[Federal Register Volume 74, Number 117 (Friday, June 19, 2009)]
[Notices]
[Pages 29216-29217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14436]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0262]
Clinical Trials Transformation Initiative (U19)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds to support the Clinical Trials
Transformation Initiative (CTTI). The goal of CTTI is to support
modernization of the clinical trial enterprise by identifying practices
that will enhance human subject protection, boost the quality of
information derived from clinical trials, and make the research process
more efficient.
DATES: Important dates are as follows:
1. The application is due by: July 6, 2009.
2. The anticipated start date is in: September 2009.
[[Page 29217]]
FOR FURTHER INFORMATION CONTACT:
Programmatic/Review Contact: Melissa Robb, Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane, rm. 14B-
45, Rockville, MD 20857, 301-827-1516, [email protected]
Grants Management Contact: Gladys M. Bohler, OAGS, Food and Drug
Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-
827-7168, [email protected].
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA-FD-09-011
Catalog of Federal Domestic Assistance Number: 93.103
A. Background
The Critical Path Initiative, launched by FDA in 2004, has the
objective of helping modernize the development, evaluation,
manufacture, and use of FDA-regulated products. Through nationwide
collaboration with other Federal, academic, scientific, and industry
organizations, the initiative seeks to develop new tools to facilitate
innovation in FDA-regulated product development. Examples of tools
include novel biomarkers, laboratory assays, genetic tests, and state-
of-the art information technologies, etc. In this initiative, FDA plays
the role of a facilitator in the creation of partnerships and
collaborations to support specific scientific projects.
FDA and Duke University's Department of Translational Medicine
Institute (DTMI) co-founded CTTI. CTTI's goal is to systematically
modernize the clinical trial process, a goal shared by FDA's Critical
Path Initiative. CTTI is made up of a broad representation of member
organizations including government, industry, patient advocacy groups,
professional societies, and academia. The participants are working
together to identify practices that through broad adoption will
increase the quality and efficiency of clinical trials.
CTTI is generating evidence about how to improve the design and
execution of clinical trials. Projects about design will address
principles generally applicable to clinical trials to ensure that they
are fit to accomplish their intended purpose.
B. Research Objectives
The goals of this program are to develop an administrative and
scientific infrastructure to support the creation and execution of a
series of projects under the auspices of CTTI, to complement the goals
of FDA's Critical Path Initiative.
This funding opportunity will use a cooperative agreement award
mechanism (U19). In the cooperative agreement mechanism, the Project
Director/Principal Investigator (PD/PI) retains the primary
responsibility and dominant role for planning, directing, and executing
the proposed project, with FDA staff being substantially involved as a
partner with the PD/PI. Substantive involvement includes, but is not
limited to, the following: (1) FDA will work closely with the DTMI
throughout the lifetime of this program and throughout all phases of
planning, implementation, conduct and reporting of this program and all
related projects; (2) FDA will appoint project officer (s) for the
task(s) associated with this program and related projects; (3) FDA will
identify appropriate staff to provide strategic and scientific input,
as needed, throughout the life of this program and related projects.
C. Eligibility Information
This is a sole source award to DTMI located within Duke University
to support the CTTI. Only one award will be made to the DTMI to support
the CTTI.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing up to $1.5 million (direct and indirect
costs combined) during fiscal year 2009 to support research and related
efforts of identified projects that are part of the Critical Path
Initiative.
B. Length of Support
Subject to the availability of Federal funds and successful
performance of the funding opportunity announcement (FOA) stated goals
and objectives, 4 additional years of support may be available
depending on annual appropriations. This award will be funded based on
the quality of the application received and is subject to availability
of Federal funds to support the program.
III. How to Submit a Paper Application
To submit a paper application in response to this FOA, applicants
should first review the full announcement located at http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm083241.htm. Persons interested in applying
for a grant may obtain application forms and instructions at http://grants.nih.gov/grants/forms.htm. For paper submissions, the following
steps are required:
Step 1: Obtain a Dun and Bradstreet Data Universal
Numbering System (DUNS) Number
Step 2: Register with Central Contractor Registration
(CCR) Instructions on how to complete these steps can be found at
http://www07.grants.gov/applicants/organization_registration.jsp
Submit paper applications to: Gladys M. Bohler, OAGS/GAAT, Food and
Drug Administration, 5630 Fishers Lane (HFA-500), rm. 2105, Rockville,
MD 20874.
Dated: June 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14436 Filed 6-18-09; 8:45 am]
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