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NAVREF News Center

  • 31 Aug 2017 12:59 PM | Hawk Tran (Administrator)

    The FY17 Defense Appropriations Act provides $10 million (M) to the Department of Defense Hearing Restoration Research Program (HRRP) to support promising, necessary research for the treatment of burdensome and very prevalent auditory system injury that will foster new directions in the field of hearing restoration and propel the science forward to therapeutic interventions that restore auditory function.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    The HRRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY17 HRRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in September 2017.  Pre-application and application deadlines will be available when the Program Announcements are released.  This pre-announcement should not be construed as an obligation by the government.

    Focus Areas: The HRRP will only consider applications that specifically address the critical needs of the Hearing restoration research community in one or more of the FY17 Focus Areas. The HRRP will solicit research applications that address at least one of the following FY17 Focus Areas:

    • Develop reliable in vitro human models for evaluating hearing restoration therapies

    • Accelerate translation of biological regeneration into therapies that restore auditory function including, for example, treatments that enhance:

    1. Synaptic plasticity

    2. Hair cell and neural regeneration

    • Develop and validate assessment techniques and/or treatment methods that address functional hearing restoration including, for example:

    1. Personalized prognostic indicators of therapeutic success

    2. Better differential diagnostic tests

    3. Improved evaluation of treatment methods

     

    Translational Research Award (TRA)

    • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.

    ·         Pre-application (Letter of Intent) is required.

    ·         Supports preclinical translational research that will accelerate the movement of promising initiatives relevant to hearing restoration into clinical applications.

    ·         In this first year of the program, applications submitted must focus on the development of reliable in vitro human models to evaluate hearing restoration therapies or research that translates biological regeneration initiatives into therapies that restore auditory function.

    • Preliminary data required.

    ·         Maximum funding of $1,000,000 for direct costs (plus indirect costs).

    ·         Maximum period of performance is 3 years.

    • Indirect costs may be proposed in accordance with the institution’s rate agreement.

     

     

    Focused Research Award (FRA)

    • Independent investigators at all academic levels (or equivalent) are eligible to submit applications.

    ·         Pre-application (Letter of Intent) is required.

    ·         Supports functional hearing restoration research that develops and validates assessment techniques and treatment methods using patient-centric outcomes to identify potential predictive indicators for successful treatment of functional auditory system deficits.

    ·         Research in this area should result in refined diagnostic tools and improved evaluation of the effectiveness of therapeutic approaches for functional hearing restoration.

    • Preliminary data required

    ·         Maximum funding of $750,000 for direct costs (plus indirect costs).

    ·         Maximum period of performance is 3 years.

    • Indirect costs may be proposed in accordance with the institution’s rate agreement.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

     

    Applications must be submitted through the federal government’s single-entry portal, Grants.gov.  Submission deadlines are not available until the Program Announcements are released.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

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

     


  • 24 Aug 2017 8:56 AM | Hawk Tran (Administrator)

    The FY17 Defense Appropriations Act provides $10 million (M) to the Department of Defense Orthotics and Prosthetics Outcomes Research Program (OPORP) to support research that evaluates the comparative effectiveness of orthotic and prosthetic clinical interventions using patient-centric outcomes for Service members and Veterans who have undergone limb amputation.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    The OPORP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY17 OPORP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in September 2017.  Pre-application and application deadlines will be available when the Program Announcement is released.  This pre-announcement should not be construed as an obligation by the government.

    Focus Areas:  The OPORP will only consider applications that specifically address the critical needs of the Orthotics and Prosthetics Outcomes research community in one or more of the FY17 Focus Areas.  The OPORP will solicit research applications that address at least one of the following FY17 Focus Areas:

    ·         Orthotic or Prosthetic Device Form:  Analysis of variables related to currently available clinical options such as, but not limited to, device size, shape, material, and configuration.

    ·         Orthotic or Prosthetic Device Fit:  Analysis of currently available clinical options that facilitate device fit-related characteristics such as comfort and usability through variables such as human-device interface and component connection.

    ·         Orthotic or Prosthetic Device Function:  Analysis of the variables related to currently available clinical options such as device control, passive response, active/actuated response, power, sensors, overall performance with respect to activities of daily living and other real-world activities.

    Orthotics and Prosthetics Outcomes Research Award

    Funding Level 1/New Investigators:  Investigators that meet the following criteria at the application submission deadline date:

    ·        Are within 5 years of their last training position

    ·        Are able to demonstrate the freedom to pursue research goals outside of a formal mentorship program or arrangement

    ·        Can provide evidence of organizational support, such as start-up funds provided by the institution and/or use of a technician, space, facilities, and resources

    ·        PIs working within a laboratory team are eligible to apply for this award, provided they meet the criteria above.

    ·        Graduate students and postdoctoral fellows are not eligible for this award.

     

    Funding Level 2:  Independent investigators at all academic levels (or equivalent) are eligible to submit applications.

    Funding Level 1/New Investigator Option may support pilot research or research that is already supported by preliminary data and has the potential to make significant advancements toward clinical translation.

    Funding Level 2 Option is supported by preliminary data and has the potential to make significant advancement towards clinical translation.

    The OPORA is focused on outcomes-based best practices through analysis of the merits of prosthetic and orthotic device options currently available, not on the development of new, or the improvement of existing, technology.  The intent of the award is to generate clinically useful evidence that will enhance and optimize patient outcomes.

    Animal studies are not allowed.

     

    Funding Level 1/ New Investigators:

    ·       Maximum funding of $500,000 for total costs.

    ·       Maximum period of performance is 3 years.

    Funding Level 2:

    ·       Maximum funding of $2.5M for total costs.

    ·       Maximum period of performance is 4 years

    •  
    • ·       All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.

    The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum number of years allowed per funding level.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

     

    Applications must be submitted through the federal government’s single-entry portal, Grants.gov.  Submission deadlines are not available until the Program Announcements are released.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the OPORP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

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


  • 14 Aug 2017 3:31 PM | Hawk Tran (Administrator)

    The FY17 Defense Appropriations Act provides $12 million (M) to the Department of Defense Reconstructive Transplant Research Program (RTRP) to support research of exceptional scientific merit that has the potential to make a significant impact on improving the function, wellness, and overall quality of life for injured military Service members and Veterans, their caregivers and family members, and the American public.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    FY17 RTRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website. 

    Focus Areas:  The FY17 RTRP encourages research projects that specifically address needs in the field of vascularized composite allotransplantation (VCA) in the following focus areas:

    1. Immune system regulation as specifically applied to VCA
    2. Psychosocial considerations and challenges associated with VCA
    3. Develop ex vivo VCA tissue preservation techniques or technologies to extend the time between procurement and transplantation (goal: 24 hours)
    4. Develop pre-habilitation or rehabilitation strategies that improve reconstructive transplant functional outcomes
    5. Develop standardized quantitative functional outcome measures for VCA, especially for face transplant
    6. Graft clinical monitoring – acute and chronic, as applied to VCA

    Concept Award – Letter of Intent due November 15

    • Investigators at or above the level of postdoctoral fellow (or equivalent)
    • Pre-application (Letter of Intent) is required.
    • Supports the exploration of a highly innovative new concept or untested theory that addresses an important problem relevant to reconstructive transplant. 
    • Preliminary data are NOT allowed.
    • Reviewers at both tiers of review will be blinded to the identity of the Principal Investigator (PI), collaborators, and their organizations.
    • Applications must address at least one of the FY17 RTRP Focus Areas.
    • Maximum funding of $200,000 for total costs (direct plus indirect costs)
    • Maximum period of performance is 18 months

    Investigator-Initiated Research Award – Preproposal due September 20

    • Independent investigators at all academic levels (or equivalent)
    • Preproposal is required; full application submission is by invitation only.
    • Supports studies with potential to make an important contribution to the reconstructive transplant research field, patient care, and/or quality of life.
    • Preliminary or published data required.
    • Multiple PI Option supports synergistic partnerships among two to four  investigators collaborating on a single application; multi-institutional collaborations are encouraged
    • Applications must address at least one of the FY17 RTRP Focus Areas.
    • Individual PIs:
    • Maximum funding of $1 million (M) for total costs
    • Maximum period of performance is 3 years
    • Multiple PI Option:
    • Maximum funding of $1.5M for total costs
    • Maximum period of performance is 3 years

    Technology Development Award – Preproposal due September 20

    • Independent investigators at all academic levels (or equivalent)
    • Preproposal is required; full application submission is by invitation only.
    • Supports research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation.
    • Proof of concept must be established.
    • Transition plan is required.
    • Applications must address at least one of the following FY17 RTRP Focus Areas:
    • Develop ex vivo VCA tissue preservation techniques or technologies to extend the time between procurement and transplantation (goal: 24 hours)
    • Graft clinical monitoring – acute and chronic, as applied to VCA
    • Maximum funding of $1M for total costs
    • Maximum period of performance is 3 years

    Qualitative Research Award – Preproposal due September 20

    • Independent investigators at all academic levels (or equivalent)
    • Preproposal is required; full application submission is by invitation only.
    • Supports qualitative research studies that will help researchers and clinicians to better understand the experiences of individuals who are considering or have already received reconstructive transplant surgery.
    • Demonstrated qualitative research experience within the research team is required.
    • Theoretical perspective of qualitative research must be identified.
    • Rigorous and appropriate data collection and data analyses methods are important components.
    • Multiple PI Option supports synergistic partnerships among two to four investigators collaborating on a single application; multi-institutional collaborations are encouraged.
    • Applications must address the following FY17 RTRP Focus Area:
    • Psychosocial considerations and challenges associated with VCA
    • Individual PIs:
    • Maximum funding of $1M for total costs
    • Maximum period of performance is 3 years
    • Multiple PI Option:
    • Maximum funding of $1.5M for total costs
    • Maximum period of performance is 3 years

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

    Applications must be submitted through the federal government’s single-entry portal, Grants.govFor email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the RTRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk

    301-682-5507
    help@eBrap.org


  • 9 Aug 2017 9:39 AM | Hawk Tran (Administrator)

    FY17 BCRP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov. 

    As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA), J9 Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    Applications submitted to the FY17 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 lay 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, less toxic, and impact survival
    • Eliminate the mortality associated with metastatic breast cancer

    Breakthrough Award – Letter of Intent for levels 1 & 2, November 21

    • ·       Investigators at all academic levels (or equivalent)
    • Senior postdoctoral fellows who do not meet the eligibility requirements of the Breakthrough Fellowship Award are encouraged to apply under Funding Levels 1 and 2
    • Each investigator may submit only one Funding Level 1 application and one Funding Level 2 application as a PI or Initiating PI,
      Supports promising research that has the 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 be significant and go beyond an incremental advancement.
    • ·       Partnering PI Option allows two Principal Investigators (PIs), termed Initiating and Partnering PIs, to collaborate on a single application.
    • ·        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.
    • ·        There are no limitations on the number of applications for which an investigator may be named as a Partnering PI.  However, applicants are discouraged from submitting 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 Level 1:

    • ·       Maximum funding of $375,000 for direct costs (plus indirect costs)
    • ·       Maximum period of performance is 3 years

    Funding Level 1 – Partnering PI Option:

    • ·       Maximum funding of $600,000 for direct costs (plus indirect costs)
    • ·       Maximum period of performance is 3 years

    Funding Level 2:

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

    Funding Level 2 – Partnering PI Option:

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

    Breakthrough Award –Preproposal for levels 3 & 4 September 29

    • ·       Independent investigators at all academic levels (or equivalent) are eligible.
    • ·       Each investigator may submit only one Funding Level 3 pre-application and one Funding Level 4 pre-application as a PI or Initiating PI
    • ·       Supports promising research that has the potential to lead to or make breakthroughs in breast cancer.
    • ·       Potential impact of the research may be near-term or ling-term, but it must be significant and go beyond an incremental advancement.
    • ·       Partnering PI Option allows two PIs, termed Initiating and Partnering PIs, to collaborate on a single application.
    • ·       Is it 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.
    • ·       There are no limitations on the number of applications for which an investigator may be named as a Partnering PI.  However, applicants are discouraged from submitting as a Partnering PI on multiple applications unless they are clearly unique, meaningful collaborations addressing distinct research questions.
    • ·       PI’s must include two or more breast cancer advocates on their research team.
    • ·       Submission of a proposal is required: application submission is by invitation only.

    Funding Level 3:

    • ·       Maximum funding of $2.5M in direct costs (plus indirect costs)
    • ·       Maximum period of performance is 4 years

    Funding Level 3 – Partnering PI Option:

    • ·       Maximum funding of $4M 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 $10M for direct costs (plus indirect costs)

    Maximum period of performance is 4 years

    Breakthrough Fellowship Award – Letter of Intent due November 21

    As of the application submission deadline, all eligible PIs must have:

    • Successfully completed the requirements for a doctoral or medical degree, and
    • Been in the laboratory or clinical research setting in which the proposed research is to be performed for no more than 2 years, and

    ·       A total of less than 4 years experience in a postdoctoral fellowship or mentored clinical research training program (excludes any clinical residency or fellowship training)

    Mentor

    Must have breast cancer research experience, including current funding and recent publications

    • ·       Supports exceptionally talented, “best and brightest” recent doctoral or medical graduates in pursuit of promising research that has the 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 be significant and go beyond an incremental advancement.
    • ·       Individualized researcher development plan and mentorship should prepare the PI for an independent career at the forefront of breast cancer research or patient care.
    • ·       The PI is not required to have previous experience in breast cancer research.
    • ·       Preliminary data are allowed, but not required.
    • ·       Maximum funding of $300,000 for direct costs (plus indirect costs)
    • Maximum period of performance is 3 years

    Era of Hope Scholar Award – Letter of Intent due November 21

    Must be an independent, non-mentored investigators within 6 years of their last training position (e.g., postdoctoral fellowship, medical residency, clinical fellowship) as of the application submission deadline

    • ·       Supports exceptionally talented, creative early-career scientists who have demonstrated that they are the “best and brightest” in their fields.
    • ·       PIs should articulate a vision that challenges current dogma and demonstrates an ability to look beyond tradition and convention.
    • ·       PIs must exhibit strong potential for leadership in breast cancer.
    • ·       Experience in breast cancer is not required: however, the application must focus on breast cancer, and the PI must maintain a 50% dedication of his/her full-time professional effort during the award period to breast cancer research.
    • PIs must include breast cancer advocates on their research team.
    • Submission of a Letter of Intent is required prior to full application submission.
    • ·        Maximum funding of $2.5M for direct costs (plus indirect costs)
    • Maximum period of performance is 4 years

    Innovator Award – Pre-application due September 29

    Must be an Associate Professor or above (or equivalent).

    • ·       Supports visionary individuals who have demonstrated creativity, innovative work, and leadership in any field.
    • ·       Provides opportunity to pursue novel, visionary, high-risk ideas that will accelerate progress toward ending breast cancer.
    • ·       Experience in breast cancer research is not required: however, the application must focus on breast cancer, and the PI must maintain a 50% dedication of his/her full-time professional effort during the award period to breast cancer.
    • ·       PIs must include breast cancer advocates on their research team.
    • Preproposal is required; application submission is by invitation only.
    • ·        Maximum funding of $5M for direct costs (plus indirect costs).
    • Maximum period of performance is 4 years.

    Distinguished Investigator Award – Pre-application due September 29

    PIs must be at or above the level of Assistant Professor (or equivalent) and more than 6 years beyond the PI’s last training position as of the application submission deadline

    • ·       Supports established visionary leaders from any filed to pursue innovative ideas that could accelerate progress toward ending breast cancer.
    • ·       The PI must propose research that is a fundamental shift from his/her track record of research.
    • ·       Does not support continuation of or incremental change from the PI’s published line of research.
    • ·       If the PI is an established breast cancer researcher, he/she must clearly articulate a motivation and commitment for proposing a fundamental shift in his/her research and must include at least one collaborator with breast cancer expertise.
    • ·       High-risk/high-reward projects pursuing innovative new paradigms are encouraged, but not required.
    • ·       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 $3M for direct costs (plus indirect costs)
    • Maximum period of performance is 4 years

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

    Applications must be submitted through the federal government’s single-entry portal, Grants.gov.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the BCRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk
    301-682-5507
    help@eBrap.org


  • 3 Aug 2017 2:13 PM | Hawk Tran (Administrator)

    ORD would like to make the following announcements about new ORD and FDA guidance documents and ORD draft guidance documents.

    1.       Issue of two new ORD Draft Guidance Documents:

    • ORD has issued a Draft Guidance document related to the use of email and texting in VA research titled, “Draft Guidance on the Use of Electronic Mail and Electronic Text Messaging for Recruiting and Communicating with VA Subjects in VA Research”.  ORD created this draft guidance after receiving input from multiple program offices.  ORD is aware that this complex guidance will require revision, and we need to obtain additional input from the VA research community.
    • ORD has issued a second Draft Guidance document is related to the use of Material Transfer Agreements titled, “Draft ORD Guidance on Material Transfer Agreements”. This document has already undergone significant revision as a result of prior comments when initially posted as draft guidance, and additional comments are sought from the VA research community.

    2.       Addition to existing ORD Guidance Documents:

    3.       Removal of ORD Guidance Template:

    • ORD has temporarily removed a previous Agreement template posted on ORD’s Policies and Guidance Documents webpage earlier this week called “Completion of Time-Effort MOU for DAPs” pending further revision.

    4.       New FDA Guidance on Waivers of Informed Consent:

    • VA conducts multiple studies involving FDA-regulated research.  ORD wants to ensure that the VA research community is aware that FDA has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirement for an FDA-regulated clinical investigation that presents no more than minimal risk and involves adequate human subjects protections as described in the FDA guidance document.  The guidance, which is in immediate effect, aligns FDA’s position on waiving or altering informed consent requirements with the Common Rule’s regulations for waiving or altering informed consent requirements as described in 38 CFR Part 16.116(d).


  • 25 Jul 2017 2:50 PM | Hawk Tran (Administrator)

    Defense Health Program
    Department of Defense Peer Reviewed Alzheimer’s Research Program

    Funding Opportunities for Fiscal Year 2017

     

    FY17 PRARP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov. 

     

    The PRARP’s mission is devoted to (1) understanding the association between traumatic brain injury (TBI) and Alzheimer’s disease (AD)/Alzheimer’s disease-related dementias (ADRD) and (2) reducing the burden on affected individuals and caregivers, especially in the military and Veteran communities.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate, manages the Defense Health Program Research, Development, Test, and Evaluation appropriation.  The managing agent for the anticipated Program Announcements/funding opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

     

    FY17 PRARP Overarching Challenges and Focus Areas:

     

    All applications for the FY17 PRARP funding opportunities must address at least one of the following FY17 Overarching Challenges. The FY17 Overarching Challenges may be mechanism-specific.

    The PRARP FY17 Overarching Challenges are listed below.

    PRARP FY17 Overarching Challenges

    Paucity of Research Resources:  The paucity of research resources to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities.

    Paucity of Clinical Studies:  The paucity of clinical studies to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities.  This includes research into risk factors which may predispose individuals to AD/ADRD subsequent to TBI.

    Diagnostic Technologies, Tests, Biomarkers, or Devices:  The need for technologies, tests, or devices to detect or prognose the progression to AD/ADRD subsequent to TBI.  This includes research into risk factors which may predispose individuals to AD/ADRD subsequent to TBI.

    Quality of Life:  The need for technologies, assessments, interventions, or devices to benefit individuals living with the common symptoms or deficits of TBI and AD/ADRD.

    Caregiver Burden:  The need for technologies, assessments, interventions, or devices with the goal of reducing burden for caregivers of individuals living with the common symptoms or deficits of TBI and AD/ADRD.

    Epidemiology:  The paucity of epidemiological research to examine the interrelationship between TBI and subsequent AD/ADRD for the military, Veteran, and civilian communities.  This includes research into risk factors which may predispose individuals to AD/ADRD subsequent to TBI.

    In addition to addressing one or more of the specified FY17 Overarching Challenges, applications should also address at least one of the following FY17 Focus Areas in support of the FY17 Overarching Challenges.  An application that proposes research outside of the FY17 Focus Areas is acceptable, as long as the applicant provides a strong rationale.  The Focus Areas will be mechanism-specific.

    The PRARP FY17 Focus Areas are listed below.

    PRARP FY17 Focus Areas

    Genomics/Proteomics:  Studies or technologies (e.g., genetic, proteomic, bioinformatics and epigenetic strategies) intended to characterize neurological change(s) associated with TBI and subsequent AD/ADRD.  In addition, relevant technologies or tests may be considered under this focus area.

    Mechanisms of Pathogenesis: Identification of contributing mechanisms (e.g., pathology of Tau, non-neuronal cells, inflammatory factors, and vascular contributions) associated with TBI and subsequent AD/ADRD pathogenesis.

    Quality of Life:  Research intended to alleviate, stabilize, or characterize the symptoms, or deficits, common to TBI, Alzheimer's disease (AD) and Alzheimer's disease-related dementias (ADRD).  Examples of research in this Focus Area include: Identification and management of co-morbidities and modifiable risk factors (e.g., sleep apnea, obesity); cognitive training interventions; studies of health and wellness and behavioral interventions.

    Caregiver Support:  Research intended to reduce the burden of care on the caregiver for individuals living with the common symptoms or deficits of TBI and AD/ADRD.  Examples of research in this focus area include:  Caregiver training, home-based support, behavioral interventions, and relationship interventions.

    Biomarkers:  Development of strategies to diagnose, prognose, or characterize neurological changes or risk factors associated with TBI and subsequent AD/ADRD (e.g., fluid based, imaging, physiological, and clinical approaches).

    Novel Target Identification:  Basic research (non-human) directly leading to the identification of new targets for the development of existing or new investigational medicines, drugs, or agents.

    Epidemiological Research:  Research focusing on the incidence, distribution, and other factors relating to the health of individuals affected by TBI and subsequent AD/ADRD.

     

    The following is a summary of the FY17 PRARP Program Announcements.  Four award mechanisms will be offered for FY16.  This pre-announcement should not be construed as an obligation by the Government.

     

    http://cdmrp.army.mil/funding/prarp

     

    Convergence Science Research Award – Letter of Intent due September 6, 2017

    The Principal Investigator (PI) must be  at or above the level of Assistant Professor (or equivalent).

    Intent:  Support efforts to generate research resources, tools, or novel research efforts for researchers and/or practitioners in health sciences.

    Applications must address one or more of the following FY17 PRARP Overarching Challenges:

    ·         Paucity of Research Resources

    ·         Paucity of Clinical Studies

    ·         Diagnostic Technologies, Tests, Biomarkers, or Devices

    ·         Epidemiology

    Applications should address at least one of the following FY17 PRARP Focus Areas:

    ·         Genomics/Proteomics

    ·         Mechanisms of Pathogenesis

    ·         Biomarkers

    ·         Novel Target Identification

    ·         Epidemiological Research

    Research considering pharmacologic interventions is specifically discouraged under this mechanism.

    Preliminary data, while not required, are encouraged.

    • Maximum funding is $500,000 for direct costs (plus indirect costs).
    • Maximum period of performance is 3 years.
    • Indirect costs may be proposed in accordance with the institution's rate agreement.

     

    Quality of Life Research Award – Letter of Intent due September 6, 2017

    The PI must be an independent investigator at or above the level of Assistant Professor (or equivalent).

    Intent:  The intent of the research funded through this award is to (1) support research to alleviate, stabilize, or characterize the symptoms or deficits common to TBI,  AD, and ADRD and (2) reduce the burden of care on the caregivers for individuals living with the common symptoms of TBI and AD/ADRD.  Research may be proposed to either facet of the intent.  Both are equally important.

    Applications must address one or more of the following FY17 PRARP Overarching Challenges:

    ·         Paucity of Clinical Studies

    ·         Epidemiology

    ·         Quality of Life

    ·         Caregiver Burden

    Applications should address at least one of the following FY17 PRARP Focus Areas:

    ·         Quality of Life

    ·         Caregiver Support

    ·         Biomarkers

    ·         Epidemiological Research

    Research considering pharmacologic interventions is specifically discouraged under this mechanism.

    Preliminary data, while not required, are encouraged.

    ·         Funding limit is $500,000 in direct costs.

    ·         Maximum period of performance is 3 years.

    ·         Indirect costs may be proposed in accordance with the institution's rate agreement.

     

    New Investigator Award

    The PI must be an independent, early-career investigator within 4 years of his/her first independent faculty position (or equivalent).

    Intent: Support early-career investigators interested in novel research efforts or new technologies addressing TBI and AD/ADRD.

    Applications must address one or more of the following FY17 PRARP Overarching Challenges:

    ·         Paucity of Research Resources

    ·         Paucity of Clinical Studies

    ·         Diagnostic Technologies, Tests, Biomarkers, or Devices

    ·         Epidemiology

    ·         Quality of Life

    ·         Caregiver Burden

    Applications should address at least one of the following FY17 PRARP Focus Areas:

    ·         Genomics/Proteomics

    ·         Mechanisms of Pathogenesis

    ·         Biomarkers

    ·         Quality of Life

    ·         Caregiver Support

    ·         Epidemiological Research

    ·         Novel Target Identification

    Research considering pharmacologic interventions is specifically discouraged under this mechanism.

    Preliminary data, while not required, are encouraged.

    • Funding limit is $225,000 in direct costs.
    • Maximum period of performance is 3 years.
    • Indirect costs may be proposed in accordance with the institution’s rate agreement.

     

    Research Partnership Award – Letter of Intent due September 6, 2017

    The PI must be an independent investigator  at or above the level of Assistant Professor (or equivalent),

    Intent:  To create an avenue for collaborative research partnerships between investigators to address a research problem or question in a manner that would be unachievable through separate efforts.

    Applications must include clearly stated plans for interactions between the partners.  The plans must include communication, coordination or research progress and results, and data sharing between all investigators and organizations participating in the project.

    Applications must address one or more of the following FY17 PRARP Overarching Challenges:

    ·         Paucity of Research Resources

    ·         Paucity of Clinical Studies

    ·         Diagnostic Technologies, Tests, Biomarkers, or Devices

    ·         Epidemiology

    ·         Quality of Life

    ·         Caregiver Burden

    Applications should address at least one of the following FY17 PRARP Focus Areas:

    ·         Genomics/Proteomics

    ·         Mechanisms of Pathogenesis

    ·         Biomarkers

    ·         Quality of Life

    ·         Caregiver Support

    ·         Epidemiological Research

    ·         Novel Target Identification

    Research considering pharmacologic interventions is specifically discouraged under this mechanism.

    Preliminary data are required.

    • Funding limit is $1.3 million in total costs.
    • Maximum period of performance is 3 years.
    • Indirect costs may be proposed in accordance with the institution’s rate agreement.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that are available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

     

    Applications must be submitted through the Federal Government’s single-entry portal, Grants.govFor email notification when Program Announcements are released, go to the CDMRP website (http://cdmrp.army.mil) and select Subscribe to Funding Opportunities & Program Communications.  For more information about the PRARP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk
    301-682-5507
    help@eBrap.org


  • 24 Jul 2017 5:00 PM | Hawk Tran (Administrator)

    Defense Health Program
    Department of Defense Epilepsy Research Program
    Funding Opportunities for Fiscal Year 2017 (FY17)

    FY17 ERP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov.

    The ERP’s mission is to fund research to understand the magnitude, and the underlying mechanisms of Post-Traumatic Epilepsy (PTE), especially in Service members and Veterans.

    FY17 ERP Focus Areas:

    Applications should also address at least one of the following FY17 Focus Areas. An application that proposes research outside of the FY17 Focus Areas is acceptable, as long as the applicant provides a strong rationale. The Focus Areas will be mechanism-specific.

    FY17 ERP Focus Areas are as follows:

    Epidemiology: Epidemiological characterization of PTE following TBI, which may include:

    • Risk factors such as demographics, genetic factors, organic head injury factors, or type of insult
    • Differentiation of PTE and Psychogenic Non-Epileptic Seizures (PNES)
    • Outcomes including latency to epilepsy, morbidities and comorbidities, and mortality
    • Pre-existing conditions including psychological and psychiatric risk factors

    Markers and Mechanisms: Identifying markers or mechanisms (via clinical prospective or preclinical models) that address PTE:

    • Early detection
    • Diagnosis
    • Prognosis
    • Morbidity
    • Comorbidity
    • Mortality
    • Risk stratification

    Models of PTE: Development of new models or better characterization of existing etiologically relevant models for PTE, including repetitive TBI.

    Psychogenic Non-Epileptic Seizures: Exploration of the epidemiology, mechanisms, risk factors, or markers of PNES subsequent to TBI.

    The following is a summary of the FY17 ERP Program Announcements. Two award mechanisms will be offered for FY17. This pre-announcement should not be construed as an obligation by the Government.

    http://cdmrp.army.mil/funding/erp

    Idea Development Award – Letter of Intent due September 6, 2017

    Level I: The Principal Investigator must be at or above the level of postdoctoral fellow (or equivalent), but below the level of Assistant Professor (or equivalent).
    Level II: The Principal Investigator must be an independent investigator at or above the level of Assistant Professor (or equivalent).

    Intent: To solicit research to understand the magnitude and underlying mechanisms of post-traumatic epilepsy (PTE). Funding Level I is intended to support high-risk or high gain research. Funding Level II is intended to support a more mature, hypothesis-driven research project.
    The following Focus areas are open to Level I:

    • Epidemiology
    • Markers and Mechanisms
    • Models of PTE
    • Psychogenic Non-Epileptic Seizures

    Preliminary data, while not required, are encouraged for both levels.

    Research considering  on interventional clinical trials (e.g., pharmacological interventions) is strongly discouraged.

    Level I:

    • Maximum funding of $300,000 for direct costs (plus indirect costs).
    • Maximum period of performance is 2 years.
    • Indirect costs may be proposed in accordance with the institution's rate agreement.

    Level II:

    • Maximum funding of $500,000 for direct costs (plus indirect costs).
    • Maximum period of performance is 3 years.
    • Indirect costs may be proposed in accordance with the institution's rate agreement.

    Epilepsy Risk Factors Award – Letter of Intent due September 6, 2017

    The Principal Investigator must be an independent investigator at or above the level of Assistant Professor (or equivalent).

    Intent:To conduct preliminary studies to support prospective, longitudinal epidemiological research relevant to the characterization of PTE. Study design should indicate how the research strategy can generate preliminary data capable of supporting larger, more complex studies.  The proposed study design may be either prospective or retrospective.  Applications should describe how the association of TBI and subsequent PTE will be characterized.


    Applications should address at least one of the following Focus Areas:

    • Epidemiology
    • Markers and Mechanisms

    Research considering a pharmacologic interventional clinical trials (e.g., pharmacological interventions) is strongly discouraged.

    As part of the application process, all applicants are required to provide an Epidemiological Research Statement.

    Preliminary data not required.

    • Funding limit is $300,000 direct costs.
    • Maximum period of performance is 2 years.
    • Indirect costs may be proposed in accordance with the institution's rate agreement.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic 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 Congressionally Directed Medical Research Programs (CDMRP) funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

    Applications must be submitted through the Federal Government’s single-entry portal, Grants.gov. For email notification when Program Announcements are released, go to the CDMRP website (http://cdmrp.army.mil) and select “Subscribe to Funding Opportunities & Program Communications.” For more information about the ERP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk
    301-682-5507
    help@eBrap.org


  • 3 Jul 2017 6:30 PM | Hawk Tran (Administrator)

    The FY17 Defense Appropriations Act provides $4 million (M) to the Department of Defense Alcohol and Substance Abuse Disorders Research Program Research Program (ASADRP). The ASADRP is seeking applications to explore integrated approaches to address alcohol and substance use disorder (ASUD) especially related to traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) through multidisciplinary, team-based research efforts that translate basic knowledge into enhanced clinical pharmacological treatments protocols. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    FY17 ASADRP Program Announcement and General Application Instruction for the following award mechanisms are posted on the Grants.gov website.

    Consortium Award – Letter of Intent Due September 13

    Independent intramural (DoD) and extramural investigators at all academic levels (or equivalents) are eligible to submit applications

    The ASADRP is seeking applications to explore integrated approaches to address alcohol and substance use disorder (ASUD) especially related to traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) through multidisciplinary, team-based research efforts that translate basic knowledge into enhanced clinical pharmacological treatments protocols.

    ·         The program’s approach is to organize multidisciplinary, team-based translational research efforts to:

    ·         Identify promising compounds; 

    ·         Conduct proof-of-principle basic research to determine which compounds are most appropriate for human research trials;

    ·         Conduct human proof-of-concept trials with promising compounds.  This approach should accelerate the translation of contemporary basic science knowledge into enhanced clinical pharmacological treatment protocols for ASUD, including a regulatory strategy for U.S. Food and Drug Administration (FDA) compliance.

    ·         The CDMRP expects to allocate FY17-19 funding, if appropriated, to fund approximately one ASADRP Consortium Award.  The maximum period of performance is 5 years.  The ASADRP Consortium will be funded initially with allocations from the FY17 ASADRP Congressional appropriation ($3.532M). The maximum allowable total costs (direct and indirect) for the entire period of performance are $10.596M (base year plus 2 option years).  Two additional options, to be included in the application, may be funded from allocations from the FY18 & FY19 Congressional appropriation (up to $3.532M each year) subject to Government Steering Committee (GSC) review, approval of the Grants Officer, and receipt of future congressional appropriations.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

     

    Applications must be submitted through the federal government’s single-entry portal, Grants.govFor email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.For more information about the ASADRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk

    301-682-5507
    help@eBrap.org


  • 14 Jun 2017 3:23 PM | Hawk Tran (Administrator)

    The FY17 Defense Appropriations Act provides $16 million (M) to the Department of Defense Parkinson’s Research Program (PRP), formerly the Neurotoxin Exposure Treatment Parkinson’s Research Program, to support research of exceptional scientific merit leading to an understanding of the cause, prevention, and treatment of the loss of dopaminergic neurons in the substantia nigra that result in Parkinson’s disease.  Applications to the FY17 PRP are being solicited by the U.S. Army Medical Research Acquisition Activity.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    FY17 PRP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov. 

    IMPORTANT:  The PRP seeks to focus applications and direct funding by providing Focus Areas to address the critical needs in Parkinson’s disease research.  Applications to the FY17 PRP must address at least one of the Focus Areas noted below: 

    • Mechanisms of neuroplasticity in the Parkinson’s disease brain
    • Studies to identify gene-environment interactions in Parkinson’s disease cohorts
    • Pathophysiological implications of tau protein in Parkinson’s disease

    Investigator-Initiated Research Award – Letter of Intent due August 17, 2017

    Independent investigators at or above the level of Assistant Professor (or equivalent).

    ·         Supports highly rigorous, high-impact research projects that have the potential to make an important contribution to Parkinson’s disease research and/or patient care.

    ·         Potential impact of research may be near-term or long-term, but it must be significant and go beyond an incremental advancement.

    ·         Clinical trials are not allowed.

    ·         Preliminary data to support feasibility are encouraged.

    ·         Partnering PI Option:

    ·         Provides a higher level of funding to support synergistic partnerships between two or three independent investigators collaborating on a single application.

    • ·         Principal Investigators (PIs) are expected to demonstrate within the application the synergistic components that will significantly advance the project, such that the research outcomes could not otherwise be accomplished through the independent efforts of a single PI.

    ·         Individual PI:

    ·         Maximum funding of $1M in total costs.

    ·         Maximum period of performance is years.

    ·         Partnering PI Option:

    ·         Maximum funding of $2.5M in total costs.

    ·         Maximum period of performance is years.

     

    Early Investigator Research Award – Letter of Intent due August 17, 2017

    Investigator must be a postdoctoral or clinical fellow within 3 years of advanced degree or residency training (or equivalent).

    Verification of eligibility criteria must be provided in an Eligibility Statement signed by an appropriate institutional official and the PI. 

    ·         Supports early-career investigators who have innovative, high-impact ideas or new technologies applicable to Parkinson’s disease research and/or patient care.

    ·         Clinical fellows must be specialized in movement disorders.

    ·         PIs must have a designated mentor who is an experienced Parkinson’s disease researcher.

    ·         The application must include an individualized, Parkinson’s disease-focused researcher development plan.

    ·         Preliminary data are not required.

    • ·         Clinical trials are not allowed.

    ·         Maximum funding of $321,000 in total costs.

    • ·         Maximum period of performance is 2 years.

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

     

    Applications must be submitted through the federal government’s single-entry portal, Grants.govFor email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the PRP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk

    301-682-5507
    help@eBrap.org


  • 12 Jun 2017 12:50 PM | Hawk Tran (Administrator)

    FY17 ARP Program Announcements and General Application Instructions for the following award mechanisms are posted on Grants.gov.

    As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency (DHA) Research and Development Directorate (J9) manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP).

    Clinical Trial Award – Preapplication due July 2, 2017

    Investigators at or above the level of Associate Professor (or equivalent), or

    • ·         Early-Career Investigator Option:
      Investigators at or above the level of Associate Professor (or equivalent) may collaborate on a single application with a Early-Career Investigator (at the level of postdoctoral fellow up to early-career independent faculty) that meets the following criteria at the application submission deadline date:
    • o    Must be within the first year of postdoctoral fellowship by the application deadline
    • o    Is no more than 7 years from the receipt of a terminal degree
    • o    Has the freedom to commit at least 50% time to the project
    • ·         Supports research with the potential to have a major impact on the treatment and/or management of autism spectrum disorder (ASD).
    • ·         Applications in the following areas are strongly encouraged:
    • o    Behavioral, cognitive, and other non-pharmacological therapies.  Studies targeting subgroups using biomarkers with preliminary data are strongly encouraged.
    • o    Pharmacological treatments in ASD. Studies targeting subgroups using biomarkers with preliminary data are strongly encouraged.
    • o    Dissemination/implementation of clinically validated interventions across the lifespan.
    • o    Therapies to alleviate conditions co-occurring with ASD.
    • o    Interventions promoting success in ley transitions to adulthood for individuals living with ASD.
    • o    Healthcare provider-focused training or tools to improve healthcare delivery for individuals with ASD, particularly adulthood.
    • Preliminary data relevant to the proposed project are required.
    • Pre-application is required; application submission is by invitation only.

     

    • ·         Nested Early-Career Investigator Option supports the development of young investigators pursuing or wishing to pursue clinical trials.
    • Maximum funding of $1,000,000 for direct costs (plus indirect costs)
    • Maximum period of performance is 4 years

     

    • ·         Nested Yearly-Career  Investigator Option:
    • Maximum funding of $1,300,000 for direct costs (plus indirect costs)
    • ·         Maximum period of performance is 4 years

     

    Idea Development Award – Preapplication due July 26, 2017

    Investigators at or above the level of Assistant Professor (or equivalent)

    • ·         Supports the development of innovation, high-impact ideas that advance the understanding of ASD and ultimately lead to improved outcomes.
    • ·         Applications in the following areas are strongly encouraged:
    • o    Assessment of novel therapeutics using valid preclinical models.
    • o    Environmental risk factors.
    • o    Mechanisms of heterogeneous clinical expression of ASD.
    • o    Factors promoting success in key transitions to independence for individuals living with ASD.
    • o    Development of healthcare provider-focused training or tools to improve healthcare delivery for individuals with ASD, particularly in adulthood.
    • o    Cultural factors in treatment efficacy, delivery, and access to services.
    • Preliminary data are required.
    • ·         Pre-application is required; application submission is by invitation only.
    • Multiple Principal Investigator (PI) Option: Up to two investigators may collaborate on a single application, each of whom will be recognized as a PI and receive a separate award.
    • Maximum allowable funding for the entire period of performance is of $500,000 in direct costs
    • For multiple PI’s the combined funding for all PIs for the entire period of performance may not exceed $500,000 in direct costs.
    • Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
    • Maximum period of performance is 3 years

     

    Clinical Translational Research Award – Preapplication due July 26, 2017

    Investigators at or above the level of Assistant Professor (or equivalent)

    • Supports early-phase, proof-of-principle translational studies with the potential to have a major impact on the treatment and/or management of ASD.
    • Applications in the following areas are strongly encouraged:
      • Behavioral, cognitive, and other non-pharmacological therapies.  Studies targeting subgroups using biomarkers with preliminary date are strongly encouraged.
      • Pharmacological treatments in ASD.  Studies targeting subgroups using biomarkers with preliminary data are strongly encouraged.
      • Dissemination/implementation of clinically validated interventions across the lifespan.
      • Therapies to alleviate conditions co-occurring with ASD.
      • Healthcare provider-focused training or tools to improve healthcare delivery for individuals with ASD, particularly in adulthood.
    • Preliminary data relevant to the proposed project are required.
    • ·         Pre-application is required; application submission is by invitation only.
    • The maximum allowable funding for the entire period of performance is $500,000 in direct costs
    • Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
    • ·         Maximum period of performance is 3 years

     

    A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions available for electronic 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 funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

    Applications must be submitted through the federal government’s single-entry portal, Grants.gov. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the ARP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

    Point of Contact:

    CDMRP Help Desk

    301-682-5507

    help@eBrap.org


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