80 FR 17450 - Jun Yang: Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 62 (April 1, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 62 (April 1, 2015)
| Page Range | 17450-17452 | |
| FR Document | 2015-07439 |
[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)] [Notices] [Pages 17450-17452] From the Federal Register Online [www.thefederalregister.org] [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
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mstockstill on DSK4VPTVN1PROD with NOTICES
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HCUP@AHRQ.GOV. Jun Yang: Debarment Order
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of one felony count under Federal law Center for Surveillance, Epidemiology scientific oversight, and guidance in
for conduct relating to the importation and Laboratory Services (CPN) and program planning and development; (7)
into the United States of an article of insert the following: establishes and implements a
food and that he is subject to a 4-year Center for Surveillance, Epidemiology communications strategy in support of
period of debarment. and Laboratory Services (CPN) The CSELS overarching goals and priorities;
As a result of the foregoing finding, mission of the Center for Surveillance, (8) provides oversight for the evaluation
Jun Yang is debarred for a period of 4 Epidemiology, and Laboratory Services of programmatic performance of all
years from importing articles of food or (CSELS) is to provide scientific service, CSELS activities to ensure health
offering such articles for import into the expertise, skills, and tools in support of impact; (9) plans, coordinates, and
United States, effective (see DATES). CDC’s efforts to promote health; prevent manages all aspects of program business
Pursuant to section 301(cc) of the FD&C disease, injury and disability; and services including human and fiscal
Act (21 U.S.C. 331(cc)), the importing or prepare for emerging health threats. resources, extramural activities, space,
offering for import into the United CSELS focuses on improving and all administrative services; (10)
States of an article of food by, with the information and data quality, laboratory devises information technology
assistance of, or at the direction of Jun systems, and the public health practices and procedures, and provides
Yang is a prohibited act. workforce, through modernization, direction, innovation, planning and
Any application by Mr. Yang for innovation, and service. To carry out its evaluation for information technology
termination of debarment under section mission, CSELS (1) leads and executes systems, services, security, and
306(d)(1) of the FD&C Act should be a national public health surveillance resources for CSELS; (11) provides
identified with Docket No. FDA–2014– strategy for human health that builds leadership on issues management,
N–0964 and sent to the Division of upon current resources, establishes budget formulation and performance
Dockets Management (see ADDRESSES). priorities for the nation’s next- integration; (12) manages inter-
All such submissions are to be filed in generation capability and provides governmental and external affairs and
four copies. The public availability of timely, comprehensive, and accessible cultivates strategic partnerships; (13)
information in these submissions is information to strengthen public health ensures scientific quality, integrity, and
governed by 21 CFR 10.20(j). practice, and provide value to clearance across the Center; (14)
Publicly available submissions may clinicians; (2) participates in the provides guidance and strategic
be seen in the Division of Dockets identification, development, evolution, oversight to the processes within the
Management between 9 a.m. and 4 p.m., and adoption of informatics standards; Center that access, collect, manage,
Monday through Friday. (3) facilitates and coordinates program analyze, and visualize data, including
Dated: March 26, 2015.
and laboratory systems integration for assistance for involvement with federal
the Agency; (4) provides leadership and advisory committees and other high
Leslie Kux,
support to strengthen the quality and level groups; (15) monitors projects for
Associate Commissioner for Policy. safety of laboratory practices; (5)
[FR Doc. 2015–07439 Filed 3–31–15; 8:45 am]
effective focus on the analytical,
provides leadership for scientific informatics, data management, and
BILLING CODE 4164–01–P workforce education and advances statistical infrastructure to deliver
professional development; (6) provides quality data, accurate analysis services
leadership on public health genomics and dependable software products and
DEPARTMENT OF HEALTH AND strategy, activities, and planning; (7)
HUMAN SERVICES systems to customers and partners; (16)
creates and promotes access to quality,
collaborates and consults with other
timely and useful cross-cutting
Centers for Disease Control and Centers, working groups, state and local
scientific guidance, products, and
Prevention health departments, other federal
services to strengthen the science and
agencies, and other partners, to
Statement of Organization, Functions, practice of public health and to improve
accomplish the mission of the Center;
and Delegations of Authority public health decision-making.
Office of the Director (CPN1). (1) (17) reviews, prepares, coordinates, and
Part C (Centers for Disease Control Provides strategic direction regarding develops Congressional testimony and
and Prevention) of the Statement of surveillance, epidemiologic briefing materials; and (18) represents
Organization, Functions, and investigation, and data and information the CSELS and at times CDC at
Delegations of Authority of the sciences; (2) supports OPHSS’s CDC- professional and scientific meetings,
Department of Health and Human wide coordination and strategic within and outside CDC.
Services (45 FR 67772–76, dated activities in areas of health informatics Division of Laboratory Systems
October 14, 1980, and corrected at 45 FR technology, including the meaningful (CPNB). The mission of the Division of
69296, October 20, 1980, as amended use of electronic health records for Laboratory Systems (DLS) is to provide
most recently at 80 FR 1417–1419, dated public health surveillance and the leadership, support, and cross-cutting
January 9, 2015) is amended to reflect coordination of partners and services to continually strengthen the
the reorganization of the Office of Public stakeholders for biosurveillance, capability, sustainability, and quality of
Health Scientific Services, Centers for genomics, and publication science; (3) laboratory science, policy, and practice
Disease Control and Prevention. leads the development of public health at CDC, in clinical and public health
Section C–B, Organization and workforce training; (4) guides the laboratories, both in the United States
Functions, is hereby amended as development of laboratory systems and with international partners. DLS
mstockstill on DSK4VPTVN1PROD with NOTICES
follows: standards for quality and safety, strives to strengthen and align the
Delete in its entirety the title and including the Clinical Laboratory capacity and ability of both clinical and
functions statements for the Health Improvement Amendments (CLIA) and public health laboratories to perform
Information Technology and engagement with relevant federal their critical roles in protecting the
Surveillance Strategy Unit (CPA3), advisory committees; (5) manages, public’s health. In this mission, DLS: (1)
Office of the Director (CPA), directs, coordinates, and evaluates the Fosters collaboration across the
Delete in its entirety the title and the activities of the Center; (6) defines goals laboratory community; (2) strengthens
mission and function statements for the and objectives for policy formation, integration of laboratory science,
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Document Created: 2015-12-18 11:04:01
Document Modified: 2015-12-18 11:04:01
| 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 April 1, 2015. | |
| 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. | |
| FR Citation | 80 FR 17450 |
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