Notice Number: NOT-CA-06-034

Key Dates
Release Date: July 28, 2006

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

The National Cancer Institute (NCI) has announced the expansion of funding opportunities centered on Circulating Cells in Cancer Detection. During the early stages of cancer development, there is a window of opportunity to detect in body fluids the emergence of precancerous cells. The purpose of this initiative is to develop novel technologies applicable to body fluids or effusions for capturing, enriching, and preserving exfoliated abnormal pre-malignant and malignant cells and macromolecules originating from such cells (e.g., DNA and proteins). The goal is to develop methods of processing body fluid specimens that would allow for sensitive and reliable detection of aberrant precancerous and cancerous features (based on appropriate biomarker analysis), even though normal cells and normal biomolecules are by far the prevailing components of such biospecimens.
The "Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis" initiative comprises three Funding Opportunity Announcements (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. Program Announcement (PA) "Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis (R21)" for pilot-exploratory projects using conventional research project grants (RPG) (a re-issuance of PA-06-423);
2. Request for Applications (RFA) "Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis (R43/R44 SBIR)" for exploratory/developmental Small Business Innovation Research (SBIR) funding mechanisms (a re-issuance of RFA-CA-06-001); and
3. RFA "Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis (R41/R42 STTR)" for exploratory/developmental Small Business Technology Transfer (STTR) funding mechanisms (a re-issuance of RFA-CA-06-001).

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.

For the R21 PA, standard receipt dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm for details. For the SBIR and STTR RFAs, there are three receipt dates (see Table 1 below).

Table 1 below summarizes the basic characteristics and requirements for all three FOAs. 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 Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis initiative may use this table and the provided individual links to initially identify which of these FOAs might be most appropriate.
Table 1. Circulating Cells in Cancer Detection FOAs and Outlines of their Characteristics.

a Over an entire R21 period, with no more than $200K in direct costs allowed in any single year.
b While no preliminary data are necessary, the applicants must demonstrate the innovative nature of the particular technology or approach proposed for development.
c Quantitative milestones for each specific aim serve 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.
d 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.
e The award of Phase II funds will be contingent on successful completion of negotiated quantitative milestones for Phase I (as determined by NCI staff in the context of peer review recommendations) and on other factors, including program priorities and the availability of funds.

Inquiries about Circulating Cells in Cancer Detection FOAs

Direct questions to:

Dr. Padma Maruvada
Division of Cancer Prevention
National Cancer Institute
6130 Executive Plaza North #3144
Executive Blvd
Bethesda, MD 20892
Telephone: (301) 496-3893
Fax: (301) 402-8990
Email: maruvadp@mail.nih.gov