Cooperative Agreement With the World Health Organization for a Plan to Develop a Global Integrated Food Safety Information Platform, 61503 [2010-24904]
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
• As appropriate, explore with the
WHO, the possibility of expanding this
information hub to other WHO Regions.
C. Eligibility Information
The following organizations/
institutions are eligible to apply: the
PAHO.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award
of $904,000 (total costs including
indirect costs) in FY 2010 in support of
this project.
B. Length of Support
The support will be 1 year with the
possibility of an additional 3 years of
noncompetitive support. Continuation
beyond the first year will be based on
satisfactory performance during the
preceding year, receipt of a noncompeting continuation application and
available Federal FY appropriations.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24906 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0494]
Cooperative Agreement With the World
Health Organization for a Plan to
Develop a Global Integrated Food
Safety Information Platform
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces its
intention to accept and consider a single
source application for awarding a
cooperative agreement to the World
Health Organization (WHO),
Department of Food Safety and
Zoonoses, to develop a plan for a global
integrated food safety information
system or platform in partnership with
the WHO Secretariat and the Member
States.
FOR FURTHER INFORMATION CONTACT:
Management Contact: Katherine C.
Bond, Office of International
Programs, Office of the
Commissioner, Food and Drug
Administration, White Oak Bldg.
32, rm. 3300, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–8318, FAX: 301–
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
595–5058, email:
Katherine.Bond@fda.hhs.gov.
Grants Contact: Kimberly Pendleton,
Division of Acquisition and Grants
(HFA–500), Food and Drug
Administration, 5630 Fishers Lane,
rm. 2104, Rockville, MD 20857,
301–827–9363, FAX: 301–827–
7101, email:
kimberly.pendleton@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
contact Kimberly Pendleton.
61503
C. Eligibility Information
The following organizations/
institutions are eligible to apply: The
WHO.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award
of $395,500 (total costs including
indirect costs) in fiscal year (FY) 2010
in support of this project.
B. Length of Support
I. Funding Opportunity Description
The total project period for an
application submitted in response to
this funding opportunity may not
exceed 1 year.
RFA–FD–10–009
Catalog of Federal Domestic Assistance
Number(s): 93.103 https://www.cfda.gov
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
A. Background
[FR Doc. 2010–24904 Filed 10–4–10; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
FDA announces its intention to accept
and consider a single source application
for awarding a cooperative agreement to
the WHO, Department of Food Safety
and Zoonoses to develop a plan for a
global integrated food safety information
system or platform in partnership with
the WHO Secretariat and the Member
States. This project represents a
collaborative agreement between WHO
and FDA in support of global solutions
to address food safety problems; global
sharing of comparable food safety data
and information; and improved global
capacity for detection of and response to
food safety threats through preventative
controls, data and surveillance and riskbased approaches.
B. Research Objectives
• Outreach to parties who have
information needs and information to
share to ascertain their interests and to
cultivate their support;
• Engagement of all relevant parties
in defining the goals and designing the
system to maximize utilization and
sustainability;
• A timeline for development, design,
pilot-testing, implementation and
maintenance of a global integrated
information platform;
• A business plan that delineates the
commitment, support and resources of
the WHO Secretariat and relevant
stakeholders essential to ensure full
implementation and long-term
sustainability; and
• A clear articulation of the benefits,
measurable outputs and impacts that
would result from a WHO global
integrated information platform to the
global community, Member States and
other relevant parties and stakeholders.
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0338]
Determination That AZDONE
(Hydrocodone Bitartrate and Aspirin)
Tablet, 5 Milligrams/500 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that AZDONE (hydrocodone bitartrate
and aspirin) Tablet, 5 milligrams (mg)/
500 mg, was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for hydrocodone
bitartrate and aspirin tablet, 5 mg/500
mg, if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Deborah Livornese, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6306,
Silver Spring, MD 20993–0002, 301–
796–0719.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
SUMMARY:
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Page 61503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24904]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0494]
Cooperative Agreement With the World Health Organization for a
Plan to Develop a Global Integrated Food Safety Information Platform
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces its intention
to accept and consider a single source application for awarding a
cooperative agreement to the World Health Organization (WHO),
Department of Food Safety and Zoonoses, to develop a plan for a global
integrated food safety information system or platform in partnership
with the WHO Secretariat and the Member States.
FOR FURTHER INFORMATION CONTACT:
Management Contact: Katherine C. Bond, Office of International
Programs, Office of the Commissioner, Food and Drug Administration,
White Oak Bldg. 32, rm. 3300, 10903 New Hampshire Ave., Silver Spring,
MD 20993, 301-796-8318, FAX: 301-595-5058, email:
Katherine.Bond@fda.hhs.gov.
Grants Contact: Kimberly Pendleton, Division of Acquisition and
Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm.
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email:
kimberly.pendleton@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please contact Kimberly Pendleton.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-10-009
Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov
A. Background
FDA announces its intention to accept and consider a single source
application for awarding a cooperative agreement to the WHO, Department
of Food Safety and Zoonoses to develop a plan for a global integrated
food safety information system or platform in partnership with the WHO
Secretariat and the Member States. This project represents a
collaborative agreement between WHO and FDA in support of global
solutions to address food safety problems; global sharing of comparable
food safety data and information; and improved global capacity for
detection of and response to food safety threats through preventative
controls, data and surveillance and risk-based approaches.
B. Research Objectives
Outreach to parties who have information needs and
information to share to ascertain their interests and to cultivate
their support;
Engagement of all relevant parties in defining the goals
and designing the system to maximize utilization and sustainability;
A timeline for development, design, pilot-testing,
implementation and maintenance of a global integrated information
platform;
A business plan that delineates the commitment, support
and resources of the WHO Secretariat and relevant stakeholders
essential to ensure full implementation and long-term sustainability;
and
A clear articulation of the benefits, measurable outputs
and impacts that would result from a WHO global integrated information
platform to the global community, Member States and other relevant
parties and stakeholders.
C. Eligibility Information
The following organizations/institutions are eligible to apply: The
WHO.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award of $395,500 (total costs
including indirect costs) in fiscal year (FY) 2010 in support of this
project.
B. Length of Support
The total project period for an application submitted in response
to this funding opportunity may not exceed 1 year.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24904 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S
