Su Van Ho: Debarment Order, 52534-52535 [2010-21258]
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52534
Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices
Proposed Project: Sickle Cell Disease
and Other Hemoglobinopathies
Program Evaluation—[NEW]
Background: In response to the
growing need for resources devoted to
sickle cell disease and other
hemoglobinopathies, Congress, under
Section 501(a)2 of the Social Security
Act (2000), authorized the appropriation
of funds for enabling the Secretary to
provide for special projects of regional
and national significance, research and
training with respect to maternal and
child health and children with special
health care needs the following: Genetic
disease testing, counseling and
information development and
dissemination programs, for grants
relating to hemophilia without regard to
age, and for the screening of newborns
for sickle cell anemia and other genetic
disorders, and follow-up services. As
stated in House Report No. 107–229
regarding the Department of Labor,
Health and Human Services, and
Education, and Related Agencies
Appropriation Bill 2002, the purpose of
the Sickle Cell Disease and Newborn
Screening Program (SCDNBSP) is ‘‘to
enhance the sickle cell disease newborn
screening program and its locally based
outreach and counseling efforts.’’ In
addition, the American Jobs Creation
Act of 2004, Public Law 108–357, states
that ‘‘* * * the Bureau of Primary
Health Care and the Maternal and Child
Health Bureau, shall conduct a
demonstration program by making
grants for up to 40 eligible entities, for
each fiscal year in which the program is
conducted under this section, for the
purpose of developing and establishing
systemic mechanisms to improve the
Questionnaires
prevention and treatment of Sickle Cell
Disease.’’ (See 42 U.S.C. 300b–1).
Purpose: HRSA’s activities under the
legislative authorities relative to the
Sickle Cell Disease and Newborn
Screening Program (SCDNBSP) have
been delegated to the Maternal and
Child Health Bureau (MCHB), Genetic
Services Branch (GSB). The MCHB’s
GSB supports seventeen community
based organizations and the National
Coordinating and Evaluation Center for
the Sickle Cell Disease and Newborn
Screening Program (SCDNBS) in
addition to nine cooperative agreements
and a National Coordinating Center for
the Sickle Cell Disease Treatment
Demonstration Program (SCDTDP). An
evaluation will be conducted to assess
the service delivery processes and
quality of the system of care delivered
by grantees under the Newborn
Screening Program to individuals
affected by Sickle Cell disease who
present at their sites for care. The
Centers for Disease Control and
Prevention defines Hemoglobinopathies
as ‘‘a group of disorders affecting red
blood cells. SCD and Thalassemia are
included in this group.’’ (See https://
www.cdc.gov/ncbddd/sicklecell/
RuSH_FAQs.html). The information
from the evaluation will be used to
evaluate the grantees’ performance in
achieving the objectives of the
hemoglobinopathies program during the
grant period, assess the breadth of
grantees’ outreach to emerging
populations affected by
hemoglobinopathies and the needs of
those populations attempting to access
services. Data collection tools for which
OMB approval is being requested are as
Responses
per
respondent
Number of
respondents
Total
responses
follows: (1) The Minimum Database
Project Sickle Cell Disease (MDP SCD)
Questionnaire, (2) the Minimum
Database Project Sickle Cell Trait/
Carrier (MDP SCT) Questionnaire, and
(3) the MDP Hemoglobinopathies
Emerging Populations Questionnaire.
Respondents: The MDP SCD and the
MDP SCT Questionnaires will be
administered by grantees to clients or
caregivers when they present for
services. At the time of enrollment,
SCDNBSP participants will be informed
about the data collection and clients
will be asked to participate in either the
SCD questionnaire or the SCT
questionnaire depending on their
disease or carrier status. The program
will enroll participants on a rolling
basis such that new patients will be
added to the program as they present for
services and provide consent. Data will
be collected at two points annually for
the SCD Questionnaire, the first, when
clients and caregivers are enrolled into
the SCDNBS Program and the second, at
follow-up after enrollment. Data will be
collected once annually for the SCT
Questionnaire. The Hemoglobinopathies
Emerging Populations Form serves as a
stand alone form for the other HRSA
hemoglobinopathies programs, with its
content. These questions are also
embedded in the MDT SCD and MDP
SCT questionnaires. The HRSA
hemoglobinopathies programs also plan
to use this questionnaire in developing
educational materials, prioritizing
outreach activities and informing
decisions for future funding requests.
The annual estimate of burden is as
follows:
Average hours
per response
Total hour
burden
Wage rate
Total hour
cost
140
1,400
2
1
280
1,400
.45
.30
126
420
$20.90
20.90
$2,633.40
8,778.00
*1,125
2
*2,250
.20
450
20.90
9,405.00
Total ..................................
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MDP SCD Questionnaire .........
MDP SCT Questionnaire .........
Hemoglobinopathies Emerging
Populations Form .................
2,665
........................
3,930
........................
996
....................
20,816.40
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: August 19, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FR Doc. 2010–21220 Filed 8–25–10; 8:45 am]
[Docket No. FDA–2010–N–0213]
BILLING CODE 4165–15–P
Su Van Ho: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
26AUN1
Federal Register / Vol. 75, No. 165 / Thursday, August 26, 2010 / Notices
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (the act) debarring Su Van
Ho for a period of 15 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. Ho was convicted of
three felonies under Federal law for
conduct relating to the importation into
the United States of an article of food.
Mr. Ho was given notice of the proposed
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. As of July 15,
2010, Mr. Ho failed to respond. Mr. Ho’s
failure to respond constitutes a waiver
of his right to a hearing concerning this
action.
DATES: This order is effective August 26,
2010.
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 Compliance
Policy (HFC–230), Office of
Enforcement, Office of Regulatory
Affairs, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD
20857, 240–632–6844.
SUPPLEMENTARY INFORMATION:
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
I. Background
Section 306(b)(1)(C) of the 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 act (21 U.S.C.
335a(b)(3)(A)), 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, 2009, the United States
District Court for the Central District of
California accepted Mr. Ho’s guilty plea
and entered judgment against him for
the offenses of: Smuggling, Causing an
Act to be Done in violation of 18 U.S.C.
545, Concealing a Material Fact by Trick
or Device in violation of 18 U.S.C.
1001(a)(1) and Receipt of an Adulterated
Food and Delivery Thereof for Pay in
violation of 21 U.S.C. 331(c), 333(a)(1),
and 342(a)(3).
FDA’s finding that debarment is
appropriate is based on the three felony
convictions referenced herein for
conduct relating to the importation into
the United States of any food. The
factual basis for those convictions is as
follows: Between at least January 1,
VerDate Mar<15>2010
20:12 Aug 25, 2010
Jkt 220001
2003, through September 16, 2004, Mr.
Ho owned and operated VincentSeafood
and Trading, a frozen seafood import
and distribution business. On or about
August 20, 2004, in violation of 18
U.S.C. 545 and 2(b), Mr. Ho knowingly
and willfully, with the intent to defraud
the United States, did pass and cause to
be passed through the customshouse a
fraudulent commercial invoice that
falsely described 610 cartons of Frozen
Silk Worm as ‘‘Frozen Dade’’ fish and
461 cartons of Pineapple Brand Betel
Nut as ‘‘Frozen Palmnut.’’
On or about September 16, 2004, in
violation of 18 U.S.C. 1001(a)(1), Mr. Ho
knowingly and willfully concealed and
covered up by trick, scheme, or device
a material fact. Specifically, he was
ordered by FDA to export or destroy 118
cartons of frozen Featherback fish from
import shipment N08–0026008–0 that
contained Salmonella bacteria, with
verification of such exportation or
destruction by FDA. Mr. Ho concealed
and covered up the material fact that he
had improperly sold 103 cartons of the
contaminated Featherback fish from
import shipment N08–0026008–0 by a
trick, scheme, or device in which he
substituted 103 cartons of Featherback
fish from other, unrelated import
shipments and presented the substitute
cartons of fish to FDA for verified
exportation or destruction as the
contaminated fish from import
shipment N08–0026008–0.
Between on or about January 17, 2004,
and September 16, 2004, in violation of
21 U.S.C. 331(c), 333(a)(1), and
342(a)(3), Mr. Ho received in interstate
commerce and delivered in exchange for
payment an adulterated food, namely,
frozen Featherback fish from import
shipment N08–0026008–0 that was
contaminated with Salmonella bacteria.
As a result of his conviction, on June
10, 2010, FDA sent Mr. Ho a notice by
certified mail proposing to debar him
for a period of 15 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 act that Mr.
Ho was convicted of three felonies
under Federal law for conduct relating
to the importation into the United States
of an article of food, and a
determination, after consideration of the
factors set forth in section 306(c)(3) of
the act (21 U.S.C. 335a(c)(3)), that the
full periods of debarment shall run
consecutively as provided by section
306(c)(2)(A)(iii) of the act (21 U.S.C.
335a(c)(2)(A)(iii)). The proposal also
offered Mr. Ho 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
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52535
failure to request a hearing constituted
a waiver of the opportunity for a hearing
and of any contentions concerning this
action. Mr. Ho 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
act, and under authority delegated to the
Director (Staff Manual Guide 1410.35),
finds that Mr. Su Van Ho has been
convicted of three felonies under
Federal law for conduct relating to the
importation of an article of food into the
United States and that the full periods
of debarment shall run consecutively
under section 306(c)(2) of the act (21
U.S.C. 335a(c)(2)).
As a result of the foregoing finding,
Mr. Ho is debarred for a period of 15
years from importing articles of food or
offering such articles for import into the
United States, effective (see DATES).
Pursuant to section 301(cc) of the 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.
Ho is a prohibited act.
Any application by Mr. Ho for
termination of debarment under section
306(d)(1) of the act should be identified
with Docket No. FDA–2010–N–0213
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 12, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of
Regulatory Affairs.
[FR Doc. 2010–21258 Filed 8–25–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–266]
Availability of Draft Toxicological
Profile
Agency for Toxic Substances
and Disease Registry (ATSDR),
AGENCY:
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 75, Number 165 (Thursday, August 26, 2010)]
[Notices]
[Pages 52534-52535]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0213]
Su Van Ho: Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 52535]]
SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the act) debarring Su
Van Ho for a period of 15 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. Ho was convicted of three
felonies under Federal law for conduct relating to the importation into
the United States of an article of food. Mr. Ho was given notice of the
proposed debarment and an opportunity to request a hearing within the
timeframe prescribed by regulation. As of July 15, 2010, Mr. Ho failed
to respond. Mr. Ho's failure to respond constitutes a waiver of his
right to a hearing concerning this action.
DATES: This order is effective August 26, 2010.
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 Compliance
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
240-632-6844.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the 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 act (21 U.S.C.
335a(b)(3)(A)), 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, 2009, the United States District Court for the Central
District of California accepted Mr. Ho's guilty plea and entered
judgment against him for the offenses of: Smuggling, Causing an Act to
be Done in violation of 18 U.S.C. 545, Concealing a Material Fact by
Trick or Device in violation of 18 U.S.C. 1001(a)(1) and Receipt of an
Adulterated Food and Delivery Thereof for Pay in violation of 21 U.S.C.
331(c), 333(a)(1), and 342(a)(3).
FDA's finding that debarment is appropriate is based on the three
felony convictions referenced herein for conduct relating to the
importation into the United States of any food. The factual basis for
those convictions is as follows: Between at least January 1, 2003,
through September 16, 2004, Mr. Ho owned and operated VincentSeafood
and Trading, a frozen seafood import and distribution business. On or
about August 20, 2004, in violation of 18 U.S.C. 545 and 2(b), Mr. Ho
knowingly and willfully, with the intent to defraud the United States,
did pass and cause to be passed through the customshouse a fraudulent
commercial invoice that falsely described 610 cartons of Frozen Silk
Worm as ``Frozen Dade'' fish and 461 cartons of Pineapple Brand Betel
Nut as ``Frozen Palmnut.''
On or about September 16, 2004, in violation of 18 U.S.C.
1001(a)(1), Mr. Ho knowingly and willfully concealed and covered up by
trick, scheme, or device a material fact. Specifically, he was ordered
by FDA to export or destroy 118 cartons of frozen Featherback fish from
import shipment N08-0026008-0 that contained Salmonella bacteria, with
verification of such exportation or destruction by FDA. Mr. Ho
concealed and covered up the material fact that he had improperly sold
103 cartons of the contaminated Featherback fish from import shipment
N08-0026008-0 by a trick, scheme, or device in which he substituted 103
cartons of Featherback fish from other, unrelated import shipments and
presented the substitute cartons of fish to FDA for verified
exportation or destruction as the contaminated fish from import
shipment N08-0026008-0.
Between on or about January 17, 2004, and September 16, 2004, in
violation of 21 U.S.C. 331(c), 333(a)(1), and 342(a)(3), Mr. Ho
received in interstate commerce and delivered in exchange for payment
an adulterated food, namely, frozen Featherback fish from import
shipment N08-0026008-0 that was contaminated with Salmonella bacteria.
As a result of his conviction, on June 10, 2010, FDA sent Mr. Ho a
notice by certified mail proposing to debar him for a period of 15
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 act that Mr. Ho was convicted of
three felonies under Federal law for conduct relating to the
importation into the United States of an article of food, and a
determination, after consideration of the factors set forth in section
306(c)(3) of the act (21 U.S.C. 335a(c)(3)), that the full periods of
debarment shall run consecutively as provided by section
306(c)(2)(A)(iii) of the act (21 U.S.C. 335a(c)(2)(A)(iii)). The
proposal also offered Mr. Ho 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. Ho 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 act, and under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Mr. Su Van Ho has been convicted of three felonies under Federal
law for conduct relating to the importation of an article of food into
the United States and that the full periods of debarment shall run
consecutively under section 306(c)(2) of the act (21 U.S.C.
335a(c)(2)).
As a result of the foregoing finding, Mr. Ho is debarred for a
period of 15 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the 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. Ho is a
prohibited act.
Any application by Mr. Ho for termination of debarment under
section 306(d)(1) of the act should be identified with Docket No. FDA-
2010-N-0213 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 12, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-21258 Filed 8-25-10; 8:45 am]
BILLING CODE 4160-01-S
