E9-14436. 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.

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, [e-mail]

Grants Management Contact: Gladys M. Bohler, OAGS, Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7168, [e-mail].

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.