Cooperative Agreement To Support Capacity Building Activities Through the World Health Organization Global Foodborne Infections Network, 61501-61502 [2010-24903]
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by FDA senior
management from the Office of the
Commissioner and the Center for Drug
Evaluation and Research.
Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
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members may question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
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coverage of FDA’s public administrative
proceedings (part 10, subpart C (21 CFR
part 10, subpart C)). Under § 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b) (see section VI of this
document). To the extent that the
conditions for the hearing, as described
in this notice, conflict with any
provisions set out in part 15, this notice
acts as a waiver of those provisions as
specified in § 15.30(h).
V. Request for Comments
Regardless of attendance at the public
hearing, interested persons may submit
either electronic or written comments to
the Division of Dockets Management
(see ADDRESSES). It is only necessary to
send one set of comments. It is no
longer necessary to send two copies of
mailed comments. Identify comments
with the docket number found in
brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Programs, Food and Drug
Administration, 5600 Fishers Lane,
Room 6–30, Rockville, MD 20857.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–24853 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0496]
Cooperative Agreement To Support
Capacity Building Activities Through
the World Health Organization Global
Foodborne Infections Network
AGENCY:
ACTION:
The Food and Drug
Administration (FDA) is announcing its
intention to accept and consider a single
source application to award a
cooperative agreement to the World
Health Organization (WHO) Advisory
Group on Integrated Surveillance of
Antimicrobial Resistance (AGISAR) and
in support of the WHO Global
Foodborne Infections Network (GFN)
and to provide guidance to the WHO on
a framework for the development of an
international network to promote and
enhance collaboration on harmonization
and data sharing among countries with
Antimicrobial Resistance (AMR)
surveillance programs.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
mstockstill on DSKH9S0YB1PROD with NOTICES
Transcripts of the public hearing will
be available for review at the Division
of Dockets Management (see ADDRESSES)
and on the Internet at https://www.
regulations.gov approximately 30 days
after the public hearing. A transcript
will also be made available in either
hard copy or on CD–ROM, upon
submission of a Freedom of Information
request. Written requests are to be sent
to Division of Freedom of Information
(HFI–35), Office of Management
18:36 Oct 04, 2010
Jkt 223001
Notice.
SUMMARY:
VI. Transcripts
VerDate Mar<15>2010
Food and Drug Administration,
HHS.
PO 00000
Program Contact: Patrick McDermott,
Division of Animal and Food
Microbiology, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Mod II, rm. 1505, Rockville, MD
20855, 301–210–4213, FAX: 301–
210–4685, email:
Patrick.McDermott@fda.hhs.gov.
Management Contact: Katherine C.
Bond, Office of International
Programs, Office of the
Commissioner, FDA, 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,
FDA, 5630 Fishers Lane (HFA–500),
rm. 2104, Rockville, MD 20857,
301–827–9363, FAX: 301–827–
7101, email:
Frm 00091
Fmt 4703
Sfmt 4703
61501
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–10–006]
[Catalog of Federal Domestic Assistance
Number(s): 93.103 https://
www.cfda.gov]
A. Background
The Food and Drug Administration
(FDA) is announcing its intention to
accept and consider a single source
application for a cooperative agreement
to the WHO GFN. This project
represents a collaborative agreement
between the WHO and FDA aimed at
capacity building in laboratory based
surveillance of foodborne pathogens and
disease in developing regions to support
AGISAR and GFN to enable FDA to
realize its goal of developing an
international database for human and
animal isolates of foodborne pathogens
and their susceptibility profiles.
B. Research Objectives
• Support WHO capacity building
activities with member countries for
AMR monitoring (development of AMR
training modules for GFN training
courses, and hosting of visiting scientist
from developing countries).
• Develop harmonized schemes for
monitoring antimicrobial resistance in
zoonotic and enteric bacteria to include
appropriate sampling.
• Promote information sharing on
AMR (development of a global AMR
databank).
• Provide expert advice to WHO, and
promote WHO and FDA collaborative
work to advise WHO Member States on
containment of AMR with a particular
focus to Human Critically Important
Antimicrobials. AGISAR should be the
core advisory group to review criteria
for ranking human and animal
antimicrobials to be reviewed by WHO;
and FDA’s resources could be used in
support of AGISAR’s participation.
• Support and advise WHO on
selection of sentinel sites to be
strategically identified around the globe
and designing pilot projects to conduct
integrated surveillance of antimicrobial
resistance.
• Promote development of
standardized methods for monitoring
antimicrobial use and work with
member states for the implementation of
these methods at the country-level.
• Promote the development of
published articles on the emergence of
AMR threats and challenges, and the
E:\FR\FM\05OCN1.SGM
05OCN1
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
]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61501-61502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24903]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0496]
Cooperative Agreement To Support Capacity Building Activities
Through the World Health Organization Global Foodborne Infections
Network
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to accept and consider a single source application to award a
cooperative agreement to the World Health Organization (WHO) Advisory
Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR)
and in support of the WHO Global Foodborne Infections Network (GFN) and
to provide guidance to the WHO on a framework for the development of an
international network to promote and enhance collaboration on
harmonization and data sharing among countries with Antimicrobial
Resistance (AMR) surveillance programs.
FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
Program Contact: Patrick McDermott, Division of Animal and Food
Microbiology, Center for Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl., Mod II, rm. 1505, Rockville, MD
20855, 301-210-4213, FAX: 301-210-4685, email:
Patrick.McDermott@fda.hhs.gov.
Management Contact: Katherine C. Bond, Office of International
Programs, Office of the Commissioner, FDA, 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, FDA, 5630 Fishers Lane (HFA-500), 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-10-006]
[Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov]
A. Background
The Food and Drug Administration (FDA) is announcing its intention
to accept and consider a single source application for a cooperative
agreement to the WHO GFN. This project represents a collaborative
agreement between the WHO and FDA aimed at capacity building in
laboratory based surveillance of foodborne pathogens and disease in
developing regions to support AGISAR and GFN to enable FDA to realize
its goal of developing an international database for human and animal
isolates of foodborne pathogens and their susceptibility profiles.
B. Research Objectives
Support WHO capacity building activities with member
countries for AMR monitoring (development of AMR training modules for
GFN training courses, and hosting of visiting scientist from developing
countries).
Develop harmonized schemes for monitoring antimicrobial
resistance in zoonotic and enteric bacteria to include appropriate
sampling.
Promote information sharing on AMR (development of a
global AMR databank).
Provide expert advice to WHO, and promote WHO and FDA
collaborative work to advise WHO Member States on containment of AMR
with a particular focus to Human Critically Important Antimicrobials.
AGISAR should be the core advisory group to review criteria for ranking
human and animal antimicrobials to be reviewed by WHO; and FDA's
resources could be used in support of AGISAR's participation.
Support and advise WHO on selection of sentinel sites to
be strategically identified around the globe and designing pilot
projects to conduct integrated surveillance of antimicrobial
resistance.
Promote development of standardized methods for monitoring
antimicrobial use and work with member states for the implementation of
these methods at the country-level.
Promote the development of published articles on the
emergence of AMR threats and challenges, and the
[[Page 61502]]
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 non-competing 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
