DoD Peer Reviewed Orthopaedic Research Program Preannouncement

Defense Health Program
Department of Defense Peer Reviewed Orthopaedic Research Program

Funding Opportunities for Fiscal Year 2019 (FY19)

The Fiscal Year 2019 (FY19) Defense Appropriation provides $30 million (M) to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support the most significant gaps in care for the leading burden of injury and for facilitating return to duty by funding innovative, high-impact, clinically relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries sustained during combat and combat-related activities.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC). 

The PRORP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY19 PRORP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website by June 2019.  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.

The PRORP will solicit research applications that specifically address at least one of the following FY19 Focus Areas:

  1. Compartment Syndrome Models: Diagnostic and/or treatment strategies developed in a large animal model that replicates compartment syndrome.  Model system should be clinically relevant and scientifically reproducible.
  • Limb Stabilization and Protection: Development of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.
  • Retention on Duty Strategies: Development and/or optimization of battlefield-feasible diagnostic capabilities, decision support tools, interventions, and/or rehabilitation strategies that can facilitate retention on duty for common combat-related musculoskeletal injuries.  (Biomarker studies are excluded.)
  • Skin-implant Interface: Identification of best practices to address infection at the skin-implant interface for osseointegrated prosthetic limbs.
  • Translation of Early Findings: Translation of early research findings in orthopaedic surgical care topic areas (volumetric muscle loss, compartment syndrome, and soft tissue trauma) to move the research toward clinical trials and clinical practice.
  • Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle, and/or composite tissue for the restoration of traumatically injured extremities (excludes isolated bone tissue engineering studies).

The following FY19 PRORP award mechanisms are planned for release (note that Focus Area requirements vary by award mechanism):

Applied Research Award

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

Pre-application is required; full application submission is by invitation only.Supports applied research applications focused on advancing optimal treatment and restoration of function for military personnel with musculoskeletal injuries sustained during combat or combat-related activities.Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation. Clinical trials are not allowed under this award mechanism. Applications must address one the following FY19 PRORP Focus Areas:Compartment Syndrome ModelsLimb Stabilization and Protection
  • Retention on Duty Strategies
  • Maximum funding of $750,000 for total costs (direct plus indirect costs).
  • Maximum period of performance is 3 years.

Clinical Trial Award

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

Pre-application is required; full application submission is by invitation only.Supports rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries or non-battle injuries that significantly impact unit readiness and return-to-duty/work rates.Funding must support a clinical trial and may not be used for preclinical research studies.Collaboration with military researchers and clinicians is encouraged.Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date. Applications must address one the following FY19 PRORP Focus Areas:Limb Stabilization and ProtectionRetention on Duty StrategiesTranslation of Early Findings

Applications submitted to the Translation of Early Findings (soft tissue trauma only) Focus Area may elect a Rehabilitation Option, which provides a higher funding maximum for surgical intervention studies that propose an integrative rehabilitation component.

Maximum funding of $2.5M for total costs. ($3M maximum total costs if requesting the Rehabilitation Option.)
  • Maximum period of performance is 4 years.

Clinical Translational Research Award

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

Pre-application is required; full application submission is by invitation only.Supports high-impact and/or emerging research that may or may not be ready for a full-scale, randomized, controlled clinical trial.Funding must support clinical research studies involving humans. Preliminary or published data relevant to the proposed research project are required.Collaboration with military researchers and clinicians is encouraged.Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 12 months of the award date.Applications must address one the following FY19 PRORP Focus Areas:Retention on Duty Strategies
  • Tissue Regeneration Therapeutics
  • Maximum funding of $2M for total 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 and other USAMRMC 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 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 PRORP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

Point of Contact:

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

DoD Psychological Health & Traumatic Brain Injury Research Funding Preannouncement

Defense Health Program
Department of Defense Psychological Health and Traumatic Brain Injury Research Program

Funding Opportunity for Fiscal Year 2019 (FY19)

The FY19 Defense Appropriation provides $125 million (M) to the Department of Defense Psychological Health and Traumatic Brain Injury Research Program (PHTBIRP) to support specific Defense Health Agency (DHA) J9 Research and Development Directorate program areas, including Joint Program Committee-5/Military Operational Medicine Research Program (JPC-5/MOMRP).  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the 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 Announcement/Funding Opportunity is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC).

The PH/TBIRP and JPC-5/MOMRP are providing the information in this pre-announcement to allow investigators time to plan and develop applications.  The FY19 PHTBIRP Program Announcement and General Application Instructions for the following award mechanism is anticipated to be posted on the Grants.gov website in May 2019.  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.

Prevention Research to Reduce Sexual Assault and/or Understand Adjustment Disorders (PSAAD)

Intramural (DoD) and extramural investigators at Assistant Professor level or above (or equivalent) are eligible to submit applications.

Applications to the FY19 PHTBIRP PSAAD Investigator Initiated Focused Research Award should address the development or adaptation of prevention efforts to reduce the occurrence of sexual assault or address approaches to better understand, screen for, and prevent Adjustment Disorders among Service members, ultimately benefiting the public at large.

  • The maximum allowable funding for the entire period of performance is $1,000,000 for direct costs.
  • The maximum period of performance is 3 years.
  • Indirect costs may be proposed in accordance with the institution’s negotiated 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 and other USAMRMC 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 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 PHTBIRP or other CDMRP-administered and supported programs, please visit the CDMRP website (https://cdmrp.army.mil).

Point of Contact: CDMRP Public Affairs
301-619-9783

FY19 KCRP, HRRP, PHTBIRP, and SCIRP Pre-Announcements

Research community- here is a list of recently released pre-announcements for the Kidney Cancer, Hearing Restoration, Psychological Health and Traumatic Brain Injury and the Spinal Cord Injury Research Programs managed by the Department of Defense office of Congressionally Directed Medical Research Programs (CDMRP) https://cdmrp.army.mil/pubs/press/press to allow investigators time to plan and develop ideas for submission to the anticipated FY19 funding opportunities.

FY19 funding opportunities are anticipated for the following programs:

Kidney Cancer Research Program (KCRP)

·       Concept Award

·       Clinical Consortia Award

·       Idea Development Award

·       Kidney Cancer Academy Dean Award

·       Kidney Cancer Academy Early Career Investigator Award

·       Translational Research Partnership Award

Hearing Restoration Research Program (HRRP)

·       Focused Research Award

Psychological Health and Traumatic Brain Injury Research Program

·       Prevention Research to Reduce Sexual Assault and/or Understand Adjustment Disorders (PSAAD) Investigator Initiated Focused Research Award

Spinal Cord Injury Research Program (SCIRP)

·       Clinical Trial Award

·       Investigator-Initiated Research Award

·       Translational Research Award

Descriptions of each of the anticipated funding opportunities, eligibility, key mechanism elements, and funding can be found in the Program pre-announcement.  FY19 pre-announcements can be found in the CDMRP home page features at https://cdmrp.army.mil.

Subsequent notifications will be sent when the program announcements/funding opportunities are released.

Please do not respond directly to this message.  To be added or removed from this email list please use the “Subscribe/unsubscribe” to program specific news and updates at https://ebrap.org.

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Pharmacotherapies for Alcohol and Substance Abuse Consortium Research Funding Opportunities

The Pharmacotherapies for Alcohol and Substance Abuse (PASA) consortium is funded by the Alcohol and Substance Abuse Disorders Research Program.  The goal of the PASA consortium is to fund study applications for developing new medications that can be brought to therapeutic use to improve treatment outcomes for alcohol and substance use disorders (ASUD), especially as related to post-traumatic stress disorder (PTSD) and traumatic brain injury (TBI). The two upcoming research funding opportunities are focused on:

1.Request for Application (RFA) #4a: Small-cost and short-duration planning grant awarded to investigators concerning a specific compound or combination of compounds. Designed to determine the clinical development plan (CDP) and associated studies needed to advance the compound to FDA approval for ASUD treatment.

2.Request for Application (RFA) #4b: Full study implementation awards for proof-of-principle basic research to determine which compounds are most appropriate for human research trials.

The RFAs are available from the PASA Consortium website at:

https://pasa.rti.org/About/Grant-Program

Eight New Frequently Asked Questions and Answers Added to OHRP’s Companion Q&As about the Revised Common Rule

OHRP has added eight new Frequently Asked Questions and Answers (FAQs &As) to its list of “Companion Q&As about the Revised Common Rule.” 

The new questions include the following three:

What is the general compliance date of the revised Common Rule and what does it mean?;

Does my institution need to revise its FWA because of the revised Common Rule?; and,

After January 21, 2019 (the general compliance date for the revised Common Rule), is the 1998 Expedited Review List still in effect for studies subject to the revised Common Rule? 

Each of the eight FAQ &As are noted as being new. The Companion Q&As about the Revised Common Rule can be accessed at: https://nam03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.hhs.gov%2Fohrp%2Feducation-and-outreach%2Frevised-common-rule%2Frevised-common-rule-q-and-a%2Findex.html&data=02%7C01%7CRschSrvsGA8%40uakron.edu%7C300c2a790c184fcf6c7308d6a96a3dbf%7Ce8575dedd7f94ecea4aa0b32991aeedd%7C1%7C0%7C636882671095712390&sdata=SErF5%2BVEyXC5VXXLMTsjb8r6V9gCtAGCoMwgnKZ3b0w%3D&reserved=0