Jun Yang: Debarment Order, 17450-17452 [2015-07439]
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Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
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Celeste Dade-Vinson,
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Medicare & Medicaid Services.
[FR Doc. 2015–07444 Filed 3–31–15; 8:45 a.m.]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0964]
Jun Yang: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\01APN1.SGM
Notice.
01APN1
Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
The U.S. Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) debarring Jun Yang for a period of
4 years from importing articles of food
or offering such articles for importation
into the United States. FDA bases this
order on a finding that Mr. Yang was
convicted, as defined in the FD&C Act,
of one felony count under Federal law
for conduct relating to the importation
into the United States of an article of
food. Mr. Yang was given notice of the
proposed debarment and an opportunity
to request a hearing within the
timeframe prescribed by regulation. As
of November 7, 2014 (30 days after
receipt of the notice), Mr. Yang had not
responded. Mr. Yang’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.
DATES: This order is effective April 1,
2015.
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 Enforcement and Import
Operations, Office of Regulatory Affairs,
Food and Drug Administration, 12420
Parklawn Dr. (ELEM–4144), Rockville,
MD 20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) 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 food.
On November 14, 2013, Mr. Yang was
convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the
U.S. District Court for the Northern
District of Illinois accepted his plea of
guilty and entered judgment against him
for the following offense: One count of
smuggling goods into the United States,
in violation of 18 U.S.C. 545.
FDA’s finding that debarment is
appropriate is based on the felony
conviction referenced herein. The
factual basis for this conviction is as
follows:
On or about February 10, 2012, Mr.
Yang facilitated the sale of imported
honey with a declared value of $92,800,
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18:37 Mar 31, 2015
Jkt 235001
knowing that the honey was of Chinese
origin and was imported and brought
into the United States contrary to law.
As part of his fraudulent practice, Mr.
Yang brokered the sale of two container
loads of purported ‘‘100% pure Indian
honey,’’ knowing that the honey was
falsely and fraudulently imported and
brought into the United States as a
product of India in avoidance of U.S.imposed anti-dumping duties, thereby
causing losses to the United States of
approximately $97,625.
Mr. Yang admitted that he operated
and controlled National Honey, Inc.,
which did business as National
Commodities Company, and served as
the principal point of contact for
brokering the sale of honey between
overseas honey suppliers and U.S.
customers. Mr. Yang further admits that
between 2009 and 2012 he sold 778
container loads of honey valued at
approximately $22,864,153 to Honey
Holding and Honey Packer 1 (U.S.
customers). This was part of a
fraudulent practice to enter and
introduce and cause others to enter and
introduce transshipped Chinese-origin
honey into the commerce of the United
States in avoidance of U.S. imposed
anti-dumping duties. Mr. Yang
continued this practice even though he
knew that the honey was falsely and
fraudulently imported, entered,
marketed, and sold as purely nonChinese honey, including as honey from
Malaysia and India. This fraudulent
practice caused losses to the United
States of as much as $37,991,375.
Mr. Yang also admitted that he
ordered honey from Chinese honey
suppliers, knowing that the Chinese
honey suppliers would send the
Chinese-origin honey to countries
including Malaysia and India, where the
honey was mislabeled as to the country
of origin before it passed through a U.S.
customhouse as non-Chinese origin
honey. Mr. Yang and National
Commodities caused the formation of at
least three companies and used at least
one other company to import and enter
honey from a Chinese honey supplier
knowing that some of the honey was
Chinese in origin. Mr. Yang and
National Commodities benefitted from
the company’s filing custom entry forms
that falsely and fraudulently declared
all the honey as originating from
Malaysia and India. Mr. Yang and
National Commodities purchased honey
imported by the companies despite
knowing that some or all of the honey
was Chinese in origin, but declared at
the time of importation and entry as
entirely originating from Malaysia and
India.
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Fmt 4703
Sfmt 4703
17451
Mr. Yang also admitted that he
obtained and circulated and caused
others to obtain and circulate false and
fraudulent bills of lading, invoices,
packing lists, country of origin
certificates, and other papers, which he
knew to be false and fraudulent. These
records were used to declare Chineseorigin honey as having originated from
Malaysia and India. Mr. Yang also
instructed an undercover law
enforcement agent to destroy
unfavorable test results that showed
purported Vietnamese honey that he
sold tested positive for the presence of
chloramphenicol, an antibiotic.
Residues of chloramphenicol in honey
cause the honey to be adulterated under
the FD&C Act. In anticipation of an
investigation by U.S. Customs and
Border Protection and FDA, Mr. Yang
knowingly concealed and covered up
three laboratory reports showing the
presence of chloramphenicol.
As a result of his conviction, on
October 1, 2014, FDA sent Mr. Yang a
notice by certified mail proposing to
debar him for a period of 4 years from
importing articles of food or offering
such articles for import into the United
States. The proposal was based on a
finding under section 306(b)(1)(C) of the
FD&C Act that Mr. Yang’s felony
conviction for smuggling of goods into
the United States in violation of 18
U.S.C. 545 constitutes conduct relating
to the importation into the United States
of an article of food because he
committed an offense related to the
importation of Chinese honey into the
United States.
The proposal was also based on a
determination, after consideration of the
factors set forth in section 306(c)(3) of
the FD&C Act, that Mr. Yang should be
subject to a 4-year period of debarment.
The proposal also offered Mr. Yang 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.
Yang failed to respond 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 Director, Office of
Enforcement and Import Operations,
Office of Regulatory Affairs, under
section 306(b)(1)(C) of the FD&C Act,
under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Jun Yang has been convicted
E:\FR\FM\01APN1.SGM
01APN1
17452
Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices
of one felony count under Federal law
for conduct relating to the importation
into the United States of an article of
food and that he is subject to a 4-year
period of debarment.
As a result of the foregoing finding,
Jun Yang is debarred for a period of 4
years from importing articles of food or
offering such articles for import into the
United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C
Act (21 U.S.C. 331(cc)), the importing or
offering for import into the United
States of an article of food by, with the
assistance of, or at the direction of Jun
Yang is a prohibited act.
Any application by Mr. Yang for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2014–
N–0964 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 may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: March 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07439 Filed 3–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 80 FR 1417–1419, dated
January 9, 2015) is amended to reflect
the reorganization of the Office of Public
Health Scientific Services, Centers for
Disease Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
Delete in its entirety the title and
functions statements for the Health
Information Technology and
Surveillance Strategy Unit (CPA3),
Office of the Director (CPA),
Delete in its entirety the title and the
mission and function statements for the
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18:37 Mar 31, 2015
Jkt 235001
Center for Surveillance, Epidemiology
and Laboratory Services (CPN) and
insert the following:
Center for Surveillance, Epidemiology
and Laboratory Services (CPN) The
mission of the Center for Surveillance,
Epidemiology, and Laboratory Services
(CSELS) is to provide scientific service,
expertise, skills, and tools in support of
CDC’s efforts to promote health; prevent
disease, injury and disability; and
prepare for emerging health threats.
CSELS focuses on improving
information and data quality, laboratory
systems, and the public health
workforce, through modernization,
innovation, and service. To carry out its
mission, CSELS (1) leads and executes
a national public health surveillance
strategy for human health that builds
upon current resources, establishes
priorities for the nation’s nextgeneration capability and provides
timely, comprehensive, and accessible
information to strengthen public health
practice, and provide value to
clinicians; (2) participates in the
identification, development, evolution,
and adoption of informatics standards;
(3) facilitates and coordinates program
and laboratory systems integration for
the Agency; (4) provides leadership and
support to strengthen the quality and
safety of laboratory practices; (5)
provides leadership for scientific
workforce education and advances
professional development; (6) provides
leadership on public health genomics
strategy, activities, and planning; (7)
creates and promotes access to quality,
timely and useful cross-cutting
scientific guidance, products, and
services to strengthen the science and
practice of public health and to improve
public health decision-making.
Office of the Director (CPN1). (1)
Provides strategic direction regarding
surveillance, epidemiologic
investigation, and data and information
sciences; (2) supports OPHSS’s CDCwide coordination and strategic
activities in areas of health informatics
technology, including the meaningful
use of electronic health records for
public health surveillance and the
coordination of partners and
stakeholders for biosurveillance,
genomics, and publication science; (3)
leads the development of public health
workforce training; (4) guides the
development of laboratory systems
standards for quality and safety,
including the Clinical Laboratory
Improvement Amendments (CLIA) and
engagement with relevant federal
advisory committees; (5) manages,
directs, coordinates, and evaluates the
activities of the Center; (6) defines goals
and objectives for policy formation,
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
scientific oversight, and guidance in
program planning and development; (7)
establishes and implements a
communications strategy in support of
CSELS overarching goals and priorities;
(8) provides oversight for the evaluation
of programmatic performance of all
CSELS activities to ensure health
impact; (9) plans, coordinates, and
manages all aspects of program business
services including human and fiscal
resources, extramural activities, space,
and all administrative services; (10)
devises information technology
practices and procedures, and provides
direction, innovation, planning and
evaluation for information technology
systems, services, security, and
resources for CSELS; (11) provides
leadership on issues management,
budget formulation and performance
integration; (12) manages intergovernmental and external affairs and
cultivates strategic partnerships; (13)
ensures scientific quality, integrity, and
clearance across the Center; (14)
provides guidance and strategic
oversight to the processes within the
Center that access, collect, manage,
analyze, and visualize data, including
assistance for involvement with federal
advisory committees and other high
level groups; (15) monitors projects for
effective focus on the analytical,
informatics, data management, and
statistical infrastructure to deliver
quality data, accurate analysis services
and dependable software products and
systems to customers and partners; (16)
collaborates and consults with other
Centers, working groups, state and local
health departments, other federal
agencies, and other partners, to
accomplish the mission of the Center;
(17) reviews, prepares, coordinates, and
develops Congressional testimony and
briefing materials; and (18) represents
the CSELS and at times CDC at
professional and scientific meetings,
within and outside CDC.
Division of Laboratory Systems
(CPNB). The mission of the Division of
Laboratory Systems (DLS) is to provide
leadership, support, and cross-cutting
services to continually strengthen the
capability, sustainability, and quality of
laboratory science, policy, and practice
at CDC, in clinical and public health
laboratories, both in the United States
and with international partners. DLS
strives to strengthen and align the
capacity and ability of both clinical and
public health laboratories to perform
their critical roles in protecting the
public’s health. In this mission, DLS: (1)
Fosters collaboration across the
laboratory community; (2) strengthens
integration of laboratory science,
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17450-17452]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07439]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0964]
Jun Yang: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 17451]]
SUMMARY: The U.S. Food and Drug Administration (FDA or Agency) is
issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) debarring Jun Yang for a period of 4 years from importing articles
of food or offering such articles for importation into the United
States. FDA bases this order on a finding that Mr. Yang was convicted,
as defined in the FD&C Act, of one felony count under Federal law for
conduct relating to the importation into the United States of an
article of food. Mr. Yang was given notice of the proposed debarment
and an opportunity to request a hearing within the timeframe prescribed
by regulation. As of November 7, 2014 (30 days after receipt of the
notice), Mr. Yang had not responded. Mr. Yang's failure to respond
constitutes a waiver of his right to a hearing concerning this action.
DATES: This order is effective April 1, 2015.
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 Enforcement and Import Operations, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144),
Rockville, MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article for import into the United States if FDA
finds, as required by section 306(b)(3)(A) 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 food.
On November 14, 2013, Mr. Yang was convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the
Northern District of Illinois accepted his plea of guilty and entered
judgment against him for the following offense: One count of smuggling
goods into the United States, in violation of 18 U.S.C. 545.
FDA's finding that debarment is appropriate is based on the felony
conviction referenced herein. The factual basis for this conviction is
as follows:
On or about February 10, 2012, Mr. Yang facilitated the sale of
imported honey with a declared value of $92,800, knowing that the honey
was of Chinese origin and was imported and brought into the United
States contrary to law. As part of his fraudulent practice, Mr. Yang
brokered the sale of two container loads of purported ``100% pure
Indian honey,'' knowing that the honey was falsely and fraudulently
imported and brought into the United States as a product of India in
avoidance of U.S.-imposed anti-dumping duties, thereby causing losses
to the United States of approximately $97,625.
Mr. Yang admitted that he operated and controlled National Honey,
Inc., which did business as National Commodities Company, and served as
the principal point of contact for brokering the sale of honey between
overseas honey suppliers and U.S. customers. Mr. Yang further admits
that between 2009 and 2012 he sold 778 container loads of honey valued
at approximately $22,864,153 to Honey Holding and Honey Packer 1 (U.S.
customers). This was part of a fraudulent practice to enter and
introduce and cause others to enter and introduce transshipped Chinese-
origin honey into the commerce of the United States in avoidance of
U.S. imposed anti-dumping duties. Mr. Yang continued this practice even
though he knew that the honey was falsely and fraudulently imported,
entered, marketed, and sold as purely non-Chinese honey, including as
honey from Malaysia and India. This fraudulent practice caused losses
to the United States of as much as $37,991,375.
Mr. Yang also admitted that he ordered honey from Chinese honey
suppliers, knowing that the Chinese honey suppliers would send the
Chinese-origin honey to countries including Malaysia and India, where
the honey was mislabeled as to the country of origin before it passed
through a U.S. customhouse as non-Chinese origin honey. Mr. Yang and
National Commodities caused the formation of at least three companies
and used at least one other company to import and enter honey from a
Chinese honey supplier knowing that some of the honey was Chinese in
origin. Mr. Yang and National Commodities benefitted from the company's
filing custom entry forms that falsely and fraudulently declared all
the honey as originating from Malaysia and India. Mr. Yang and National
Commodities purchased honey imported by the companies despite knowing
that some or all of the honey was Chinese in origin, but declared at
the time of importation and entry as entirely originating from Malaysia
and India.
Mr. Yang also admitted that he obtained and circulated and caused
others to obtain and circulate false and fraudulent bills of lading,
invoices, packing lists, country of origin certificates, and other
papers, which he knew to be false and fraudulent. These records were
used to declare Chinese-origin honey as having originated from Malaysia
and India. Mr. Yang also instructed an undercover law enforcement agent
to destroy unfavorable test results that showed purported Vietnamese
honey that he sold tested positive for the presence of chloramphenicol,
an antibiotic. Residues of chloramphenicol in honey cause the honey to
be adulterated under the FD&C Act. In anticipation of an investigation
by U.S. Customs and Border Protection and FDA, Mr. Yang knowingly
concealed and covered up three laboratory reports showing the presence
of chloramphenicol.
As a result of his conviction, on October 1, 2014, FDA sent Mr.
Yang a notice by certified mail proposing to debar him for a period of
4 years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Mr. Yang's felony
conviction for smuggling of goods into the United States in violation
of 18 U.S.C. 545 constitutes conduct relating to the importation into
the United States of an article of food because he committed an offense
related to the importation of Chinese honey into the United States.
The proposal was also based on a determination, after consideration
of the factors set forth in section 306(c)(3) of the FD&C Act, that Mr.
Yang should be subject to a 4-year period of debarment. The proposal
also offered Mr. Yang 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. Yang failed to respond 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 Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section 306(b)(1)(C) of
the FD&C Act, under authority delegated to the Director (Staff Manual
Guide 1410.35), finds that Jun Yang has been convicted
[[Page 17452]]
of one felony count under Federal law for conduct relating to the
importation into the United States of an article of food and that he is
subject to a 4-year period of debarment.
As a result of the foregoing finding, Jun Yang is debarred for a
period of 4 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Jun Yang is
a prohibited act.
Any application by Mr. Yang for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2014-N-0964 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 may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: March 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07439 Filed 3-31-15; 8:45 am]
BILLING CODE 4164-01-P
