[Federal Register Volume 71, Number 67 (Friday, April 7, 2006)]
[Notices]
[Pages 17893-17894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Cooperative Agreement to Support a Single-Source Application--The 
Critical Path Institute: Collaborative Cardiovascular Drug Safety and 
Biomarker Research Program--ACTION; Availability of Sole Source 
Cooperative Agreement; Request for Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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I. Funding Opportunity Description

    The Food and Drug Administration (FDA), Office of the Commissioner 
(OC) is announcing its intent to accept and consider a single source 
application (RFA-FDA-OC-2006-1) for the award of a Cooperative 
Agreement to the Critical Path Institute. FDA anticipates providing up 
to $750,000 (direct and indirect costs combined) in fiscal year 2006 to 
support this multiphased research program that will include, but will 
not be limited to, the development of an infrastructure to support this 
program and subsequent related studies in cardiovascular disease and 
genomic/proteomic biomarker research, as stipulated by Congress.
    Subject to the availability of Federal funds and successful 
performance, an additional 2 years of support up to $750,000(direct and 
indirect costs combined) per year may be available.
    FDA will support the research covered by this notice under the 
authority of section 301 of the Public Health Service (PHS) Act (42 
U.S.C. 241). FDA's research program is described in the Catalog of 
Federal Domestic Assistance No. 93.103. Before entering into 
cooperative agreements, FDA carefully considers the benefits such 
agreements will provide to the public.
    The cooperative agreement ensures FDA's continued participation in 
the Collaborative Cardiovascular Drug Safety and Biomarker Research 
Program, as proposed by Congress and to be conducted under FDA's 
Critical Path Initiative. A goal of the Critical Path Initiative is to 
foster the development of new tools to both promote drug safety and 
accelerate the development of innovative new therapies, through 
appropriate collaboration with multiple parties. This collaborative 
research program is expected to be conducted in a multiphase process, 
leveraging resources and expertise from the awardee, other 
collaborators, and FDA to address public health needs involving 
cardiovascular disease and biomarker research.

II. Eligibility Information

    Competition is limited because of Congressional mandate, the 
mission of the Critical Path Institute, its established collaboration 
with the University of Utah, and the combined ability of these parties 
to leverage existing databases, specimen repositories, clinical and 
other technical expertise in support of this program.

III. Application and Submission

    For further information or a copy of the complete Request for 
Applications (RFA) contact Cynthia Polit, Grants Management Officer, 
Division of Contracts and Grants Management

[[Page 17894]]

(HFA-500), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-7180, e-mail: [email protected]. This RFA can 
be viewed on Grants.gov under ``Grant Find.'' A copy of the complete 
RFA can also be viewed on the FDA Web site at http://www.fda.gov/oc/initiatives/criticalpath/. For issues regarding the programmatic and 
scientific aspects of this notice contact Wendy Sanhai, Ph. D., Senior 
Scientific Advisor, Office of the Commissioner (HF-1), Food and Drug 
Administration, 5600 Fishers Lane, rm. 1471, Rockville, MD 20857, 301-
827-7867, e-mail: [email protected].

    Dated: March 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-3408 Filed 4-5-06; 2:33 pm]
BILLING CODE 4160-01-S