E9-19010. Office of Critical Path Programs-Critical Path Initiative

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of Office of Critical Path Programs (OCPP). The goal of OCPP is to develop an administrative and scientific infrastructure to support the creation and execution of a series of projects under the FDA's Critical Path Initiative.

DATES:

Important dates are as follows:

1. The application due date is September 7, 2009.

2. The anticipated start date is in September 2009.

3. The opening date is August 10, 2009.

4. The expiration date is September 8, 2009.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:

Nancy Stanisic, Office of Critical Path Programs (HF-18), rm. 14B45, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1660.

Gladys M. Bohler, Grants Management Specialist, Office of Acquisitions and Grants Services (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7168.

For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://www.fda.gov/​oc/​initiatives/​criticalpath/​.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Funding Opportunity Description Number: RFA FD-09-019

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.

B. Research Objectives

FDA's Office of the Commissioner is announcing its intent to accept and consider a single source application for the award of a Cooperative Agreement to the Critical Path Institute (C-Path).

FDA anticipates providing up to $1.5 million (direct and indirect costs combined) during fiscal year (FY) 2009 to support research and related efforts of identified projects that are part of the Critical Path Initiative.

This Cooperative Agreement ensures substantial FDA involvement in this program, and will include, but will not be limited to, co-development of study priorities, protocols, decisionmaking, reports, and publications at specified program milestones related to performance. FDA will support research covered by this document under the authority of section 301 of the Public Health Service Act (42 U.S.C. 341). Administrative regulations found in 45 CFR parts 74 and/or 92 are applicable.

C. Eligibility Information

The following organization/institution is eligible to apply: Critical Path Institute.

Competition is limited because of FDA's ongoing collaboration with the University of Utah and the Critical Path Institute, in support of FDA's Critical Path Initiative, and the combined ability of these parties to leverage existing databases, specimen repositories, clinical, and other technical expertise in support of this program.

II. Award Information/Funds Available

A. Award Amount

It is anticipated that FDA will fund this Cooperative Agreement up to $1.5 million (direct and indirect costs) in FY 09 based on the quality of the application received and the availability of Federal funds.

B. Length of Support

Funding beyond the first year (up to 5 years) will be noncompetitive and will depend on: (1) Satisfactory performance during the preceding year and (2) the availability of Federal fiscal year funds.

III. Paper Application, Registration, and Submission Information

To submit a paper application in response to this FOA, applicants should first review the full announcement located at http://www.fda.gov/​oc/​initiatives/​criticalpath/​. Persons interested in applying for a grant may obtain an application at http://grants.nih.gov/​grants/​forms.htm.

For all paper application submissions, the following steps are required:

• Step 1: Obtain a Dun and Bradstreet (DUNS) Number
• Step 2: Register With Central Contractor Registration
• Step 3: Register With Electronic Research Administration (eRA) Commons

Steps 1 and 2, in detail, can be found at http://www07.grants.gov/​applicants/​organization_​registration.jsp. Step 3, in detail, can be found at https://commons.era.nih.gov/​commons/​registration/​registrationInstructions.jsp. After you have followed these steps, submit paper applications to: Gladys M. Bohler (see FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT).

Dated: August 4, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.