Hung Ta Fan: Debarment Order, 50739-50740 [2011-20780]
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50739
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
The preliminary design is included as
follows:
TABLE 1—STUDY DESIGN
Condition A ........................
Format of disease information
Disease outcome
information
Medical condition
Integrated
Control
(no disease information)
Separated
No Outcomes
Outcomes
Condition B ........................
No Outcomes
Outcomes
Condition C ........................
No Outcomes
Outcomes
FDA estimates the burden of this
collection of information as follows: We
estimate the response burden to be 20
minutes in the pretests and the study,
for a burden of 1,985 hours. This will
be a one time (rather than annual)
collection of information. The
questionnaire is available upon request.
The response burden chart is listed as
follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN5
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
respondents
Average burden
per response
Total hours
Screener ............................................................
Pretests .............................................................
Study .................................................................
6,750
900
4,500
1
1
1
6,750
900
4,500
0.03 (2 min.) .....
0.33 (20 min.) ...
0.33 (20 min.) ...
203
297
1,485
Total ...........................................................
............................
............................
............................
...........................
1,985
Dated: August 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20814 Filed 8–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0183]
Hung Ta Fan: 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
Hung Ta Fan 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
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
5 There
are no capital costs or operating and
maintenance costs associated with this collection of
information.
VerDate Mar<15>2010
18:07 Aug 15, 2011
Jkt 223001
a finding that Mr. Fan was convicted of
a felony under Federal law for conduct
relating to the importation into the
United States of an article of food. Mr.
Fan was given notice of the proposed
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. As of July 13,
2011 (30 days after receipt of the
notice), Mr. Fan had not responded.
Mr. Fan’s failure to respond constitutes
a waiver of his right to a hearing
concerning this action.
DATES: This order is effective August 16,
2011.
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 (HFC–230), Food and Drug
Administration, 5600 Fishers Lane,
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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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 August 4, 2010, the United States
District Court for the Northern District
of Illinois accepted Mr. Fan’s guilty plea
and entered judgment against him for
the offense of conspiracy, in violation of
18 U.S.C. 371 and 2, for conspiring to
defraud the United States and to violate
18 U.S.C. 542 (entry of Goods into the
United States by means of false
statements) and 18 U.S.C. 545
(importation contrary to law).
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
2006, in violation of 18 U.S.C. 371 and
2, Mr. Fan agreed and conspired with
others to defraud the United States and
E:\FR\FM\16AUN1.SGM
16AUN1
emcdonald on DSK2BSOYB1PROD with NOTICES
50740
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
to commit offenses against the United
States, to wit: Entry of Goods into the
United States by means of False
statements in violation of 18 U.S.C. 542
and Smuggled Goods into the United
States in violation of 18 U.S.C. 545.
Specifically, Mr. Fan owned and
operated Blue Action Enterprise, Inc., 7
Tiger Enterprise, Inc., Honey World
Enterprise, Inc., Kazak Food Corp., and
Kashaka USA, Inc., through which he
imported honey into the United States.
Mr. Fan conspired to cause these
companies to import, enter, and sell
Chinese-origin honey into the United
States and avoid payment of
antidumping duties by falsely declaring
to the U.S. Department of Homeland
Security, Bureau of Customs and Border
Protection that the imported honey
originated from countries other than
China, including India, South Korea,
Taiwan, and Thailand, when in fact he
knew that the honey originated in
China. Mr. Fan’s actions allowed him to
avoid paying approximately $5,378,370
in antidumping duties to the United
States.
Further, in or around January 2009, in
violation of 18 U.S.C. 371 and 2, Mr.
Fan agreed and conspired with others to
enter into the commerce of the United
States honey diluted and blended with
approximately 20 to 30 percent artificial
sugar, by means of false and fraudulent
declarations and practices in violation
of 18 U.S.C. 542, for the purpose of
increasing his profits.
As a result of his conviction, on June
8, 2011, FDA sent Mr. Fan a notice by
certified mail proposing to debar him
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 Mr. Fan was convicted of a felony
under Federal law for conduct relating
to the importation into the United States
of an article of food because he
conspired to commit offenses related to
the importation of Chinese honey into
the United States, and a determination,
after consideration of the factors set
forth in section 306(c)(3) of the FD&C
Act that Mr. Fan should be subject to
the maximum possible period of
debarment. The proposal also offered
Mr. Fan 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. Fan failed to respond within
the timeframe prescribed by regulation
and has, therefore, waived his
opportunity for a hearing and waived
VerDate Mar<15>2010
18:07 Aug 15, 2011
Jkt 223001
any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Director, Office of
Enforcement, Office of Regulatory
Affairs, under section 306(b)(1)(C) of the
FD&C Act, and under authority
delegated to the Director (Staff Manual
Guide 1410.35), finds that Mr. Hung Ta
Fan 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 he is
subject to the full period of debarment.
As a result of the foregoing finding,
Mr. Fan 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 Mr.
Fan is a prohibited act.
Any application by Mr. Fan for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2011–
N–0183 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: August 8, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2011–20780 Filed 8–15–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0514]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Procedures for Handling Section 522
Postmarket Surveillance Studies;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Procedures for Handling
Section 522 Postmarket Surveillance
SUMMARY:
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Frm 00026
Fmt 4703
Sfmt 4703
Studies.’’ This guidance document is
intended to assist device manufacturers
subject to a section 522 postmarket
surveillance order imposed by FDA by
providing an overview of section 522 of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), procedural
information on how to fulfill section
522 obligations, and recommendations
on the format, content, and review of
postmarket surveillance study
submissions. This draft guidance is not
final nor is it in effect at this time.
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 on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 14,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Procedures for
Handling Section 522 Postmarket
Surveillance Studies’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft 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:
Mary Beth Ritchey, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4115, Silver Spring,
MD 20993–0002, 301– 96–6638.
SUPPLEMENTARY INFORMATION:
I. Background
Postmarket surveillance under section
522 of the FD&C Act (21 U.S.C. 306l) is
one means by which FDA can obtain
additional information when it is
necessary to protect the public health or
provide safety and/or effectiveness data
for a device after it has been cleared or
approved. The Food and Drug
Administration Amendments Act of
2007 amended section 522 of the FD&C
E:\FR\FM\16AUN1.SGM
16AUN1
Agencies
[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50739-50740]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20780]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0183]
Hung Ta Fan: 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
Hung Ta Fan 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 Mr. Fan was convicted of a felony
under Federal law for conduct relating to the importation into the
United States of an article of food. Mr. Fan was given notice of the
proposed debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. As of July 13, 2011 (30 days after
receipt of the notice), Mr. Fan had not responded. Mr. Fan's failure to
respond constitutes a waiver of his right to a hearing concerning this
action.
DATES: This order is effective August 16, 2011.
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 (HFC-230), Food and Drug Administration, 5600 Fishers Lane,
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 August 4, 2010, the United States District Court for the
Northern District of Illinois accepted Mr. Fan's guilty plea and
entered judgment against him for the offense of conspiracy, in
violation of 18 U.S.C. 371 and 2, for conspiring to defraud the United
States and to violate 18 U.S.C. 542 (entry of Goods into the United
States by means of false statements) and 18 U.S.C. 545 (importation
contrary to law).
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 2006, in violation of 18 U.S.C. 371 and 2, Mr.
Fan agreed and conspired with others to defraud the United States and
[[Page 50740]]
to commit offenses against the United States, to wit: Entry of Goods
into the United States by means of False statements in violation of 18
U.S.C. 542 and Smuggled Goods into the United States in violation of 18
U.S.C. 545. Specifically, Mr. Fan owned and operated Blue Action
Enterprise, Inc., 7 Tiger Enterprise, Inc., Honey World Enterprise,
Inc., Kazak Food Corp., and Kashaka USA, Inc., through which he
imported honey into the United States. Mr. Fan conspired to cause these
companies to import, enter, and sell Chinese-origin honey into the
United States and avoid payment of antidumping duties by falsely
declaring to the U.S. Department of Homeland Security, Bureau of
Customs and Border Protection that the imported honey originated from
countries other than China, including India, South Korea, Taiwan, and
Thailand, when in fact he knew that the honey originated in China. Mr.
Fan's actions allowed him to avoid paying approximately $5,378,370 in
antidumping duties to the United States.
Further, in or around January 2009, in violation of 18 U.S.C. 371
and 2, Mr. Fan agreed and conspired with others to enter into the
commerce of the United States honey diluted and blended with
approximately 20 to 30 percent artificial sugar, by means of false and
fraudulent declarations and practices in violation of 18 U.S.C. 542,
for the purpose of increasing his profits.
As a result of his conviction, on June 8, 2011, FDA sent Mr. Fan a
notice by certified mail proposing to debar him 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 Mr. Fan was convicted of a
felony under Federal law for conduct relating to the importation into
the United States of an article of food because he conspired to commit
offenses related to the importation of Chinese honey into the United
States, and a determination, after consideration of the factors set
forth in section 306(c)(3) of the FD&C Act that Mr. Fan should be
subject to the maximum possible period of debarment. The proposal also
offered Mr. Fan 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. Fan 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, Office of
Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and
under authority delegated to the Director (Staff Manual Guide 1410.35),
finds that Mr. Hung Ta Fan 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 he is subject to the full period of
debarment.
As a result of the foregoing finding, Mr. Fan 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 Mr. Fan is a
prohibited act.
Any application by Mr. Fan for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2011-N-0183 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: August 8, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-20780 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P