DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: December 12, 2022

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Breast Cancer Research Program (BCRP)
Anticipated Funding Opportunities for Fiscal Year 2023 (FY23)

The FY23 Defense Appropriations Bill has not been signed into law. Although FY23 funds have not yet been appropriated for the BCRP, the BCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY23 funding opportunities. This pre-announcement should not be construed as an obligation by the government.

The FY23 Defense Appropriations Act is anticipated to provide funding for the BCRP to support innovative, high-impact research with clinical relevance that will accelerate progress to end breast cancer for Service Members, Veterans, and the general public. The managing agent for the anticipated funding opportunity is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The BCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY23 funding opportunities. The FY23 BCRP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

Applications submitted to the FY23 BCRP must address one or more of the following overarching challenges:

  • Prevent breast cancer (primary prevention)
  • Identify determinants of breast cancer initiation, risk, or susceptibility
  • Distinguish deadly from non-deadly 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; determine how to prevent lethal recurrence
  • Revolutionize treatment regimens by replacing them with ones that are more effective, less toxic, and impact survival
  • Eliminate the mortality associated with metastatic breast cancer
Award Mechanism Eligibility Key Mechanism Elements Funding
Breakthrough Award Investigators at all academic levels (or equivalent)
  • Supports promising research that has high potential to lead to or make breakthroughs in breast cancer.
  • Potential impact of the research may be near-term or long-term, but it must move beyond a minor advancement and have the potential to lead to a new approach that is fundamentally better than interventions already approved or in clinical development.
  • Partnering Principal Investigator (PI) Option allows two PIs, termed the Initiating and Partnering PIs, to collaborate on a single application.
  • Different funding levels, based on the scope of research, are available. It is the responsibility of the 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 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 1: Innovative, high-risk/high-reward research that is in the earliest stages of idea development or an untested theory that addresses an important problem. To foster research that yields new avenues of investigation, preliminary data are not required. Proof of concept is the anticipated outcome.
  • Funding Level 2: Research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the breast cancer landscape.
  • Funding Level 2 – Population Science and Prevention Studies: Studies that investigate why certain human patient populations differ in cancer risk or clinical prognosis. The studies should focus on the analysis of human data and biospecimens and, with compelling justification, may request higher levels of funding and an additional year in the period of performance.
  • Funding Level 3: Advanced translational studies with a high degree of project readiness. Where relevant, proof of availability of and access to necessary data, human samples, cohort(s), and/or critical reagents must be provided. If the proposed research would ultimately require U.S. Food and Drug Administration (FDA) involvement, applications must demonstrate the availability of and access to clinical reagents (e.g., therapeutic molecules) and subject population(s). Applications must state a realistic timeline for near-term clinical investigation. Small-scale clinical trials (e.g., first in human; phase 1/1b) may be appropriate.
  • Funding Level 4: Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer. Human clinical trials are required. PIs are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical project successfully. Where relevant, applications must demonstrate availability of and access to necessary data, human samples, cohort(s), and/or critical reagents. For proposed research that will require FDA involvement, project readiness requirements at the time of application submission include: proof of availability of and access to clinical reagents (e.g., therapeutics) that meet regulatory compliance guidelines; proof of availability of and access to appropriate subject population(s); validated projections for patient recruitment; and submission of an Investigational New Drug or Investigational Device Exemption application to the FDA, if applicable.

Funding Levels 1 and 2

  • Each investigator may be named as a PI or Initiating PI on only one application per funding level. There are no limitations on the number of applications for which an investigator may be named as a Partnering PI. However, investigators are discouraged from being named as a Partnering PI on multiple applications unless they are clearly unique, meaningful collaborations addressing distinct research questions.
  • Additional funds are available for applications submitted under the Partnering PI Option.
  • Clinical trials are not allowed.
  • Submission of a Letter of Intent is required prior to full application submission.

Funding Levels 3 and 4

  • There are no limits on the number of pre-applications for which an investigator may be named as a PI, Initiating PI, or Partnering PI
  • Investigators are discouraged from being named on multiple pre-applications unless they are clearly addressing distinct research questions.
  • Additional funds are available for Funding Level 3 applications submitted under the Partnering PI Option.
  • PIs must include two or more breast cancer advocates on their research team.
  • Clinical trials are allowed (Funding Level 3) or required (Funding Level 4).
  • Submission of a preproposal is required; application submission is by invitation only.
Funding Level 1
  • Maximum funding of $450,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

Funding Level 1 – Partnering PI Option

  • Maximum funding of $750,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

Funding Level 2

  • Maximum funding of $1 million (M) for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

Funding Level 2 – Partnering PI Option

  • Maximum funding of $1.5M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

Funding Level 2 – Population Science and Prevention Studies

  • Maximum funding of $1.5M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

Funding Level 2 – Population Science and Prevention Studies – Partnering PI Option

  • Maximum funding of $2M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

Funding Level 3

  • Maximum funding of $4M in direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

Funding Level 3 – Partnering PI Option

  • Maximum funding of $5M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

Funding Level 4 and Funding Level 4 – Partnering PI Option

  • Maximum funding of $15M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Era of Hope Scholar Award Independent, non-mentored investigators within 6 years of their last training position as of the application submission deadline (excluding time spent on family medical leave). Postdoctoral fellows, clinical fellows (including residents and interns), and other researchers currently in training positions are not eligible.
  • Supports exceptionally talented, early-career scientists who have demonstrated that they are the “best and brightest” in their fields through extraordinary creativity, vision, innovation, and productivity.
  • PIs should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention.
  • PIs must demonstrate experience in forming effective partnerships and collaborations and exhibit strong potential for future leadership in breast cancer research.
  • PIs are required to include two or more breast cancer advocates on their research team.
  • Submission of a Letter of Intent is required prior to full application submission.
  • Maximum funding of $3M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Innovator Award Independent investigators at or above the level of Associate Professor (or equivalent)
  • Supports visionary individuals who have demonstrated exceptional creativity, innovative work, and paradigm-shifting leadership in any field.
  • Provides opportunity to pursue novel, visionary, high-risk ideas that will accelerate progress toward ending breast cancer.
  • PIs must include two or more breast cancer advocates on their research team.
  • Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $7M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Clinical Research Extension Award

Investigators at all academic levels (or equivalent)
  • Supports research that extends the data collection, follow-up, and analysis of breast cancer clinical research studies.
  • The intent of this mechanism is to increase the clinically relevant impact of breast cancer patient participation in clinical research by addressing the knowledge lost due to limited or early termination of patient follow-up and sample collection and analysis.
  • Although not all-inclusive, research proposed under this mechanism may entail a deeper molecular analysis of clinical samples, initiation of new correlative studies, biomarker validation, or continuing clinical follow-up of patients currently/previously enrolled in an open/ongoing or completed clinical trial.
  • PIs are required to include two or more breast cancer advocates on their research team.
  • Partnering PI Option allows two PIs, termed Initiating and Partnering PIs, to partner on a single application.
  • Submission of a Letter of Intent is required prior to full application submission.
  • Clinical trials are not allowed.
  • Maximum funding of $5M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

      Partnering PI Option:

  • Maximum funding of $6M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Transformative Breast Cancer Consortium Award Independent investigators at all academic levels (or equivalent)
  • Supports collaborations and ideas that will transform or improve the lives of individuals with, and/or at risk for, breast cancer and will significantly accelerate progress toward ending breast cancer.
  • Requires synergistic, highly integrated, multidisciplinary, and multi-institutional research team of leading scientists, clinicians, and consumer advocates who will be assembled into a consortium to address a major problem in a way that could not be accomplished by a single investigator or group.
  • The consortium should have at least four, but no more than five, project teams, each investigating different projects under a central hypothesis. No more than two project teams may be based at one institution. Each team’s work must be integrated within the consortium so that every component is working toward the consortium’s central hypothesis.
  • The consortium must include at least one breast cancer consumer advocate per project team.
  • May include clinical trials up to and including phase 1 or equivalent; however, clinical trials are not required, and the primary thrust of the application should not be a clinical trial.
  • Submission of a preproposal is required; application submission is by invitation only.
  • Maximum funding of $25M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years
Transformative Breast Cancer Consortium Development Award

NEW for FY23
Independent investigators at all academic levels (or equivalent)
  • Provides the time and resources needed to bring investigators and breast cancer advocates together to conduct preliminary research that will support application to a future (subject to availability of funds) Transformative Breast Cancer Consortium Award.
  • Supports the following: (1) generation of necessary preliminary data to serve as proof of concept or for project integration, (2) acquisition of research resources, (3) infrastructure development including building appropriate collaborations, outlining an administrative and management plan, developing a research and communication plan, and devising an intellectual property plan, and (4) development of a framework of necessary statistical analyses.
  • PIs are required to include breast cancer advocate(s) on the research team.
  • Submission of a Letter of Intent is required prior to full application submission.
  • Maximum funding of $100,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 1 year

A pre-application is required and must be submitted through the Biomedical Research Application Portal (eBRAP) prior to the pre-application deadline. All applications must conform to the final funding opportunity announcement that will be available for downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Submission deadlines are not available until the funding opportunity announcements are released. For email notification when announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage. For more information about the BCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).


Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@health.mil


Last updated Sunday, December 31, 1600