Cooperative Agreement to Support the World Trade Organization's Standards and Trade Development Facility, 42084-42085 [2013-16860]
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42084
Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0812]
Electronic Study Data Submission;
Data Standard Support; Availability of
the Center for Drug Evaluation and
Research Data Standards Program
Documents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Center for Drug
Evaluation and Research (CDER) of the
Food and Drug Administration (FDA) is
announcing the availability of the CDER
Data Standards Strategy (version 1.0)
and the CDER Data Standards Strategy—
Action Plan (version 1.0). This action is
being taken to ensure that all interested
stakeholders are aware that the data
standards program documents are
available and is intended to increase
awareness of CDER’s data standards
plans, ongoing projects, and avenues of
communication. Comments may be
submitted to the email address listed
below.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Office of Strategic Programs, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1100,
Silver Spring, MD 20993, 301–796–
3800; email:
CDERDataStandards@fda.hhs.gov.
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
On December 5, 2012, the CDER Data
Standards Strategy (version 1.0) was
released. Its purpose is to reinforce
FDA’s ongoing commitment to the
development, implementation, and
maintenance of a comprehensive data
standards program to facilitate the
efficient and effective review of
regulatory submissions so that safe and
effective products can get to market
sooner. It is aligned with the objectives
of FDA’s Strategic Plan and the
performance goals of the Prescription
Drug User Fee Act V Reauthorization as
captured in the FDA Safety and
Innovation Act. The CDER Data
Standards Strategy supersedes version
1.1 of the CDER Data Standards Plan,
which was issued in December 2010.
The first release of the companion
document to the Data Standards
Strategy, the CDER Data Standards
Strategy—Action Plan, was issued on
March 20, 2013. The Action Plan
provides internal and external
VerDate Mar<15>2010
18:53 Jul 12, 2013
Jkt 229001
stakeholders with an overview and
progress of current relevant data
standards initiatives. The plan will be
updated quarterly to indicate progress of
current projects as well as initiation of
new projects.
These documents are available from
the CDER Data Standards Program Web
site at: https://www.fda.gov/Drugs/
DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/ucm249979.htm.
MD 20857, 301–827–9363, email:
kimberly.pendleton@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
Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
RFA–FD–13–036
[FR Doc. 2013–16861 Filed 7–12–13; 8:45 am]
A. Background
BILLING CODE 4160–01–P
The STDF is a unique global
partnership established by the Food and
Agriculture Organization, World
Organization for Animal Health, World
Bank, World Health Organization
(WHO) and the WTO. The STDF
supports developing countries in
building their capacity to implement
international sanitary and phytosanitary
(SPS) standards, guidelines, and
recommendations as a means to
improve their human, animal, and plant
health status and ability to gain or
maintain access to markets. In achieving
its aims, the STDF acts as both a
coordinating and a financing
mechanism.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0010]
Cooperative Agreement to Support the
World Trade Organization’s Standards
and Trade Development Facility
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 the award
of a cooperative agreement in fiscal year
2013 (FY 2013) to the World Trade
Organization’s (WTO) Standards and
Trade Development Facility (STDF).
DATES: Important dates are as follows:
1. The application due date is August
1, 2013.
2. The anticipated start date is
September 2013.
3. The expiration date is August 2,
2013.
SUMMARY:
Submit electronic
applications to: https://www.grants.gov.
For more information, see section III of
the SUPPLEMENTARY INFORMATION section
of this notice.
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, email:
julie.moss@fda.hhs.gov.
Grants Management Contact:
Kimberly Pendleton Chew, Office of
Acquisitions and Grant Services (HFA–
500), Food and Drug Administration,
5630 Fishers Lane, rm. 2105, Rockville,
ADDRESSES:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
93.103
The STDF is a widely established
knowledge platform for information
exchange, sharing experiences and the
identification and dissemination of good
practice on SPS-related technical
cooperation. Since 2004, over 60
projects and 52 project preparation
grants have assisted developing
countries to overcome SPS constraints,
and gain and maintain market access.
Over 50% have benefited least
developed and other low-income
countries.
The STDF utilizes a key decisionsupport tool, Multi-Criteria Decision
Analysis (MCDA), to help establish SPS
priorities and ensure resources are used
as efficiently as possible. The use of the
MCDA tool is unique within the STDF
and is a highly-valued attribute; the
MCDA tool facilitates an open and
transparent discussion among public
and private stakeholders about capacitybuilding needs and resources. The STDF
is committed to the Paris Principles on
Aid Effectiveness and to achieving the
Millennium Development Goals.
With an increasingly diverse and
complex global food supply, FDA’s
interest is to strengthen food safety
systems globally to prevent food safety
E:\FR\FM\15JYN1.SGM
15JYN1
Federal Register / Vol. 78, No. 135 / Monday, July 15, 2013 / Notices
regional, and global level. Engaging the
STDF through this cooperative
agreement will provide FDA with ample
opportunities to leverage additional
resources among WTO member
countries.
Overall, the objectives of the STDF are
directly in line with the 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.
B. Research Objectives
The purpose of this cooperative
agreement is to:
1. Contribute to the knowledge base
and development of food safety systems
globally 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 among WTO
member countries;
4. Support FDA’s Food Safety
Modernization Act (FSMA) and its
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.
tkelley on DSK3SPTVN1PROD with NOTICES
problems rather than merely reacting to
problems after they occur. FDA
recognizes that it cannot do this alone.
By leveraging with other WTO member
countries and partnering with the STDF,
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 leverage resources
with other countries.
II. Award Information/Funds Available
C. Eligibility Information
Competition is limited to the STDF
hosted by the WTO. The STDF is a
global partnership with a wellestablished, trusted presence and is
uniquely qualified to further the global
food safety capacity building objectives
of this cooperative agreement. STDF’s
mandate is to: (1) Increase awareness,
mobilize resources, strengthen
collaboration, identify and disseminate
good practice; and (2) provide support
and funding for the development and
implementation of projects that promote
compliance with international SPS
requirements.
An independent external evaluation
of the STDF in 2008 concluded that the
STDF ‘‘carries out an important role that
no other single body would be able to
accomplish.’’ (Source: STDF Newsletter,
Vol. 2, Issue 1, February 2009,
accessible at: www.standardsfacility.org)
As such, the STDF is uniquely equipped
to fulfill the objectives of this
cooperative agreement due to its diverse
access to WTO members in both
developed and developing countries
and its ability to coordinate capacity
building programs at a national,
VerDate Mar<15>2010
18:53 Jul 12, 2013
Jkt 229001
A. Award Amount
42085
registration/registrationInstructions.jsp.
After you have followed these steps,
submit electronic applications to:
https://www.grants.gov.
Dated: July 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–16860 Filed 7–12–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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.
[Docket No. FDA–2013–D–0814]
B. Length of Support
AGENCY:
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/
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Draft Guidance for Industry on
Pediatric Study Plans: Content of and
Process for Submitting Initial Pediatric
Study Plans and Amended Pediatric
Study Plans; Availability
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Pediatric Study
Plans: Content of and Process for
Submitting Initial Pediatric Study Plans
and Amended Pediatric Study Plans.’’
This draft guidance is intended to
provide information to industry on how
to submit initial and amended pediatric
study plans (PSPs) as required under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as amended by the Food and
Drug Administration Safety and
Innovation Act (FDASIA).
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 comment 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 September 13,
2013.
ADDRESSES: 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, or Office
of Communication, Outreach, and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
SUMMARY:
E:\FR\FM\15JYN1.SGM
15JYN1
Agencies
[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42084-42085]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0010]
Cooperative Agreement to Support the World Trade Organization's
Standards and Trade Development Facility
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 the
award of a cooperative agreement in fiscal year 2013 (FY 2013) to the
World Trade Organization's (WTO) Standards and Trade Development
Facility (STDF).
DATES: Important dates are as follows:
1. The application due date is August 1, 2013.
2. The anticipated start date is September 2013.
3. The expiration date is August 2, 2013.
ADDRESSES: Submit electronic applications to: https://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.
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, email: julie.moss@fda.hhs.gov.
Grants Management Contact: Kimberly Pendleton Chew, Office of
Acquisitions and Grant Services (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-
827-9363, email: kimberly.pendleton@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
RFA-FD-13-036
93.103
A. Background
The STDF is a unique global partnership established by the Food and
Agriculture Organization, World Organization for Animal Health, World
Bank, World Health Organization (WHO) and the WTO. The STDF supports
developing countries in building their capacity to implement
international sanitary and phytosanitary (SPS) standards, guidelines,
and recommendations as a means to improve their human, animal, and
plant health status and ability to gain or maintain access to markets.
In achieving its aims, the STDF acts as both a coordinating and a
financing mechanism.
The STDF is a widely established knowledge platform for information
exchange, sharing experiences and the identification and dissemination
of good practice on SPS-related technical cooperation. Since 2004, over
60 projects and 52 project preparation grants have assisted developing
countries to overcome SPS constraints, and gain and maintain market
access. Over 50% have benefited least developed and other low-income
countries.
The STDF utilizes a key decision-support tool, Multi-Criteria
Decision Analysis (MCDA), to help establish SPS priorities and ensure
resources are used as efficiently as possible. The use of the MCDA tool
is unique within the STDF and is a highly-valued attribute; the MCDA
tool facilitates an open and transparent discussion among public and
private stakeholders about capacity-building needs and resources. The
STDF is committed to the Paris Principles on Aid Effectiveness and to
achieving the Millennium Development Goals.
With an increasingly diverse and complex global food supply, FDA's
interest is to strengthen food safety systems globally to prevent food
safety
[[Page 42085]]
problems rather than merely reacting to problems after they occur. FDA
recognizes that it cannot do this alone. By leveraging with other WTO
member countries and partnering with the STDF, 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 leverage resources with
other countries.
B. Research Objectives
The purpose of this cooperative agreement is to:
1. Contribute to the knowledge base and development of food safety
systems globally 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 among WTO
member countries;
4. Support FDA's Food Safety Modernization Act (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.
C. Eligibility Information
Competition is limited to the STDF hosted by the WTO. The STDF is a
global partnership with a well-established, trusted presence and is
uniquely qualified to further the global food safety capacity building
objectives of this cooperative agreement. STDF's mandate is to: (1)
Increase awareness, mobilize resources, strengthen collaboration,
identify and disseminate good practice; and (2) provide support and
funding for the development and implementation of projects that promote
compliance with international SPS requirements.
An independent external evaluation of the STDF in 2008 concluded
that the STDF ``carries out an important role that no other single body
would be able to accomplish.'' (Source: STDF Newsletter, Vol. 2, Issue
1, February 2009, accessible at: www.standardsfacility.org) As such,
the STDF is uniquely equipped to fulfill the objectives of this
cooperative agreement due to its diverse access to WTO members in both
developed and developing countries and its ability to coordinate
capacity building programs at a national, regional, and global level.
Engaging the STDF through this cooperative agreement will provide FDA
with ample opportunities to leverage additional resources among WTO
member countries.
Overall, the objectives of the STDF are directly in line with the
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 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16860 Filed 7-12-13; 8:45 am]
BILLING CODE 4160-01-P