
wastewater treatment. Sodium chlorite
cannot be sold for human consumption
and suppliers of the chemical include a
warning sheet stating that it can cause
potentially fatal side effects if
swallowed. Mr. Smith obtained
chemicals needed to manufacture the
misbranded drug MMS without
revealing to regulators and suppliers the
true purpose of the chemicals; used
those chemicals to manufacture the
misbranded drug MMS in a facility that
was not disclosed to regulators; offered
the misbranded drug MMS for sale on
Web sites Mr. Smith had established;
and sold that drug in interstate
commerce.
From on or about September 11, 2004,
to at least on or about July 16, 2012, in
the Eastern District of Washington and
elsewhere, Mr. Smith introduced,
delivered for introduction into interstate
commerce, and caused the introduction
and delivery for introduction into
interstate commerce, with the intent to
defraud or mislead, misbranded drugs.
In addition, he knowingly defrauded the
United States and also impeded the
lawful government functions of FDA,
specifically, FDA’s duty to protect the
health and safety of the public by,
among other things, ensuring that drugs
marketed in the United States are safe
and effective for their intended uses and
are manufactured in establishments that
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
80077
are registered with FDA, and that the
labeling of such drugs bears true and
accurate information.
As a result of this conviction, FDA
sent Mr. Smith by certified mail on
August 5, 2016, a notice proposing to
permanently debar him 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) of the FD&C Act, that Mr.
Smith was convicted of felonies under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
a drug product, or conduct otherwise
relating to the regulation of a drug
product under the FD&C Act. The
proposal also offered Mr. Smith 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.
Smith received the proposal on August
8, 2016. Mr. Smith 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) of the FD&C Act, under
authority delegated to him (Staff Manual
Guide 1410.35), finds that Louis Daniel
Smith has been convicted of felonies
under Federal law for conduct relating
to the development or approval,
including the process for development
or approval, of a drug product, or
conduct otherwise relating to the
regulation of a drug product under the
FD&C Act.
As a result of the foregoing finding,
Louis Daniel Smith 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) (21 U.S.C. 321(dd)),
306(c)(1)(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 Louis
Daniel Smith, in any capacity during his
debarment, will be subject to civil
money penalties (section 307(a)(6) of the
E:\FR\FM\15NON1.SGM
15NON1
80078
Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
FD&C Act (21 U.S.C. 335b(a)(6))). If Mr.
Smith 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 Mr. Smith during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Smith for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2016–N–1162 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.
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: November 9, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and
Import Operations, Office of Regulatory
Affairs.
[FR Doc. 2016–27417 Filed 11–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Federal Financial Participation in State
Assistance Expenditures; Federal
Matching Shares for Medicaid, the
Children’s Health Insurance Program,
and Aid to Needy Aged, Blind, or
Disabled Persons for October 1, 2017
Through September 30, 2018
Office of the Secretary, DHHS.
Notice.
AGENCY:
ACTION:
The Federal Medical
Assistance Percentages (FMAP),
Enhanced Federal Medical Assistance
Percentages (eFMAP), and disasterrecovery FMAP adjustments for Fiscal
Year 2018 have been calculated
pursuant to the Social Security Act (the
Act). These percentages will be effective
from October 1, 2017 through
September 30, 2018. This notice
announces the calculated FMAP rates,
in accordance with sections 1101(a)(8)
and 1905(b) of the Act, that the U.S.
Department of Health and Human
Services (HHS) will use in determining
the amount of federal matching for state
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SUMMARY:
VerDate Sep<11>2014
22:00 Nov 11, 2016
Jkt 241001
medical assistance (Medicaid),
Temporary Assistance for Needy
Families (TANF) Contingency Funds,
Child Support Enforcement collections,
Child Care Mandatory and Matching
Funds of the Child Care and
Development Fund, Title IV–E Foster
Care Maintenance payments, Adoption
Assistance payments and Guardianship
Assistance payments, and the eFMAP
rates for the Children’s Health Insurance
Program (CHIP) expenditures. Table 1
gives figures for each of the 50 states,
the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American
Samoa, and the Commonwealth of the
Northern Mariana Islands. This notice
reminds states of available disasterrecovery FMAP adjustments for
qualifying states, and adjustments
available for states meeting
requirements for negative growth in
total state personal income. At this time,
no states qualify for such adjustments.
This notice also contains the
increased eFMAPs for CHIP as
authorized under the Patient Protection
and Affordable Care Act (Affordable
Care Act) for fiscal years 2016 through
2019 (October 1, 2015 through
September 30, 2019).
Programs under title XIX of the Act
exist in each jurisdiction. Programs
under titles I, X, and XIV operate only
in Guam and the Virgin Islands. The
percentages in this notice apply to state
expenditures for most medical
assistance and child health assistance,
and assistance payments for certain
social services. The Act provides
separately for federal matching of
administrative costs.
Sections 1905(b) and 1101(a)(8)(B) of
the Social Security Act (the Act) require
the Secretary of HHS to publish the
FMAP rates each year. The Secretary
calculates the percentages, using
formulas in sections 1905(b) and
1101(a)(8), and calculations by the
Department of Commerce of average
income per person in each state and for
the Nation as a whole. The percentages
must fall within the upper and lower
limits specified in section 1905(b) of the
Act. The percentages for the District of
Columbia, Puerto Rico, the Virgin
Islands, Guam, American Samoa, and
the Northern Mariana Islands are
specified in statute, and thus are not
based on the statutory formula that
determines the percentages for the 50
states.
Federal Medical Assistance Percentage
(FMAP)
Section 1905(b) of the Act specifies
the formula for calculating FMAPs as
follows:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
‘‘ ‘‘Federal medical assistance percentage’’
for any state shall be 100 per centum less the
state percentage; and the state percentage
shall be that percentage which bears the same
ratio to 45 per centum as the square of the
per capita income of such state bears to the
square of the per capita income of the
continental United States (including Alaska)
and Hawaii; except that (1) the Federal
medical assistance percentage shall in no
case be less than 50 per centum or more than
83 per centum, (2) the Federal medical
assistance percentage for Puerto Rico, the
Virgin Islands, Guam, the Northern Mariana
Islands, and American Samoa shall be 55
percent. . .’’.
Section 4725(b) of the Balanced
Budget Act of 1997 amended section
1905(b) to provide that the FMAP for
the District of Columbia for purposes of
titles XIX and XXI shall be 70 percent.
For the District of Columbia, we note
under Table 1 that other rates may apply
in certain other programs. In addition,
we note the rate that applies for Puerto
Rico, the Virgin Islands, Guam,
American Samoa, and the
Commonwealth of the Northern Mariana
Islands in certain other programs
pursuant to section 1118 of the Act. The
rates for the States, District of Columbia
and the territories are displayed in
Table 1, Column 1.
Section 1905(y) of the Act, as added
by section 2001 of the Patient Protection
and Affordable Care Act of 2010
(’’Affordable Care Act’’), provides for a
significant increase in the FMAP for
medical assistance expenditures for
individuals determined eligible under
the new adult group in the state and
who will be considered to be ‘‘newly
eligible’’ in 2014, as defined in section
1905(y)(2)(A) of the Act. This newly
eligible FMAP is 100 percent for
Calendar Years 2014, 2015, and 2016,
gradually declining to 90 percent in
2020 where it remains indefinitely. In
addition, section 1905(z) of the Act, as
added by section 10201 of the
Affordable Care Act, provides that states
that had expanded substantial coverage
to low-income parents and nonpregnant
adults without children prior to the
enactment of the Affordable Care Act,
referred to as ‘‘expansion states,’’ shall
receive an enhanced FMAP beginning in
2014 for medical assistance
expenditures for nonpregnant childless
adults who may be required to enroll in
benchmark coverage. These provisions
are discussed in more detail in the
Medicaid Eligibility proposed rule
published on August 17, 2011 (76 FR
51172) and the final rule published on
March 23, 2012 (77 FR 17143). This
notice is not intended to set forth the
newly eligible or expansion state FMAP
rates.
E:\FR\FM\15NON1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)]
[Notices]
[Pages 80077-80078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27417]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1162]
Louis Daniel Smith: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The U.S. 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 Louis Daniel Smith 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.
Smith was convicted of felonies under Federal law for conduct relating
to the development or approval, including the process for development
or approval, of a drug product, or otherwise relating to the regulation
of a drug product under the FD&C Act. Mr. Smith was given notice of the
proposed permanent debarment and an opportunity to request a hearing
within the timeframe prescribed by regulation. Mr. Smith failed to
respond. Mr. Smith's failure to respond constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is effective November 15, 2016.
ADDRESSES: Submit applications for special 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 Enforcement and Import Operations, 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(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A))
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct relating
to the development or approval, including the process for development
or approval, of any drug product. Section 306(a)(2)(B) of the FD&C Act
requires debarment of an individual if FDA finds that the individual
has been convicted of a felony under Federal law for conduct otherwise
relating to the regulation of any drug product under the FD&C Act.
On October 27, 2015, the U.S. District Court for the Eastern
District of Washington entered judgment against Mr. Smith for one count
of conspiracy, in violation of 18 U.S.C. 371, three counts of
introducing misbranded drugs into interstate commerce with intent to
defraud or mislead, in violation of section 301(a) of the FD&C Act (21
U.S.C. 331(a)), which according to section 303(a)(2) of the FD&C Act
(21 U.S.C. 333(a)(2)) constitutes a felony, and one count of smuggling
in violation of 18 U.S.C. 545.
The factual basis for this conviction is as follows: Mr. Smith was
a managing member of PGL International, LLC (PGL), and served as the
director of PGL's operations. PGL is a Nevada corporation, which
marketed and sold various health-related products, including Miracle
Mineral Solution (MMS), a mixture of sodium chlorite and water. Sodium
chlorite is an industrial chemical used as a pesticide and for
hydraulic fracking and wastewater treatment. Sodium chlorite cannot be
sold for human consumption and suppliers of the chemical include a
warning sheet stating that it can cause potentially fatal side effects
if swallowed. Mr. Smith obtained chemicals needed to manufacture the
misbranded drug MMS without revealing to regulators and suppliers the
true purpose of the chemicals; used those chemicals to manufacture the
misbranded drug MMS in a facility that was not disclosed to regulators;
offered the misbranded drug MMS for sale on Web sites Mr. Smith had
established; and sold that drug in interstate commerce.
From on or about September 11, 2004, to at least on or about July
16, 2012, in the Eastern District of Washington and elsewhere, Mr.
Smith introduced, delivered for introduction into interstate commerce,
and caused the introduction and delivery for introduction into
interstate commerce, with the intent to defraud or mislead, misbranded
drugs. In addition, he knowingly defrauded the United States and also
impeded the lawful government functions of FDA, specifically, FDA's
duty to protect the health and safety of the public by, among other
things, ensuring that drugs marketed in the United States are safe and
effective for their intended uses and are manufactured in
establishments that are registered with FDA, and that the labeling of
such drugs bears true and accurate information.
As a result of this conviction, FDA sent Mr. Smith by certified
mail on August 5, 2016, a notice proposing to permanently debar him
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) of the FD&C Act, that Mr. Smith was
convicted of felonies under Federal law for conduct relating to the
development or approval, including the process for development or
approval, of a drug product, or conduct otherwise relating to the
regulation of a drug product under the FD&C Act. The proposal also
offered Mr. Smith 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. Smith received the proposal on August 8,
2016. Mr. Smith 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) of
the FD&C Act, under authority delegated to him (Staff Manual Guide
1410.35), finds that Louis Daniel Smith has been convicted of felonies
under Federal law for conduct relating to the development or approval,
including the process for development or approval, of a drug product,
or conduct otherwise relating to the regulation of a drug product under
the FD&C Act.
As a result of the foregoing finding, Louis Daniel Smith 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) (21 U.S.C. 321(dd)),
306(c)(1)(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 Louis Daniel Smith, in any capacity during his debarment, will be
subject to civil money penalties (section 307(a)(6) of the
[[Page 80078]]
FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Smith 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
Mr. Smith during his period of debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Smith for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2016-N-1162 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.
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: November 9, 2016.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of
Regulatory Affairs.
[FR Doc. 2016-27417 Filed 11-14-16; 8:45 am]
BILLING CODE 4164-01-P
