Written by: Peter Martin, NAVREF Program Support Specialist

From the General Counsel’s Office - Derwood J. Haskell, General Counsel

Hello to member nonprofit Title 38 corporations (NPCs) leadership and staff. In this column, I want to update you on some of the work I have been doing and alert you to trends I am seeing that might serve as guidance in your practice.

A common referral I receive from NPCs is a request for advice on subawards to the NPC involving commitments of VA data and/or VA intellectual property (IP). Under VHA Directive 1206, Use of a Cooperative Research and Development Agreement, NPCs are “highly encouraged” but not mandated to use a VA CRADA template for subawards originating from a federal agency. Most NPCs do not add VA as a party to federal subawards on the standard Federal Demonstration Partnership form, nor do the NPCs typically consult VA OGC Specialty Team Advising Research (STAR), unless there is novel language that raises a concern. One example is language that commits data or IP arising from performance of the statement of work to the pass through entity (PTE) for its use. Since it is VA and not the NPC that is conducting the research, the data and intellectual property derived from the research is VA property, not NPC property. If you have a federal subaward that has language such as, “the PTE may use data and intellectual property for its own internal research and non-commercial purposes,” or any similar clause, please consult me or your STAR attorney. The NPCs are not agencies or instrumentalities of the United States and do not have legal authority to make commitments of VA data or VA IP. 38 U.S.C. §7361(d)(2). I will try and negotiate that language out of the subaward. If the PTE will not agree to remove the language, STAR will have to be consulted and VA added as a party and signatory to the subaward.

Some of the interesting referrals I am working on at the moment include: Master Service Agreements between NPCs and vendors, one for research subject compensation and the other for blood sample analysis; two SWOG clinical trial agreement templates; a potential substantial donation of company stock to an NPC; a problem with NPC matching retirement fund contributions; research subject injury during an MRI procedure and a claim against the NPC; nonpayment of funds due by a CRADA collaborator; and help facilitating a significant multisite clinical trial. On the advocacy front, we are still waiting for distribution of the revised VHA Directive 1200.17 to the NPCs for comment. We are asking that the mandatory requirement for financial officers be deleted and for NPC authority to manage quality improvement and innovation CRADAs. Also, there still has been no legislative action to cure the dually appointed personnel compensation problem created by the U.S. Department of Justice’s opinion on 18 U.S.C. §209. VHA is aware of the §209 problem and consulting congressional staff to seek a solution.

Please do not hesitate to reach-out to me for assistance. It is my privilege to work with you.

dhaskell@navref.org

The VIPER Act has garnered some progress last week as it moved through the house by roll call vote at the request by Virginia Congressman, Rep. Bob Good. The bill passed the house with a final vote of 381-39. It now heads to the Senate where NAVREF will be working closely with the Senate VA Committee leadership to bringing the bill to the final steps of becoming law.

The VIPER Act was first introduced in October 2021 and aims to improve the VA Medical and Prosthetic Research program by providing additional authority and resources for VA research.

The legislation would add stability and efficiency for the VA research program by formally authorizing VA’s Office of Research and Development and excluding VA research from the Paperwork Reduction Act requirements, better aligning VA with other federal research agencies. The VIPER Act will also work to enhance the diversity of the VA research workforce, increasing scientific opportunities and leading to improved health care for veterans.

The bill also includes provisions to:

• End the Section 209 interpretation by the DOJ.
• Expand the VA’s hiring authority for certain classes of research occupations, including data scientists and statisticians.
• Create a career development award grant program for researchers at smaller universities.
• Mandate a Government Accountability Office study on the retention of VA clinician-scientists and the productivity of their research.

Written by Maryam Azarion, STAR 

OGC STAR has been billing VA NPCs for the same rate for the past ten years. Effective January 1, 2023, OGC will have a new rate and billing schedule. The new rates were captured based on reviewing the cumulative legal work and the need to simplify existing rates. These rates were negotiated and finalized in coordination with the NAVREF Board and STAR. They are valid for 2 years.  To discuss this forthcoming change, and to address any questions about billing, NAVREF will be hosting two Town Hall calls.  These calls are scheduled for November 7^th at noon and November 16^th at 1pm Eastern. Please contact NAVREF if you need the webinar link.

Attachment Download - Attorney Fee SOP (October 2022)

Written by Peter Martin, NAVREF Program Support Specialist

Have you explored the possibilities of Public Service Loan Forgiveness? Although much of the attention has been geared towards general student loan relief plan, we would be remiss if we did not bring attention to the end of the PSLF extension and PSLF accessibility in general. 

For those that do not know, currently, public servants with any type of federal loan, can retroactively apply their payments to the 120 total payments (10 years’ worth of payments) required for forgiveness. This includes payments from federal loans that are not direct loans, late payments to federal loans, payments that did not meet the minimum amount, and payments towards federal loan from employment prior to public service(Federal Student Aid). Outside of the current expanded benefits, the Student Borrower Protection Center estimates that out of the 9 million borrowers that are eligible to benefit from PSLF, only 15% have filed the paperwork to follow their progress (Student Borrower Protection Agency).  

PSLF has the potential to be useful for hiring and retention, two subjects that are often challenge areas for many NPCs. By encouraging and helping employees apply, employers will also be creating a culture that prioritizes the interests of employees. Thus, NPCs can add an entirely new avenue of service to their missions, especially as a sector that employs veterans, former hospital workers, and others public servants. 

Implementation of PSLF assistance at your NPC: 

• Easy access to certification of years of employment 

• To apply for PSLF, applicants will need to certify their time in public service. Employers will be required to fill a form on behalf of their employees that are applying. 

• As and ED, make sure that your office or your Human Resources director has the resources on hand to assist employees 

• Both sites below are good starting points for those tackling their student loans 

• Student Loans, Forgiveness | U.S. Department of Education 

• Home | Federal Student Aid 

• Make PSLF a staple of your onboarding process: When starting a new job, loan forgiveness may not always be a something new employees think about when starting in a new position. 

• Remember that your do not have to be an expert, but you should be familiar with the process. Use he guide below to familiarize yourself with potential form of assistance and share it with your employees. 

• Consumer Financial Protection Bureau’s guide for employers 

Beyond this expanded period of loan forgiveness, PSLF will still be available, and the unfortunate reality is that much of the vital information is not reaching those in debt. Many loan servicers fail to provide information on programs such as PSLF.  

If you have not yet taken advantage of the PSLF expansion, we encourage you to find out more through the links below: 

PSLF Explained- Youtube Video 
White House- Public Student Loan Forgiveness 
PSLF Help tool- studentaid.gov 

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