80_FR_8696 80 FR 8664 - Hung Yi Lin; Debarment Order

80 FR 8664 - Hung Yi Lin; Debarment Order

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 32 (February 18, 2015)

Page Range8664-8665
FR Document2015-03210

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Hung Yi Lin for a period of 12 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Lin was convicted, as defined in the FD&C Act, of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Lin was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of August 29, 2014 (30 days after receipt of the notice), Ms. Lin had not responded. Ms. Lin's failure to respond constitutes a waiver of her right to a hearing concerning this action.

Federal Register, Volume 80 Issue 32 (Wednesday, February 18, 2015) 
[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8664-8665]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03210]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1484]


Hung Yi Lin; Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring Hung Yi Lin for a period of 12 years from importing articles 
of food or offering such articles for importation into the United 
States. FDA bases this order on a finding that Ms. Lin was convicted, 
as defined in the FD&C Act, of three felony counts under Federal law 
for conduct relating to the importation into the United States of an 
article of food. Ms. Lin was given notice of the proposed debarment and 
an opportunity to request a hearing within the timeframe prescribed by 
regulation. As of August 29, 2014 (30 days after receipt of the 
notice), Ms. Lin had not responded. Ms. Lin's failure to respond 
constitutes a waiver of her right to a hearing concerning this action.

DATES: This order is effective February 18, 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. (ELEM4144), 
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 September 30, 2013, Ms. Lin 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 her plea of guilty and entered 
judgment against her for the following offense: Three counts of entry 
of goods into the United States by means of false statements, in 
violation of 18 U.S.C. 542.
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein. The factual basis for these convictions 
is as follows: Ms. Lin owned and operated KBB Express Inc., a freight 
forwarding company located in South El Monte, CA that provided 
nationwide transportation, delivery, and other logistical services for 
imported and entered merchandise, including Chinese-origin honey. Ms. 
Lin also served as the U.S. agent for at least 12 importers for which 
she handled the process of importing, and coordinating with brokers to 
enter and bring in, Chinese-origin honey into the United States.
    On or about December 13, 2009, Ms. Lin entered and introduced 
Chinese-origin honey into the United States by means of a false and 
fraudulent practice, false statement, and fraudulent and false papers, 
including Bureau of Customs and Border Protection (CBP) forms that 
falsely declared that approximately four container loads of Chinese-
origin honey with a declared value upon entry of approximately $92,822 
was Chinese honey syrup. By so doing, Ms. Lin caused losses to the 
United States of approximately $205,141 in uncollected anti-dumping 
duties and honey assessment fees, when in fact she knew the product was 
Chinese honey. This was in violation of 18 U.S.C. 542.
    On or about December 13, 2009, Ms. Lin entered and introduced 
Chinese-origin honey into the United States by means of a false and 
fraudulent practice, false statement, and fraudulent and false papers, 
including CBP forms that falsely declared that approximately three 
container loads of Chinese-origin honey with a declared value upon 
entry of approximately $69,617 was Chinese honey syrup. By so doing, 
Ms. Lin caused losses to the United States of approximately $153,855 in 
uncollected anti-dumping duties and honey assessment fees, when in fact 
she knew the product was Chinese honey. This was in violation of 18 
U.S.C. 542.
    On or about December 13, 2009, Ms. Lin entered and introduced 
Chinese-origin honey into the United States by means of a false and 
fraudulent practice, false statement, and fraudulent and false papers, 
including CPB forms that falsely declared that approximately three 
container loads of Chinese-origin honey with a declared value upon 
entry of approximately $69,617 was Chinese honey syrup. By so doing, 
Ms. Lin caused losses to the United States of approximately $153,855 in 
uncollected anti-dumping duties and honey assessment fees, when in fact 
she knew the product was Chinese honey. This was in violation of 18 
U.S.C. 542.
    Ms. Lin admitted that between 2009 and 2012, she caused up to 764 
shipping containers of Chinese-origin honey valued at approximately 
$11,489,306 to be fraudulently imported and entered into the United 
States, thereby causing losses to the United States of as much as 
$39,203,144 through her fraudulent practices.
    As a result of her conviction, on July 25, 2014, FDA sent Ms. Lin a 
notice by certified mail proposing to debar her for

[[Page 8665]]

a period of 12 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 Ms. Lin's 
felony convictions for entry of goods by means of false statements in 
violation of 18 U.S.C. 542 constitute conduct relating to the 
importation into the United States of an article of food because she 
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 Ms. 
Lin should be subject to a 12-year period of debarment. The proposal 
also offered Ms. Lin 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. Lin failed to respond within the timeframe 
prescribed by regulation and has, therefore, waived her opportunity for 
a hearing and 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)(1)(C) of 
the FD&C Act, under authority delegated to the Director (Staff Manual 
Guide 1410.35), finds that Hung Yi Lin has been convicted of three 
felony counts under Federal law for conduct relating to the importation 
into the United States of an article of food and that she is subject to 
a 12-year period of debarment.
    As a result of the foregoing finding, Hung Yi Lin is debarred for a 
period of 12 years from importing articles of food or offering such 
articles for import into the United States, effective (see DATES). 
Under 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 Hung Yi Lin 
is a prohibited act.
    Any application by Ms. Lin for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2013-N-1484 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: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03210 Filed 2-17-15; 8:45 am]
BILLING CODE 4164-01-P

8664 Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices Final Consultations food or offering such articles for importers for which she handled the Final consultations are a one-time importation into the United States. FDA process of importing, and coordinating burden. At some stage in the process of bases this order on a finding that Ms. with brokers to enter and bring in, research and development, a developer Lin was convicted, as defined in the Chinese-origin honey into the United will have accumulated the information FD&C Act, of three felony counts under States. Federal law for conduct relating to the On or about December 13, 2009, Ms. that the developer believes is adequate importation into the United States of an Lin entered and introduced Chinese- to ensure that food derived from the article of food. Ms. Lin was given notice origin honey into the United States by new plant variety is safe and that it of the proposed debarment and an means of a false and fraudulent practice, demonstrates compliance with the opportunity to request a hearing within false statement, and fraudulent and false relevant provisions of the FD&C Act. the timeframe prescribed by regulation. papers, including Bureau of Customs The developer will then be in a position As of August 29, 2014 (30 days after and Border Protection (CBP) forms that to conclude any ongoing consultation receipt of the notice), Ms. Lin had not falsely declared that approximately four with FDA. The developer submits to responded. Ms. Lin’s failure to respond container loads of Chinese-origin honey FDA a summary of the safety and with a declared value upon entry of nutritional assessment that has been constitutes a waiver of her right to a hearing concerning this action. approximately $92,822 was Chinese conducted about the bioengineered food honey syrup. By so doing, Ms. Lin that is intended to be introduced into DATES: This order is effective February 18, 2015. caused losses to the United States of commercial distribution. FDA evaluates approximately $205,141 in uncollected the submission to ensure that all ADDRESSES: Submit applications for anti-dumping duties and honey potential safety and regulatory questions termination of debarment to the assessment fees, when in fact she knew have been addressed. FDA has Division of Dockets Management (HFA– the product was Chinese honey. This developed a form that prompts a 305), Food and Drug Administration, was in violation of 18 U.S.C. 542. developer to include certain elements in 5630 Fishers Lane, Rm. 1061, Rockville, On or about December 13, 2009, Ms. the final consultation in a standard MD 20852. Lin entered and introduced Chinese- format: Form FDA 3665, entitled, ‘‘Final FOR FURTHER INFORMATION CONTACT: origin honey into the United States by Consultation for Food Derived From a Kenny Shade, Division Of Enforcement, means of a false and fraudulent practice, New Plant Variety (Biotechnology Final Office of Enforcement and Import false statement, and fraudulent and false Consultation).’’ The form, and elements Operations, Office of Regulatory Affairs, papers, including CBP forms that falsely that would be prepared as attachments Food and Drug Administration, 12420 declared that approximately three to the form, can be submitted in Parklawn Dr. (ELEM4144), Rockville, container loads of Chinese-origin honey electronic format. MD 20857, 301–796–4640. with a declared value upon entry of Upon implementation of the SUPPLEMENTARY INFORMATION: approximately $69,617 was Chinese collection, FDA contacted five firms that honey syrup. By so doing, Ms. Lin had made one or more biotechnology I. Background caused losses to the United States of consultation submissions. We asked Section 306(b)(1)(C) of the FD&C Act approximately $153,855 in uncollected each of these firms for an estimate of the (21 U.S.C. 335a(b)(1)(C)) permits FDA to anti-dumping duties and honey hourly burden to prepare a submission debar an individual from importing an assessment fees, when in fact she knew under the voluntary biotechnology article of food or offering such an article the product was Chinese honey. This consultation process. Based on for import into the United States if FDA was in violation of 18 U.S.C. 542. information provided by the three firms finds, as required by section On or about December 13, 2009, Ms. who responded, we estimate the average 306(b)(3)(A) of the FD&C Act, that the Lin entered and introduced Chinese- time to prepare a submission for final individual has been convicted of a origin honey into the United States by consultation to be 150 hours. felony for conduct relating to the means of a false and fraudulent practice, Dated: February 11, 2015. importation into the United States of false statement, and fraudulent and false Leslie Kux, any food. papers, including CPB forms that falsely On September 30, 2013, Ms. Lin was declared that approximately three Associate Commissioner for Policy. convicted, as defined in section container loads of Chinese-origin honey [FR Doc. 2015–03207 Filed 2–17–15; 8:45 am] 306(l)(1)(B) of the FD&C Act, when the with a declared value upon entry of BILLING CODE 4164–01–P U.S. District Court for the Northern approximately $69,617 was Chinese District of Illinois accepted her plea of honey syrup. By so doing, Ms. Lin guilty and entered judgment against her caused losses to the United States of DEPARTMENT OF HEALTH AND for the following offense: Three counts approximately $153,855 in uncollected HUMAN SERVICES of entry of goods into the United States anti-dumping duties and honey Food and Drug Administration by means of false statements, in assessment fees, when in fact she knew violation of 18 U.S.C. 542. the product was Chinese honey. This [Docket No. FDA–2013–N–1484] FDA’s finding that debarment is was in violation of 18 U.S.C. 542. appropriate is based on the felony Ms. Lin admitted that between 2009 Hung Yi Lin; Debarment Order convictions referenced herein. The and 2012, she caused up to 764 AGENCY: Food and Drug Administration, factual basis for these convictions is as shipping containers of Chinese-origin HHS. follows: Ms. Lin owned and operated honey valued at approximately emcdonald on DSK67QTVN1PROD with NOTICES ACTION: Notice. KBB Express Inc., a freight forwarding $11,489,306 to be fraudulently imported company located in South El Monte, CA and entered into the United States, SUMMARY: The Food and Drug that provided nationwide thereby causing losses to the United Administration (FDA or Agency) is transportation, delivery, and other States of as much as $39,203,144 issuing an order under the Federal logistical services for imported and through her fraudulent practices. Food, Drug, and Cosmetic Act (FD&C entered merchandise, including As a result of her conviction, on July Act) debarring Hung Yi Lin for a period Chinese-origin honey. Ms. Lin also 25, 2014, FDA sent Ms. Lin a notice by of 12 years from importing articles of served as the U.S. agent for at least 12 certified mail proposing to debar her for VerDate Sep<11>2014 19:32 Feb 17, 2015 Jkt 235001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1

Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices 8665 a period of 12 years from importing Management between 9 a.m. and 4 p.m., Submit electronic comments on the articles of food or offering such articles Monday through Friday. guidance to http://www.regulations.gov. for import into the United States. The Dated: February 11, 2015. Submit written comments to the proposal was based on a finding under Leslie Kux, Division of Dockets Management (HFA– section 306(b)(1)(C) of the FD&C Act 305), Food and Drug Administration, Associate Commissioner for Policy. that Ms. Lin’s felony convictions for 5630 Fishers Lane, Rm. 1061, Rockville, entry of goods by means of false [FR Doc. 2015–03210 Filed 2–17–15; 8:45 am] MD 20852. Identify comments with the statements in violation of 18 U.S.C. 542 BILLING CODE 4164–01–P docket number found in brackets in the constitute conduct relating to the heading of this document. importation into the United States of an FOR FURTHER INFORMATION CONTACT: article of food because she committed DEPARTMENT OF HEALTH AND HUMAN SERVICES Patrick Hintz, Center for Devices and an offense related to the importation of Radiological Health, Food and Drug Chinese honey into the United States. Food and Drug Administration Administration, 10903 New Hampshire The proposal was also based on a Ave., Bldg. 66, Rm. 4248, Silver Spring, determination, after consideration of the [Docket No. FDA–2014–D–2245] MD 20993–0002, 301–796–6927. factors set forth in section 306(c)(3) of Immediately in Effect Guidance SUPPLEMENTARY INFORMATION: the FD&C Act, that Ms. Lin should be subject to a 12-year period of Document: Classification and I. Background debarment. The proposal also offered Requirements for Laser Illuminated Projectors; Guidance for Industry and FDA is announcing the availability of Ms. Lin an opportunity to request a Food and Drug Administration Staff; a guidance for industry and FDA staff hearing, providing her 30 days from the Availability entitled ‘‘Immediately in Effect date of receipt of the letter in which to Guidance Document: Classification and file the request, and advised her that AGENCY: Food and Drug Administration, Requirements for Laser Illuminated failure to request a hearing constituted HHS. Projectors.’’ This guidance is being a waiver of the opportunity for a hearing and of any contentions concerning this ACTION: Notice. issued consistent with FDA’s good action. Ms. Lin failed to respond within guidance practices (GGPs) regulation (21 SUMMARY: The Food and Drug CFR 10.115). The guidance is being the timeframe prescribed by regulation Administration (FDA) is announcing the and has, therefore, waived her implemented without prior public availability of the guidance entitled comment because the Agency has opportunity for a hearing and waived ‘‘Immediately in Effect Guidance any contentions concerning her determined that prior public Document: Classification and participation is not feasible or debarment (21 CFR part 12). Requirements for Laser Illuminated appropriate (21 CFR 10.115(g)(2)). The II. Findings and Order Projectors (LIPs).’’ This guidance Agency made this determination describes FDA’s policy with respect to because the guidance presents a less Therefore, the Director, Office of certain LIPs that comply with burdensome policy consistent with the Enforcement and Import Operations, International Electrotechnical public health. Although this guidance is Office of Regulatory Affairs, under Commission (IEC) standards during immediately in effect, it remains subject section 306(b)(1)(C) of the FD&C Act, laser product classification under the to comment in accordance with the under authority delegated to the Electronic Product Radiation Control Agency’s GGPs regulation. This Director (Staff Manual Guide 1410.35), provisions of the Federal Food, Drug guidance describes FDA’s policy with finds that Hung Yi Lin has been and Cosmetic Act (the FD&C Act) that respect to certain LIPs that comply with convicted of three felony counts under apply to electronic products. IEC standards during laser product Federal law for conduct relating to the DATES: Although you can comment on classification under the Electronic importation into the United States of an article of food and that she is subject to any guidance at any time (see 21 CFR Product Radiation Control provisions of a 12-year period of debarment. 10.115(g)(5)), to ensure that the Agency the FD&C Act that apply to electronic As a result of the foregoing finding, considers your comment, submit either products. The regulations for classifying Hung Yi Lin is debarred for a period of electronic or written comments on the laser products are set forth in part 1040 12 years from importing articles of food guidance by April 20, 2015. (21 CFR part 1040). or offering such articles for import into ADDRESSES: An electronic copy of the For purposes of this guidance, the the United States, effective (see DATES). guidance document is available for term ‘‘laser illuminated projector’’ refers Under section 301(cc) of the FD&C Act download from the Internet. See the to a type of demonstration laser product (21 U.S.C. 331(cc)), the importing or SUPPLEMENTARY INFORMATION section for regulated under § 1040.10(b)(13) that is offering for import into the United information on electronic access to the designed to project full-frame digital States of an article of food by, with the guidance. Submit written requests for a images. The term ‘‘demonstration laser assistance of, or at the direction of Hung single hard copy of the guidance product’’ is defined under Yi Lin is a prohibited act. document entitled ‘‘Immediately in § 1040.10(b)(13) to mean, ‘‘Any laser Any application by Ms. Lin for Effect Guidance Document: product manufactured, designed, termination of debarment under section Classification and Requirements for intended, or promoted for purposes of 306(d)(1) of the FD&C Act should be Laser Illuminated Projectors’’ to the demonstration, entertainment, identified with Docket No. FDA–2013– Office of the Center Director, Guidance advertising display, or artistic emcdonald on DSK67QTVN1PROD with NOTICES N–1484 and sent to the Division of and Policy Development, Center for composition.’’ LIPs may be used in Dockets Management (see ADDRESSES). Devices and Radiological Health, Food locations such as indoor or outdoor All such submissions are to be filed in and Drug Administration, 10903 New cinema theaters, laser shows, four copies. The public availability of Hampshire Ave., Bldg. 66, Rm. 5431, presentations at conventions, as image/ information in these submissions is Silver Spring, MD 20993–0002. Send data projectors in an office setting, or in governed by 21 CFR 10.20(j). one self-addressed adhesive label to a home. Publicly available submissions may assist that office in processing your Lasers are being used in LIPs as an be seen in the Division of Dockets request. alternative to conventional lamps in VerDate Sep<11>2014 19:32 Feb 17, 2015 Jkt 235001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\18FEN1.SGM 18FEN1


Document Created: 2018-02-16 11:10:43
Document Modified: 2018-02-16 11:10:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis order is effective February 18, 2015.
ContactKenny Shade, Division Of Enforcement, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM4144), Rockville, MD 20857, 301-796-4640.
FR Citation80 FR 8664 
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