Cooperative Agreement With the Pan American Health Organization for the Development of an Information Hub for Medical Products and Related Regulatory Processes and Systems in the Americas Region, 61502-61503 [2010-24906]
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61502
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
need for AMR surveillance with a
forward-look toward sustainable
solutions through global collaboration
and evidence-based approaches.
C. Eligibility Information
The following organizations/
institutions are eligible to apply: The
World Health Organization
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award
of $847,500 (total costs including
indirect costs) in fiscal year (FY) 2010
in support of this project. Subject to the
availability of funds and successful
performance, 2 additional years of
support up to $565,000 per year will be
available.
B. Length of Support
The support will be 1 year with the
possibility of an additional 2 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. 2010–24903 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–0495]
Cooperative Agreement With the Pan
American Health Organization for the
Development of an Information Hub for
Medical Products and Related
Regulatory Processes and Systems in
the Americas Region
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 to award a
cooperative agreement to the Pan
American Health Organization (PAHO)
for the development of an information
hub in the areas of medical products
and related regulatory processes and
systems (e.g., including drugs, biologics,
vaccines, medical devices, and other
medical products as appropriate) in the
region of the Americas.
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
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
to award a cooperative agreement to the
PAHO for the development of an
information hub in the areas of medical
products and related regulatory
processes and systems (e.g., including
drugs, biologics, vaccines, medical
devices, and other medical products as
appropriate) in the region of the
Americas.
B. Research Objectives
• The development of an online
database (e.g., Web-based) in English
and Spanish for a series of countries
providing:
Æ Overview of the regulated sector
including description and specific
data relating to the medical
products and related regulatory
processes and systems market;
Æ Structural overview of the national
regulatory process(es) including
information relating to national
entities participating in the
regulatory process;
Æ Data presented by specific
regulatory areas (for example,
biologics, vaccines, drugs, medical
devices) on processes relating to
product registration, licensing
(manufacturer, wholesaler and
pharmacy/vendor), quality control
assessment and postmarketing
surveillance;
Æ Data presented on other regulatory
areas such as clinical trials and
supply chains;
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
Æ Key regulations governing the areas
of medical products and related
regulatory processes and systems
(e.g., including drugs, biologics,
vaccines, medical devices, and
other medical products as
appropriate) per country and/or
links to sources where such
information is available.
Æ Data collected and presented in
such a way that ensures consistency
of terminology, consistency in data
collection methods, and robustness,
comprehensiveness, and
comparability of data.
• The establishment of information
exchange mechanisms with the active
participation of national regulatory
agencies (NRAs) in the region of the
Americas that facilitates the process by
which the information hub and database
is populated with information that is
reviewed and maintained in an up-todate and continual basis.
Æ A detailed mechanism to maintain
and update the hub information is
developed detailing the
responsibilities of PAHO and its
Members States in keeping the data
and information contained therein
relevant, up-to-date, and
comprehensive to encompass the
future growth and complexity in the
areas of medical products and
related regulatory processes and
systems.
• As appropriate, PAHO would work
to align or link the information hub with
other ongoing global initiatives of the
World Health Organization (WHO) or its
regional offices in regulatory aspects
relating to medical products and related
regulatory processes and systems.
• As appropriate, PAHO would work
to enable effective linkage(s) of the
information hub with other ongoing
initiatives in regulatory aspects relating
to medical products and related
regulatory processes and systems
including harmonization efforts, such as
the Pan American Network for Drug
Regulatory Harmonization (PANDRH),
the ICH Global Cooperation Group; the
Global Health Task Force on Health
Technologies; the Asia-Pacific
Economic Cooperation (APEC)
harmonization efforts, and other
relevant efforts and initiatives as
appropriate.
• The utilization of the data and
information contained within the
information hub by NRAs to enable
harmonized approaches, standards and
guidelines for regulatory systems. It will
support evidence-based decisionmaking
by NRAs and regulated industry sectors,
facilitate the exchange of timely and
accurate data, and promote transparency
of regulated approaches and efforts.
E:\FR\FM\05OCN1.SGM
05OCN1
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
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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]
[Pages 61502-61503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24906]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0495]
Cooperative Agreement With the Pan American Health Organization
for the Development of an Information Hub for Medical Products and
Related Regulatory Processes and Systems in the Americas Region
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 to award a
cooperative agreement to the Pan American Health Organization (PAHO)
for the development of an information hub in the areas of medical
products and related regulatory processes and systems (e.g., including
drugs, biologics, vaccines, medical devices, and other medical products
as appropriate) in the region of the Americas.
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 to award a cooperative agreement to the PAHO for the
development of an information hub in the areas of medical products and
related regulatory processes and systems (e.g., including drugs,
biologics, vaccines, medical devices, and other medical products as
appropriate) in the region of the Americas.
B. Research Objectives
The development of an online database (e.g., Web-based) in
English and Spanish for a series of countries providing:
[cir] Overview of the regulated sector including description and
specific data relating to the medical products and related regulatory
processes and systems market;
[cir] Structural overview of the national regulatory process(es)
including information relating to national entities participating in
the regulatory process;
[cir] Data presented by specific regulatory areas (for example,
biologics, vaccines, drugs, medical devices) on processes relating to
product registration, licensing (manufacturer, wholesaler and pharmacy/
vendor), quality control assessment and postmarketing surveillance;
[cir] Data presented on other regulatory areas such as clinical
trials and supply chains;
[cir] Key regulations governing the areas of medical products and
related regulatory processes and systems (e.g., including drugs,
biologics, vaccines, medical devices, and other medical products as
appropriate) per country and/or links to sources where such information
is available.
[cir] Data collected and presented in such a way that ensures
consistency of terminology, consistency in data collection methods, and
robustness, comprehensiveness, and comparability of data.
The establishment of information exchange mechanisms with
the active participation of national regulatory agencies (NRAs) in the
region of the Americas that facilitates the process by which the
information hub and database is populated with information that is
reviewed and maintained in an up-to-date and continual basis.
[cir] A detailed mechanism to maintain and update the hub
information is developed detailing the responsibilities of PAHO and its
Members States in keeping the data and information contained therein
relevant, up-to-date, and comprehensive to encompass the future growth
and complexity in the areas of medical products and related regulatory
processes and systems.
As appropriate, PAHO would work to align or link the
information hub with other ongoing global initiatives of the World
Health Organization (WHO) or its regional offices in regulatory aspects
relating to medical products and related regulatory processes and
systems.
As appropriate, PAHO would work to enable effective
linkage(s) of the information hub with other ongoing initiatives in
regulatory aspects relating to medical products and related regulatory
processes and systems including harmonization efforts, such as the Pan
American Network for Drug Regulatory Harmonization (PANDRH), the ICH
Global Cooperation Group; the Global Health Task Force on Health
Technologies; the Asia-Pacific Economic Cooperation (APEC)
harmonization efforts, and other relevant efforts and initiatives as
appropriate.
The utilization of the data and information contained
within the information hub by NRAs to enable harmonized approaches,
standards and guidelines for regulatory systems. It will support
evidence-based decisionmaking by NRAs and regulated industry sectors,
facilitate the exchange of timely and accurate data, and promote
transparency of regulated approaches and efforts.
[[Page 61503]]
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 non-competing 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
