Hung Yi Lin; Debarment Order, 8664-8665 [2015-03210]
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Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices
Final Consultations
Final consultations are a one-time
burden. At some stage in the process of
research and development, a developer
will have accumulated the information
that the developer believes is adequate
to ensure that food derived from the
new plant variety is safe and that it
demonstrates compliance with the
relevant provisions of the FD&C Act.
The developer will then be in a position
to conclude any ongoing consultation
with FDA. The developer submits to
FDA a summary of the safety and
nutritional assessment that has been
conducted about the bioengineered food
that is intended to be introduced into
commercial distribution. FDA evaluates
the submission to ensure that all
potential safety and regulatory questions
have been addressed. FDA has
developed a form that prompts a
developer to include certain elements in
the final consultation in a standard
format: Form FDA 3665, entitled, ‘‘Final
Consultation for Food Derived From a
New Plant Variety (Biotechnology Final
Consultation).’’ The form, and elements
that would be prepared as attachments
to the form, can be submitted in
electronic format.
Upon implementation of the
collection, FDA contacted five firms that
had made one or more biotechnology
consultation submissions. We asked
each of these firms for an estimate of the
hourly burden to prepare a submission
under the voluntary biotechnology
consultation process. Based on
information provided by the three firms
who responded, we estimate the average
time to prepare a submission for final
consultation to be 150 hours.
Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03207 Filed 2–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1484]
Hung Yi Lin; Debarment Order
emcdonald on DSK67QTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
VerDate Sep<11>2014
19:32 Feb 17, 2015
Jkt 235001
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
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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 Chineseorigin 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 Chineseorigin 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 Chineseorigin 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
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 80, No. 32 / Wednesday, February 18, 2015 / Notices
emcdonald on DSK67QTVN1PROD with NOTICES
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
VerDate Sep<11>2014
19:32 Feb 17, 2015
Jkt 235001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–2245]
Immediately in Effect Guidance
Document: Classification and
Requirements for Laser Illuminated
Projectors; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Immediately in Effect Guidance
Document: Classification and
Requirements for Laser Illuminated
Projectors (LIPs).’’ This guidance
describes FDA’s policy with respect to
certain LIPs that comply with
International Electrotechnical
Commission (IEC) standards during
laser product classification under the
Electronic Product Radiation Control
provisions of the Federal Food, Drug
and Cosmetic Act (the FD&C Act) that
apply to electronic products.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment, submit either
electronic or written comments on the
guidance by April 20, 2015.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Immediately in
Effect Guidance Document:
Classification and Requirements for
Laser Illuminated Projectors’’ to the
Office of the Center Director, Guidance
and Policy Development, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request.
SUMMARY:
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
8665
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Patrick Hintz, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4248, Silver Spring,
MD 20993–0002, 301–796–6927.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry and FDA staff
entitled ‘‘Immediately in Effect
Guidance Document: Classification and
Requirements for Laser Illuminated
Projectors.’’ This guidance is being
issued consistent with FDA’s good
guidance practices (GGPs) regulation (21
CFR 10.115). The guidance is being
implemented without prior public
comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (21 CFR 10.115(g)(2)). The
Agency made this determination
because the guidance presents a less
burdensome policy consistent with the
public health. Although this guidance is
immediately in effect, it remains subject
to comment in accordance with the
Agency’s GGPs regulation. This
guidance describes FDA’s policy with
respect to certain LIPs that comply with
IEC standards during laser product
classification under the Electronic
Product Radiation Control provisions of
the FD&C Act that apply to electronic
products. The regulations for classifying
laser products are set forth in part 1040
(21 CFR part 1040).
For purposes of this guidance, the
term ‘‘laser illuminated projector’’ refers
to a type of demonstration laser product
regulated under § 1040.10(b)(13) that is
designed to project full-frame digital
images. The term ‘‘demonstration laser
product’’ is defined under
§ 1040.10(b)(13) to mean, ‘‘Any laser
product manufactured, designed,
intended, or promoted for purposes of
demonstration, entertainment,
advertising display, or artistic
composition.’’ LIPs may be used in
locations such as indoor or outdoor
cinema theaters, laser shows,
presentations at conventions, as image/
data projectors in an office setting, or in
a home.
Lasers are being used in LIPs as an
alternative to conventional lamps in
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Notices]
[Pages 8664-8665]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03210]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
