The National Institutes of Health (NIH) recently released a revised NIH Grants Policy Statement (NIHGPS, rev. October 2018).  The NIHGPS makes available in a single document the policy requirements that serve as the terms and conditions of NIH grant awards. The October 2018 revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2018.

 

More information:

• NIH Notice regarding Publication of the Revised NIH Grants Policy Statement (Rev. October 2018) for FY 2019 (NOT-OD-19-021)
• Revised NIHGPS document available for download in HTML and PDF formats: https://grants.nih.gov/policy/nihgps/index.htm
• A summary of the significant changes that are implemented with the October 2018 NIHGPS: https://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2018.pdf

NAVREF Response to the

GAO Westat Report Assessment

BACKGROUND:NPCs have voiced concerns for a number of years about the process of determining where federal awards will be submitted and administered. At some sites it was alleged there was no approved deliberative process, decision-makers were sometimes conflicted, and the academic affiliate (AA) wielded disproportionate influence.

In response to our members’ concern, NAVREF raised this issue with the VA Office of Research & Development and discussed it as part of testimony before the House Veterans’ Affairs Committee, Subcommittee on Oversight & Investigations in June 2016 and 2017. At the 2017 hearing, Dr. Ramoni announced she would engage an outside firm to thoroughly review the management of extramural funding across the VA research enterprise. In October 2017, ORD contracted with Westat to perform this review and many of you participated in their interviews and surveys over the last 12 months.

FINDINGS: Westat’s final report released by ORD on 9-28-18, contained a number of findings, including:

NAVREF’s PERSPECTIVE:

• Every VAMC is slightly different and each needs to work out a way to optimize its relationship with their NPC and their AA in a way that enhances the mission of serving Veterans.

• The arrangement for administration of extramural awards should be:
• • logical,
  • local (reflecting the local circumstances),
  • legitimate (taking away the decision of grant administration from conflicted individuals),
  • low cost (aim for the lowest taxpayer cost where possible), and
  • shared (supporting an NPC that is financially healthy and a working relationship with the affiliate that is collaborative and productive).

We appreciate the fact that what works at one site may not be suitable at another, and that each VA, AA, and NPC need to jointly establish a process that works for them. The key is that all three parties work together with the common goal of serving Veterans. Many sites already enjoy this collaborative relationship.

Two NPCs have successfully requested and received approval to increase their micro-purchase threshold from $10,000 to $25,000. The process is straight-forward and can be handled through email request and response.  As detailed in OMB Memo M-18-18, dated June 20, 2018,

“to receive a higher threshold, the institution must either have "clean single audit findings" (i.e., in accordance with 2 C.F.R. § 200.520 - Criteria for a low-risk auditee), have an acceptable internal institutional risk assessment, or the higher threshold must be consistent with State law for public institutions.”

Requests for approval should be submitted to the institution's cognizant Federal agency for indirect cost rates—please reach out to NAVREF for specific contact information and please check out the documents below to help you successfully increase your micro-purchase threshold. 

SAMPLE DOCUMENTS PROVIDED BY THE SEATTLE INSTITUTE FOR BIOMEDICAL AND CLINICAL RESEARCH:

SIBCR Procurement Policy

SIBCR Vendor Justification Form

SIBCR Purchase Order Form

FY19 Purchase Order Instructions

DHHS Micro-Threshold Approval Email Message

The FY19 Defense Appropriations Act provides $10 million (M) to the Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP) to support innovative and high-impact research into preclinical development of therapeutics for Amyotrophic Lateral Sclerosis.  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 ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY19 ALSRP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in November 2018.  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 mission of the ALSRP is to fund innovative preclinical research to develop new treatments for ALS for the benefit of Service members, Veterans, and the general public.

http://cdmrp.army.mil/pubs/press/2019/19alsrppreann

The following mechanisms are planned for release:

Therapeutic Development Award

• Independent investigators at all academic levels
• Pre-application is required; full application submission is by invitation only
• Supports post-discovery, preclinical advancement of therapeutics for ALS
• Preliminary data, including identity and purity of an identified bioactive compound(s), are required
• Clinical trials are not allowed
• Types of efforts that will be supported include:
• • Confirmation of candidate therapeutics obtained from screening or by other means
  • Validation of early pilot studies in multiple model systems and/or replicating preliminary data with more time points or additional doses
  • Optimization of potency and pharmacology, studies of formulation, stability, and production methods based on Good Manufacturing Practices
  • Investigational New Drug-enabling studies
  • Optional Therapeutic Relevance Option: Applications proposing development of markers to improve the drug development process in parallel with the main therapeutic advancement effort and that meet the criteria outlined in the Program Announcement/Funding Opportunity will qualify for a higher level of funding

• Maximum funding of $1,000,000 for direct costs (plus indirect costs)
• If applying for the Therapeutic Relevance Option, the maximum funding is $1,250,000 for direct costs (plus indirect costs)
• Maximum period of performance is 2 years

Therapeutic Idea Award

• Independent investigators at all academic levels
• Pre-application is required; full application submission is by invitation only
• Supports new ideas aimed at drug or treatment discovery that are still in the early stages of development
• Preliminary data are not required
• Types of efforts that will be supported include:
• • Exploitation of pathways known to be relevant to ALS for the purpose of improving treatment and/or advancing a novel treatment modality
  • Development, modification, and use of high-throughput screens and novel model systems to define or assess lead compounds
• Projects that focus primarily on investigating the pathophysiology of ALS are outside the scope of this award mechanism
• Maximum funding of $500,000 for direct costs (plus indirect 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 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 ALSRP 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

Book mark the CDMRP website:

cdmrp.army.mil

Follow CDMRP on Twitter at:

twitter.com/CDMRP

View CDMRP research results on YouTube:

www.youtube.com/user/CDMRP

Like us on FaceBook:

www.facebook.com/TheCDMRP

FY19 Topic Areas for the Peer Reviewed Cancer Research Program

*            Bladder cancer

*            Blood Cancers

*            Brain Cancer

*            Cancer in children, adolescents, and young adults1

*            Colorectal cancer

*            Immunotherapy2

*            Listeria vaccine for cancer

*            Liver cancer

*            Lymphoma

*            Mesothelioma

*            Neuroblastoma

*            Pancreatic cancer

*            Pediatric brain tumors

*            Rare cancers3

*            Stomach cancer

Funding for research into breast, kidney, lung, melanoma, ovarian, and prostate cancers is not allowed under the FY19 Peer Reviewed Cancer Research Program.

1The definition of adolescents and young adults is derived from the National Cancer Institute (https://www.cancer.gov/types/aya) and can be considered to be people between the ages of 15-39 years. Cancers studied under this Topic Area should be within the scope of the Congressional language and the intent of the Program Announcement(s). Research should be targeted toward children (ages 0-14 years), adolescents (ages 15-24 years) and/or young adults (ages 25-39 years).

2As derived from the National Cancer Institute Dictionary of Cancer terms (http://www.cancer.gov/publications/dictionaries/cancer-terms). Immunotherapy is a type of biological therapy that uses substances to stimulate or suppress the immune system to help the body fight cancer. Cancers studied under this Topic Area should be within the scope of the Congressional language and the intent of the Program Announcement(s).

3Rare cancer is defined by the National Cancer Institute as a cancer that occurs in fewer than 15 out of 100,000 people each year (http://www.cancer.gov/publications/dictionaries/cancer-terms/def/791790). Cancers studied under this Topic Area should be within the scope of the Congressional language and the intent of the Program Announcement(s).

Jennie Mettert-Young

Public Affairs

For the USAMRMC, CDMRP

Ripple Effect

Fort Detrick, MD 21702-5024

Usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil

Book mark the CDMRP website:

cdmrp.army.mil

Follow CDMRP on Twitter at:

twitter.com/CDMRP

View CDMRP research results on YouTube:

www.youtube.com/user/CDMRP

Like us on FaceBook:

www.facebook.com/TheCDMRP

The Fiscal Year 2019 Department of Defense Appropriations Act provides research funding for the following peer reviewed programs managed by the Department of Defense office of Congressionally Directed Medical Research Programs (CDMRP):

http://cdmrp.army.mil/pubs/press/2019/funding_press_release19

• Alcohol and Substance Abuse Research Program - $4.0 million
• Amyotrophic Lateral Sclerosis Research Program - $10.0 million
• Autism Research Program - $7.5 million
• Bone Marrow Failure Research Program - $3.0 million
• Breast Cancer Research Program - $130.0 million
• Duchenne Muscular Dystrophy Research Program - $3.2 million
• Epilepsy Research Program - $7.5 million
• Gulf War Illness Research Program - $22.0 million
• Hearing Restoration Research Program - $10.0 million
• Kidney Cancer Research Program - $20.0 million
• Joint Warfighter Medical Research Program - $50.0 million
• Lung Cancer Research Program - $14.0 million
• Lupus Research Program - $5.0 million
• *Melanoma Research Program - $10.0 million (*new for FY19)
• Military Burn Research Program - $8.0 million
• Multiple Sclerosis Research Program - $6.0 million
• Neurofibromatosis Research Program - $15.0 million
• Orthotics and Prosthetics Outcomes Research Program- $10.0 million
• Ovarian Cancer Research Program - $20.0 million
• Parkinson's Research Program - $16.0 million
• Peer Reviewed Alzheimer's Research Program - $15.0 million
• Peer Reviewed Cancer Research Program (15 Topics) - $90.0 million
• Peer Reviewed Medical Research Program (49 Topics) - $350.0 million
• Peer Reviewed Orthopaedic Research Program - $30.0 million
• Prostate Cancer Research Program - $100.0 million
• Reconstructive Transplant Research Program - $12.0 million
• Spinal Cord Injury Research Program - $30.0 million
• Tick-Borne Disease Research Program - $5.0 million
• Tuberous Sclerosis Complex Research Program - $6.0 million
• Vision Research Program - $20.0 million

Comprehensive Program Announcements will be released during 2019. The Program Announcements will include detailed descriptions of funding mechanisms, evaluation criteria, submission requirements, and deadlines. Each Program Announcement may be downloaded from the Grants.gov website http://www.grants.gov, or the CDMRP website http://cdmrp.army.mil upon its release.

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 CDMRP, our research programs, previous awardees, as well as research highlights and videos, please visit the website at http://cdmrp.army.mil.

Point of Contact:

CDMRP Public Affairs
301-619-7783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil

Book mark the CDMRP website:

cdmrp.army.mil

 

Follow CDMRP on Twitter at:

twitter.com/CDMRP

 

View CDMRP research results on YouTube:

www.youtube.com/user/CDMRP

 

Like us on FaceBook:

www.facebook.com/TheCDMRP

The U.S. Army Medical Research Acquisition Activity (USAMRAA) has shared with NAVREF its position regarding funding VA paid research personnel on Department of Defense (DoD) projects involving Veterans Affairs Medical Centers (VAMCs) and/or Veterans Affairs Non-Profit Corporations (NPCs).  This information is intended to assist NPCs in preparing funding proposals and to understand how USAMRAA staff will review such requests. 

DoD concurs that VA paid research personnel may be proposed and budgeted on applications submitted by NPCs.  NPCs have statutory authority to reimburse the VA for VA employee salaries and other costs incurred on DoD projects.  A Personnel Agreement (described on page 2) between the VA and the NPC is used to document the arrangement to reimburse for the VA employee’s time and effort devoted to DoD funded projects.

The DoD also allows for combined work hours in excess of 40, but usually not exceeding 60 hours weekly for investigators with VAMC/University Affiliate, and NPC (if applicable), appointments.  A Memorandum of Understanding (MOU) (described on page 2) defining work/effort distribution between these entities will be needed should the project be funded.

NPCs may reimburse a University Affiliate through a Personnel Agreement (e.g., if the PI is using university time on the NPC award, then the NPC may reimburse the university for the PI time under a Personnel Agreement).  Additionally, a University Affiliate may reimburse the NPC through a Personnel Agreement (e.g., if the PI is using VA time on a University Affiliate award, then the university may reimburse the NPC for the PI time under a Personnel Agreement; the NPC would then reimburse the VA for the VA employee’s time). 

NPCs should work with their University Affiliate to establish a policy and/or process for use of Personnel Agreements as described above. 

NPCs should seek approval from the appropriate VA attorney if considering paying VA employees above 40 hours per week.  This step is necessary to document that the work being performed under the DoD award is significantly distinct from the work being performed under their VA paid appointments.

REFERENCES

USC Title 38, Part V, Chapter 73, Subchapter IV

USC Title 38, Part VI, Chapter 83, Section 8301

VHA ORD-AO Guide, ver.2018 Feb 2, replaces 2018-1-11

VHA Handbook 1200.17, April 27, 2016, revised May 9, 2017
DEFINITIONS

Memorandum of Understanding (for work/effort distribution): is used to document an investigator’s duties as part of his/her total professional responsibilities.   The MOU includes the title of the investigator’s appointment, responsibilities (e.g., teaching, research, administration, and clinical), and the percent effort available for research.   These responsibilities comprise 100% of total professional responsibilities and there is no dual compensation for the same work nor is there an actual or apparent conflict of interest regarding such work.   These MOUs are typically between the VAMC and the University Affiliate and are signed by the appropriate officials at each institution.   The NPC may be a party to the MOU under certain circumstances. 

Personnel Agreements: are written agreements for assignment of personnel and reimbursement of salary and fringe benefits from one institution to another.  These agreements may be referred to as a Joint Personnel Agreements (JPA), Memorandum of Understanding (MOU) and/or an Intergovernmental Personnel Act (IPA) Mobility Program agreement.   Parties to the agreements may include the NPC and the University Affiliate or the NPC and the VAMC.

DOWNLOAD THE PDF HERE

FOR IMMEDIATE RELEASE

September 12, 2018

NAVREF Announces Annual Awardees

Non Profit Association Honors Excellence

(Washington, D.C.) - The National Association of Veterans’ Research and Education Foundations (NAVREF) held its fourth annual awards event on September 10^th, honoring NAVREF members and staff nominated by their peers for demonstrating excellence in support of research and education for Veterans. The awards dinner was hosted by NAVREF CEO Rick Starrs at The Ritz Carlton Hotel Pentagon City in Arlington, Virginia in conjunction with NAVREF’s 26^th Annual Conference.

The 2018 winners included Ms. Mary Thornton of the Palo Alto Veterans Institute of Research (PAVIR), who was awarded NAVREF’s prestigious Barbara West Award. Other awardees included Ms. Rebecca Rosales, Executive Director of the Northern California Institute of Research and Education (NCIRE) in San Francisco, and Mr. Kevin Hull, Executive Director of the West Side Institute for Science and Education (WISE) in Chicago.

Ms. Thornton was recognized for her outstanding service and dedication both to her nonprofit corporation (NPC) and to NAVREF.  For 20 years, Ms. Thornton has provided valuable service to principal investigators and research staff through a variety of roles and responsibilities. Ms. Thornton participated in the establishment of the Palo Alto Institute for Research & Education, PAVIR's predecessor organization, and established most of the policies and procedures that have enabled PAVIR to become the second largest VA-affiliated NPC. Ms. Thornton is well-known and respected by her peers across the NPC community for developing systems and sharing her expertise.

Ms. Rebecca Rosales took home the NAVREF Board of Directors Award for the various contributions she has made to her local nonprofit corporation and the NAVREF community. Although she joined NCIRE less than two years ago, Ms. Rosales has overcome several local challenges while contributing her expertise and insight to the broader NAVREF community as a member of the conference program committee and the clinical trials committee.

Mr. Kevin Hull was awarded the Best Practice and Innovation Award for his novel approaches to engaging and partnering with the local community to improve the lives of veterans at the Jesse Brown VA Medical Center.  Mr. Hull’s creative thinking is bringing a new approach to how NPCs can build successful, meaningful, and sustaining partnerships within their communities. His passionate outreach has generated projects to beautify and improve his medical center and raised additional funding sources to support VA research and education activities.

Due to Hurricane Florence, USAMRAA and CDMRP are extending the pre-application and/or application submission deadlines for all applicants to the funding opportunities listed below. For the updated submission deadlines, please consult the Funding Opportunities & Forms tab in eBRAP and/or the modified Funding Opportunities that will be available on Grants.gov, eBRAP, and the CDMRP website.

Breast Cancer Research Program

- Breakthrough Award Levels 3 and 4

Defense Medical Research and Development Program

- Advancing Innovation in Military Medicine (AIMM) Award

Defense Medical Research and Development Program

- FY18 Trauma Resiliency Immersive Adaptive Gaming Environment Award

Epilepsy Research Program

- Idea Development Award

- Longitudinal Risk Factors Award

Parkinson's Research Program

- Early Investigator Research Award

- Investigator-Initiated Research Award

Peer Reviewed Alzheimer's Research Program

- Convergence Science Research Award

- Quality of Life Research Award

- New Investigator Research Award

- Research Partnership Award

Prostate Cancer Research Program

- Health Disparity Research Award

- Health Disparity Fellowship Award

Please do not respond directly to this message.  Please contact the CDMRP Helpdesk at (301) 682-5507 or help@ebrap.org with any questions.

Jennie Mettert-Young

Public Affairs

For the USAMRMC, CDMRP

Ripple Effect

Fort Detrick, MD 21702-5024

Usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil

Book mark the CDMRP website:

http://cdmrp.army.mil

Follow CDMRP on Twitter at:

https://twitter.com/CDMRP

View CDMRP research results on YouTube:

http://www.youtube.com/user/CDMRP

The FY18 Defense Appropriation provides $125 million (M) to the Department of Defense Psychological Health/Traumatic Brain Injury Research Program (PH/TBIRP) to support critical PH- and TBI-related research and development efforts to benefit Service members, Veterans, and other beneficiaries of the military health system.  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 (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 CDMRP provides PH/TBIRP execution management support for DHP core research program areas, including the Joint Program Committee 6/ Combat Casualty Care Research Program (JPC-6/CCCRP).  JPC-6/CCCRP provides strategic oversight for the PH/TBI funds associated with this funding Program Announcement.  The Defense Health Agency is working in collaboration with the U.S. Department of Veterans Affairs (VA) and other Federal agencies on research efforts to improve the lives of Service members and Veterans affected by traumatic brain injury, posttraumatic stress disorder, and other mental health conditions.

The FY18 PH/TBIRP Program Announcement and General Application Instructions for the following award mechanism is posted on the Grants.gov website.

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

 

FY18 PHTBIRP Joint DoD and VA Long-term Impact of Military-relevant Brain Injury Consortium (LIMBIC) – Preproposal due October 8

• Independent investigators at all academic levels (or equivalent)
• Supports a consortium conducting a single large longitudinal study and supporting sub-studies to analyze a large TBI cohort to include Service member and Veterans.
• Applicants must be able to demonstrate the ability to enroll relevant cohorts, including military and Veteran populations, and follow them over time.
• Applicants must address the Required Research Elements outlined in the Program Announcement.
• Applications should describe a single large longitudinal cohort study and a minimum of four related sub-studies.
• All projects shall be limited to clinical and epidemiological research.
• Clinical trials are not supported.
• Coordinating Center and study sites must apply through a single application.
• Preproposal is required; application submission is by invitation only.
• Maximum allowable costs (direct and indirect) are $25M via the DoD.
• Up to an additional $5M per year for 5 years will be provided by the VA to VA sites, depending on availability of funds.
• Maximum period of performance is 5 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 and other USAMRMC 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 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 PH/TBIRP 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