Selection of Funding Opportunities for the Technology Component of the Cancer Genome Atlas (TCGA) Project

Notice Number: NOT-CA-06-029

Key Dates
Release Date: June 14, 2006

Issued by
National Cancer Institute (NCI), (http://www.nci.nih.gov)

The National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI) have announced new funding opportunities centered on Genomic Technologies, as components of the Cancer Genome Atlas (TCGA) Pilot Project. This Genomic Technology initiative intends to inspire and promote the development of highly innovative tools and new ways to interrogate genomic alterations in cancer. The emphasis is on new and improved high resolution, high-throughput technologies to detect alterations in the cancer genome, epigenome, or transcriptome, including, but not limited to: changes in DNA segment copy numbers, translocations, loss of heterozygosity, epigenomic modifications, and aberrant gene expression profiles. The scope includes attempts to significantly improve sensitivity, such that reliable, whole-genome data are generated from small specimens (up to 1,000 cells) and from samples that are preserved in various ways (i.e., flash frozen, embedded and frozen in a cryopreservation medium, or paraffin embedded). The proposed projects should maximize genome coverage and resolution to provide complete and comprehensive analysis of the cancer genome, epigenome, and/or transcriptome.

The technology component of TCGA Project comprises three FOAs. All three FOAs are closely related in terms of their scientific scope, but they involve different funding mechanisms with distinct submission requirements. The purpose of this Notice is to help potential applicants to identify a most appropriate FOA from this list:

1. Development of Advanced Genomic Characterization Technologies (R21) for pilot-exploratory projects using conventional research project grants (RPG);
2. Development of Advanced Genomic Characterization Technologies (R43/R44 SBIR) for exploratory/developmental Small Business Innovation Research (SBIR) funding mechanisms; and
3. Development of Advanced Genomic Characterization Technologies (R41/R42 STTR) for exploratory/developmental Small Business Technology Transfer (STTR) funding mechanisms.

All three FOAs are appropriate for high-risk exploratory research projects that emphasize innovative approaches (Phase I). The SBIR and STTR mechanisms, however, additionally allow for projects centered on further development of technologies/applications for which proofs-of-concept have been achieved (Phase II); or for projects that combine both Phase I and Phase II efforts in one application/award ( Phased Innovation or Fast-Track awards). The SBIR/STTR mechanisms are particularly appropriate for projects that have potential for commercializable products or services.

In addition to NIH and NHGRI, also National Institute of Environmental Health Sciences (NIEHS) will participate in the Genomic Technology RFAs utilizing the SBIR/STTR mechanisms. Although NIEHS does not commit any specific set-aside funds to this RFA, applications arising from this solicitation that address topics of interest to NIEHS may be considered for funding along with other unsolicited SBIR/STTR applications assigned to NIEHS.

The receipt date for all three FOAs is August 24, 2006.

Table 1 below summarizes the basic characteristics and requirements for all three Genomic Technology RFAs. Please note that for comprehensive information on all the submission requirements and other details, it is absolutely essential that every applicant reads and utilizes the selected individual FOA document for preparing and submitting an application. Nonetheless, potential applicants who are interested in the Genomic Technology initiative may use this table and the provided individual links to initially identify which of these FOAs might be most appropriate.

Table 1. Genomic Technology RFAs and Outlines of their Characteristics.

RFA (Award Type)	Funding Mechanism	Project Type	General Requirements	Set-Aside Funds in FY 2007d
RFA-07-021 (RPG)	R21	Exploratory-pilot	Required: Innovation of technology/approacha; Quantitative milestonesb; Not required (but allowed): Preliminary data.	~$3M
RFA-07-029 (SBIR)	R43	Exploratory/ Phase I	Required: Innovation of technology/approach; Quantitative milestones; Small Business-specific requirements. Not required (but allowed): Preliminary data.	~$2M
	R44	Developmental/ Phase II	Required: Feasibility data and successful completion of Phase I project; Small Business-specific requirements (including commercialization plans).
	R43/R44	Exploratory/ Developmental Phase I/Phase II (Fast-Track)	Required: Innovation of technology/approach; Quantitative milestones for Phase I; Small Business-specific requirements (including commercialization plans).
RFA-07-030 (STTR)	R41	Exploratory/ Phase I	Required: Innovation of technology/approach; Quantitative milestones required; Small Business-specific requirements. Not required (but allowed): Preliminary data.	~$1M
	R42	Developmental/ Phase II	Required: Feasibility data and successful completion of Phase I project; Small Business-specific requirements (including commercialization plans).
	R41/R42	Exploratory/ Developmental Phase I/Phase II (Fast-Track)	Required: Innovation of technology/approach; Quantitative milestones for Phase I; Small Business-specific requirements (including commercialization plans).

^aWhile no preliminary data are necessary, the applicants must demonstrate the innovative nature of the particular technology or approach proposed for development.

^bQuantitative milestones for each specific aim must be provided as a way of determining during the project and at its completion whether an applicant has successfully reached the specified goal. Milestones should be clearly stated as numerical quantitative specifications for relevant measures/properties.

^c Detailed preliminary data must be provided in support of the feasibility of the technology or approach that is proposed for development. Such data may reflect successful completion of Phase I and associated milestones. For SBIR/STTR FOAs, feasibility data need to be largely obtained through a NIH-sponsored Phase I project.

^d The duration of all projects under all three FOAs cannot exceed 2 years.

Inquiries about TCGA Project and individual Genomic Technology FOAs

Direct questions to:

Daniela S. Gerhard, Ph.D.
Director,
Office of Cancer Genomics
Office of the Director
National Cancer Institute
Building 31, Room 10A07, MSC 2580
31 Center Drive
Bethesda, MD 20892-2580
Telephone: (301) 451-8027
Fax: (301) 480-4368
E-mail: [email protected]

Or

Bradley A. Ozenberger, Ph.D.
Program Director, Technology Development
National Human Genome Research Institute
National Institutes of Health
5635 Fishers Lane, Suite 4076, MSC 9305
Bethesda, MD 20892-9305
Telephone: (301) 496-7531
Fax: (301) 480-2770
E-mail: [email protected]

Or (SBIR/STTR FOAs only)

Jerrold Heindel, Ph.D.
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
POB 12233 (U.S. Postal Service Express or regular mail)
4401 Bldg, 3rd Floor (for express/courier service; non-USPS service)
79 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-0781
Fax: (919)541-5064
E-mail: [email protected]