[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16680-16681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1044]


Shu Bei Yuan: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring 
Shu Bei Yuan for a period of 5 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. Yuan was convicted of one felony 
count under Federal law for conduct relating to the importation into 
the United States of an article of food. Ms. Yuan was given notice of 
the proposed debarment and an opportunity to request a hearing within 
the timeframe prescribed by regulation. As of December 31, 2012 (30 
days after receipt of the notice), Ms. Yuan had not responded. Ms. 
Yuan's failure to respond constitutes a waiver of her right to a 
hearing concerning this action.

DATES: This order is effective March 18, 2013.

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, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Dr., 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 June 22, 2012, Ms. Yuan 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: One count 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 
conviction referenced herein for conduct relating to the importation 
into the United States of any food. The factual basis for this 
conviction is as follows: In or around March 2005 and continuing until 
in or around November 2005, Ms. Yuan conducted a scheme to fraudulently 
enter goods into the United States by means of false statements and 
documents in violation of 18 U.S.C. 542. The purpose of Ms. Yuan's 
scheme was to import, enter, and sell Chinese-origin honey into the 
United States and avoid the payment of antidumping duties by falsely 
declaring to the U.S. Department of Homeland Security, Bureau of 
Customs and Border Protection (CBP) that the imported honey originated 
from countries other than China, including South Korea, when in fact 
Ms. Yuan knew that the honey originated from China.
    Between August and November 2005, Ms. Yuan and others caused the 
fraudulent import and entry into the United States of approximately 26 
entries of Chinese origin honey falsely declared as Korean honey, 
having a total declared entry value of approximately $808,287, thereby 
avoiding antidumping duties totaling approximately $1,485,631.
    As a result of her conviction, on November 30, 2012, FDA sent Ms. 
Yuan a notice by certified mail proposing to debar her for a period of 
5 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. Yuan was convicted 
of a felony under Federal law for 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 by means of false statements.
    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. 
Yuan should be subject to a 5-year period of debarment. The proposal 
also offered Ms. Yuan 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. Yuan 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 Associate Commissioner for Regulatory Affairs, 
Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C 
Act, and under authority delegated to the Associate Commissioner (Staff 
Manual Guide 1410.21), finds that Ms. Shu Bei Yuan has been convicted 
of a felony under Federal law for conduct relating to the importation 
of an article of food into the United States and that she is subject to 
a 5-year period of debarment.
    As a result of the foregoing finding, Ms. Yuan is debarred for a 
period of 5 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 Ms. Yuan is 
a prohibited act.
    Any application by Ms. Yuan for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2012-N-1044 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).

[[Page 16681]]

    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 28, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of 
Regulatory Affairs.
[FR Doc. 2013-06165 Filed 3-15-13; 8:45 am]
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