Memorandum of Understanding Between the United States Food and Drug Administration and the C-Path Institute, 74823-74827 [05-24100]
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Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices
amendments thereto, is hereby
withdrawn, effective December 27,
2005.
In a final rule published elsewhere in
this issue of the Federal Register, FDA
is amending the animal drug regulations
to reflect the withdrawal of approval of
these NADAs.
Dated: December 7, 2005.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 05–24103 Filed 12–15–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Nonprescription
Drugs Advisory Committee and the
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees:
Nonprescription Drugs Advisory
Committee (NDAC) and the
Endocrinologic and Metabolic Drugs
Advisory Committee (EMDAC).
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 23, 2006, from 8 a.m.
to 5 p.m.
Location: Holiday Inn Select
Bethesda, Versailles Ballrooms, 8120
Wisconsin Ave., Bethesda, MD. The
hotel telephone number is 301–652–
2000.
Contact Person: Darrell Lyons, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail: lyonsd@cder.fda.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area) codes 3014512541 or 3014512536.
Please call the Information Line for upto-date information on this meeting.
Agenda: The committees will
consider the safety and efficacy of new
drug application (NDA) 21–887,
proposing over-the-counter (OTC) use of
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ORLISTAT (tetrahydrolipstatin)
capsules (60 milligrams (mg)),
GlaxoSmithKline Consumer Healthcare,
L.P., to promote weight loss in
overweight adults when used along with
a reduced calorie and low fat diet. The
background material will become
available no later than the day before
the meeting and will be posted under
NDAC or EMDAC’s docket site at https://
www.fda.gov/ohrms/dockets/ac/
acmenu.htm (click on the year 2006 and
scroll down to NDAC or EMDAC).
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
submissions may be made to the contact
person by January 13, 2006. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before January 13, 2006, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Darrell Lyons
at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 2, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–24101 Filed 12–15–05; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[FDA 225–05–8000]
Memorandum of Understanding
Between the United States Food and
Drug Administration and the C–Path
Institute
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between the
United States Food and Drug
Administration and the C–Path
Institute. The specific purpose of this
MOU is to establish an overarching
framework for collaboration between the
parties. This framework will be based
on mutually agreed upon programs and
activities in the areas of applied
scientific research and training/
education to foster the development of
new evaluation tools to inform medical
product development. The parties shall
each leverage its own expertise and
resources to facilitate programs of
shared interests across the diverse
disciplines of therapeutics, biological
sciences, engineering and medical
devices in building applied research
and training/education programs. The
appropriate formal agreements will be
executed as required by law for any
activities that result from this
collaboration.
DATES: The agreement became effective
October 14, 2005.
FOR FURTHER INFORMATION CONTACT: For
C–Path Institute: Raymond L. Woosley,
The Critical Path Institute, 4280 N.
Campbell Ave., #214, Tucson, AZ
85718, 520–547–3440, FAX: 520–547–
3456, e-mail: rwoosley@c-path.org.
For The Food and Drug
Administration: Mary I. Poos, Office
of External Relations, Food and
Drug Administration (HF–10), 5600
Fishers Lane, Rockville, MD 20857,
301–827–2825, FAX: 301–827–
3042, e-mail: mary.poos@fda.gov.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
Dated: December 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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Federal Register / Vol. 70, No. 241 / Friday, December 16, 2005 / Notices
[FR Doc. 05–24100 Filed 12–15–05; 8:45 am]
Subject name, address
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Program Exclusions: November 2005
AGENCY:
Office of Inspector General,
HHS.
ACTION:
Notice of program exclusions.
During the month of November 2005,
the HHS Office of Inspector General
imposed exclusions in the cases set
forth below. When an exclusions is
imposed, no program payment is made
to anyone for any items or services
(other than an emergency item or
service not provided in a hospital
emergency room) furnished, ordered or
prescribed by an excluded party under
the Medicare, Medicaid, and all Federal
Health Care programs. In addition, no
program payment is made to any
business or facility, e.g., a hospital, that
submits bills for payment for items or
services provided by an excluded party.
Program beneficiaries remain free to
decide for themselves whether they will
continue to use the services of an
excluded party even though no program
payments will be made for items and
services provided by that excluded
party. The exclusions have national
effect and also apply to all Executive
Branch procurement and nonprocurement programs and activities.
Subject name, address
Effective
date
PROGRAM-RELATED CONVICTIONS
BASONE, RENNAE ..................
AKRON, OH
BERTIE, LIONEL ......................
TOLEDO, OH
BRAVO, THERESA ..................
SAN DIEGO, CA
BROUSSARD, JERRY .............
BEAUMONT, TX
BRUMBAUGH, JAY ..................
COLLINSVILLE, OK
CABRERA, DAISY ...................
BRONX, NY
CARTER, ANGELA ..................
OSKALOOSA, IA
CHINI, JERI ..............................
PORT CLINTON, OH
CLOSE, CHRISTOPHER .........
ATWATER, CA
DYE, HEATHER .......................
MILWAUKEE, WI
EDWARDS, TERRI ..................
GAHANNA, OH
FRID, BORIS ............................
WOODLAND HILLS, CA
GORELICK, STUART ...............
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BLOOMFIELD HILLS, MI
HARVEY, JAMES .....................
LAKEWOOD, WA
HARVEY, RUBY .......................
LAKEWOOD, WA
HATHAWAY, BRIAN ................
REYNOLDSBURG, OH
HOWARD, JULIE .....................
FULTON, MS
KHANNA, ARUN ......................
STONE MOUNTAIN, GA
LOCKE, STEPHANIE ...............
HOUSTON, TX
MASON, CLINT ........................
FORK, SC
MERRITT, RICKLEY ................
GREER, SC
MILLER, MICHELLE .................
SHAKOPEE, MN
MOORE, MERLYN ...................
RIALTO, CA
MR J’S LIQUOR, INC ...............
LOS ANGELES, CA
PABBATHI, RAMMOHAN ........
TRENTON, NJ
PROFESSIONAL AMBULANCE SVC OF NORWICH,
INC ........................................
NORWICH, CT
PROVINCE, KIMBERLY ...........
CLARKSDALE, MS
RINGGENBERG, JULIE ...........
OTTUMWA, IA
ROBY, JARROD .......................
COLUMBUS, OH
ROSEL, NICOLE ......................
COOPERSVILLE, MI
SATTARI, PARI ........................
TARZANA, CA
SAULTER, MONROE ...............
THREE RIVERS, TX
SCHAEFER, CHRISTA ............
MARICOPA, AZ
TAMAYO, HEIROL ...................
MONTGOMERY, AL
VALLE, LUIS ............................
GLENDALE, CA
VUKASIN, ALAN ......................
COTTONWOOD, ID
WEILAND, JEANETTE .............
HURSON, SD
WHITE, ROBERT .....................
WILSONVILLE, OR
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date
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MEMPHIS, TN
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FELONY CONTROL SUBSTANCE
CONVICTION
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12/20/2005
CHLYSTA, RUSSELL ...............
YANKTON, SD
FERNANDEX, BRENDA ..........
NACOGDOCHES, TX
GRAYS, SONYA ......................
WACO, TX
HAAKE, DONNA ......................
BELLEVUE, NE
HEIKENS, ANGELA .................
BELLE FOURCHE, SD
KUTZNER, JAMES ...................
LOUISVILLE, KY
MARTENS, DALE .....................
LONDONDERRY, VT
MCCARTNEY, LUANNE ..........
COAHOMA, TX
NYMAN, CATHERINE ..............
DENVER, CO
ODVODY, DAWN .....................
GREENVILLE, IL
PALMER, MARTIN ...................
WASILLA, AK
RIOJAS, JEANETTE ................
DEER PARK, TX
RYABIK, BRETT .......................
DORAVILLE, GA
SCOTT, BRUCE .......................
QUINCY, IL
SHULTZ, ALAN ........................
MOUNT STERLING, KY
WAY, NANCY ...........................
FT WORTH, TX
WHITAKER, DARWIN ..............
HAZARD, KY
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PATIENT ABUSE/NEGLECT CONVICTIONS
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FELONY CONVICTION FOR HEALTH CARE
FRAUD
BUNKER, JASON .....................
SAN BERNARDINO, CA
CATANZARO, DANIEL ............
CARTERSVILLE, GA
DENNETT, ROBIN ...................
AUGUSTA, ME
HAMPTON, STACEY ...............
ST LOUIS, MO
MOORE, MARK ........................
DAYTON, OH
NJOROGE, GEOFFREY ..........
OKLAHOMA CITY, OK
PALMER, CARLTON ................
COLUMBUS, OH
SIM, TOM .................................
SANTA CLARA, CA
WHITE, JACQUESE .................
Subject name, address
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ANDERSON, ERNEIS ..............
CLINTON, SC
BASSO, ALICIA ........................
ROCHESTER, NY
CANTU, HELEN .......................
MADERA, CA
CLARK, RUBY ..........................
PIONEER, LA
CLENDENEN, BRENDA ..........
HODGEN, OK
COPES, RESHAWN .................
LEESVILLE, LA
HAWKINS, BRIAN ....................
FOUNTAIN HILLS, AZ
JIMENEZ, ALICIA .....................
LOS ANGELES, CA
LAMBERT, STEPHANIE ..........
JANESVILLE, WI
MOENICH, KIM ........................
CLEVELAND, OH
MOORE, MICHAEL ..................
HENNESSEY, OK
NAVARRO, JEA .......................
VALLEJO, CA
NORRIS, KIMBERLY ...............
CHILDRESS, TX
POPPY, THOMAS ....................
SPRING HILL, FL
PRADA, GERMAN ...................
SPRINGBORO, OH
SAGUIBO, VERONICA ............
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]]>Agencies
[Federal Register Volume 70, Number 241 (Friday, December 16, 2005)]
[Notices]
[Pages 74823-74827]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-24100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[FDA 225-05-8000]
Memorandum of Understanding Between the United States Food and
Drug Administration and the C-Path Institute
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between the United States Food and
Drug Administration and the C-Path Institute. The specific purpose of
this MOU is to establish an overarching framework for collaboration
between the parties. This framework will be based on mutually agreed
upon programs and activities in the areas of applied scientific
research and training/education to foster the development of new
evaluation tools to inform medical product development. The parties
shall each leverage its own expertise and resources to facilitate
programs of shared interests across the diverse disciplines of
therapeutics, biological sciences, engineering and medical devices in
building applied research and training/education programs. The
appropriate formal agreements will be executed as required by law for
any activities that result from this collaboration.
DATES: The agreement became effective October 14, 2005.
FOR FURTHER INFORMATION CONTACT: For C-Path Institute: Raymond L.
Woosley, The Critical Path Institute, 4280 N. Campbell Ave.,
214, Tucson, AZ 85718, 520-547-3440, FAX: 520-547-3456, e-
mail: path.org">rwoosley@c-path.org.
For The Food and Drug Administration: Mary I. Poos, Office of
External Relations, Food and Drug Administration (HF-10), 5600 Fishers
Lane, Rockville, MD 20857, 301-827-2825, FAX: 301-827-3042, e-mail:
mary.poos@fda.gov.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOUs between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: December 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S
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[FR Doc. 05-24100 Filed 12-15-05; 8:45 am]
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