Document ID: FDA-2009-N-0366-0001
Agency: fda
Document Type: Notice
Title: Office of Critical Path Programs-Critical Path Initiative
Posted Date: 2009-08-10T04:00Z

[Federal Register: August 10, 2009 (Volume 74, Number 152)]
[Notices]               
[Page 39963-39964]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10au09-40]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0366]

 
 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

[[Page 39964]]

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.
[FR Doc. E9-19010 Filed 8-7-09; 8:45 am]

BILLING CODE 4160-01-P