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Congressionally Directed Medical Research Programs -- Breast Cancer Research Program -- Breakthrough Award -- Level 3
The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The critical components of this award mechanism are:
Impact: Research supported by the Breakthrough Award will have the potential for a major impact and accelerate progress toward ending breast cancer. The impact may be near-term or long-term, but must be significant and move beyond an incremental advancement. Applications must articulate the pathway to making a clinical impact for individuals with, or at risk for, breast cancer, even if clinical impact is not an immediate outcome.
Research Scope: Research proposed under this award mechanism may be small- to large-scale projects, at different stages of idea and research development. Two different funding levels, based on the scope of the research, are available under this Program Announcement. Two additional funding levels, Funding Levels 1 and 2, are available under a different Program Announcement/Funding Opportunity (W81XWH-16-BCRP-BREAKTHROUGH_FL12). It is the responsibility of the Principal Investigator (PI) to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the scope of the research project, rather than the amount of the budget.
The following is a general description, although not all-inclusive, of the scope of research projects that would be appropriate to propose under this Program Announcement:
The following are general descriptions, although not all-inclusive, of the scope of research projects that would be appropriate to propose under each funding level:
• Funding Level 3: Advanced translational studies that have potential for near-term clinical investigation. Small-scale clinical trials may apply.
• Funding Level 4: Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer. Near-term clinical impact is expected. PIs are expected to have experience in successfully leading large-scale projects.
• Pre-Application Deadline: 5:00 p.m. Eastern time (ET), April 27, 2016
• Invitation to Submit an Application: June 13, 2016
• Application Submission Deadline: 11:59 p.m. ET, August 11, 2016
Areas of Interest
Considering the current breast cancer landscape and the BCRP’s vision to end breast cancer, each FY16 Distinguished Investigator Award application must address one or more of the following overarching challenges. Alternatively, with adequate justification, applications may identify and address another overarching challenge related to the breast cancer landscape. Justification must be provided in the application.
• Prevent breast cancer (primary prevention)
• Identify determinants of breast cancer initiation, risk, or susceptibility
• Distinguish deadly from indolent breast cancers
• Conquer the problems of overdiagnosis and overtreatment
• Identify what drives breast cancer growth; determine how to stop it
• Identify why some breast cancers become metastatic
• Determine why/how breast cancer cells lie dormant for years and then re-emerge (recurrence); determine how to prevent recurrence
• Revolutionize treatment regimens by replacing them with ones that are more effective and less toxic
• Eliminate the mortality associated with metastatic breast cancer
• Independent investigators at all academic levels (or equivalent) are eligible to submit an application. • Each individual may submit only one pre-application as a PI or Initiating PI. • There are no limitations on the number of applications for which an investigator may be named as a Partnering PI. To meet the intent of the Partnering PI Option, applicants are discouraged from submitting as a Partnering PI on multiple applications unless they are clearly unique, meaningful collaborations addressing distinct research questions. PIs will be required to provide a brief description of all their applications submitted as an Initiating PI, Partnering PI, or collaborator, under this Breakthrough Award Levels 3 and 4 Program Announcement/Funding Opportunity. • Cost sharing/matching is not an eligibility requirement. • Eligible investigators must apply through an organization. Organizations eligible to apply include Federal agencies, national, international, for-profit, nonprofit, public, and private organizations.
The requested funding level should be appropriate for the scope of research proposed.
Funding Level 3: • The maximum period of performance is 4 years. • The anticipated direct costs budgeted for the entire period of performance will not exceed $2.5M. Indirect costs are to be budgeted in accordance with the organization’s negotiated rate. No budget will be approved by the Government exceeding $2.5M direct costs or using an indirect rate exceeding the organization’s negotiated rate.
Funding Level 3 with Partnering PI Option: • The maximum period of performance is 4 years. • The anticipated combined direct costs budgeted for the entire period of performance for the Initiating PI and the Partnering PI applications will not exceed $4M. The combined total direct costs of Initiating PI and the Partnering PI awards will not exceed $4M direct costs. Collaborating organizations should budget associated indirect costs in accordance with each organization’s negotiated rate. The combined budgeted direct costs approved by the Government will not exceed $4M or use an indirect rate exceeding each organization’s negotiated rate.
Funding Level 4: Applications with a single PI or Partnering PI Option have the same funding limits. • The maximum period of performance is 4 years. • The anticipated direct costs budgeted for the entire period of performance will not exceed $10M. Associated indirect costs can be budgeted in accordance with the organization’s negotiated rate. No budget will be approved by the Government exceeding $10M direct costs or using an indirect rate exceeding the organization’s negotiated rate. • Research milestones to be accomplished by the end of each year in the period of performance must be clearly defined in the project SOW and will be finalized during award negotiations. The PI(s) will be required to present an update on progress toward accomplishing research milestones and goals of the project at an annual Milestone Meeting to be held in the National Capital Region. Annual Milestone Meetings will be held at the conclusion of Year 2 and every subsequent year in the period of performance and will be attended by members of the BCRP Programmatic Panel, CDMRP staff, and the USAMRAA Grants Officer.