81 FR 80077 - Louis Daniel Smith: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 220 (November 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 220 (November 15, 2016)
| Page Range | 80077-80078 | |
| FR Document | 2016-27417 |
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)] [Notices] [Pages 80077-80078] From the Federal Register Online [www.thefederalregister.org] [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 http://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
![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices 80077
Dated: November 8, 2016. development or approval, of any drug are registered with FDA, and that the
Leslie Kux, product. Section 306(a)(2)(B) of the labeling of such drugs bears true and
Associate Commissioner for Policy. FD&C Act requires debarment of an accurate information.
[FR Doc. 2016–27330 Filed 11–14–16; 8:45 am] individual if FDA finds that the As a result of this conviction, FDA
BILLING CODE 4164–01–P
individual has been convicted of a sent Mr. Smith by certified mail on
felony under Federal law for conduct August 5, 2016, a notice proposing to
otherwise relating to the regulation of permanently debar him from providing
DEPARTMENT OF HEALTH AND any drug product under the FD&C Act. services in any capacity to a person that
HUMAN SERVICES On October 27, 2015, the U.S. District has an approved or pending drug
Court for the Eastern District of product application. The proposal was
Food and Drug Administration Washington entered judgment against based on a finding, under section
Mr. Smith for one count of conspiracy, 306(a)(2) of the FD&C Act, that Mr.
[Docket No. FDA–2016–N–1162]
in violation of 18 U.S.C. 371, three Smith was convicted of felonies under
Louis Daniel Smith: Debarment Order counts of introducing misbranded drugs Federal law for conduct relating to the
into interstate commerce with intent to development or approval, including the
AGENCY: Food and Drug Administration, defraud or mislead, in violation of process for development or approval, of
HHS. section 301(a) of the FD&C Act (21 a drug product, or conduct otherwise
ACTION: Notice. U.S.C. 331(a)), which according to relating to the regulation of a drug
section 303(a)(2) of the FD&C Act (21 product under the FD&C Act. The
SUMMARY: The U.S. Food and Drug U.S.C. 333(a)(2)) constitutes a felony, proposal also offered Mr. Smith an
Administration (FDA or Agency) is and one count of smuggling in violation opportunity to request a hearing,
issuing an order under the Federal of 18 U.S.C. 545. providing him 30 days from the date of
Food, Drug, and Cosmetic Act (the The factual basis for this conviction is receipt of the letter in which to file the
FD&C Act) permanently debarring Louis as follows: Mr. Smith was a managing request, and advised him that failure to
Daniel Smith from providing services in member of PGL International, LLC request a hearing constituted a waiver of
any capacity to a person that has an (PGL), and served as the director of the opportunity for a hearing and of any
approved or pending drug product PGL’s operations. PGL is a Nevada contentions concerning this action. Mr.
application. FDA bases this order on a corporation, which marketed and sold Smith received the proposal on August
finding that Mr. Smith was convicted of various health-related products, 8, 2016. Mr. Smith did not request a
felonies under Federal law for conduct including Miracle Mineral Solution hearing and has, therefore, waived his
relating to the development or approval, (MMS), a mixture of sodium chlorite opportunity for a hearing and any
including the process for development and water. Sodium chlorite is an contentions concerning his debarment
or approval, of a drug product, or industrial chemical used as a pesticide (21 CFR part 12).
otherwise relating to the regulation of a and for hydraulic fracking and
wastewater treatment. Sodium chlorite II. Findings and Order
drug product under the FD&C Act. Mr.
Smith was given notice of the proposed cannot be sold for human consumption Therefore, the Director, Office of
permanent debarment and an and suppliers of the chemical include a Enforcement and Import Operations,
opportunity to request a hearing within warning sheet stating that it can cause Office of Regulatory Affairs, under
the timeframe prescribed by regulation. potentially fatal side effects if section 306(a)(2) of the FD&C Act, under
Mr. Smith failed to respond. Mr. Smith’s swallowed. Mr. Smith obtained authority delegated to him (Staff Manual
failure to respond constitutes a waiver chemicals needed to manufacture the Guide 1410.35), finds that Louis Daniel
of his right to a hearing concerning this misbranded drug MMS without Smith has been convicted of felonies
action. revealing to regulators and suppliers the under Federal law for conduct relating
true purpose of the chemicals; used to the development or approval,
DATES: This order is effective November
those chemicals to manufacture the including the process for development
15, 2016.
misbranded drug MMS in a facility that or approval, of a drug product, or
ADDRESSES: Submit applications for conduct otherwise relating to the
was not disclosed to regulators; offered
special termination of debarment to the the misbranded drug MMS for sale on regulation of a drug product under the
Division of Dockets Management (HFA– Web sites Mr. Smith had established; FD&C Act.
305), Food and Drug Administration, and sold that drug in interstate As a result of the foregoing finding,
5630 Fishers Lane, Rm. 1061, Rockville, commerce. Louis Daniel Smith is permanently
MD 20852. From on or about September 11, 2004, debarred from providing services in any
FOR FURTHER INFORMATION CONTACT: to at least on or about July 16, 2012, in capacity to a person with an approved
Kenny Shade, Division of Enforcement, the Eastern District of Washington and or pending drug product application
Office of Enforcement and Import elsewhere, Mr. Smith introduced, under sections 505, 512, or 802 of the
Operations, Office of Regulatory Affairs delivered for introduction into interstate FD&C Act (21 U.S.C. 355, 360b, or 382),
(ELEM–4144), Food and Drug commerce, and caused the introduction or under section 351 of the Public
Administration, 12420 Parklawn Dr., and delivery for introduction into Health Service Act (42 U.S.C. 262),
Rockville, MD 20857, 301–796–4640. interstate commerce, with the intent to effective (see DATES) (see section
SUPPLEMENTARY INFORMATION: defraud or mislead, misbranded drugs. 201(dd) (21 U.S.C. 321(dd)),
In addition, he knowingly defrauded the 306(c)(1)(B), and 306(c)(2)(A)(ii) of the
I. Background United States and also impeded the FD&C Act). Any person with an
mstockstill on DSK3G9T082PROD with NOTICES
Section 306(a)(2)(A) of the FD&C Act lawful government functions of FDA, approved or pending drug product
(21 U.S.C. 335a(a)(2)(A)) requires specifically, FDA’s duty to protect the application who knowingly employs or
debarment of an individual if FDA finds health and safety of the public by, retains as a consultant or contractor, or
that the individual has been convicted among other things, ensuring that drugs otherwise uses the services of Louis
of a felony under Federal law for marketed in the United States are safe Daniel Smith, in any capacity during his
conduct relating to the development or and effective for their intended uses and debarment, will be subject to civil
approval, including the process for are manufactured in establishments that money penalties (section 307(a)(6) of the
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![80078 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. medical assistance (Medicaid), ‘‘ ‘‘Federal medical assistance percentage’’
Smith provides services in any capacity Temporary Assistance for Needy for any state shall be 100 per centum less the
to a person with an approved or Families (TANF) Contingency Funds, state percentage; and the state percentage
pending drug product application Child Support Enforcement collections, shall be that percentage which bears the same
ratio to 45 per centum as the square of the
during his period of debarment he will Child Care Mandatory and Matching per capita income of such state bears to the
be subject to civil money penalties Funds of the Child Care and square of the per capita income of the
(section 307(a)(7) of the FD&C Act). In Development Fund, Title IV–E Foster continental United States (including Alaska)
addition, FDA will not accept or review Care Maintenance payments, Adoption and Hawaii; except that (1) the Federal
any abbreviated new drug applications Assistance payments and Guardianship medical assistance percentage shall in no
from Mr. Smith during his period of Assistance payments, and the eFMAP case be less than 50 per centum or more than
debarment (section 306(c)(1)(B) of the rates for the Children’s Health Insurance 83 per centum, (2) the Federal medical
FD&C Act). Program (CHIP) expenditures. Table 1 assistance percentage for Puerto Rico, the
Any application by Mr. Smith for gives figures for each of the 50 states, Virgin Islands, Guam, the Northern Mariana
Islands, and American Samoa shall be 55
special termination of debarment under the District of Columbia, Puerto Rico, percent. . .’’.
section 306(d)(4) of the FD&C Act the Virgin Islands, Guam, American
should be identified with Docket No. Samoa, and the Commonwealth of the Section 4725(b) of the Balanced
FDA–2016–N–1162 and sent to the Northern Mariana Islands. This notice Budget Act of 1997 amended section
Division of Dockets Management (see reminds states of available disaster- 1905(b) to provide that the FMAP for
ADDRESSES). All such submissions are to recovery FMAP adjustments for the District of Columbia for purposes of
be filed in four copies. The public qualifying states, and adjustments titles XIX and XXI shall be 70 percent.
availability of information in these available for states meeting For the District of Columbia, we note
submissions is governed by 21 CFR requirements for negative growth in under Table 1 that other rates may apply
10.20. total state personal income. At this time, in certain other programs. In addition,
Publicly available submissions will be no states qualify for such adjustments. we note the rate that applies for Puerto
placed in the docket, and will be This notice also contains the Rico, the Virgin Islands, Guam,
viewable at http://www.regulations.gov increased eFMAPs for CHIP as American Samoa, and the
or at the Division of Dockets authorized under the Patient Protection Commonwealth of the Northern Mariana
Management (see ADDRESSES) between 9 and Affordable Care Act (Affordable Islands in certain other programs
a.m. and 4 p.m., Monday through Care Act) for fiscal years 2016 through pursuant to section 1118 of the Act. The
Friday. 2019 (October 1, 2015 through rates for the States, District of Columbia
Dated: November 9, 2016. September 30, 2019). and the territories are displayed in
Armando Zamora, Programs under title XIX of the Act Table 1, Column 1.
Deputy Director, Office of Enforcement and exist in each jurisdiction. Programs Section 1905(y) of the Act, as added
Import Operations, Office of Regulatory under titles I, X, and XIV operate only by section 2001 of the Patient Protection
Affairs. in Guam and the Virgin Islands. The and Affordable Care Act of 2010
[FR Doc. 2016–27417 Filed 11–14–16; 8:45 am] percentages in this notice apply to state (’’Affordable Care Act’’), provides for a
BILLING CODE 4164–01–P expenditures for most medical significant increase in the FMAP for
assistance and child health assistance, medical assistance expenditures for
and assistance payments for certain individuals determined eligible under
DEPARTMENT OF HEALTH AND social services. The Act provides the new adult group in the state and
HUMAN SERVICES separately for federal matching of who will be considered to be ‘‘newly
administrative costs. eligible’’ in 2014, as defined in section
Federal Financial Participation in State Sections 1905(b) and 1101(a)(8)(B) of 1905(y)(2)(A) of the Act. This newly
Assistance Expenditures; Federal the Social Security Act (the Act) require eligible FMAP is 100 percent for
Matching Shares for Medicaid, the the Secretary of HHS to publish the Calendar Years 2014, 2015, and 2016,
Children’s Health Insurance Program, FMAP rates each year. The Secretary gradually declining to 90 percent in
and Aid to Needy Aged, Blind, or calculates the percentages, using 2020 where it remains indefinitely. In
Disabled Persons for October 1, 2017 formulas in sections 1905(b) and addition, section 1905(z) of the Act, as
Through September 30, 2018 1101(a)(8), and calculations by the added by section 10201 of the
AGENCY: Office of the Secretary, DHHS. Department of Commerce of average Affordable Care Act, provides that states
ACTION: Notice. income per person in each state and for that had expanded substantial coverage
the Nation as a whole. The percentages to low-income parents and nonpregnant
SUMMARY: The Federal Medical must fall within the upper and lower adults without children prior to the
Assistance Percentages (FMAP), limits specified in section 1905(b) of the enactment of the Affordable Care Act,
Enhanced Federal Medical Assistance Act. The percentages for the District of referred to as ‘‘expansion states,’’ shall
Percentages (eFMAP), and disaster- Columbia, Puerto Rico, the Virgin receive an enhanced FMAP beginning in
recovery FMAP adjustments for Fiscal Islands, Guam, American Samoa, and 2014 for medical assistance
Year 2018 have been calculated the Northern Mariana Islands are expenditures for nonpregnant childless
pursuant to the Social Security Act (the specified in statute, and thus are not adults who may be required to enroll in
Act). These percentages will be effective based on the statutory formula that benchmark coverage. These provisions
from October 1, 2017 through determines the percentages for the 50 are discussed in more detail in the
mstockstill on DSK3G9T082PROD with NOTICES
September 30, 2018. This notice states. Medicaid Eligibility proposed rule
announces the calculated FMAP rates, published on August 17, 2011 (76 FR
Federal Medical Assistance Percentage
in accordance with sections 1101(a)(8) 51172) and the final rule published on
(FMAP)
and 1905(b) of the Act, that the U.S. March 23, 2012 (77 FR 17143). This
Department of Health and Human Section 1905(b) of the Act specifies notice is not intended to set forth the
Services (HHS) will use in determining the formula for calculating FMAPs as newly eligible or expansion state FMAP
the amount of federal matching for state follows: rates.
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Document Created: 2016-11-15 00:48:11
Document Modified: 2016-11-15 00:48:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This order is effective November 15, 2016. | |
| 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. | |
| FR Citation | 81 FR 80077 |
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