Anneri Izurieta: Debarment Order, 2070-2071 [2012-542]
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2070
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
FDAAA Section of the 2007 amendments
FDA form No.
Total hours
222 3 .........................................................
222 2 .........................................................
222 3 .........................................................
222 3 .........................................................
223 3 .........................................................
224 (waiver request) 2 ..............................
224 (waiver request) 3 ..............................
3673
3673
3673
3673
3673
3673
3673
21,254
2,162
8,067
1,305
17,750
14
1
1
1
1
1
1
1
1
21,254
2,162
8,067
1,305
17,750
14
1
0.75
0.50
1
0.25
1
1
2
15,941
1,081
8,067
326
17,750
14
2
Total ..................................................
........................
........................
........................
........................
........................
43,181
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
3 Annual recurring burden.
2 One-time
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
FDAAA Section of the 2007 amendments
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
222 2 .....................................................................................
223 2 .....................................................................................
23,806
11,746
1
4
23,806
46,984
0.25
0.5
5,952
23,492
Total ..............................................................................
........................
........................
........................
........................
29,444
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recurring burden.
Dated: January 9, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2012–503 Filed 1–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0589]
Anneri Izurieta: 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
Anneri Izurieta for a period of 30 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. Izurieta was
convicted of six felony counts under
Federal law for conduct relating to the
importation into the United States of an
article of food. Ms. Izurieta was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of November 4, 2011 (30
days after receipt of the notice), Ms.
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SUMMARY:
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
Izurieta had not responded. Ms.
Izurieta’s failure to respond constitutes
a waiver of her right to a hearing
concerning this action.
DATES: This order is effective January
13, 2012.
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 May 11, 2011, in the U.S. District
Court for the Southern District of
Florida, Ms. Izurieta was convicted of
one count of conspiracy to smuggle
goods into the United States, in
violation of 18 U.S.C. 371, and five
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Fmt 4703
Sfmt 4703
counts of smuggling goods into the
United States, in violation of 18 U.S.C.
545. The U.S. District Court for the
Southern District of Florida entered
judgment against Ms. Izurieta on July
29, 2011.
FDA’s finding that debarment is
appropriate is based on the felony
convictions referenced herein for
conduct relating to the importation into
the United States of any food. The
factual basis for these convictions is as
follows: On or about April 18, 2007, and
continuing through on or about
December 23, 2010, in violation of 18
U.S.C. 371, Ms. Izurieta knowingly, and
with the intent to further the object of
the conspiracy, conspired with others to
commit an offense against the United
States to fraudulently and knowingly
import and bring into the United States
merchandise contrary to law in
violation of 18 U.S.C. 545. Specifically,
Ms. Izurieta conspired to distribute and
sell imported dairy products that FDA
had detained after receiving notice from
FDA that the dairy products were
suspected to be adulterated.
While serving as president and
director of Naver Trading, Ms. Izurieta
caused dairy products and other food to
be imported from Honduras and
Nicaragua. Despite a request from FDA
to disclose the location of shipments of
dairy products after learning that FDA
had slated specific shipments for
examination due to concerns of
adulteration with Escherichia coli,
E:\FR\FM\13JAN1.SGM
13JAN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 9 / Friday, January 13, 2012 / Notices
Staphylococcus aureus, and Salmonella,
Ms. Izurieta failed to do so. Ms. Izurieta
also distributed shipments of dairy
products after learning that FDA had
slated specific shipments for
examination due to concerns of
adulteration with E. coli, S. aureus, and
Salmonella. Ms. Izurieta failed to
redeliver for destruction and
exportation shipments of dairy products
that FDA had determined to be
adulterated with E. coli, S. aureus, and
Salmonella and that were not
authorized for entry into the United
States. Ms. Izurieta then distributed
dairy products that were adulterated
and not authorized for entry into the
United States. This conduct was in
violation of 18 U.S.C. 545.
From approximately April 18, 2007,
and continuing to approximately
December 7, 2010, Ms. Izurieta
fraudulently and knowingly imported
and brought into the United States
merchandise contrary to law. Further,
Ms. Izurieta failed to redeliver, export,
and destroy with FDA supervision the
dairy products and other food products
contained in these shipments after
receiving notice from FDA regarding
concerns about the adulteration of these
products with E. coli, S. aureus, and/or
Salmonella.
As a result of her conviction, on
September 28, 2011, FDA sent Ms.
Izurieta a notice by certified mail
proposing to debar her for a period of
30 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.
Izurieta was convicted of six felony
counts under Federal law for conduct
relating to the importation into the
United States of an article of food
because she conspired to and did
commit offenses related to the
importation of dairy products and other
products 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 Ms. Izurieta should
be subject to the maximum possible
period of debarment. The proposal also
offered Ms. Izurieta 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. Izurieta
failed to respond within the timeframe
prescribed by regulation and has,
therefore, waived her opportunity for a
hearing and waived any contentions
VerDate Mar<15>2010
15:46 Jan 12, 2012
Jkt 226001
concerning her 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 Ms. Anneri
Izurieta has been convicted of six felony
counts under Federal law for conduct
relating to the importation of an article
of food into the United States and that
she is subject to the full period of
debarment.
As a result of the foregoing finding,
Ms. Izurieta is debarred for a period of
30 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.
Izurieta is a prohibited act.
Any application by Ms. Izurieta for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2011–
N–0589 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: January 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–542 Filed 1–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2011–M–0502, FDA–
2011–M–0503, FDA–2011–M–0563, FDA–
2011–M–0564, FDA–2011–M–0600, FDA–
2011–M–0601, FDA–2011–M–0630, and
FDA–2011–M–0707]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
SUMMARY:
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Frm 00042
Fmt 4703
Sfmt 4703
2071
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
Agency’s Division of Dockets
Management.
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993–0002, (301) 796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from July 1, 2011, through
September 30, 2011. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
E:\FR\FM\13JAN1.SGM
13JAN1
]]>Agencies
[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2070-2071]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0589]
Anneri Izurieta: 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
Anneri Izurieta for a period of 30 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. Izurieta was convicted of
six felony counts under Federal law for conduct relating to the
importation into the United States of an article of food. Ms. Izurieta
was given notice of the proposed debarment and an opportunity to
request a hearing within the timeframe prescribed by regulation. As of
November 4, 2011 (30 days after receipt of the notice), Ms. Izurieta
had not responded. Ms. Izurieta's failure to respond constitutes a
waiver of her right to a hearing concerning this action.
DATES: This order is effective January 13, 2012.
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 May 11, 2011, in the U.S. District Court for the Southern
District of Florida, Ms. Izurieta was convicted of one count of
conspiracy to smuggle goods into the United States, in violation of 18
U.S.C. 371, and five counts of smuggling goods into the United States,
in violation of 18 U.S.C. 545. The U.S. District Court for the Southern
District of Florida entered judgment against Ms. Izurieta on July 29,
2011.
FDA's finding that debarment is appropriate is based on the felony
convictions referenced herein for conduct relating to the importation
into the United States of any food. The factual basis for these
convictions is as follows: On or about April 18, 2007, and continuing
through on or about December 23, 2010, in violation of 18 U.S.C. 371,
Ms. Izurieta knowingly, and with the intent to further the object of
the conspiracy, conspired with others to commit an offense against the
United States to fraudulently and knowingly import and bring into the
United States merchandise contrary to law in violation of 18 U.S.C.
545. Specifically, Ms. Izurieta conspired to distribute and sell
imported dairy products that FDA had detained after receiving notice
from FDA that the dairy products were suspected to be adulterated.
While serving as president and director of Naver Trading, Ms.
Izurieta caused dairy products and other food to be imported from
Honduras and Nicaragua. Despite a request from FDA to disclose the
location of shipments of dairy products after learning that FDA had
slated specific shipments for examination due to concerns of
adulteration with Escherichia coli,
[[Page 2071]]
Staphylococcus aureus, and Salmonella, Ms. Izurieta failed to do so.
Ms. Izurieta also distributed shipments of dairy products after
learning that FDA had slated specific shipments for examination due to
concerns of adulteration with E. coli, S. aureus, and Salmonella. Ms.
Izurieta failed to redeliver for destruction and exportation shipments
of dairy products that FDA had determined to be adulterated with E.
coli, S. aureus, and Salmonella and that were not authorized for entry
into the United States. Ms. Izurieta then distributed dairy products
that were adulterated and not authorized for entry into the United
States. This conduct was in violation of 18 U.S.C. 545.
From approximately April 18, 2007, and continuing to approximately
December 7, 2010, Ms. Izurieta fraudulently and knowingly imported and
brought into the United States merchandise contrary to law. Further,
Ms. Izurieta failed to redeliver, export, and destroy with FDA
supervision the dairy products and other food products contained in
these shipments after receiving notice from FDA regarding concerns
about the adulteration of these products with E. coli, S. aureus, and/
or Salmonella.
As a result of her conviction, on September 28, 2011, FDA sent Ms.
Izurieta a notice by certified mail proposing to debar her for a period
of 30 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. Izurieta was
convicted of six felony counts under Federal law for conduct relating
to the importation into the United States of an article of food because
she conspired to and did commit offenses related to the importation of
dairy products and other products 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 Ms. Izurieta should be subject to the
maximum possible period of debarment. The proposal also offered Ms.
Izurieta 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. Izurieta 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, 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 Ms. Anneri Izurieta has been convicted of six felony counts
under Federal law for conduct relating to the importation of an article
of food into the United States and that she is subject to the full
period of debarment.
As a result of the foregoing finding, Ms. Izurieta is debarred for
a period of 30 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. Izurieta
is a prohibited act.
Any application by Ms. Izurieta for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2011-N-0589 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: January 4, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-542 Filed 1-12-12; 8:45 am]
BILLING CODE 4160-01-P
