Health Center Program, 25457-25458 [2013-10294]
Download as PDF
<![CDATA[
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
25458
Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Notices
Health Service Act.) that will be
awarded to West End Medical Center,
Inc. (WEMC), Atlanta, Georgia, during
the budget period June 1, 2012, through
May 31, 2013. This award will support
the delivery of primary care services in
Gwinnett County, Georgia, to prevent a
disruption in services.
SUPPLEMENTARY INFORMATION:
Original Period of Grant Support:
June 1, 2012, to May 31, 2013 (Budget
Period).
Amount of Supplemental Award:
$250,000.
Period of Supplemental Funding: June
1, 2012, to May 31, 2013.
Authority: Section 330 of the Public Health
Service Act, 42 U.S.C. 245b.
CFDA Number: 93.224.
Justification for the Exception to
Competition: The former grantee,
Gwinnett County Board of Health
(GCBH), relinquished the grant and its
responsibilities. WEMC has been a
HRSA funded Health Center grantee
since 2002 and is a well-established
organization with sound fiscal and
grants management operations.
As a means of providing continued
services in the Gwinnett County service
area (formerly served by the GCBH),
WEMC has arranged for the provision of
services via an agreement with an
existing health care provider in this area
until the competitive award is
announced.
FOR FURTHER INFORMATION CONTACT:
Darrin Bowden via phone at (301) 594–
4420 or via email at dbowden@hrsa.gov.
Dated: April 25, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013–10294 Filed 4–30–13; 8:45 am]
BILLING CODE 4165–15–P
will provide a one-time noncompetitive
Ryan White HIV/AIDS Program Part C
funds award to the Bartz-Altadonna
Community Health Center (BACHC),
Lancaster, California.
SUPPLEMENTARY INFORMATION: The
amount of the award to ensure ongoing
HIV medical services is $402,187.
Authority: Section 2651 of the Public
Health Service (PHS) Act, 42 U.S.C. 300ff–51.
CFDA Number: 93.918.
Project period: The period of support
for this award is 15 months, explained
below in further detail.
Justification for the Exception to
Competition: The Catalyst Foundation,
Lancaster, California (Grant Number:
H76HA00784) announced the
relinquishment of their Part C grant on
February 14, 2013. To prevent a lapse in
HIV medical care, grant funds of
$402,187 are to be awarded to BACHC
to provide interim HIV medical care.
BACHC is a Federally Qualified Health
Center under section 330 of the PHS Act
(H80CS22686), and the sub-grantee to
Catalyst that is already providing the
clinical care for the Ryan White HIV/
AIDS Program Part C clients. The
Catalyst Foundation has identified
BACHC as a successor for the Part C
grant. The $402,187 represents a
proportional share of the last award to
the Catalyst Foundation to cover 15
months of HIV primary medical care
services until the service area is
competed by July 1, 2014.
FOR FURTHER INFORMATION CONTACT: John
Fanning, Public Health Analyst,
Division of Community Based Programs,
HIV/AIDS Bureau, Health Resources
and Services Administration, by email
at jfanning@hrsa.gov, or by phone at
(301) 443–0493.
Dated: April 25, 2013.
Mary K. Wakefield,
Administrator.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–10304 Filed 4–30–13; 8:45 am]
BILLING CODE 4165–15–P
Health Resources and Services
Administration
Ryan White HIV/AIDS Program, Part C
Early Intervention Services Grant
Under the Ryan White HIV/AIDS
Program
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
wreier-aviles on DSK5TPTVN1PROD with NOTICES
AGENCY:
National Eye Institute; Notice of
Meeting
SUMMARY: To prevent a lapse in
comprehensive primary care services for
persons living with HIV/AIDS, HRSA
Pursuant to Section 10(d) of the
Federal Advisory Committee Act, as
Amended (5 U.S.C. App.), Notice is
Hereby Given of the National Advisory
Eye Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Ryan White HIV/AIDS
Program Part C Early Intervention
Services One-Time Noncompetitive
Award to Ensure Continued HIV
Primary Medical Care.
VerDate Mar<15>2010
14:21 Apr 30, 2013
Jkt 229001
PO 00000
Frm 00045
Fmt 4703
Sfmt 9990
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Eye Council.
Date: June 13, 2013.
Open: 8:30 a.m. to 2:00 p.m.
Agenda: Following opening remarks by the
Director, NEI, there will be presentations by
the staff of the Institute and discussions
concerning Institute programs.
Place: National Institutes of Health, 45
Center Drive, Bethesda, MD 20892.
Closed: 2:00 p.m. to Adjournment.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 45
Center Drive, Bethesda, MD 20892.
Contact Person: Lore Anne McNicol, Ph.D.,
Director, Division of Extramural Research,
National Eye Institute, National Institutes of
Health, 301–451–2020, lam@nei.nih.gov.
Any person interested may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page:
www.nei.nih.gov, where an agenda and any
additional information will be posted when
available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
Dated: April 25, 2013
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–10201 Filed 4–30–13; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\01MYN1.SGM
01MYN1
]]>Agencies
[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25457-25458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Health Center Program
AGENCY: 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.
-----------------------------------------------------------------------
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
[[Page 25458]]
Health Service Act.) that will be awarded to West End Medical Center,
Inc. (WEMC), Atlanta, Georgia, during the budget period June 1, 2012,
through May 31, 2013. This award will support the delivery of primary
care services in Gwinnett County, Georgia, to prevent a disruption in
services.
SUPPLEMENTARY INFORMATION:
Original Period of Grant Support: June 1, 2012, to May 31, 2013
(Budget Period).
Amount of Supplemental Award: $250,000.
Period of Supplemental Funding: June 1, 2012, to May 31, 2013.
Authority: Section 330 of the Public Health Service Act, 42
U.S.C. 245b.
CFDA Number: 93.224.
Justification for the Exception to Competition: The former grantee,
Gwinnett County Board of Health (GCBH), relinquished the grant and its
responsibilities. WEMC has been a HRSA funded Health Center grantee
since 2002 and is a well-established organization with sound fiscal and
grants management operations.
As a means of providing continued services in the Gwinnett County
service area (formerly served by the GCBH), WEMC has arranged for the
provision of services via an agreement with an existing health care
provider in this area until the competitive award is announced.
FOR FURTHER INFORMATION CONTACT: Darrin Bowden via phone at (301) 594-
4420 or via email at dbowden@hrsa.gov.
Dated: April 25, 2013.
Mary K. Wakefield,
Administrator.
[FR Doc. 2013-10294 Filed 4-30-13; 8:45 am]
BILLING CODE 4165-15-P
