National Advisory Council (NANDSC) Meeting - May 2021

May 26, 2021 | 1:00 - May 27, 2021 | 5:00

Contact: Kelly Baker
Contact Number: 301-496-9248
Contact Email: kelly.baker@nih.gov
Location:

NSC, Conference Room C/D/E


The 212th meeting of the National Advisory Neurological Disorders and Stroke Council will be held on Wednesday, May 26 - Thursday, May 27, 2021. For more information, visit the Advisory Council web page.
 

Related Resources

Agenda

May 26, 2021

Open Session

Time Agenda Item
1:00 PM I.   Call to Order and Opening Remarks
       Dr. Walter Koroshetz, Chairperson
       Director, NINDS
1:05 PM

II.   Report of the Director, Division of Extramural Activities, NINDS
        Dr. Robert Finkelstein
       Associate Director, Division of Extramural Activities Executive Secretary, NANDS Council

A.  Consideration of Minutes of February 3-4, 2021, Meeting

B.  Confirmation of Dates for Future Council Meetings

Wed & Thurs, September 8-9, 2021 (virtual)
Wed & Thurs, February 2-3, 2022
Wed & Thurs, May 18-19, 2022
Wed & Thurs, September 7-8, 2022
***NEW 2023 DATES***
Wed & Thurs, February 1-2, 2023
Wed & Thurs, May 31, 2023 – June 1, 2023
Wed & Thurs, September 6-7, 2023

C.  Other Items
             Expedited Review Process
             Extramural Announcements

1:15 PM III.   Report of the Director, NINDS
          Dr. Walter Koroshetz
1:35 PM IV.   Discussion of Director’s Report
2:00 PM **BREAK**
2:15 PM V.  Extramural Policy Updates
         Dr. Robert Finkelstein
         Director, Division of Extramural Activities


         Dr. David Owens
         Deputy Director, Division of Extramural Activities
2:45 PM VI. Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) Update
         Dr. Rod Corriveau
         Program Director, Division of Neuroscience


         Dr. Keith Whitaker
         Program Manager, Division of Neuroscience
3:15 PM VII.  Neuroethics and NINDS
           Dr. Nita Farahany
            Robinson O. Everett Professor of Law and Philosophy
            Duke University Law School

            Dr. Khara Ramos
            Director, NINDS Neuroethics Program
4:00 PM VIII.  Initiatives Requiring Concept Clearance
4:45 PM    IX.  Initiatives Requiring Concept Clearance
5:30 PM Adjournment (*This time is tentative.)

May 27, 2021

Closed Session

Time Agenda
1:00 PM

This portion of the meeting is being closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

X.  Review of Conflict of Interest, Confidentiality, and Council Procedures
       Council Consideration of Pending Applications

       Dr. Robert Finkelstein
       Executive Secretary, NANDS Council
5:00 PM **ADJOURNMENT**
** This time is tentative

Meeting Minutes

Summary of Meeting1
 

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 212th meeting on May 26-27, 2021 via Zoom remote meeting. Dr. Walter Koroshetz, Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson.

In accordance with Public Law 92-463, the meeting was:

Open:       May 26, 2021: 1:00 p.m. to 5:20 p.m. for the review and discussion of program development, needs, and policy; and
Closed:    May 27, 2021: 1:00 p.m. to 5:55 p.m. for the consideration of individual grant applications.

Council members present:
Dr. Allan Basbaum
Dr. S. Thomas Carmichael
Dr. Hollis Cline
Ms. Susan Dickinson
Dr. Nita Farahany
Dr. Aaron Gitler
Dr. David Hackney
Dr. Karen Johnston
Dr. Arnold Kriegstein
Dr. Claudia Lucchinetti
Dr. Kenneth Maynard
Ms. Eileen Murray
Dr. Gina Poe
Dr. Timothy Ryan
Dr. Sameer Sheth
Dr. N. Edwin Trevathan
Ms. Christin Veasley

Ad Hoc present:
Dr. Ekemini Riley

Ex officio member present:
David Brody, M.D., Ph.D., Department of Defense
Christopher Bever, Jr., M.D., Department of Veterans Affairs

The entire meeting was held virtually over Zoom and all observers including members of the public attended virtually.

Members of the public present for portions of the open meeting included:
Kathy Sedgwick, NOVA Research Company

Federal attendees are listed at the end of these minutes.

I.  Call to Order and Opening Remarks

Dr. Koroshetz welcomed Council members, visitors, and staff to the 212th meeting of the National Advisory Neurological Disorders and Stroke Council.

II.  Report of the Director, Division of Extramural Activities, NINDS

Dr. Robert Finkelstein

Approval of Council Minutes — Dr. Finkelstein requested, and the Council voted approval of the February 3-4, 2021, Council meeting minutes.

The following future Council meeting dates were confirmed:

Thurs & Fri, September 9-10, 2021 (virtual) *updated date
Wed & Thurs, February 2-3, 2022
Wed & Thurs, May 18-19, 2022
Wed & Thurs, September 7-8, 2022

***NEW 2023 DATES***
Wed & Thurs, February 1-2, 2023
Wed & Thurs, May 31, 2023-June 1, 2023
Wed & Thurs, September 6-7, 2023

Council Operating Procedures – Dr. Finkelstein requested, and the Council voted approval of the Council Operating Procedures.

Expedited Review Process – Each Council round, a subset of Council members approves applications in advance of the meeting with scores within the payline. This expedited review process focuses on applications for which there are no unresolved issues. Dr. Finkelstein thanked Council members Nita Farahany, Ed Trevathan, and Arnold Kriegstein for handling this responsibility for this meeting and the fiscal year. For the current Council round, 155 applications were eligible to be expedited. A portion of these awards already have been issued, and the others will be issued after Council.

Extramural Announcements

All extramural introductions were posted to the NINDS Electronic Council Book (ECB).

III.  Report of the Director, NINDS

Dr. Walter Koroshetz, Director, NINDS

Dr. Koroshetz acknowledged Dr. Richard J. Youle, Senior Investigator in the NINDS Division of Intramural Research (DIR), who received the 2021 Breakthrough Prize in Life Sciences for his work in Parkinson ’s disease.

Budget—The NINDS Fiscal Year (FY) 2021 budget increased only 1.75 percent, which led the Institute to decrease the payline to the 14th percentile. The budget includes considerable funds allocated for the Helping to End Addiction Long-term (HEAL) Initiative (approximately $270 million) and the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative® (approximately $179 million). The 2022 President’s budget will be released at the end of the week.

Funding— Dr. Koroshetz noted that the cost of the average NIH R01 award has increased to $559,680. Direct costs for modular R01 grants remain at the $250,000 level set in 1999. Notably, NINDS no longer applies administrative cuts to the modular R01s. Modular grants were designed to focus attention on science rather than budget details.  However,  the number of modular awards has decreased precipitously over time because the budget cap has not changed in over twenty years. Dr. Koroshetz asked Council to consider the actual costs to run a modular R01 project, how increasing the modular R01 cap might affect the NINDS payline, and the potential benefits if NINDS were to incentivize modular applications over non-modular applications.

Impact of COVID-19 on the research community—Outcomes of two 2020 NIH extramural surveys on this topic found a significant negative effect across all career stages, with postdoctoral fellows and residents and early faculty (0-6 years) potentially being the most negatively impacted. Although the numbers of men and women reporting dependent care (young children, parents, or other family members) were about equal, women reported greater difficulty completing work responsibilities. Thus there is concern that the disruption will have a greater impact on women scientists.

NINDS trainee applications have increased 16 percent since the Pandemic. The percentage of R01 applications from female Principal Investigators (PIs) increased until the last submission period (January to April 2021). The initial increase in R01 applications from underrepresented minority PIs dropped during the September to December receipt dates and dropped even further in the January to April receipt dates. NINDS considers this a serious problem, with the pandemic having a greater effect on underrepresented minorities. Dr. Koroshetz described NIH support for trainees and early-career investigators and published NOTICES allowing them to request paid extensions under various circumstances including COVID-19. Trainees in their last year of NIH Fellowship (F) and Career Development (K) awards who have been impacted by COVID-19 can request paid extensions NOT-OD-21-052. Fellows who have children while supported by the NINDS F32 (childbirth or adoption) can request a 6 month paid extension of their fellowship PAR-21-032. Early stage investigators (ESIs) can request an extension of their ESI status through eRA commons and, and NIH Ruth L. Kirschstein National Research Service Award (NRSA) Fellows  can request childcare support costs in new and continuing applications or administrative supplements effective April 8, 2021 NOT-OD-21-074.

Post-acute sequelae of SARS-CoV-2 infection (PASC)—In December, Congress appropriated $1.15 billion to try to understand persistent symptoms some COVID-19 patients experience six months or longer after acute infection. Preliminary studies (e.g. Davis HE

; Al-Aly

) indicate 10-60% of COVID-19 infections result in PASC. In addition to cardiopulmonary and mental health symptoms, many of the prominent symptoms are neurologic in origin—fatigue, memory and concentration difficulties, sleep issues, postural orthostatic tachycardia, pain syndromes, etc. In February, the NIH PASC Initiative was launched with a goal of understanding the clinical spectrum and biology underlying PASC.

NINDS Strategic Plan—Dr. Koroshetz reported that the NINDS 2021-2025 Strategic Plan is now complete. Goals are to support and perform rigorous and important neuroscience research; fund and conduct neuroscience research training and career development programs to ensure a vibrant, talented, and diverse neuroscience workforce; promote dynamic communication and diverse stakeholder engagement; and create and sustain a supportive work culture for the NINDS workforce that serves as a model for biomedical research and the neuroscience community. Cross-cutting strategies include rigor and transparency; balancing of investigator-initiated and team science; data sharing and data science; neuroscience research models; technology access; diversity and inclusion; neuroethics; patient engagement; collaboration and partnership; and NINDS Intramural Research. Dr. Koroshetz noted that the plan identifies actionable items.

Increasing diversity, eliminating racial bias, and promoting health equityNINDS is working with the NIH UNITE Initiative to improve diversity in the workforce, eliminate racial bias, and promote health equity. UNITE extramural goals include a public commitment to identify and correct NIH policies or practices that may have helped perpetuate structural racism; enhance recruitment of underrepresented groups in science, science leadership, and science administration; improve the success rate in NIH grant funding that support researchers from diverse backgrounds; enhance portfolio diversity; and launch new Common Fund Initiatives on health disparities. Two Requests for Applications (RFA-RM-21-021 and RFA-RM-21-022) have been announced to support research that addresses health disparities.

The NINDS Office of Programs to Enhance Neuroscience Workforce Diversity (OPEN – WD) coordinates NINDS’s diversity activities designed to increase applications from underrepresented groups, identify and root out bias in peer review and all other aspects of funding decisions, and develop and track metrics openly.

Individuals from underrepresented groups account for only 6 percent of NIH R01 applicants and 5 percent of R01 awardees. NINDS issued a Notice of Special Interest (NOSI) to encourage a more diverse pool of PIs to contribute to the Institute’s research areas via R01 applications and advance scientific discovery by enhancing the diversity of perspectives brought to fulfill the NINDS mission. The NINDS Select Pay program selects grants that are considered high program priorities that score within 10 percent of the payline; this may include grants that bring diverse perspectives that improve the overall health of NINDS science.

The BRAIN​ Initiative® offers Diversity Supplements, K99/R00 Awards to promote diversity, and F99/K00 Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Awards. A new BRAIN RFA-MH-21-180 (U24) supports establishment of facilities at minority-serving institutions (MSIs) and Institutional Development Award (IDeA) institutions for developing reagent resources for brain cell type-specific access and manipulation. In addition, the Initiative is requiring applications to include a “Plan to Enhance Diverse Perspectives” (PEDP) as a scorable component in their grants, a decision that other Institutes are likely to follow.

The NINDS Office of Global Health and Health Disparities is engaged in a strategic planning process that will expand on previous work in the stroke area to emphasize development of evidenced-based, feasible, and widely scalable interventions to diminish disparities and inequities in neurological disorders. The Office has organized the NINDS Health Disparities and Inequities in Neurological Disorders (HEADWAY) Workshop to be held September 22–24, 2021. A new NIH public health Mind Your Risks messaging campaign will target high blood pressure in black men between the ages of 28 and 45. NIH-funded studies have shown that black men in middle age have the greatest disparities in rates of death due to stroke.

IV.  Discussion of Director’s Report and COVID-Related Activities

Council members discussed modular R01 grant funding—$250,000 is not enough—and put forth various recommendations (e.g., increase to $350,000 which allows for recognition of increase in personnel costs, establish a mechanism of protection, eliminate modular grants altogether, focus modular grants on team science). Council response to the proposed split payline stopgap concept was mixed.

V.  Extramural Policy Updates

Dr. John Ngai, Director, NIH BRAIN Initiative

Dr. Robert Finkelstein, Director, NINDS Division of Extramural Activities (DEA), and Dr. David Owens, Deputy Director, NINDS DEA

Drs. Owens and Finkelstein provided responses to questions posed during the previous Council meeting.

Percent Effort Required for NINDS R35 Research Program Awards
Dr. Owens responded to a question from last Council about the 50 percent effort required for NINDS R35 Research Program Award (RPA). The R35 RPA provides longer-term support (8 years), increased flexibility for investigators to follow the scientific direction most compelling to them, and reduced pressure to: i) generate results quickly for short-term grant renewals, ii) write applications and iii) administer multiple grants. PIs must fold all of their NINDS research into a single grant. As such, NINDS requires a minimum 50 percent effort. A NINDS staff working group recommended (1) keeping the 50 percent effort requirement and (2) explaining the R35 RPA parameters clearly and more broadly (e.g., via webinar). A minority opinion was that effort should scale to budget (e.g., 10 percent effort for every $150,000). Dr. Owens noted that other NIH Institutes/Centers (ICs) R35 programs also require a minimum 50 percent effort. Lowering the requirement could have unintended consequences (e.g., increasing applications and decreasing success rates).

Clarification to Other Support for PIs requiring Special Council Review
Dr. Finkelstein clarified calculation of “other support” for PIs requiring Special Council Review (SCR) and explained that awards that are in No Cost Extension or end within the 90-day SCR grace period are not included in the PI’s Funding level for SCR and thus will not be included in the Other Support information presented to Council. Dr. Finkelstein noted that NIH SCR policy requires that pending SCR applications must be significantly different from the PI’s previous work unless the grant is a continuation of a previous grant. Although NANDS Council set a NINDS SCR payline at half of NINDS’ regular percentiled payline for the Council round in question several years ago, a Council member may raise an issue and open discussion of any SCR application.

VI. Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD) Update

Dr. Rod Corriveau, Program Director, NINDS Division of Neuroscience (DN), and Dr. Keith Whitaker, Program Manager, NINDS DN

Dr. Corriveau provided an overview of the congressionally-mandated AD/ADRD program. ADRD refers to types of dementias that share cognitive and pathological features with AD and/or commonly co-occur with typical AD pathology. They include vascular contributions to cognitive impairment (VCID), Lewy Body Dementia (LBD), frontotemporal degeneration (FTD), and mixed- or multiple-etiology dementias (MED). [Note: LBD is defined as Parkinson’s Disease dementia and LBD.]

The National Institute on Aging (NIA) leads the NIH response to the National Plan to Address AD. NINDS leads the LBD, FTD, VCID, and ADRD portfolios and the ADRD triennial summits that shape ADRD scientific priorities, set milestones and inform the Bypass Budgets delivered by NIH to Congress. NINDS and NIA collaborate closely on Funding Opportunity Announcements (FOAs), a large supplement program to expand the field, paylines for grants, and planning summits.

Dr. Corriveau highlighted recommendations from the 2019 ADRD Summit(pdf, 2131 KB)(pdf, 2131 KB). He then summarized NINDS ADRD funded award statistics for FTD, LBD, VCID, MED, health disparities from NINDS led funding initiatives (46) to Investigator-Initiated awards from 2016 to the present. 557 awards have been made during this period.  In addition, NIH ADRD research funding increased 4.9-fold between 2015 and 2020 to an estimated $595 million.

Major ADRD research programs and consortia established since FY 2016 include ALLFTD

, LBD Center Without Walls, CONNECT-TBI

, and the intramural Center for AD Research (CARD). ADRD advances toward intervention have occurred in biomarkers, technology, and biology. The NINDS ADRD program has been responsive to nearly all of the ADRD Summit milestones and guided transformative research and contributed to new and advanced understanding toward interventions. Current approaches to AD/ADRD research are exploring multiple potential pathways to dementia that include lifestyle, environmental, psychosocial, health disparities, and genetic factors as well as other medical risks, aging, and sex.

Dr. Corriveau presented NINDS ADRD  14 Initiatives for concept clearance. Proposed concepts have been vetted by Dr. Koroshetz, further refined by program staff, and approved by both Dr. Koroshetz and NIA Director Dr. Hodes.
Approved AD/ADRD Initiatives for Concept Clearance:

  1. AD/ADRD Reissue: Biomarkers for the Lewy Body Dementias
    Dr. Rod Corriveau
  2. AD/ADRD Reissue: Detecting Cognitive Impairment, Including Dementia, in Primary Care and Other Everyday Clinical Settings for the General Public and in Health Disparities Populations
    Dr. Rod Corriveau
  3. AD/ADRD- Clinical and Biological Measures of TBI-related dementia including Chronic Traumatic Encephalopathy
    Dr. Rod Corriveau
  4. AD/ADRD- Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD) Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed)
    Dr. Rod Corriveau
  5. AD/ADRD- NINDS Institutional AD/ADRD Research Training Program (T32 Clinical Trial Not Allowed)
    Dr. Rod Corriveau
  6. AD/ADRD- Role of Astrocytes in Health and Degeneration of the Neurovascular Unit
    Dr. Rod Corriveau
  7. AD/ADRD- Postmortem Pathology, Cellular, and Molecular Analyses to Determine the Significance of White Matter Lesions and other Imaging Findings of Presumed Vascular Origin During Life
    Dr. Rod Corriveau
  8. AD/ADRD- Prodromal Synaptic and Circuit Changes that Contribute to AD/ADRD Onset and Progression
    Dr. Rod Corriveau
  9. AD/ADRD- Clinical Relevance of the Linkage between Environmental Toxicant Exposures and Alzheimer’s Disease and Alzheimer’s Disease-Related Dementias (AD/ADRD)
    Dr. Rod Corriveau
  10. AD/ADRD- Comparative Analysis of Single-Cell Omics Data Within Pathologically Characterized Tissue from People with Early Stage AD/ADRD-Related Cognitive Impairment
    Dr. Rod Corriveau
  11. AD/ADRD- New Multi-Disciplinary Collaborations to Understand Mechanisms of Systemic Immune Signaling and Inflammation in ADRD its Progression
    Dr. Rod Corriveau
  12. AD/ADRD- Leveraging Existing Data Resources for Computational Model and Tool Development to Discover Novel Candidate Mechanisms and Biomarkers for ADRD
    Dr. Rod Corriveau
  13. AD/ADRD- Selective targeting of mechanistic studies and technology development to understand how changes or dysfunction at the brain small vessel level can have long-term impact on AD/ADRD
    Dr. Rod Corriveau
  14. AD/ADRD- Administrative Supplements to accelerate discovery by including TBI exposure measures in existing AD/ADRD cohort studies
    Dr. Rod Corriveau

A motion was made, seconded, and carried to approve the proposed concepts.

VII. Neuroethics and NINDS

Dr. Nita Farahany, Robinson O. Everett Professor of Law and Philosophy, Duke University Law School, and Dr. Khara Ramos, Director, NINDS Neuroethics Program

Dr. Ramos presented an overview of neuroethics, the study of ethical issues raised by the evolving understanding of the brain and our ability to monitor and modulate brain function. The neuroethics strategy for the BRAIN Initiative® emphasizes proactive, ongoing assessment of the neuroethical implications of the development and application of BRAIN-funded tools and neurotechnologies. Neuroethics can empower neuroscience research; help inform how research is designed, conducted, interpreted, and applied; and support public engagement around neuroscience.

Neuroethics issues faced in the BRAIN Initiative® have included ethical considerations around post-trial access to investigational brain implants for clinical trials participants; the ethics of nontherapeutic invasive human neurophysiologic research, research opportunities in human neurosurgery patients, and an ALS patient using a BrainGate neural implant to type

words quickly. Neuroethics activities in the BRAIN Initiative® have been focused on neurotechnology research and development and application. Increasing collective awareness and understanding of ethical considerations have led to the following observations: as neurotechnology is translated for use in disease-specific spaces, the NIH institutional home for neuroethics moves away from the disease-agnostic BRAIN Initiative® to Institute mission spaces. Furthermore, ethical considerations are fundamentally intrinsic to the context of neuroscience research and translation of neuroscience advances into practice.

About 18 months ago, an NINDS-internal neuroethics consultation service was launched to support NINDS staff as they navigate neuroethics questions that arise relevant to their work and opens a window on neuroethics questions coming up in NINDS-supported research. Potential neuroethics challenges relevant to NINDS fall into two categories: ethical conduct of research and implications of research for individual groups and society. Ethical conduct of research implications includes research data management and sharing; informed consent; risk-benefit profiles; and science communication. Research implications include justice and potential affordability challenges.

Dr. Farahany outlined a case study in neuroethics and communication. BRAIN-funded researchers at Yale University had developed a way to deliver an artificial blood supply to the isolated postmortem brain of a pig. They provided a progress report to NIH, where a Program Director flagged potential neuroethical issues. A neuroethics working group was engaged for a closed consultation with the investigator. A follow-on workshop engaged academics and policymakers on related topics and generated a consensus comment published in Nature highlighting the benefits of the models and ethical issues to guide researchers (e.g., the need for better metrics to evaluate sentient capabilities, definition of death, the line between humans and animals). Dialogue with the researchers continued as the research progressed and guided some of the choices they made (e.g., neuronal activity blocker usage).  When the research was submitted for publication, Dr. Farahany worked with Nature to prepare an ethical commentary

for copublication with the research to make it more accessible to the public. The commentary raised issues on the need for better metrics to evaluate sentient capabilities, defining the line between humans and animals, and future possibilities for human research. NIH engaged neuroscientists on research and its implications (e.g., media training, plain language materials) and organized a media briefing with top science writers. As a result, news coverage was accurate and widespread, with minimal sensationalizing in the media.

The research also had implications for the U.S. Uniform Declaration of Death Act

(UDDA). The Uniform Law Commission, which provides states with non-partisan, well-conceived, well-drafted legislation that brings clarity and stability to critical areas of state statutory law, is revisiting the UDDA. This raises questions about: (1) what we know about the persistence of neurohormonal functioning that occurs after declaration of brain death, which does not align with the UDDA definition of death; (2) what is meant by irreversibility; (3) the concept of death across countries and cultures; and (4) the need to consent to a brain death evaluation and possible religious objections. 

Dr. Farahany pointed to emerging neuroscience discoveries used in the legal system

. These discoveries have implications for concepts of culpability, impact of traumatic brain injury on individual behavior, and objective measures of pain, and more.

Discussion
Council members commented on the ethical implications of future nonclinical applications of neuroscience research (e.g., cognitive optimization) that might be outside the NINDS domain; embedding neuroethics work within NINDS-funded projects or as a supplement; and differences between ethical considerations around brain tissue versus whole animal brain.

VIII. Initiatives Requiring Concept Clearance

  1. Research in Neuroethics Initiative
    Dr. Khara Ramos, NINDS Neuroethics Program
    The proposed initiative would provide new opportunities for conceptually rigorous and empirically grounded neuroethics research relevant to the full span of the NINDS portfolio with emphasis on integration of neuroethics into neuroscience research. Areas of interest focus on ethical questions associated with conduct of neuroscience research and biomedical application of its findings.
    Council approved moving forward with development of the proposed concept.
  2. HEAL Initiative: Interdisciplinary Teams to Elucidate the Mechanisms of Device-Based Pain Relief (RM1)
    Dr. Michael Oshinsky, Division of Neuroscience/Dr. Nick Langhals, Division of Translational Research
    The proposed initiative would develop interdisciplinary centers that use large animal models to study the mechanisms of action for Food and Drug Administration (FDA)-approved devices in order to optimize them and better identify patients who would benefit from their use.
  3. HEAL Initiative: Discovery & Functional Evaluation of Human Pain-Associated Genes and Cells
    Dr. Michael Oshinsky, Division of Neuroscience/Dr. Nick Langhals, Division of Translational Research
    The proposed initiative would support centers to conduct functional genomics, epigenomic signatures, and other omic studies of human tissue to discover and functionally evaluate this tissue for pain-associated genes and cell activity and physiology.
  4. HEAL Initiative: Advancing Health Equity in Pain Management
    Dr. Linda Porter/Dr. Cheryse Sankar, Office of Pain Policy and Planning
    The proposed concept was developed by a newly established disparities and diversity work group within the Trans-NIH Pain Consortium and aims to accelerate development, testing, and implementation of evidence-based interventions to mitigate disparities in provision of care and treatment decisions, reduce susceptibility to chronic pain, and improve patient outcomes in populations that experience health disparities.
    Council voted to approve the three proposed HEAL initiatives (items 2-4) above.
  5. Undiagnosed Diseases Network (UDN) Data Management and Coordinating Center (DMCC)
    Dr. Argenia Doss, Division of Neuroscience
    The proposed concept would leverage UDN sustainability efforts by supporting networking and coordination functions. Common Fund support ends in FY 2022. Two trans-NIH funding announcements are proposed: an RFA for the DMCC (U01) and a PAR for Diagnostic Centers of Excellence (X01).
  6. NIH Blueprint for Neuroscience Research Short Courses in Neurotherapeutics Development (R25)
    Chuck Cywin, Division of Translational Research
  7. Reissue: BRAIN Initiative: Targeted BRAIN Circuits Projects- TargetedBCP (R01)
    Dr. Jim Gnadt/Dr. Karen David, Division of Neuroscience
  8. Reissue: BRAIN Initiative: Targeted BRAIN Circuits Planning Projects - TargetedBCPP (R34)
    Dr. Jim Gnadt/Dr. Karen David, Division of Neuroscience
  9. Reissue: BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain
    Dr. Jim Gnadt/Dr. Karen David, Division of Neuroscience
  10. Reissue: BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs – eTeamBCP (U01 Basic Experimental Studies with Humans Optional)
    Dr. Jim Gnadt/Dr. Karen David, Division of Neuroscience
  11. Reissue: BRAIN Initiative: Team-Research BRAIN Circuit Programs – TeamBCP
    Dr. Jim Gnadt/Dr. Karen David, Division of Neuroscience
  12. Reissue: NINDS Exploratory Clinical Trials for Small Business (R41/R42)
  13. Reissue: NINDS Exploratory Clinical Trials for Small Business (R43/R44)
    Dr. Emily Caporello, Division of Translational Research
  14. Reissue: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44)
    Dr. Emily Caporello, Division of Translational Research
  15. Reissue: Career Transition Award for NINDS Intramural Clinician-Scientists (K22)
    Dr. Steve Korn, Office of Training & Workforce Development
  16. Reissue: NINDS Research Education Opportunities (R25)
    Dr. Steve Korn, Office of Training & Workforce Development

Council voted to approve the above proposed initiatives (items 5-16).

IX.  Review of Conflict of Interest, Confidentiality, and Council Procedures; Council Consideration of Pending Applications

This portion of the meeting was closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

Conflict of Interest – Regulations concerning conflict of interest were reviewed.  Council members were reminded that materials furnished for review purposes and discussion during the closed portions of the meeting are considered privileged information. All Council members present signed a statement certifying that they had not been involved in any conflict-of-interest situations during the review of grant applications. 

Confidentiality – During the closed session, any information that is discussed and the outcome of any recommendation are considered privileged information.  They may not be discussed outside of the closed session.  If an applicant requests support for his or her application from a Council member, the Council member must respond that he/she is not permitted to discuss the application.  Any inquiry should be referred to Dr. Robert Finkelstein, NINDS Advisory Council Executive Secretary, who then will refer the question to the appropriate staff member for response. 

Research Training and Career Development Programs – The Council reviewed a total of 350 research career development and institutional training grant applications with primary assignment to NINDS, and 198 of them (57 percent) were scored in the amount of $16.9 million first-year direct costs.  It is anticipated that, of the research career development and institutional training grant applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $6.8 million (76 grants).

Research Project and Center Awards – The Council reviewed a total of 1,524 research project and center applications with primary assignment to NINDS, and 865 of them (57 percent) were scored/percentiled in the amount of $328.4 million first-year direct costs.  It is anticipated that, of the research grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $87.8 million (265 grants).

Senator Jacob Javits Neuroscience Investigator Awards – The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period.  Candidates are nominated and selected at each Council meeting.  Council approved one Javits nomination at this meeting: Jaideep Kapur, M.B.B.S., Ph.D. (University of Virginia).

Small Business Innovation Research and Small Business Technology Transfer Award Programs – The Council reviewed a total of 157 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications with primary assignment to NINDS, and 92 of them (59 percent) were scored in the amount of $43.4 million first-year direct costs.  It is anticipated that, of the SBIR and STTR applications competing at this Council, NINDS will be able to pay first-year direct costs of approximately $4.7 million (11 grants).

X.  Adjournment

The meeting was adjourned at 5:00 p.m. on Thursday, February 4, 2021.

NINDS employees present for portions of the meeting included:

Amy Adams
DeAnna Adkins
Ram Arudchandran
Kari Ashmont
Taryn Aubrecht
Debra Babcock
Julia Bachman
Allison Bailey
Kelly Baker
Linda Bambrick
Karen Barnes
Jennifer Beierlein
Sarah Bell
Patrick Bellgowan
Richard Benson
Bill Benzing
Rebecca Berman
Victoria Bitzer-Wales
Naomi Booker
Melissa Bojos
Francesca Bosetti
Chris Boshoff
Ann-Marie Broome
Jeremy Brown
Ryan Calabrese
Roger Campbell
Emily Caporello
Stacey Chambers
Chi Chang
Maria Charlier
Denise Chatman
Thomas Cheever
Daofen Chen
Bo-Shiun Chen
Liyun Chen
Severn Churn
Mary Coats
Robin Conwit
Janice Cordell
Roderick Corriveau
Devon Crawford
Diana Cummings
Charles Cywin
William Daley
Karen David
Tracey David
Sara Dauber
Sara Dodson
Denise Dorsey
Argenia Doss
Nadia Douaji
Neel Dhruv
Kristin Dupre
Debbie Eng
Judy Fabrikant
Christina Fang
Carlos Faraco
Cassie Fields
Robert Finkelstein
Monica Flemming
Nhi Floyd
Rob Folson
Jane Fountain
Megan Frankowski
Natalie Frazin
Heidi Matos Galicia
Alissa Gallagher
Maryam Ghaleh
Paul Girolami
Jim Gnadt
Kalynda Gonzales Stokes
Maureen Gormley
Brooks Gross
Amelie Gubitz
Mohamed Hachicha
Maureen Hambrecht
Adam Hartman
Brandon Hartsell
Brain Haugen
Janet He
Alicia Heslip
Jane Hettinger
David Higgins
Rebecca Hommer
Mir Ahamad Hossain
Nina Hsu
Eric Hudak
Xan Humphries
Smriti Iyengar
Lyn Jakeman
Scott Janis
Dave Jett
Li Jia
Lataisia Jones
Michelle Jones-London
Barbara Karp
Brenda Kibler
Jenny Kim
Brian Klein
Jim Koenig
Steve Korn
Walter Koroshetz
Kranthi Kotha
Sahana Kukke
Pascal Laeng
Christine Lam
Nick Langhals
Mark Langer
Crystal Lantz
Timothy LaVaute
Crystal Lee
Miriam Leenders
Nina Lichtenberg
Genevieve Lind
Erica Littlejohn
Cara Long
Codrin Lungu
Quynh Ly
Timothy Lyden
Ernie Lyons
Laura Mamounas
Marguerite Matthews
Amber McCartney
Linda McGavern
Barbara McMakin
Alissa Meister
Carolina Mendoza-Puccini
Mirela Milescu
Daniel Miller
DP Mohapatra
Karen Molina
Marilyn Moore-Hoon
Paul Myers
Cristina Nigro
John Ngai
Glen Nuckolls
John Ogawa
Ana Olariu
Oreisa O’Neil-Mathurin
Michael Oshinsky
Ada O’Donnell
David Owens
Tatiana Pasternak
Michele Pearson
Mary Ann Pelleymounter
Marlene Peters-Lawrence
Erna Petrich
Leah Pogorzala
Linda Porter
Kevin Powell
Pragya Prakash
Rebecca Price
Sangeetha Pulicherla
Shamsi Raeissi
Shanta Rajaram
Khara Ramos
Ranga Rangarajan
Yogendra Raol
K. Paul Rezaizadeh
Robert Riddle
Sarah Robinson- Schwartz
John Rohde
Becky Roof
Cheryse Sankar
Joel Saydoff
Alisa Schaefer
Nina Schor
Paul Scott
Shalini Sharma
Siddharth Shenoy
Kelly Sheppard
Andrew Siddons
Beth-Anne Sieber
Shai Silberberg
Adissa Silue
Andrew Singh
Mario Skiadopoulos
Andrew Skinner
Shardell Spriggs
Rukmareddy Sripathi
Natalia Strunnikova
Abhi Subedi
Maripierre Surpris
Christine Swanson-Fischer
Brooke Sydnor
Edmund Talley
Amir Tamiz
Anna Taylor
Carol Taylor-Burds
Michael Tennekoon
Christine Torborg
Delany Torres
Natalie Trzcinski
Alexander Tuttle
Lauren Ullrich
George Umanah
Ursula Utz
Joanna Vivalda
Laura Wandner
Margo Warren
Keith Whitaker
Lekyla Whitaker
Samantha White
Vicky Whittemore
Sarah Woller
Ling Wong
May Wong
Clinton Wright
Bob Zalutsky
Ephrem Zelelew
Ran Zhang

Other federal employees present for portions of the meeting included:

Rob Folson, CIT
Dr. Peter Guthrie, CSR
Dr. Roger Janz, CSR
Dr. Aleksey Kazantsev, CSR
Dr. Alexei Kondratyev, CSR
John Rohde, NIH OD
Sarah Robinson Schwartz, NIH OD
Dr. Elyse Schauwecker, CSR
Dr. Laurent Taupenot, CSR

We certify that, to the best of our knowledge, the foregoing minutes and attachments are accurate and complete.

 

______
Date

_____________________________
Robert Finkelstein, Ph.D.
Executive Secretary
National Advisory Neurological Disorders
and Stroke Council

Director, Division of Extramural Research
National Institute of Neurological Disorders
and Stroke

______
Date
_____________________________
Walter Koroshetz, M.D.
Chairperson
National Advisory Neurological Disorders
and Stroke Council

Director
National Institute of Neurological Disorders
and Stroke

These minutes will be formally considered by the Council at its next meeting. Corrections or notations will be incorporated in the minutes of that meeting


1For the record, it is noted that members absent themselves from the meeting when the Council is discussing applications (a) from their respective institutions or (b) in which a real or apparent conflict of interest might occur.