Cooperative Agreement to Support the Food and Agriculture Organization, 46963-46965 [2013-18631]
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Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
TABLE 1—FEE SCHEDULE FOR FY
2014
Fee category
Fee rates for FY 2014
Initial BPD .............
Annual BPD ..........
Reactivation ..........
Applications 1
Requiring clinical
data ................
Not requiring
clinical data ....
Supplement requiring clinical data
Establishment .......
Product .................
$216,910
216,910
433,820
........................................
2,169,100
1,084,550
1,084,550
554,600
104,060
1 Under section 744H(a)(2)(A) of the FD&C
Act, if a sponsor that submits a biosimilar biological product application has previously paid
initial BPD fees, annual BPD fees, and/or reactivation fees for the product that is the subject of the application, the fee for the application is reduced by the cumulative amount of
these previously paid fees.
IV. Fee Payment Options and
Procedures
sroberts on DSK5SPTVN1PROD with NOTICES
A. Initial BPD, Reactivation,
Application, and Supplement Fees
The fees established in the new fee
schedule are effective October 1, 2013.
The initial BPD fee for a product is due
when the sponsor submits an IND that
FDA determines is intended to support
a biosimilar biological product
application for the product, or within 5
calendar days after FDA grants the first
BPD meeting for the product, whichever
occurs first. For sponsors who have
discontinued participation in the BPD
Program, a reactivation fee will be due
when the sponsor submits an IND for an
investigation that FDA determines is
intended to support a biosimilar
biological product application, or
within 5 calendar days after FDA grants
the sponsor’s request for a BPD meeting
for a product, whichever occurs first.
The application or supplement fee for
a biosimilar biological product is due
upon submission of the application or
supplement.
To make a payment of the initial BPD,
reactivation, supplement, or application
fee, you must complete the Biosimilar
User Fee Cover Sheet, available on
FDA’s Web site (https://www.fda.gov/
ForIndustry/UserFees/
BiosimilarUserFeeActBsUFA/
default.htm) starting October 1, 2013,
and generate a user fee identification
(ID) number. Payment must be made in
U.S. currency by electronic check,
check, bank draft, U.S. postal money
order, or wire transfer.
FDA has partnered with the U.S.
Department of the Treasury to use
Pay.gov, a Web-based payment
application, for online electronic
VerDate Mar<15>2010
18:55 Aug 01, 2013
Jkt 229001
payment. The Pay.gov feature is
available on FDA’s Web site after
completing the Biosimilar User Fee
Cover Sheet and generating the user fee
ID number.
Please include the user fee ID number
on your check, bank draft, or postal
money order, and make it payable to the
order of the Food and Drug
Administration. Your payment can be
mailed to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. If checks are to
be sent by a courier that requests a street
address, the courier can deliver the
checks to: U.S. Bank, Attention:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This U.S. Bank address is for
courier delivery only.) Please make sure
that the FDA post office box number
(P.O. Box 979108) is written on the
check, bank draft, or postal money
order.
If paying by wire transfer, please
reference your unique user fee ID
number when completing your transfer.
The originating financial institution
may charge a wire transfer fee. Please
ask your financial institution about the
fee and include it with your payment to
ensure that your fee is fully paid. The
account information is as follows: New
York Federal Reserve Bank, U.S.
Department of Treasury, TREAS NYC,
33 Liberty St., New York, NY 10045,
Acct. No.: 75060099, Routing No.:
021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 1350 Piccard Dr.,
Rockville, MD, 20850.
The tax identification number of FDA
is 53–0196965.
B. Annual BPD, Establishment, and
Product Fees
FDA will issue invoices for annual
BPD, biosimilar biological product
establishment, and biosimilar biological
product fees under the new fee schedule
in August 2013. Payment instructions
will be included in the invoices.
Payment will be due on October 1, 2013.
FDA will issue invoices in November
2014 for any annual BPD, products and
establishments subject to fees for FY
2014 that qualify for fee assessments
after the August 2013 billing.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18621 Filed 8–1–13; 8:45 am]
BILLING CODE 4160–01–P
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46963
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0010]
Cooperative Agreement to Support the
Food and Agriculture Organization
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing its
intention to receive and consider a
single source application for award of a
cooperative agreement in fiscal year
2013 to the Food and Agriculture
Organization (FAO) of the United
Nations to support global strategies that
address food safety and public health.
The goal of this collaborative project
between FDA and FAO is to contribute
to the knowledge base and development
of food safety systems globally due to
the increasingly diverse and complex
food supply. The project is also
designed to enhance and broaden FDA’s
ability to address global food safety and
public health issues associated with
food as well as provide opportunities to
leverage additional resources of other
countries. The collaborative project will
also support the FDA’s implementation
of the FDA Food Safety Modernization
Act (FSMA), including FDA’s
International Food Safety Capacity
Building Plan, which emphasizes the
concept of preventing food safetyrelated problems before they occur and
the importance of establishing strong
relationships and mutual support
among all stakeholders, including
multilateral organizations, to improve
worldwide food safety. In addition, the
collaborative project will support food
safety, nutrition, and public health
programs that align with FDA’s mission.
DATES: Important dates are as follows:
1. The application due date is
September 1, 2013.
2. The anticipated start date is
September 2013.
3. The expiration date is September 2,
2013.
ADDRESSES: Submit electronic
applications to: https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Scientific/Programmatic Contact: Julie
Moss, Center for Food Safety and
Applied Nutrition (HFS–550), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2031, Julie.moss@fda.hhs.gov.
Grants Management Contact: Gladys
SUMMARY:
E:\FR\FM\02AUN1.SGM
02AUN1
46964
Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
Melendez, Office of Acquisitions and
Grant Services (HFA 500), Food and
Drug Administration, 5630 Fishers
Lane, rm. 2032, Rockville, MD 20857,
301–827–7175,
gladys.bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at
www.fda.gov/food/newsevents/
default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
93.103 RFA–FD–13–037
sroberts on DSK5SPTVN1PROD with NOTICES
A. Background
An intergovernmental organization,
FAO has 191 Member Nations, two
associate members, and one member
organization (the European Union).
Achieving food security for all is at the
heart of FAO’s efforts—to make sure
people have regular access to enough
high-quality food to lead active, healthy
lives. FAO’s mandate is to raise levels
of nutrition, improve agricultural
productivity, better the lives of rural
populations, and contribute to the
growth of the world economy. FAO’s
activities comprise four main areas:
Putting information within reach:
FAO serves as a knowledge network.
The organization uses the expertise of
its staff—agronomists, foresters,
fisheries and livestock specialists,
nutritionists, social scientists,
economists, statisticians and other
professionals—to collect, analyze, and
disseminate data that aid development.
Sharing policy expertise: FAO lends
its years of experience to member
countries in devising agricultural
policy, supporting planning, drafting
effective legislation, and creating
national strategies to achieve rural
development and hunger alleviation
goals.
Providing a meeting place for nations:
As a neutral forum, experts from around
the globe convene at headquarters or in
field offices to forge agreements on
major food and agriculture issues.
Bringing knowledge to the field: FAO
provides the technical know-how and
mobilizes and manages millions of
dollars provided by industrialized
countries, development banks, and
other sources to make sure the projects
achieve their goals.
Capacity Development is a core
function highlighted in FAO’s new
strategic framework. Member Countries
place strong emphasis on FAO
enhancing delivery in this area as they
recently approved the Corporate
Strategy on Capacity Development. The
VerDate Mar<15>2010
18:55 Aug 01, 2013
Jkt 229001
Strategy was developed in consultation
with Member Countries and all FAO
units worldwide. Taking a corporate
approach to Capacity Development
allows FAO to learn from its collective
efforts and to support Member Countries
in their own Capacity Development
activities. The new FAO Capacity
Development framework will guide
FAO staff and their partners in
analyzing capacities in Member
Countries and identifying the
appropriate intervention(s) for fostering
sustainable development.
FAO supports Member Countries in
developing their capacities to effectively
manage food safety and quality as a key
step to safeguarding the health and wellbeing of people as well as to accessing
domestic, regional, and international
markets. Capacity Development in Food
Safety and Quality is the process
through which relevant stakeholders
from farm to table (including
government agencies, food enterprises,
academia, and consumers) are able to
better perform their functions and to
assume their responsibilities in ensuring
safety and quality of food for domestic
consumption and export.
For the Food Safety and Quality Unit
(AGN) within FAO, its overall goal is to
improve systems of food safety and
quality management, based on scientific
principles, that lead to reduced
foodborne illness and support fair and
transparent trade, thereby contributing
to economic development, improved
livelihoods, and food security. This
unit:
1. Provides independent scientific
advice on food safety and nutrition,
which serves as the basis for
international food standards.
2. Develops institutional and
individual capacities for food control
and food safety management in many
countries, including the management of
food safety emergencies.
3. Supports processes for the
development of food safety policy
frameworks.
4. Facilitates global access to
information and encourages and
supports the development of food
safety/quality networks.
While the specific projects to be
undertaken under this agreement will be
determined following the agreement
entering into force, examples of the
types of food safety projects of interest
to FDA that could be undertaken by the
FAO include the following:
Development of policy support tools to
guide planning and investment in
national food control systems; provision
of technical advice for the development
and improvement of integrated and
modern food control systems;
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
enhancement of effective participation
in the work of the Codex Alimentarius
Commission and other international
fora; addressing emerging food safety
issues; and development of technical
tools and guides related to various
technical and managerial aspects of food
control. In addition to the
aforementioned types of projects, FDA
would also be interested in supporting
nutrition projects through this
Agreement. Examples of such projects
include the FAO’s Nutrition Education
and Communication project focusing on
professional education, as well as
assistance with countries seeking to
develop effective food-based dietary
guidelines.
AGN also houses the secretariat of the
Joint FAO/World Health Organization
Codex Alimentarius Secretariat.
B. Research Objectives
With an increasingly diverse and
complex global food supply, FDA’s
interest is to strengthen food safety
systems globally to prevent food safety
problems rather than merely reacting to
problems after they occur. FDA
recognizes that it can’t do this alone. By
working with other World Trade
Organization member countries and
partnering with the FAO, FDA can
broaden the reach of food safety
capacity building efforts.
This Cooperative Agreement will
allow FDA to deepen its international
food safety capacity building
partnerships, provide a wider scope of
impact than exists currently, and merge
resources with other countries.
This cooperative agreement will
provide support so that the FAO can
meet the following projected milestones:
1. Contribute to the knowledge base
and development of food safety systems
due to the increasingly diverse and
complex food supply.
2. Enhance and broaden FDA’s ability
to address global food safety and public
health issues associated with food.
3. Provide opportunities to leverage
additional resources of other countries.
4. Support FSMA and its International
Food Safety Capacity Building Plan,
which emphasizes the concept of
preventing food safety-related problems
before they occur and the importance of
establishing strong relationships and
mutual support among all stakeholders,
including multilateral organizations, to
improve worldwide food safety.
5. Support food safety, nutrition, and
public health programs that align with
FDA’s mission.
C. Eligibility Information
Competition is limited to the FAO
because, as a global organization with a
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 78, No. 149 / Friday, August 2, 2013 / Notices
well-established, trusted presence,
access to 191 Member Nations, and an
ability to coordinate capacity building
programs at a regional and international
level, it is uniquely qualified to further
the global food safety capacity building
objectives of this cooperative agreement.
This ability to advance the objectives of
this cooperative agreement through
Member Country engagement and
leveraging is a requisite for success.
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and
Applied Nutrition intends to fund one
award up to $750,000 total costs (direct
plus indirect costs) for FY 2013. Future
year amounts will depend on annual
appropriations and successful
performance.
B. Length of Support
The award will provide 1 year of
support and include future
recommended support for 4 additional
years, contingent upon satisfactory
performance in the achievement of
project and program reporting objectives
during the preceding year and the
availability of Federal fiscal year
appropriations.
sroberts on DSK5SPTVN1PROD with NOTICES
III. Electronic Application,
Registration, and Submission
Only electronic applications will be
accepted. To submit an electronic
application in response to this FOA,
applicants should first review the full
announcement located at www.fda.gov/
food/newsevents/default.htm. (FDA has
verified the Web site addresses
throughout this document, but FDA is
not responsible for any subsequent
changes to the Web sites after this
document publishes in the Federal
Register.) For all electronically
submitted applications, the following
steps are required.
• Step 1: Obtain a Dun and Bradstreet
(DUNS) Number
• Step 2: Register With System for
Award Management (SAM)
• Step 3: Obtain Username &
Password
• Step 4: Authorized Organization
Representative (AOR) Authorization
• Step 5: Track AOR Status
• Step 6: Register With Electronic
Research Administration (eRA)
Commons
Steps 1 through 5, in detail, can be
found at https://www07.grants.gov/
applicants/organization_registration.jsp.
Step 6, in detail, can be found at https://
commons.era.nih.gov/commons/
registration/registrationInstructions.jsp.
After you have followed these steps,
VerDate Mar<15>2010
18:55 Aug 01, 2013
Jkt 229001
submit electronic applications to: https://
www.grants.gov.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–18631 Filed 8–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Draft Guidance for Industry on
Bioequivalence Recommendations for
Mesalamine Rectal Suppositories;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Bioequivalence
Recommendations for Mesalamine.’’
The recommendations provide specific
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for mesalamine rectal
suppositories. The draft guidance is a
revised version of a previously issued
draft guidance on the same subject.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 1,
2013.
SUMMARY:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kris
Andre, Center for Drug Evaluation and
ADDRESSES:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
46965
Research (HFD–600), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9326.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. As described in that
guidance, FDA adopted this process as
a means to develop and disseminate
product-specific BE recommendations
and provide a meaningful opportunity
for the public to consider and comment
on those recommendations. This notice
announces the availability of a draft
guidance on mesalamine (Draft
Mesalamine Rectal Suppository BE
Recommendations of 2013).
CANASA (Mesalamine, USP) Rectal
Suppositories, new drug application
021252, 500 milligram (mg) and 1,000
mg strengths were approved by FDA in
January 2001 and November 2004,
respectively. The 500 mg strength is no
longer marketed. There are no approved
ANDAs for this product.
In May 2007, FDA posted on its Web
site a draft guidance for industry on the
Agency’s recommendations for BE
studies to support ANDAs for
mesalamine rectal suppositories (Draft
Mesalamine Rectal Suppository BE
Recommendations of May 2007). In that
draft guidance, FDA recommended in
vivo studies to demonstrate BE of
generic mesalamine rectal suppositories:
A BE study with clinical endpoints and
a fasting BE study with pharmacokinetic
endpoints. FDA has reconsidered the
recommendations in the Draft
Mesalamine Rectal Suppository BE
Recommendations of May 2007 and has
decided to revise it. In March 2013, FDA
withdrew the Draft Mesalamine Rectal
Suppository BE Recommendations of
May 2007 and posted on its Web site a
revised draft guidance for industry, the
Draft Mesalamine Rectal Suppository BE
Recommendations of 2013. In this
revised draft guidance, FDA
recommends in vivo and in vitro studies
to demonstrate BE of generic
mesalamine rectal suppositories: A
fasting BE study with pharmacokinetic
endpoints and comparative in vitro
studies (melting point, differential
scanning calorimetry, density, and
viscosity). FDA is no longer
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46963-46965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18631]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0010]
Cooperative Agreement to Support the Food and Agriculture
Organization
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to receive and consider a single source application for award
of a cooperative agreement in fiscal year 2013 to the Food and
Agriculture Organization (FAO) of the United Nations to support global
strategies that address food safety and public health.
The goal of this collaborative project between FDA and FAO is to
contribute to the knowledge base and development of food safety systems
globally due to the increasingly diverse and complex food supply. The
project is also designed to enhance and broaden FDA's ability to
address global food safety and public health issues associated with
food as well as provide opportunities to leverage additional resources
of other countries. The collaborative project will also support the
FDA's implementation of the FDA Food Safety Modernization Act (FSMA),
including FDA's International Food Safety Capacity Building Plan, which
emphasizes the concept of preventing food safety-related problems
before they occur and the importance of establishing strong
relationships and mutual support among all stakeholders, including
multilateral organizations, to improve worldwide food safety. In
addition, the collaborative project will support food safety,
nutrition, and public health programs that align with FDA's mission.
DATES: Important dates are as follows:
1. The application due date is September 1, 2013.
2. The anticipated start date is September 2013.
3. The expiration date is September 2, 2013.
ADDRESSES: Submit electronic applications to: https://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section.
FOR FURTHER INFORMATION CONTACT: Scientific/Programmatic Contact: Julie
Moss, Center for Food Safety and Applied Nutrition (HFS-550), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
240-402-2031, Julie.moss@fda.hhs.gov. Grants Management Contact: Gladys
[[Page 46964]]
Melendez, Office of Acquisitions and Grant Services (HFA 500), Food and
Drug Administration, 5630 Fishers Lane, rm. 2032, Rockville, MD 20857,
301-827-7175, gladys.bohler@fda.hhs.gov.
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at www.fda.gov/food/newsevents/default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
93.103 RFA-FD-13-037
A. Background
An intergovernmental organization, FAO has 191 Member Nations, two
associate members, and one member organization (the European Union).
Achieving food security for all is at the heart of FAO's efforts--to
make sure people have regular access to enough high-quality food to
lead active, healthy lives. FAO's mandate is to raise levels of
nutrition, improve agricultural productivity, better the lives of rural
populations, and contribute to the growth of the world economy. FAO's
activities comprise four main areas:
Putting information within reach: FAO serves as a knowledge
network. The organization uses the expertise of its staff--agronomists,
foresters, fisheries and livestock specialists, nutritionists, social
scientists, economists, statisticians and other professionals--to
collect, analyze, and disseminate data that aid development.
Sharing policy expertise: FAO lends its years of experience to
member countries in devising agricultural policy, supporting planning,
drafting effective legislation, and creating national strategies to
achieve rural development and hunger alleviation goals.
Providing a meeting place for nations: As a neutral forum, experts
from around the globe convene at headquarters or in field offices to
forge agreements on major food and agriculture issues.
Bringing knowledge to the field: FAO provides the technical know-
how and mobilizes and manages millions of dollars provided by
industrialized countries, development banks, and other sources to make
sure the projects achieve their goals.
Capacity Development is a core function highlighted in FAO's new
strategic framework. Member Countries place strong emphasis on FAO
enhancing delivery in this area as they recently approved the Corporate
Strategy on Capacity Development. The Strategy was developed in
consultation with Member Countries and all FAO units worldwide. Taking
a corporate approach to Capacity Development allows FAO to learn from
its collective efforts and to support Member Countries in their own
Capacity Development activities. The new FAO Capacity Development
framework will guide FAO staff and their partners in analyzing
capacities in Member Countries and identifying the appropriate
intervention(s) for fostering sustainable development.
FAO supports Member Countries in developing their capacities to
effectively manage food safety and quality as a key step to
safeguarding the health and well-being of people as well as to
accessing domestic, regional, and international markets. Capacity
Development in Food Safety and Quality is the process through which
relevant stakeholders from farm to table (including government
agencies, food enterprises, academia, and consumers) are able to better
perform their functions and to assume their responsibilities in
ensuring safety and quality of food for domestic consumption and
export.
For the Food Safety and Quality Unit (AGN) within FAO, its overall
goal is to improve systems of food safety and quality management, based
on scientific principles, that lead to reduced foodborne illness and
support fair and transparent trade, thereby contributing to economic
development, improved livelihoods, and food security. This unit:
1. Provides independent scientific advice on food safety and
nutrition, which serves as the basis for international food standards.
2. Develops institutional and individual capacities for food
control and food safety management in many countries, including the
management of food safety emergencies.
3. Supports processes for the development of food safety policy
frameworks.
4. Facilitates global access to information and encourages and
supports the development of food safety/quality networks.
While the specific projects to be undertaken under this agreement
will be determined following the agreement entering into force,
examples of the types of food safety projects of interest to FDA that
could be undertaken by the FAO include the following: Development of
policy support tools to guide planning and investment in national food
control systems; provision of technical advice for the development and
improvement of integrated and modern food control systems; enhancement
of effective participation in the work of the Codex Alimentarius
Commission and other international fora; addressing emerging food
safety issues; and development of technical tools and guides related to
various technical and managerial aspects of food control. In addition
to the aforementioned types of projects, FDA would also be interested
in supporting nutrition projects through this Agreement. Examples of
such projects include the FAO's Nutrition Education and Communication
project focusing on professional education, as well as assistance with
countries seeking to develop effective food-based dietary guidelines.
AGN also houses the secretariat of the Joint FAO/World Health
Organization Codex Alimentarius Secretariat.
B. Research Objectives
With an increasingly diverse and complex global food supply, FDA's
interest is to strengthen food safety systems globally to prevent food
safety problems rather than merely reacting to problems after they
occur. FDA recognizes that it can't do this alone. By working with
other World Trade Organization member countries and partnering with the
FAO, FDA can broaden the reach of food safety capacity building
efforts.
This Cooperative Agreement will allow FDA to deepen its
international food safety capacity building partnerships, provide a
wider scope of impact than exists currently, and merge resources with
other countries.
This cooperative agreement will provide support so that the FAO can
meet the following projected milestones:
1. Contribute to the knowledge base and development of food safety
systems due to the increasingly diverse and complex food supply.
2. Enhance and broaden FDA's ability to address global food safety
and public health issues associated with food.
3. Provide opportunities to leverage additional resources of other
countries.
4. Support FSMA and its International Food Safety Capacity Building
Plan, which emphasizes the concept of preventing food safety-related
problems before they occur and the importance of establishing strong
relationships and mutual support among all stakeholders, including
multilateral organizations, to improve worldwide food safety.
5. Support food safety, nutrition, and public health programs that
align with FDA's mission.
C. Eligibility Information
Competition is limited to the FAO because, as a global organization
with a
[[Page 46965]]
well-established, trusted presence, access to 191 Member Nations, and
an ability to coordinate capacity building programs at a regional and
international level, it is uniquely qualified to further the global
food safety capacity building objectives of this cooperative agreement.
This ability to advance the objectives of this cooperative agreement
through Member Country engagement and leveraging is a requisite for
success.
II. Award Information/Funds Available
A. Award Amount
The Center for Food Safety and Applied Nutrition intends to fund
one award up to $750,000 total costs (direct plus indirect costs) for
FY 2013. Future year amounts will depend on annual appropriations and
successful performance.
B. Length of Support
The award will provide 1 year of support and include future
recommended support for 4 additional years, contingent upon
satisfactory performance in the achievement of project and program
reporting objectives during the preceding year and the availability of
Federal fiscal year appropriations.
III. Electronic Application, Registration, and Submission
Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at www.fda.gov/food/newsevents/default.htm. (FDA has verified the Web site addresses throughout this
document, but FDA is not responsible for any subsequent changes to the
Web sites after this document publishes in the Federal Register.) For
all electronically submitted applications, the following steps are
required.
Step 1: Obtain a Dun and Bradstreet (DUNS) Number
Step 2: Register With System for Award Management (SAM)
Step 3: Obtain Username & Password
Step 4: Authorized Organization Representative (AOR)
Authorization
Step 5: Track AOR Status
Step 6: Register With Electronic Research Administration
(eRA) Commons
Steps 1 through 5, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: https://www.grants.gov.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18631 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P
