Fiscal Year 2022 (FY22) pre-announcement for the Department of Defense (DOD) program managed by the Congressionally Directed Medical Research Programs (CDMRP).

The Toxic Exposures Research Program is a new CDMRP program that will allow the research community to improve scientific understanding and pathobiology of toxic exposures, efficiently assess comorbidities, and speed the development of treatments, cures, and preventions. This message is being sent to individuals subscribed to multiple applicable programs to ensure widest dissemination.

FY22 Pre-announcement released:

New! Toxic Exposures Research Program

https://cdmrp.army.mil/pubs/press/2022/22terppreann

·       Investigator Initiated Research Award

·       Translational Research Award

• ·       Translational Research Award – Partnership Option
• ·       Clinical Trial Award
• ·       Clinical Trial Award-Partnership Option

…………………………………………………………………………….

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at Caution-https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Funding Opportunities/Program Announcements and General Application Instructions which can be found on the Grants.gov website (https://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 Assistance Listing (formerly CFDA) Number 12.420.

New for FY22: The applicant organization must be registered as an entity in SAM (https://www.sam.gov/SAM/ ) and receive confirmation of an “Active” status before submitting an application through Grants.gov.  As published in the Federal Register 10 July 2019 (https://www.federalregister.gov/documents/2019/07/10/2019-14665/unique-entity-id-standard-for-awards-management), the Unique Entity Identifier for awards management generated through SAM will replace the Data Universal Numbering System (DUNS) number as of April 2022. CDMRP has transitioned to use of the Unique Entity Identifier (SAM) and will utilize the latest SF 424 which includes the UEI. The DUNS will no longer be accepted.

For email notification when CDMRP funding opportunities 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 CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

For more information on types of funding opportunities offered and application strategies review the CDMRP Webinar Series: https://cdmrp.army.mil/pubs/Webinars/webinar_series .

This message is being sent to the VINCI Cyberseminar list. Attendance is optional.

The VA Informatics and Computing Infrastructure (VINCI) in its continuing efforts to assist our users will be holding its VINCI Training Hour August 17th at 3PM ET. The training format will present an in-depth look at a particular topic and then take questions. This month's topic is:

VINCI Millennium Data Provisioning Update and SOP Release
This presentation will cover the standardized scripts used by VINCI Data Services to extract basic information from Millennium (CDWWork2). These scripts will be shared on CIPHER but an explanation of how they work will be discussed during this presentation. An update on the provisioning process for Millennium will also be discussed.

VINCI Office Hour (Moderated by Andrew Holbrook every Wednesday at 3PM ET except 3rd Wednesday for VINCI Training Hour)
If you have questions about where you might be able to find certain data elements in the CDW, how to access the various VINCI resources for researchers and analysts, or any VINCI data-related questions, please drop by and ask. If we don't have enough questions to answer during the hour, we will use the time to construct an FAQ list based on questions we see a lot, so even if you don't have a specific question to ask us, that might be useful. Note that the VINCI Office Hour Teams meeting (link below) is the same one that is used for the monthly Training Hour.

 Join Microsoft Teams Meeting

+1 872-701-0185 United States, Chicago (Toll)
Conference ID: 480 505 813#

WASHINGTON, DC - It is with great pleasure and excitement that we announce  the onboarding of a talented and fresh perspective to the NAVREF team. Beginning August 1st, Mr. Marlon Ferguson will be joining NAVREF as the new Chief Executive Officer. Marlon has been dedicated to civic service throughout his professional career which has spanned from serving as an enlisted sailor in the United States Navy to his most recent position as the Regional Director for Senator Bob Casey’s office. Marlon is also no stranger to the NPC community with his tenure as an active board member with the Veterans Health Foundation located in Pittsburgh, PA. His experience with our unique industry will serve as an asset as he leads NAVREF into our next era. He will be equipped with a new strategic plan and in a position to effectively manage an organization that has started to pivot towards enhancing core relationships and programs.

Among his many civic achievements, Marlon has also served as President of the Penn Hills Community Development Corporation; Director of Administration & Finance for the University of Pittsburgh School of Law; and Director of Administration for Duquesne University.

A more formal announcement will be made in the coming weeks highlighting additional information about Marlon and what his leadership to NAVREF will mean to our community. 

Today we are saddened to hear about the passing of Mr. Allan Krehbiel, an Air Force Veteran, a longtime good friend of NAVREF, and a dedicated supporter of our unique nonprofit community. The loss of Mr. Krehbiel is the loss of a pillar that held our community to higher standards. In the decades we have worked with Mr. Krehbiel, his professionalism and knowledge kept the VA-Affiliated Nonprofit Research Corporations (NPC) poised to grow and enhance their operations. Mr. Krehbiel saw our community as a family, and like any other family, his exigence was out of care and compassion for the NPC to succeed through their next phases.  The entire NAVREF community offers our condolences to his family, friends, and to his colleagues across the Department of Veterans Affairs. 

We anticipate more information to be announced in the coming days regarding memorial services.

The family has asked donations be made to Tunnels to Towers via the following link:

https://t2t.org/wp-content/uploads/2022/04/In-Memory-of-Online-Form_Interactive-Online-Form.pdf

The FY22 Defense Appropriations Act is anticipated to provide funding for the KCRP to support research of exceptional scientific merit in the area of kidney cancer.  The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The FY22 KCRP funding opportunity announcements for the following award mechanisms are posted on the Grants.gov website. 

 

Applications submitted to the FY22 KCRP must address one or more of the following Focus Areas:

 

• Conduct basic biology research to better understand etiology and cancer progression, metastatic disease, refractory disease and therapeutic resistance, genetic and environmental risk factors and the prevention of kidney cancer.
• Define the biology of rare kidney cancers and develop treatments to improve outcomes and reduce death.
• Identify and develop new strategies for screening, early-stage detection, accurate diagnosis and prognosis prediction of kidney cancers, with examples including biomarkers and imaging.
• Develop novel therapeutic strategies for the treatment of kidney cancer, such as novel drug targets, therapeutic modalities and agents, treatment combinations, and drug delivery systems.
• Identify and implement strategies to improve the quality of life and survivorship for patients.
• Identify and implement strategies to mitigate health disparities, such as access to healthcare, social and cultural factors, environmental factors, and biological contributors.
• Support preparation and development of the next generation of kidney cancer researchers, or cultivate collaborations in kidney cancer research or patient care in alignment with the KCRP Overarching Strategic Goals.

Funding Opportunities - FY22 Kidney Cancer Research Program, Congressionally Directed Medical Research Programs (CDMRP) (army.mil)

Academy of Kidney Cancer Scholars – Early-Career Investigator Award – Letter of Intent September 29, 2022

Must be within 4 years of last postdoctoral research position (Ph.D.) or clinical fellowship (M.D.), or equivalent, as of full application submission deadline.

Letter attesting to eligibility required.

·        Supports the addition of new Early-Career Scholars to the unique, interactive virtual academy providing intensive mentoring, national networking, and a peer group for junior faculty.

·        Early-Career Scholars whose ability to commit to conducting kidney cancer research is limited by lack of resources or other overwhelming obstacles are encouraged to apply.

·        A Designated Mentor who is an experienced kidney cancer researcher with a record of kidney cancer funding is required.

·        The Designated Mentor not required to be at the same institution as the Early-Career Scholar.

·        Preliminary data required.

·        Clinical trials are not allowed.

·        Maximum funding of $725,000 for direct costs (plus indirect costs).

·        Maximum period of performance 4 years.

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

 

Nurse-Initiated Research Award – Letter of Intent due September 29, 2022

Must have a Registered Nurse license and/or a Master’s or Doctoral degree in nursing.

• Supports nursing research pertaining to kidney cancer patient care.
• Clinical trials are not allowed; correlative studies to clinical trials are allowed. Qualified Collaboration Option: Leveraging of existing infrastructure of a federally funded partnership/consortium is encouraged.
• •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 negotiated rate agreement.

 

Clinical Trial Award Modified for FY22 – Letter of Intent due September 29, 2022

Independent investigators at all levels.

•                  Supports projects ranging from small proof-of-concept trials (e.g., pilot, first in human, phase 0) to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.

•                  Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies.

•                  Investigational New Drug (IND) or Investigational Device Exemption (IDE) application, if applicable, must be submitted to the U.S. Department of Food and Drug Administration (FDA) by the time of application submission.

•                  Documented availability of and access to the drug/compound, device, and/or other materials needed, as appropriate, for the proposed duration of the study must be provided.

•                  Clinical trials are expected to begin no later than 12 months after the award date, or 18 months after the award date for FDA-regulated studies.

•                  Qualified Collaboration Option: Leveraging of existing infrastructure of a federally funded partnership/consortium is encouraged.

•                  Maximum funding of

·       $1,500,000 for direct costs (plus indirect costs).

•                  Maximum period of performance is 4 years.

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

·       Cell Therapy Focus Option:

•                  Maximum funding of

·       $2,000,000 for direct costs (plus indirect costs).

•                  Maximum period of performance is 4 years.

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

 

Concept Award – Letter of Intent due June 23, 2022

•                  All investigators at or above the level of postdoctoral fellow (or equivalent) are eligible.

•                  Supports highly innovative, untested, potentially groundbreaking concepts in kidney cancer.

•                  Emphasis on innovation.

•                  Preliminary data are not allowed.

•                  Clinical trials are not allowed.

•                  Blinded review.

•                  Maximum of $100,000 for direct costs (plus indirect costs).

•                  Maximum period of performance is 1 year. Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

 

Idea Development Award Modified for FY22 – Preproposal due June 2, 2022

Established Investigators: 

Independent investigators at or above the level of Assistant Professor (or equivalent) and 10 years or more from a terminal degree.

Early-Career Investigators:

Investigators at the level of Assistant Professor, Instructor, or Assistant Research Professor (or equivalent) and less than 10 years from a terminal degree (excluding time spent in medical residency/fellowship or family medical leave) at the time of application submission deadline.

·      Supports new ideas that represent innovative, high-risk/high-gain approaches to kidney cancer research, and have the potential to make an important contribution to kidney cancer.

·      Preliminary data required.

·      Innovation and impact are the most important review criteria.

·      Clinical trials are not allowed.

Different funding options, based on the scope of proposed research, are available with compelling justification. .  Maximum funding of $675,000 in direct costs (plus indirect costs).

·      Maximum period of performance 3 years.

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

·      Early Detection Studies Option: 

·      Maximum funding of $700,000 in direct costs (plus indirect costs).

·      Maximum period of performance 3 years.

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

Population Science and Prevention Studies Option:

·      Maximum funding of $2 million in direct costs (plus indirect costs)

·      Maximum period of performance 4 years

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

 

Postdoctoral and Clinical Fellowship Award – Letter of Intent due June 23, 2022

Must have completed requirements for a Ph.D. and/or M.D.  

Must be in the laboratory or clinical setting where proposed research will be performed.

Must have no more than 4 years of postdoctoral and/or mentored clinical research experience.

Investigators in non-postdoctoral and/or clinical fellow positions are not eligible.

•                  Supports research opportunities focused on kidney cancer for individuals in the early stages of their careers.

•                  A designated mentor who is an experienced kidney cancer researcher is required.

•                  Clinical trials are not allowed.

•                  Maximum funding of $195,000 for direct costs (plus indirect costs).

•                  Maximum period of performance is 3 years.

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

 

Translational Research Partnership Award – Preproposal due June 2, 2022

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

The Partnering PI must be at or above the level of Assistant Professor or equivalent. 

Postdoctoral fellows are not eligible to be Partnering PIs.

•Supports partnerships between clinicians and laboratory scientists that accelerate ideas in kidney cancer into clinical applications.

•Supports translational correlative studies.

•Preliminary data are required.

•Clinical trials are not allowed.

•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 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 funding opportunity announcements 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. 

 

For email notification when 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 KCRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

 

Point of Contact:

CDMRP Help Desk

301-682-5507
help@eBrap.org

A Word from the NAVREF Interim CEO

Dear NAVREF Family,

I’d like to thank you for entrusting me to be an interim steward of the association as we enter new beginnings. The past 8 years of NAVREF knowledge will go into good use during this time.

In the past month, NAVREF has worked on improving processes internally so that we can better focus on strengthening existing relationships within our community and with our external stakeholders. As we move into the next 30 days, the community will begin to see the fruits of our labor. Enhancements like the modernization to how we approach membership renewals, and empowerment of the Industry Partner Consortium’s mission are just small examples of what we are working towards. The update you will read below only touches the surface of what we intend to make happen, and with the June newsletter we will take a deeper dive into what is next. One highlight we all can look forward to is the upcoming and reimagined 30^th NAVREF Conference which is going to be filled with new elements and surprises.

I am truly humbled by your trust in me, and alongside with our strong NAVREF team, we will all work hard to prepare our association for what the future holds. 

NAVREF Membership Renewals

It’s June and that means it’s time for NAVREF Membership Renewals for the 2022-2023 year. Please use this link to complete your online renewal application.

OGC Position on Clinical Trial Insurance

OGC STAR was asked to provide guidance on whether the VA-affiliated Nonprofit Corporations (NPCs) should obtain clinical trial insurance to offset VA’s potential expenses resulting from injury to subjects participating in VA-approved research studies. STAR concluded that NPCs should not obtain clinical trial insurance. VA conducts the research, not the NPC. NPCs have no authority to make agreements for VA, such as purchasing insurance for VA. (see attachment)

NAVREF Awards

Nomination season is upon us! The criteria for nominees have been simplified so please submit your nominations via our new online form here.

Board Nominations

NAVREF has several board positions opening in the coming months! Please apply asap if you are considering a position. The following board positions are available:

·       Medical Center Director

·       ACOS-E

·       Executive Director (two positions becoming available)

·       Class B

Upcoming Training – SAVE THE DATES

·       June 16 at 2 PM ET - Preparing for the NPPO Review Webinar

·       July 14 and 15, 1-4 PM ET - Post Award Grant Management Virtual Training by SRAI

·       July 28 and 29, 1-4 PM ET - Pre Award Grant Management Virtual Training by SRAI

·       July 20 at 2 PM ET - NAVREF Advocacy Course Part 1 of 3: The NAVREF Advocacy Agenda

NPPO Reminder

Please prepare for your NPPO reviews by thoroughly reading the letter and materials sent by NPPO ahead of time. Their office would appreciate your cooperation and will ease the time NPPO spends at the NPC.

New Staff and Volunteer

You will notice a couple of new names flying around NAVREF. Please welcome:

Peter Martin, Program Support Specialist

pmartin@navref.org

David Grajales, Volunteer

dgrajales@navref.org

30^th NAVREF Annual Conference

Registration is now open for our annual conference. Please click here to learn more about our event and to register. The preliminary agenda has also been posted on our conference page so please check out the information and let us know if you have any questions!

IRS Increase in Mileage Reimbursement

The IRS has increased the mileage reimbursement rate for 2022.  The rate announced starting January 1, 2022 was 58.5 per mile.  Starting July 1, 2022 it is 62.5. 

IRS increases mileage rate for remainder of 2022 | Internal Revenue Service

The FY22 Defense Appropriations Act provides funding for the Hearing Restoration Research Program (HRRP) to support innovative and impactful research that pursues the treatment of auditory system injuries and the restoration of hearing.  The managing agent for the anticipated funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The FY22 HRRP funding opportunity announcements for the following award mechanisms is posted on the Grants.gov website. 

 

Applications submitted to the FY22 HRRP must address one or more of the following Focus Areas:

 

• Accelerate translation of biological regeneration/repair mechanisms into therapies that treat auditory system injury and restore auditory function.  For example, but not limited to:

• ○       Hair cell regeneration/repair/recovery
• ○       Neural regeneration/repair/recovery
• ○       Treatment for synaptopathy and hidden hearing loss

• Diagnostic tests that help differentiate sensory, neural, synaptic, and central processing disorders, that may inform applicability and outcomes for current or future hearing restoration therapeutics.
• Develop reliable in-vitro human models to facilitate the understanding, derivation and characterization of human auditory cells, and/or to facilitate the evaluation of hearing restoration therapies.
• Develop and/or validate techniques/methods beyond the audiogram to diagnose acute auditory system injury in austere or remote environments.  For example, but not limited to, simple and rapid assessments that are compatible with portable platforms.

•  
• Funding Opportunities-FY22 HRRP, Congressionally Directed Medical Research Programs (CDMRP), US DoD (army.mil)
•  
• Focused Research Award – Preproposal due July 22, 2022
• Independent investigators at all academic levels (or equivalent) are eligible to submit applications.
• ·    Pre-application submission is required; application submission is by invitation only.
• ·    Supports promising research that will accelerate drug discovery and therapeutic development for hearing restoration or accelerate advances in the assessment, diagnostics, and treatment of auditory dysfunction.

·    Research must address one or more of the FY22 HRRP Focus Areas.

·    Funding Level 1 supports exploratory, high-risk/high-reward research that is in the earliest stages of idea development.

·    Funding Level 2 supports the advancement of more mature research toward clinical translation.

·    Funding Level 3 supports research with a translational research component and a related pilot clinical trial component.

·    It is the responsibility of the applicant to select the funding level that is most appropriate for the research proposed.  The funding level should be selected based on the stage and maturity of the research, rather than the amount of the budget.

·    Tinnitus or vestibular-related research is excluded.

Funding Level 1:

·    Maximum funding of $250,000 for direct costs (plus indirect costs).

·    Maximum period of performance is 2 years.

Funding Level 2:

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

·    Maximum period of performance is 3 years.

Funding Level 3:

·    Maximum funding of $1,250,000 for direct costs (plus indirect 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 funding opportunity announcements 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.

 

For email notification when 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 HRRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

 

Point of Contact:

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

The RTRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities.  This pre-announcement should not be construed as an obligation by the government.

 

The FY22 Defense Appropriations Act is anticipated to provide funding for the RTRP to support research of exceptional scientific merit to refine approaches for and increase access to reconstructive transplants and state-of-the-art immunotherapy.  The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The RTRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities.  This pre-announcement should not be construed as an obligation by the government.  The FY22 RTRP 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 FY22 RTRP Investigator-Initiated Research Award must address one or more of the following Focus Areas:

 

Reduce the risks of vascularized composite allotransplantation (VCA)-associated immunosuppression

• Define the unique manifestations and/or mechanisms of VCA immunogenicity
• Develop novel approaches for achieving VCA immune tolerance
• Develop less-toxic and/or personalized regimens for maintenance immunosuppression
• Identify unique immunosuppression requirements for VCA compared to other solid organ transplants

 

Identify and/ or validate reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring

• Identify and/or validate reliable non-invasive biomarkers for monitoring acute and chronic VCA graft rejection in human subjects or banked human specimens and medical records suitable for use in the clinic or at home
• Develop assays or devices for clinical graft monitoring utilizing validated biomarkers

 

Develop VCA-specific outcome measures to include:

• Measures of clinical outcomes, including but not limited to, graft health and survival, frequency and/or severity of graft rejections, immunosuppression-related toxicity
• Measures of functional outcomes, including but not limited to, neuromusculoskeletal function, range of motion, resolution of phantom limb pain
• Measures of social outcomes, including but not limited to, activities of daily living, return to work, community integration, VCA-specific quality of life measures

 

Applications submitted to the FY22 RTRP Advanced Technology Development Award must address one or more of the following Focus Areas:

 

Advance existing tissue preservation strategies to extend the timeline between procurement and transplantation

• Develop promising approaches and technologies for translation to the clinic, including but not limited to, perfusion, hypothermic, high-subzero and low-subzero, or static preservation strategies
• Determine the extent to which VCA tissue preservation technology impacts VCA immunogenicity

 

Advance reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring

• Validate reliable non-invasive biomarkers for monitoring acute and chronic VCA graft rejection in a human model or banked human specimens and medical records
• Develop assays or devices for clinical implementation of graft monitoring utilizing validated biomarkers

 

Applications submitted to the FY22 RTRP Concept Award must address one or more of the following Focus Areas:

 

Reduce the risks of VCA-associated immunotherapy

• Define the unique manifestations and/or mechanisms of VCA immunogenicity
• Develop novel approaches for achieving VCA immune tolerance
• Develop less-toxic and/or personalized regimens for maintenance immunosuppression
• Identify unique immunosuppression requirements for VCA compared to other solid organ transplants

 

Identify reliable non-invasive prognostic/diagnostic biomarkers, methods, or tools for monitoring VCA graft rejection, including applications that would be suitable for point-of-care testing or home monitoring

• Identify new peripheral biomarkers for acute and chronic VCA graft rejection in human subjects or banked human specimens and medical records suitable for use in the clinic or at home
• Develop assays or devices for clinical implementation of graft monitoring utilizing validated biomarkers

 

Applications submitted to the FY22 RTRP Clinical Network Award must address the standardization, assessment, and validation of protocols and/or clinical practice guidelines (CPGs) for each of the following aspects of VCA for face and hand transplantation:

• Patient inclusion/exclusion criteria
• Patient education
• Surgical procedures
• Immunosuppression and/or immunoregulation
• Outcome metrics
• Quality-of-life measures
• Rehabilitation
• Patient reporting (e.g., registry)

 

Press Release: 2022 Reconstructive Transplant Research Program, Congressionally Directed Medical Research Program (army.mil)

 

Investigator-Initiated Research Award

Independent investigators at all academic levels (or equivalent)

·      Supports studies with the potential to make an important contribution to the reconstructive transplant research field, patient care, and/or quality of life.

·      Preproposal is required; full application submission is by invitation only.

·      Applications must address at least one of the FY22 RTRP Investigator-Initiated Research Award Focus Areas.

·      Preliminary or published data are required for all Focus Areas.

·      Multiple PI Option:

·      Supports synergistic partnerships among two to four investigators collaborating on a single application.

Single PI:

·        Maximum funding of $1 million (M) for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

Multiple PI Option:

·        Maximum total funding of $1.5M for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

 

Advanced Technology Development Award

Independent investigators at all academic levels (or equivalent)

·      Supports research critical for the translation of promising preclinical findings into products focused on reconstructive transplantation.

·      Applications must address at least one of the FY22 RTRP Advanced Technology Development Award Focus Areas.

·      Preproposal is required; full application submission is by invitation only.

·      Preliminary or published data are required.

·      Multiple Principal Investigator (PI) Option:

Supports synergistic partnerships among two to four investigators collaborating on a single application; multi-institutional collaborations are encouraged.

Single PI:

·        Maximum funding of $1M for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

Multiple PI Option:

·        Maximum total funding of $1.5M for total costs (direct plus indirect costs).

·        Maximum period of performance is 3 years.

 

Concept Award

Independent 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 transplantation.

·      Preliminary data are NOT allowed.

·      Reviewers at both tiers of review will be blinded to the identities of the PI, collaborators, and their organizations.

·      Applications must address at least one of the FY22 RTRP Concept Award Focus Areas.

·      Maximum funding of $200,000 for total costs (direct plus indirect costs).

·      Maximum period of performance is 18 months.

 

Clinical Network Award

Independent investigators at or above the level of Assistant Professor (or equivalent) are eligible to be named PI.

·      To promote a major multi-institutional network of VCA Centers and associated collaborators for the purpose of standardizing clinical protocols and CPGs for face and hand transplantation, as well as assessing and validating those protocols and CPGs in multi-institutional clinical trials.

·      This effort will be executed through a two-phase approach in the form of a single award to the Clinical Network Coordinating Center.  The Coordinating Center will serve as the Clinical Network information and planning nexus, providing administrative, operational, and data management support services to implement Clinical Network activities in a timely manner.

·      Phase 1 Objectives

○       Establish the Clinical Network

○       Develop standardized protocols and Standard Operating Procedures

○       Develop clinical trial applications

○       Coordinate external Peer Review

○       Obtain all regulatory approvals

·      Phase 2 Objectives

○       Conduct clinical trials (one for face transplantation and one for hand transplantation)

○       Submission of a Letter of Intent is required prior to full application submission.

Phase I:

• Maximum funding of $3M for total costs (direct plus indirect costs) to the Coordinating Center.
• Maximum period of performance is 2 years.

Phase II:

• Maximum funding of $10M for total costs (direct plus indirect costs) to the Coordinating Center.
• 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 funding opportunity announcements 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 at https://eBRAP.org.  For more information about the RTRP 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

The Fiscal Year 2022 (FY22) Defense Appropriations Bill has not been signed into law.  Although FY22 funds have not been appropriated for the Kidney Cancer Research Program (KCRP), the KCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

 

The FY22 Defense Appropriations Act is anticipated to provide funding for the KCRP to support research of exceptional scientific merit in the area of kidney cancer.  The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The KCRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities.  This pre-announcement should not be construed as an obligation by the Government.  The FY22 KCRP 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 FY22 KCRP must address one or more of the following Focus Areas:

 

• Conduct basic biology research to better understand etiology and cancer progression, metastatic disease, refractory disease and therapeutic resistance, genetic and environmental risk factors and the prevention of kidney cancer.
• Define the biology of rare kidney cancers and develop treatments to improve outcomes and reduce death.
• Identify and develop new strategies for screening, early-stage detection, accurate diagnosis and prognosis prediction of kidney cancers, with examples including biomarkers and imaging.
• Develop novel therapeutic strategies for the treatment of kidney cancer, such as novel drug targets, therapeutic modalities and agents, treatment combinations, and drug delivery systems.
• Identify and implement strategies to improve the quality of life and survivorship for patients.
• Identify and implement strategies to mitigate health disparities, such as access to healthcare, social and cultural factors, environmental factors, and biological contributors.
• Support preparation and development of the next generation of kidney cancer researchers, or cultivate collaborations in kidney cancer research or patient care in alignment with the KCRP Overarching Strategic Goals.

Press Release: 2022 Kidney Cancer Research Program, Congressionally Directed Medical Research Program (army.mil)

Academy of Kidney Cancer Scholars – Early-Career Investigator Award

Within 4 years of last postdoctoral research position (Ph.D.) or clinical fellowship (M.D.), or equivalent, as of full application submission deadline.

Letter attesting to eligibility required.

·        Supports addition of new Early-Career Investigators (ECIs) to the unique, interactive virtual academy that provides intensive mentoring, national networking, and a peer group for junior faculty.

·        ECIs whose ability to commit to conducting kidney cancer research is limited by lack of resources or other overwhelming obstacles are encouraged to apply.

·        Requires Designated Mentor who is an independent, established kidney cancer investigator with a record of kidney cancer publications in peer-reviewed journals.

·        Designated Mentor not required to be at the same institution as the ECI.

·        Preliminary data required.

·        Funding for clinical trials not allowed.

Submission of a Letter of Intent required prior to full application submission.

·        Maximum funding of $725,000 for direct costs (plus indirect costs).

·        Maximum period of performance 4 years.

 

Clinical Research Nurse Development Award

As of full application submission deadline, Principal Investigators must possess an RN, Bachelor’s, Master’s, or Doctoral degree in nursing.

·      Prepares nurses for active careers in collaborative clinical kidney cancer research and patient care.

·      Requires participation of a mentor with extensive experience in kidney cancer clinical research.

·      Emphasis placed on structured, interdisciplinary clinical research training environment.

·      Submission of a Letter of Intent required prior to full application submission.

·     Maximum funding of $300,000 for direct costs (plus indirect costs).

·     Maximum period of performance 2 years.

 

Clinical Trial Award Modified for FY22

Independent investigators at all levels.

·        Supports hypothesis-based, early-phase clinical trials (e.g., phase 0, phase 1, pilot phase 2) to test interventions that will have a major impact in the field of kidney cancer.

·        Interventions may include drugs, devices, biologics, surgical procedures, behavior modifications, or other types.

·        Investigational New Drug or Investigational Device Exemption approvals, if applicable, must be in place by the time of application submission.

·        Letter of support demonstrating proof of possession of sufficient drug supply to conduct study must be provided (if appropriate).

·        Clinical trials are expected to be initiated within 12 months of the award date.

·        Submission of a Letter of Intent required prior to full application submission.

·      Maximum funding of $1,500,000 for direct costs (plus indirect costs).

·      Maximum period of performance is 4 years.

Cell Therapy Option:

·        Maximum funding of $2,000,000 for direct costs (plus indirect costs).

·        Maximum period of performance is 4 years.

 

Concept Award

Investigators at all academic levels.

·      Supports highly innovative, untested, potentially groundbreaking concepts in kidney cancer.

·      Emphasis on innovation.

·      Funding for clinical trials not allowed.

·      Preliminary data not allowed and should not be discussed.

·      Blinded review.

Submission of a Letter of Intent required prior to full application submission.

·     Maximum funding of $100,000 for direct costs (plus indirect costs).

·     Maximum period of performance 1 year.

 

Idea Development Award Modified for FY22

Established Investigators: 

Independent investigators at or above the level of Assistant Professor (or equivalent) and 10 years or more from a terminal degree.

Early-Career Investigators:

Investigators at the level of Assistant Professor, Instructor, or Assistant Research Professor (or equivalent) and less than 10 years from a terminal degree (excluding time spent in medical residency/fellowship or family medical leave) at the time of application submission deadline.

·      Supports new ideas that represent innovative, high-risk/high-gain approaches to kidney cancer research, and have the potential to make an important contribution to kidney cancer.

·      Preliminary data required.

·      Innovation and impact are the most important review criteria.

·      Funding for clinical trials not allowed.

Different funding options, based on the scope of research.  It is the responsibility of the PI to select the funding option that is most appropriate for the research proposed. 

·      Maximum funding of $675,000 in direct costs (plus indirect costs).

·      Maximum period of performance 3 years.

·      Early Detection Studies Option:  Supports basic or preclinical research that focuses on biomarkers, improved imaging capabilities, and/or new technologies that may foster new paradigms for the early detection of kidney cancer.  With justification, applications under the Early Detection Studies Option may request a higher level of funding within the defined period of performance.  Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens.

·      Population Science and Prevention Studies Option:  Supports preclinical research that is already supported by substantial preliminary or published data and strongly validates clinical translation in a well-defined context within the kidney cancer field.  With compelling justification, applications under the Population Science and Prevention Studies Option may request higher levels of funding within the defined period of performance.  Such studies may require additional resources due to the participation of human subjects and/or use of human biospecimens.

·      Pre-application is required; application submission is by invitation only

Early Detection Option:

·      Maximum funding of $700,000 in direct costs (plus indirect costs).

·      Maximum period of performance 3 years.

Population Science and Prevention Studies Option:

·      Maximum funding of $2 million in direct costs (plus indirect costs)

·      Maximum period of performance 4 years

 

Postdoctoral and Clinical Fellowship Award

As of full application submission deadline, Principal Investigators:

·      Must possess a doctoral and/or medical degree (or equivalent).

·      Have 4 years or less of postdoctoral and/or mentored clinical research training experience (excluding family medical leave).

All other academic ranks are ineligible.

·      Supports research opportunities focused on kidney cancer for individuals in the early stages of their careers.

·      Requires participation of a designated mentor who is an experienced kidney cancer researcher.

Submission of a Letter of Intent required prior to full application submission.

·      Maximum funding of $195,000 for direct costs (plus indirect costs).

·      Maximum period of performance 3 years.

 

Translational Research Partnership Award

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

·      Supports partnerships between clinicians and laboratory scientists that accelerate ideas in kidney cancer into clinical applications.

·      Supports translational correlative studies.

·      Preliminary data required.

·      Funding for clinical trials not allowed.

·      Pre-application is required; application submission is by invitation only.

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

·      Maximum period of performance 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 funding opportunity announcements 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 at https://eBRAP.org.  For more information about the KCRP 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

The FY22 Defense Appropriations Bill has not been signed into law.  Although FY22 funds have not been appropriated for the NFRP, the program is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY22 funding opportunities.  This pre-announcement should not be construed as an obligation by the government.

 

The FY22 Defense Appropriations Act is anticipated to provide funding to the Department of Defense NFRP to support innovative, high-impact NF research.  The managing agent for the anticipated funding opportunities is the Congressionally Directed Medical Research Programs at the U.S. Army Medical Research and Development Command.

 

The FY22 NFRP 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 FY22 NFRP must address one or more of the following Areas of Emphasis:

• Neurofibromatosis (NF) Type 2-related areas (e.g., hearing, balance, ependymoma, meningioma)
• Biomarker discovery, utility, development, and validation
• Non-tumor manifestations not limited to:

o   Pain

o   Cognitive manifestations

o   Sleep

• ·        Heterogeneity of NF-related tumors
• ·        Novel disease and treatment response markers using genetics, genomics, epigenetics, systems biology, metabolomics, or similar approaches
• ·        Preclinical efficacy studies
• ·        Target identification, drug discovery
• ·        Nutritional, environmental, and other modifiers of NF
• ·        Health services research
•  
• Press Release: 2022 Neurofibromatosis Research Program, Congressionally Directed Medical Research Program (army.mil)
•  
• Clinical Trial Award
• Investigators must be at or above the level of Assistant Professor (or equivalent).

·     Funds phase 0, I, or II clinical trials relevant to NF and/or schwannomatosis; combinations of phases are permitted.

·     Funding must support a clinical trial and may not be used for preclinical studies.

·     Scientific rationale and preliminary data are required for phase I and II clinical trial applications.

·     Maximum funding of $800,000 for direct costs (plus indirect costs).

·     Maximum funding of $1 million (M) for direct costs (plus indirect costs) for applications including a Collaborator.

·     Maximum period of performance is 4 years.

•  
• Exploration – Hypothesis Development Award
• Investigators may be from all academic levels (or equivalent).

·     Funds the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in NF research.

·     Projects involving human subjects or human biological substances must be exempt under Code of Federal Regulations, Title 32, Section  219, Part 104(d) (32 CFR 219.104[d]) or eligible for expedited review under 32 CFR 219.110 or 21 CFR 56.110.

·     Preliminary and/or published data are encouraged but not required.

·     Clinical trials are not allowed.

·     Mentorship is highly encouraged.

·     Maximum funding of $100,000 for direct costs (plus indirect costs).

·     Maximum period of performance is 2 years.

•  
• Investigator-Initiated Research Award
• Investigators must be at or above the level of Assistant Professor (or equivalent) and must plan to commit at least a 10% level of effort for each budget period throughout the entirety of the award.

·     Funds highly rigorous, high-impact research projects that have the potential to make an important contribution to NF research and/or patient care.

·     Optional Features:  Applications meeting the criteria identified in the announcement may apply for a higher level of funding for the following options:  Qualified Collaborator and/or NF Open Science Initiative (NF-OSI).

·     Preliminary and/or published data are required.

·     Clinical trials are not allowed.

·     Maximum funding of $525,000 for direct costs (plus indirect costs).

·     Maximum funding of $575,000 for direct costs (plus indirect costs) for applications including either an Optional Qualified Collaborator or NF-OSI option.

·     Maximum funding of $625,000 for direct costs (plus indirect costs) for applications including both the Optional Qualified Collaborator and NF-OSI options.

•  
• New Investigator Award

Early-Stage Investigator (ESI):  An independent investigator at or below the level of Assistant Professor (or equivalent) and commit at least 30% during each budget year of their efforts toward the proposed NF research project.

Established Investigator (EI): An independent investigator above the level of Assistant Professor and commit at least 10% during each budget year of their efforts toward the proposed NF research project.

·     ESI: Supports the continued development of promising independent investigators.

·     EI: Supports transition of established investigators from other research fields who will bring their expertise into a career in the field of NF research.

·     Experience in NF research is allowed, but not required.

·     Preliminary and/or published data are required.

·     Clinical trials are not allowed.

·     Must not have received a New Investigator Award previously from any program within the CDMRP.

·     Maximum funding of $450,000 for direct costs (plus indirect costs).Maximum period of performance is 3 years.

 

Early Investigator Research Award

·    Investigators must be involved in a postdoctoral training or medical residency program and possess up to 4 years continuous postdoctoral research experience.

·    Investigators must have successfully defended a doctoral thesis or possess an M.D. degree and commit at least 50% of his/her effort towards the project.

·     Supports research opportunities focused on NF for individuals in the early stages of their careers.

·     Investigators must have a designated mentor who is an experienced NF researcher.

·     Maximum funding of $200,000 for direct costs (plus indirect costs).

·     Maximum period of performance is 2 years.

 

• Synergistic Idea Award
• Investigators must be at or above the level of Assistant Professor (or equivalent).

·     Supports new or existing partnerships between two or three investigators to address a central innovative question or problem in NF that may include high risk, provided there is a potential for significant impact.

·     Investigators are expected to demonstrate within the application the synergistic components (i.e., leveraging disciplines, expertise, or critical resources) that will significantly advance the project such that the research outcomes as a whole will be realized rapidly and efficiently and could not otherwise be accomplished through the independent efforts of a single investigator.

·     Preliminary and/or published data are required.

·     Synergy, Research Strategy, Personnel, and Impact are the most important review criteria.

·     Clinical trials are not allowed.

·     Maximum funding of $2M for direct costs (plus indirect 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 funding opportunity announcements 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 U.S. Army Medical Research and Development Command 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 at https://eBRAP.org.  For more information about the NFRP 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