[Federal Register Volume 74, Number 117 (Friday, June 19, 2009)]
[Pages 29216-29217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14436]



Food and Drug Administration

[Docket No. FDA-2009-N-0262]

Clinical Trials Transformation Initiative (U19)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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]]

    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].


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 

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 
    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]