Ashley Brandon Foyle: Debarment Order, 25456-25457 [2013-10313]
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Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
Resettlement, 901 D Street SW.,
Washington, DC 20447, Telephone (202)
401–4997. Email:
jallyn.sualog@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: Since the
beginning of FY 2013, the
Unaccompanied Alien Children (UAC)
program has seen a dramatic increase in
the number of DHS referrals. The influx
of border crossers referred by DHS has
grown beyond anticipated rates
resulting in the need for a significant
increase in the number of shelter beds
and supportive services for the children.
The UAC program has specific
requirements for the provision of
services to unaccompanied alien
children. The named organizations were
chosen for the noncompetitive awards
because they already have the
infrastructure, licensing, and
appropriate levels of trained staff to
meet service requirements and the
urgent need for expanded services in
order to respond to the increased
numbers of unaccompanied children.
The immediate provision of services
will alleviate the buildup of children
held in border patrol stations while
awaiting placement in shelter care.
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 31, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Medical Devices; Inspection
by Accredited Persons Program’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0510. The
approval expires on April 30, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Statutory Authority: Section 462 of the
Homeland Security Act, (6 U.S.C. 279) and
sections 235(c) and 235(d) of the William
Wilberforce Trafficking Victims Protection
Reauthorization Act of 2008, (8 U.S.C.
1232(c) and 1232(d)).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Eskinder Negash,
Director, Office of Refugee Resettlement.
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance: Emergency Use
Authorization of Medical Products
[FR Doc. 2013–10311 Filed 4–30–13; 8:45 am]
BILLING CODE 4184–45–P
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Devices; Inspection by
Accredited Persons Program
AGENCY:
Food and Drug Administration,
HHS.
wreier-aviles on DSK5TPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Devices; Inspection by
Accredited Persons Program’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
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14:21 Apr 30, 2013
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BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0867]
[FR Doc. 2013–10248 Filed 4–30–13; 8:45 am]
HHS.
BILLING CODE 4160–01–P
ACTION:
Food and Drug Administration
[Docket No. FDA–2012–N–0976]
ACTION:
[Docket No. FDA–2012–N–0427]
[FR Doc. 2013–10247 Filed 4–30–13; 8:45 am]
Ashley Brandon Foyle: Debarment
Order
Food and Drug Administration,
HHS.
Food and Drug Administration
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: April 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0595. The
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Emergency Use Authorization of
Medical Products’’ has been approved
by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
January 8, 2013, the Agency submitted
a proposed collection of information
entitled ‘‘Emergency Use Authorization
of Medical Products’’ to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
AGENCY:
Food and Drug Administration,
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
Ashley Brandon Foyle for 5 years from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr. Foyle
was convicted of introducing and
delivering for introduction into
interstate commerce a misbranded drug,
which relates to the development or
approval, including the process for
development or approval, of drug
products and to the regulation of drug
products under the FD&C Act. In
addition, FDA determined that the type
of conduct that served as the basis for
Mr. Foyle’s conviction undermines the
process for the regulation of drugs. Mr.
Foyle was given notice of the proposed
debarment and an opportunity to
request a hearing within the prescribed
timeframe by regulation but failed to
respond. Mr. Foyle’s failure to respond
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective May 1,
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
E:\FR\FM\01MYN1.SGM
01MYN1
Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
wreier-aviles on DSK5TPTVN1PROD with NOTICES
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C
Act (21 U.S.C. 335a(b)(2)(B)(i)(I))
permits FDA to debar an individual if it
finds that the individual has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product or otherwise relating
to the regulation of drug products under
the FD&C Act, and if FDA finds that the
type of conduct that served as the basis
for the conviction undermines the
process for the regulation of drugs.
On May 5, 2010, Mr. Foyle pleaded
guilty to a misdemeanor offense of
introducing and delivering for
introduction into interstate commerce a
misbranded drug in violation of 21
U.S.C. 352(o), 331(a), and 333(a)(1). On
July 7, 2011, the U.S. District Court for
the District of Nevada entered judgment
against Mr. Foyle for the misdemeanor
offense of misbranding.
FDA’s finding that debarment is
appropriate is based on the
misdemeanor conviction referenced
herein. The factual basis for the
conviction is as follows: On July 23,
2008, Agents from Customs and Border
Protection found two express mail
packages at JFK International Mail
Facility, each with a return address of
Muhi Trading Corporation, Bahadur
Manzil. A border search was conducted
on both packages, which revealed 1,000
capsules labeled as the prescription
drug omeprazole in each package. The
pills were in blister packs on which was
written ‘‘Omega Biotech LTD.’’ Mr.
Foyle and his co-defendant, David
Freeman, were the importers of record
for the packages. At all relevant times,
neither Muhi Trading Corporation nor
Omega Biotech LTD. were registered to
manufacture, prepare, propagate,
compound, or process drugs.
On January 20, 2009, an Agent with
the Office of Criminal Investigations at
FDA (OCI) conducted an undercover
purchase of omeprazole through a Web
site Mr. Foyle and Mr. Freeman used to
sell their misbranded drugs. Mr. Foyle
and Mr. Freeman repackaged
omeprazole in their apartment and
mailed it to the undercover Agent.
Laboratory testing of the tablets
confirmed that the tablets contained
omeprazole. On February 24, 2009, OCI
Agents searched Mr. Foyle and Mr.
Freeman’s residence and found
unapproved drugs. The omeprazole pills
that Mr. Foyle and Mr. Freeman
VerDate Mar<15>2010
14:21 Apr 30, 2013
Jkt 229001
imported, repackaged, and sold had not
been approved by or registered with
FDA. At no time was Mr. Foyle and Mr.
Freeman’s apartment registered as a
location where drugs could be
manufactured, prepared, propagated,
compounded, or processed.
As a result of his convictions, on
October 31, 2012, FDA sent Mr. Foyle a
notice by certified mail proposing to
debar him for 5 years from providing
services in any capacity to a person that
has an approved or pending drug
product application. The proposal was
based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act that
Mr. Foyle was convicted of a
misdemeanor under Federal law for
conduct relating to the development or
approval, including the process for
development or approval, of drug
products and to the regulation of drug
products under the FD&C Act, and the
conduct that served as the basis for Mr.
Foyle’s conviction undermines the
process for the regulation of drugs
because the introduction of misbranded
drugs into interstate commerce is
prohibited by the FD&C Act. The
proposal also offered Mr. Foyle 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.
Foyle 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 and Import Operations,
Office of Regulatory Affairs, under
section 306(b)(2)(B)(i)(I) of the FD&C
Act under authority delegated to him
(Staff Manual Guide 1410.35), finds that
Ashley Brandon Foyle has been
convicted of a misdemeanor under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
drug products and relating to the
regulation of drug products under the
FD&C Act, and that the type of conduct
that served as the basis for the
conviction undermines the process for
the regulation of drugs.
As a result of the foregoing finding,
Mr. Foyle is debarred for 5 years from
providing services in any capacity to a
person with an approved or pending
drug product application under sections
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382), or under
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
25457
section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B),
(c)(2)(A)(iii), and 201(dd) of the FD&C
Act (21 U.S.C. 335a(c)(1)(B),
(c)(2)(A)(iii), and 321(dd))). Any person
with an approved or pending drug
product application who knowingly
employs or retains as a consultant or
contractor, or otherwise uses the
services of Mr. Foyle, in any capacity
during Mr. Foyle’s debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act). If Mr. Foyle
provides services in any capacity to a
person with an approved or pending
drug product application during his
period of debarment he will be subject
to civil money penalties (section
307(a)(7) of the FD&C Act). In addition,
FDA will not accept or review any
abbreviated new drug applications
submitted by or with the assistance of
Mr. Foyle during his period of
debarment (section 306(c)(1)(B) of the
FD&C Act).
Any application by Mr. Foyle for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2012–
N–0867 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: April 3, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for
Regulatory Affairs, Office of Regulatory
Affairs.
[FR Doc. 2013–10313 Filed 4–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Administrative
Supplement to West End Medical
Center, Inc. for provision of services in
Gwinnett County, Georgia.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) will be
issuing a non-competitive award of
$250,000 under the Health Center
Program (section 330 of the Public
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25456-25457]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10313]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0867]
Ashley Brandon Foyle: 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
Ashley Brandon Foyle for 5 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Foyle was
convicted of introducing and delivering for introduction into
interstate commerce a misbranded drug, which relates to the development
or approval, including the process for development or approval, of drug
products and to the regulation of drug products under the FD&C Act. In
addition, FDA determined that the type of conduct that served as the
basis for Mr. Foyle's conviction undermines the process for the
regulation of drugs. Mr. Foyle was given notice of the proposed
debarment and an opportunity to request a hearing within the prescribed
timeframe by regulation but failed to respond. Mr. Foyle's failure to
respond constitutes a waiver of his right to a hearing concerning this
action.
DATES: This order is effective May 1, 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
[[Page 25457]]
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857, 301-796-4640.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the development or approval, including the
process for development or approval, of any drug product or otherwise
relating to the regulation of drug products under the FD&C Act, and if
FDA finds that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
On May 5, 2010, Mr. Foyle pleaded guilty to a misdemeanor offense
of introducing and delivering for introduction into interstate commerce
a misbranded drug in violation of 21 U.S.C. 352(o), 331(a), and
333(a)(1). On July 7, 2011, the U.S. District Court for the District of
Nevada entered judgment against Mr. Foyle for the misdemeanor offense
of misbranding.
FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: On July 23, 2008, Agents from Customs and
Border Protection found two express mail packages at JFK International
Mail Facility, each with a return address of Muhi Trading Corporation,
Bahadur Manzil. A border search was conducted on both packages, which
revealed 1,000 capsules labeled as the prescription drug omeprazole in
each package. The pills were in blister packs on which was written
``Omega Biotech LTD.'' Mr. Foyle and his co-defendant, David Freeman,
were the importers of record for the packages. At all relevant times,
neither Muhi Trading Corporation nor Omega Biotech LTD. were registered
to manufacture, prepare, propagate, compound, or process drugs.
On January 20, 2009, an Agent with the Office of Criminal
Investigations at FDA (OCI) conducted an undercover purchase of
omeprazole through a Web site Mr. Foyle and Mr. Freeman used to sell
their misbranded drugs. Mr. Foyle and Mr. Freeman repackaged omeprazole
in their apartment and mailed it to the undercover Agent. Laboratory
testing of the tablets confirmed that the tablets contained omeprazole.
On February 24, 2009, OCI Agents searched Mr. Foyle and Mr. Freeman's
residence and found unapproved drugs. The omeprazole pills that Mr.
Foyle and Mr. Freeman imported, repackaged, and sold had not been
approved by or registered with FDA. At no time was Mr. Foyle and Mr.
Freeman's apartment registered as a location where drugs could be
manufactured, prepared, propagated, compounded, or processed.
As a result of his convictions, on October 31, 2012, FDA sent Mr.
Foyle a notice by certified mail proposing to debar him for 5 years
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act that Mr.
Foyle was convicted of a misdemeanor under Federal law for conduct
relating to the development or approval, including the process for
development or approval, of drug products and to the regulation of drug
products under the FD&C Act, and the conduct that served as the basis
for Mr. Foyle's conviction undermines the process for the regulation of
drugs because the introduction of misbranded drugs into interstate
commerce is prohibited by the FD&C Act. The proposal also offered Mr.
Foyle 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. Foyle 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 and Import
Operations, Office of Regulatory Affairs, under section
306(b)(2)(B)(i)(I) of the FD&C Act under authority delegated to him
(Staff Manual Guide 1410.35), finds that Ashley Brandon Foyle has been
convicted of a misdemeanor under Federal law for conduct relating to
the development or approval, including the process for development or
approval, of drug products and relating to the regulation of drug
products under the FD&C Act, and that the type of conduct that served
as the basis for the conviction undermines the process for the
regulation of drugs.
As a result of the foregoing finding, Mr. Foyle is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Foyle, in any capacity during Mr.
Foyle's debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act). If Mr. Foyle provides services in any
capacity to a person with an approved or pending drug product
application during his period of debarment he will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA
will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Mr. Foyle during his period of
debarment (section 306(c)(1)(B) of the FD&C Act).
Any application by Mr. Foyle for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0867 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: April 3, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of
Regulatory Affairs.
[FR Doc. 2013-10313 Filed 4-30-13; 8:45 am]
BILLING CODE 4160-01-P
