Shu Bei Yuan: Debarment Order, 16680-16681 [2013-06165]
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Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices
comment. In general, medical policy
decisions reached by the Council are
communicated and implemented in
accordance with FDA’s good guidance
practices regulation (21 CFR 10.115) or
notice and comment procedures.
IV. Request for Comments
Interested persons may submit either
written comments regarding this notice
to the Division of Dockets Management
(see ADDRESSES) or electronic comments
to https://www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–06142 Filed 3–15–13; 8:45 am]
BILLING CODE 4160–01–P
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.
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–
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<14>2013
15:16 Mar 15, 2013
Jkt 229001
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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).
E:\FR\FM\18MRN1.SGM
18MRN1
Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices
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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0222]
International Conference on
Harmonisation; Proposed Change to
Rodent Carcinogenicity Testing of
Pharmaceuticals; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
considering a proposed change to the
International Conference on
Harmonisation (ICH) Sl guidance on
rodent carcinogenicity testing. The goal
of this potential change is to introduce
a more comprehensive and integrated
approach to address the risk of human
carcinogenicity of small molecule
pharmaceuticals, and to define
conditions under which 2-year rodent
carcinogenicity studies add value to that
assessment. The basis of this proposed
change is the retrospective analyses of
several datasets that reflect three
decades of experience with such
studies. The datasets suggest that
knowledge of certain pharmacologic and
toxicologic data can sometimes provide
sufficient information to anticipate the
outcome of 2-year rodent studies and
their potential value in predicting the
risk of human carcinogenicity of a given
pharmaceutical. FDA is requesting
public comment regarding a proposed
change in approach to carcinogenicity
assessment, on the prospective
evaluation period intended to test this
new approach, and on the proposed
weight-of-evidence factors for
carcinogenicity assessment.
DATES: Submit electronic or written
comments on the proposed change by
May 17, 2013.
ADDRESSES: Submit electronic
comments on the proposed change to
https://www.regulations.gov. Submit
written comments to the Division of
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<14>2013
15:16 Mar 15, 2013
Jkt 229001
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Todd Bourcier, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 3102,
Silver Spring, MD 20993–0002, 301–
796–1179.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is considering a change in the
current ICH S1 guidance on rodent
carcinogenicity testing.1 The goal of this
potential change is to introduce a more
comprehensive and integrated approach
to address the risk of human
carcinogenicity of small molecule
pharmaceuticals, and to define
conditions under which 2-year rodent
carcinogenicity studies add value to that
assessment.
Datasets evaluated by the ICH S1
expert working group (S1 EWG) suggest
that knowledge of pharmacologic targets
and pathways together with
toxicological and other data can, in
certain cases, provide sufficient
information to anticipate the outcome of
2-year rodent studies and their potential
value in predicting the risk of human
carcinogenicity of a given
pharmaceutical. It is hypothesized that
consideration of this information can
provide sufficient information to
conclude that a given pharmaceutical in
certain cases presents a negligible risk
or, conversely, a likely risk of human
carcinogenicity without conducting a 2year rodent study. It is envisioned that
sponsors of such pharmaceuticals
would provide drug regulatory agencies
(DRAs) a carcinogenicity assessment
document (CAD) that could justify a
‘‘waiver request’’ that would seek to
omit the conduct of 2-year rodent
studies. The CAD would address the
overall carcinogenic risk of the
investigational drug as predicted by the
endpoints discussed in this document
and a rationale for why the conduct of
2-year rodent studies would or would
not add value to that assessment.
Prospective evaluation of this
proposed hypothesis is necessary to
1 See the ICH S1 guidance documents, ‘‘S1A The
Need for Long-Term Rodent Carcinogenicity
Studies of Pharmaceuticals’’ (ICH S1A), ‘‘S1B
Testing for Carcinogenicity of Pharmaceuticals’’
(ICH S1B), and ‘‘S1C(R2) Dose Selection for
Carcinogenicity Studies of Pharmaceuticals’’ (ICH
S1C), available on the Internet at https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/default.htm or https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatoryInformation/
Guidances/default.htm.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
16681
justify proceeding with revision of the
ICH S1 guidance. A prospective
evaluation period would be sought
wherein sponsors would be requested to
submit CADs to DRAs for all
investigational pharmaceuticals with
ongoing or planned 2-year rodent
studies. DRAs from each region would
independently review the submitted
assessments to evaluate the degree of
concordance with sponsors and between
regulatory regions. During this
prospective evaluation period, the
waiver requests would not to be granted
and rather are intended solely for
gathering experience and hypothesis
testing. Submitted assessments would
be compared to the outcome of the 2year rodent studies to evaluate the
accuracy and relevance of the
predictions to the actual experimental
results. Experience from this
prospective evaluation period is
considered critical to informing the S1
EWG’s efforts in revising the current
paradigm of assessing the
carcinogenicity of small molecules as
described in the ICH S1 guidance. FDA
is requesting public comment regarding
the proposed change in approach to
carcinogenicity assessment, on the
prospective evaluation period intended
to test this new approach, and on the
weight-of-evidence (WOE) factors
proposed for inclusion in CADs.
II. Past Experience With
Carcinogenicity Assessment
The strategy of testing for
carcinogenic potential was the first
safety topic addressed by ICH. The main
topics were the need to conduct a study
(ICH S1A), the selection criteria for the
rodent species (ICH S1B), and the
criteria for selecting the maximum dose
(ICH S1C). During the discussion in that
period, the relevance of the lifetime
carcinogenicity studies in rats and mice
was already highly debated, but in the
absence of an alternative, the outcome
of the negotiations did not really change
the basic strategy of testing
pharmaceuticals for human use in two
rodent species. A proposal to not use
the mouse as a second species did not
receive sufficient support, although it
paved the way to introduce transgenic
mice with a 6- to 9-month treatment as
an appropriate alternative (ICH S1B).
In the following years, considerable
resources have been spent to evaluate
the approaches using the transgenic
mice (Ref. 1). Also, other models and
approaches received attention,
especially the possibility to predict the
outcome of carcinogenicity studies on
the basis of the results of 3- to 6-month
studies (Ref. 2).
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16680-16681]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06165]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-P
