DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
NATIONAL INSTITUTES OF HEALTH
NATIONAL ADVISORY NEUROLOGICAL DISORDERS AND STROKE COUNCIL

Summary of Meeting
September 14-15, 2000

• Summary of the Meeting
• Call to Order and Opening Remarks
• Report of the Associate Director for Extramural Research
• Report of the Director, NINDS
• Brain Tumor Progress Report
• The National Research Council Reports on Biomedical and Behavioral Scientists
• Council Subcommittee Reports
• NINDS/NIMH Joint Session
• Council Review of Pending Applications
• Adjournment

Summary of Meeting

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 149th meeting on September 14, 2000 in Building 31, Conference Room 10, National Institutes of Health, Bethesda, Maryland. Dr. Gerald Fischbach, 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: September 14, 2000 -- 8:45 a.m. to 3:15 p.m.
September 15, 2000 -- 8:00 a.m. to 10:00 a.m.

for the review and discussion of program development, needs, and policy; and

Closed: September 14, 2000 - 3:15 p.m. to 6:15 p.m.

for discussion and consideration of individual grant applications.

Council members present were:

Mr. Robert V. Abendroth
Dr. Keith Black
Ms. Jeanne Carpenter (absent 9/15)
Dr. Martha Denckla
Dr. Uta Francke
Dr. John Griffin
Dr. Julian Hoff
Ms. Kathleen Hunter
Dr. Daniel Lowenstein
Dr. Peter MacLeish
Mr. Bradley Margus
Dr. John Mazziotta
Dr. Jerome Posner
Dr. Joshua Sanes
Dr. Richard Tsien

Council members absent were:

Mr. Morton Kondracke
Dr. Lydia Villa-Komaroff

Council Roster (Attachment 1)

Ex Officio Members present:
Dr. Paul Hoffman, Department of Veterans Affairs

Members of the public present for portions of the open meeting included:

Ms. Melinda Kelley--Paralyzed Veterans Association
Ms. Lisa Cash--Spinal Cord Connections
Mr. Ron Bartek--Friedreich's Ataxia Research Alliance
Ms. Nura Shehzd--The Blue Sheet
Ms. Pamela Moore--Capitol Publications
Ms. Dianne Flescher--Epilepsy Foundation
Dr. David Louis--Massachusetts General Hospital
Dr. Ruzena Bajcsy--University of Pennsylvania

NINDS employees present for portions of the meeting included:

Dr. Audrey S. Penn Dr. Constance Atwell Dr. Gerald Fischbach Ms. Brenda Kibler Dr. Cheryl Kitt Dr. F. J. Brinley Dr. Al Kerza Dr. Giovanna Spinella Dr. William Heetderks Dr. Paul Nichols Ms. Margaret Jacobs Ms. Marian Emr Dr.KatherineWoodbury-Harris Dr. Robert Baughman Dr. Eugene Oliver Mr. Phillip Wiethorn Ms. Shirley Broderick Dr. Alan Willard Dr. Arlene Chiu Mr. Gahan Briethaupt Dr. Mary Ellen Cheung Dr. Yuan Liu Ms. Mary Miers Ms. Nancy Hart Dr. Thomas Miller Dr. Lewis Rowland Ms. Joellen Harper Dr. Toby Behar Ms. Verly Taylor Dr. Emmeline Edwards Ms. Quandra Scudder Ms. Cikena Reid Dr. Lynn Morin Dr. Carlos Pena Mr. James Washington

Dr. John Marler Dr. Paul Sheehy Dr. Lillian Pubols Mr. Levon Parker Ms. Nena Wells Dr. Gabrielle Leblanc Dr. Thomas Jacobs Ms. Maureen Hambrecht Ms. Ruth Linn Mr. Andy Baldus Dr. Robert Zalutsky Mr. Kevin Kirby Dr. Alfred Gordon Dr. Paul Scott Dr. Story Landis Ms. Marcia Vital Ms. Sandra Talley Mr. George Bramhall Ms. Shannon Garnett Dr. David Eckstein Mr. Paul Girolami Ms. Stephanie Clipper Dr. Diane Murphy Dr. Henry Khachaturian Dr. Dennis Landis Ms. Mary Tomanek Mr. Nolan Jones Dr. Barbara Radziszewska Dr. Robert Finkelstein Mr. James Stables Mr. Curt Pospisil Ms. Pat Turner Dr. Jill Heemskerk Dr. Meredith Temple Mr. Sudip Parikh

Other Federal employees present for portions of the meeting included:

Ms. Susan Solomon, OD
Ms. Cherie Nichols, NCI
Dr. Richard Kaplan, NCI
Ms. Kate Nagy, NCI
Dr. Jay Joshi, CSR
Dr. Michael Lang, CSR
Dr. David Simpson, CSR
Dr. Joanne Fujii, CSR
Dr. Gillian Einstein, CSR
Dr. Donald Schneider, CSR

<top>

I. Call to Order and Opening Remarks

Dr. Gerald Fischbach, Director, NINDS, welcomed Council members, guests and staff to the 149^th Council meeting. He introduced the following new Council members: Dr. Keith Black, Director, Cedars-Sinai Neurological Institute in Los Angeles and Chairman, Department of Neurological Surgery, University of California at Irvine; Dr. Daniel Lowenstein, Dean, Medical Education, Harvard Medical School; Mr. Bradley Margus; President, A-T Children's Project; and Dr. Paul Hoffman, Director of Medical Research Service, Department of Veterans Affairs, who is representing Dr. John Booss while Dr. Booss is on sabbatical. Dr. Lydia Villa-Komaroff, Vice President for Research, Northwestern University, also a new member, was unable to attend this meeting. Dr. Fischbach also introduced Dr. Howard Federoff, Director, Center for Aging and Development, University of Rochester, and Chair of the Center for Scientific Review (CSR) Brain Disorders and Clinical Neurosciences 3 Initial Review Group, as a special visitor. Dr. Fischbach also alerted Council members to the upcoming NINDS 50^th Anniversary celebration, which is scheduled for March 21, 2001. (Note--the date of the celebration was subsequently changed to October 9-11, 2001.) He noted that the Council would hold a joint session with the National Institute of Mental Health (NIMH) the following day.

II. Report of the Associate Director for Extramural Research

Government in the Sunshine Act and the Federal Advisory Committee Acts

Dr. Constance Atwell, Associate Director for Extramural Research, NINDS, reviewed the Government in the Sunshine Act and the Federal Advisory Committee Acts, which require the Department of Health and Human Services to open to public observation as many advisory committee meetings as possible, including the National Advisory Councils. The NANDS Council meeting, as well as the joint session with NIMH, was open to the public, except during review of grant applications. Notice of the date and place for the Council meeting was published in the Federal Register thirty days prior to the meeting.

Conflict of Interest

The regulations concerning conflict of interest were reviewed, and 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 did not participate in the discussion of, or vote on, an application from any organization, institution, or any part of a university system, of which they are an employee, consultant, officer, director or trustee, or in which they have a financial interest. Institutions or organizations, which have multi-campus institution waivers or which are specifically designated, as separate organizations under 18 U.S.C. 208(a) are exempt from this provision.

Consideration of Minutes of Previous Council Meeting

The minutes of the Council meeting of May 25-26, 2000, were considered and accepted as written.

Consideration of Dates for Future Council Meetings

The following dates for future Council meetings were reconfirmed:

February 15-16, 2001 (Thursday and Friday)
May 24-25, 2001 (Thursday and Friday)
September 13-14, 2001 (Thursday and Friday)
February 14-15, 2002 (Thursday and Friday)
May 30-31, 2002 (Thursday and Friday)
September 12-13, 2002 (Thursday and Friday)

Other Items

Program Announcements/Request for Applications--Dr. Atwell reminded Council of the many Program Announcements (PAs) and Requests for Applications (RFAs) published in the NIH Guide for Grants and Contracts since the last meeting. Copies had been e-mailed to Council members since their last meeting.

Reports Book--Dr. Atwell called Council's attention to the Report Book, which includes a list of all funding actions since the previous Council meeting. She highlighted the last section, which provides the status of applications designated as High Program Priority (HPP). Because NINDS has not yet received a final budget, HPP applications for this Council round will be considered at the February 2001 Council meeting.

Committee Meetings--Dr. Atwell requested Council feedback on a proposal to set aside one and one half to two hours at the beginning of each Council session for committee meetings. It was agreed that this arrangement saves travel time and would be implemented at the next session.

R21 Grants--Dr. Atwell announced that NINDS had published a notice in the NIH Guide for Grants and Contracts of the Institute's willingness to accept unsolicited R21 (Exploratory/Developmental Grants) applications.

Expedited Review--Through the expedited review process, NINDS anticipated making awards of between $10 and $14 million by the end of September.

New Staff--Dr. Atwell introduced new staff members. Dr. Richard Crosland has joined the Scientific Review Branch as a Scientific Review Administrator for the Neurological Sciences and Disorders A Committee. Dr. Raul Saavedra, also a new Scientific Review Administrator, will manage the Training Grant and Career Development Review Committee. Mr. James Washington is a new Grants Management Specialist in the Grants Management Branch. NINDS also welcomes three new Program Analysts: Dr. Todd Horich in the Channels, Synapses and Circuits Cluster, Dr. Carlos Pena in the Neurodegeneration Cluster, and Dr. Meredith Temple in the Repair and Plasticity Cluster.

<top>

III. Report of the Director, NINDS

Dr. Fischbach opened with a review of some of the major planning efforts that are underway. Implementation of the Parkinson's Disease agenda has begun with meetings of the NIH-wide Parkinson's Disease Implementation Committee. Dr. Jerome Posner and Dr. David Louis chaired a recent Brain Tumor Review Group in collaboration with the National Cancer Institute. Two other planning groups that are in the embryonic stages are the Epilepsy Planning Group and the Stroke Planning Group.

Dr. Fischbach introduced the budget review by discussing the urgent need to increase the Research Management and Services (RMS) budget. He noted that as the Institute expands programs and areas of interest, more administrative staff is needed. The FY 2001 request for RMS funding would increase this portion of the budget to 12 percent of the total from the current 3 percent. The House and Senate have agreed to a proposed increase of around $160 million in the NINDS budget and $2.7 billion in the NIH budget. In FY 2001, NINDS would distribute funding in the same manner as FY 2000 with about 80 percent of the budget devoted to RPG awards or centers. There would also be monies in the budget for the new Neuroscience Research Center that had been discussed previously.

Highlighting some recent awards, Dr. Fischbach noted that two awards had been made in the Creutzfeldt-Jakob disease Request for Proposals (RFP) and two awards may potentially be made in the High Throughput in situ Hybridization RFP. The latter is aimed at publishing, on the web, a database showing where genes are expressed and a novel way of accessing these genes. NINDS also contributed to the full-length mammalian gene collection described in a recent issue of Science.

NINDS has been very active in making supplemental awards. The Institute awarded $10 million in small equipment grants for a total of $30 million over the last two years. Five small grants to explore the benefit of array technology were awarded. Additional grants were made through the general and the minority supplements programs.

NINDS experienced similar success with recent RFAs. The Deep Brain Stimulation RFA resulted in $5 million in grants. There will be a follow-up meeting in October to discuss the planning of surgical trials. Several good applications came in response to the RFAs on Spinal Cord Circuits, Exploratory Grants in Pediatric Brain Disorder, and Specialized Neuroscience Research Programs (SNRP) at minority institutions. Three additional SNRPs will be funded. The Juvenile Diabetes Foundation (JDF) collaborated with NINDS and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in funding $4 million in grants for neurobiology of diabetic complications. This partnership, in which NIH managed the review and JDF suggested reviewers, encouraged applications and provided part of the funding, could serve as a model for future public/private joint efforts.

Collaborative Research Grants

Dr. Fischbach introduced Dr. William Heetderks, Program Director, Repair and Plasticity Cluster, NINDS, to discuss "glue" grants, a proposed mechanism to fund research consortia. These grants would bring together a group of investigators from possibly distributed institutions to attack a specific problem that lends itself to integration. Led by a principal investigator and a steering committee composed of some of the participating investigators and an NINDS Program Director, the consortium grant would provide for core facilities, data sharing and training. The grant would be awarded in two phases: phase I for planning and phase II for implementation, and reviewed by the NINDS Scientific Review Branch.

In the subsequent discussion, some Council members supported the concept and suggested that the guidelines for the grants be flexible enough to accommodate some minimal spending on the individual research efforts within the consortia to support the integration of the multiple projects. Other members recommended against approval, as mechanisms exist for core projects, exploratory projects and pilot projects. Further, conference grants and support for travel to meetings were already very effective ways for NINDS to support collaborations by investigators. Questions were also raised about the involvement of NINDS program staff in managing these efforts. Dr. Fischbach assured Council that all of these points would be considered as NINDS continued to explore the use of this mechanism.

Dr. Fischbach turned to a review of recently published NIH guidelines for the use of human, pluripotent, embryonic stem cells in research. These guidelines allow NIH to support research using stem cells, but not research that involves the derivation of stem cells. Only frozen human embryos that are in excess of clinical demand can be used. The use of frozen embryos allows for an appropriate waiting period to ensure that donors are given sufficient time to understand all options before consenting to the donation. NIH investigators cannot use stem cells from embryos developed specifically for research. All applications involving stem cells will be reviewed by the Human Pluripotent Stem Cell Review Group and the Council for adherence to the new guidelines. NIH will closely monitor all approved grants. Dr. Fischbach also described a recent collaborative workshop with the Food and Drug Administration on developing guidelines for clinical trials involving stem cells.

Council members discussed the use of embryonic cells and stem cells derived from adult bone marrow. Members also put forth the view that NINDS should maintain leadership and ensure that safety and efficacy standards are maintained. Dramatic visible failures could severely affect the development of this field. Dr. Fischbach alerted the group to the possibility of reviewing applications involving stem cells as early as May 2001.

Initiating a presentation on human subjects protection, Dr. Fischbach referred Council to three articles in The New England Journal of Medicine: "Protecting Research Subjects - What Must Be Done," by Dr. Donna Shalala, Secretary, Department of Health and Human Services (9/14/00); "Is Academic Medicine for Sale," by Dr. Marcia Angell (5/18/00); and "Uneasy Alliance - Clinical Investigators and the Pharmaceutical Industry," by Thomas Bodenheimer (5/18/00). The Shalala article outlined new guidelines and policies related to informed consent, including more training, and penalties for violating these guidelines. Bodenheimer and Angell focused on the issue of conflict of interest in research, particularly financial conflict.

In the discussion that followed, Council members expressed the view that these new rules, especially the financial penalties, could have a chilling effect on clinical research. Members also stated concern about the potential increased role of commercial organizations in clinical research, if academic institutions are unwilling to assume increased risk. Dr. Fischbach suggested that Dr. Greg Koski of the new Office of Human Subjects Research should present at a future Council meeting to further explore these issues.

Dr. Fischbach then gave a brief overview of the Human Frontiers Program, which is a consortium that supports international collaborations through research grants, training, and fellowships. The U.S. contributes $4-5 million to a $50 million budget, but receives about 65 percent of the funding. NINDS has raised its annual contribution to the program from $130,000 to $500,000. Dr. Fischbach requested and received Council's approval to continue with annual increases so as to more aggressively fund this program.

After an introduction of Dr. Ruzena Bajcsy, chairperson of the Department of Computer Science, University of Pennsylvania, Dr. Fischbach introduced the Brain Tumor Progress Report.

Copies of the slides used in Dr. Fischbach's presentation are attached as Appendix 1.

<top>

IV. Brain Tumor Progress Report

Progress on the Diagnosis of Brain Tumors

Dr. David N. Louis, Associate Professor of Pathology, Harvard Medical School, reported that brain tumors constitute a bewildering array of different entities, with proper therapies based on the ability to distinguish one tumor type from another. The ongoing revolution in molecular genetics has impacted brain tumor diagnosis by elucidating the changes underlying some of the major types of brain tumor. In particular, molecular genetic analysis has provided a means for subdividing some histologically defined brain tumor entities into clinically meaningful subgroups. Examples include the recent abilities to differentiate highly chemosensitive anaplastic oligodendrogliomas from relatively chemoresistant anaplastic oligodendrogliomas, as well as to separate atypical teratoid/rhabdoid tumors from medulloblastomas.

These initial inroads suggest that molecular genetic analysis will assume a greater and greater role in neuro-oncology in the future. Importantly, such progress in tissue-based diagnosis will occur alongside novel molecular imaging strategies that will also impact on brain tumor diagnosis. Finally, parallel with improvements in diagnosis, advances in the molecular understanding of brain tumors will contribute to the development of novel therapeutic approaches.

Progress Review Group on Brain Tumors

Dr. Tom Jacobs, Program Director, Neural Environment Cluster, described the Brain Tumor Progress Review Group as a panel of prominent scientists, industrial representatives, clinicians, and consumer advocates charged with the responsibility of setting priorities in brain tumor research and developing a five-year research agenda. Drawing upon the oncology and neuroscience community, this group held several smaller meetings and a major meeting last summer to examine NIH's current research portfolio and make recommendations for future directions. The final report should be available in November 2000. Another valuable outcome of this process was the establishment of an NCI/NINDS Brain Tumor Working Group, which will encourage future collaborations in this area of research.

Dr. Jerome Posner, NANDS Council member, continued the presentation by acknowledging the support and direction that the group received from NCI, which was able to offer expertise developed through three previous review groups. He reviewed the major components of the upcoming report; section one will address research and resource priorities and section two will contain detailed summaries of the many breakout sessions. He emphasized that the most important results of the process were the links that were established between neuroscientists and cancer biologists, which should foster future research collaborations.

During the discussion, there was agreement on the need to closely monitor implementation of the recommendations in the report. Committee members noted that the evaluation of the success of the work will not focus on research dollars spent, but on actual scientific results. Dr. Fischbach highlighted again the collaboration achieved through this project and the implications of these expanded efforts for the work of NINDS.

<top>

V. The National Research Council Reports on Biomedical and Behavioral Scientists

Dr. Henry Khachaturian, Training and Special Programs Officer, NINDS, reviewed data on research training and then began discussion of the report "Trends in the Early Careers of Life Scientists." In light of current employment opportunities, this report concluded that research training and Ph.D. production in biomedical, behavioral and social sciences should not be increased. The report reached a similar conclusion for clinical scientists, but also recommended that efforts to train and retain physicians be intensified until the clinical research workforce includes substantially more M.D.s. The report suggested that NIH expand funding of National Research Service Award (NRSA) training grants and reduce funding of graduate research assistantships, because of the better outcomes experienced by NRSA grantees. Dr. Khachaturian noted that the report assessed biomedical research in general and that an Association of Neuroscience Departments and Programs report portrayed the employment outlook for Ph.D.s in Neuroscience in a more positive light. The growth in this field indicates that the demand for Ph.D.s in neuroscience will continue to be high. The second report, "Addressing the Nation's Changing Needs for Biomedical and Behavioral Scientists" echoes the recommendation against growth in the number of life-scientists.

In the discussion that followed, Council members exchanged views on the eligibility of foreign nationals for NRSA grants and factors that contribute to the success of NRSA recipients. They also discussed the need for more clinician investigators.

<top>

VI. Council Subcommittee Reports

Training and Career Development Subcommittee

Dr. Julian Hoff, NANDS Council member, noted that the Committee was charged with developing strategies for reversing the decline in physician/scientists. The Committee affirmed that: physician/scientist training is critical to the NINDS mission and made several recommendations with regards to training and development. A critical issue examined by the Committee was the impact of debt assumed during medical training on the decision to enter research.

Dr. Dennis Landis, Special Assistant for Clinical Career Development, NINDS, described in detail several programs aimed at encouraging early interest in research and providing opportunities for research training throughout the education of a physician. A common feature of most of these programs was a mechanism for reducing debt burden, a recognized barrier to participation in research training. Dr. Landis highlighted the recommendation to create a Medical Scholars Program similar to one at Howard Hughes Institute, which has a debt reduction component as well as avenues for interaction among medical students, investigators, and patient advocacy groups. Dr. Landis also provided an overview of possible programs to encourage physicians to pursue research before, during, or immediately after residency. The Committee also suggested modifications in the K08 and K23 programs. The implementation of the plan would result in an increase in the training portion of the NINDS budget from 4 percent to 5.5 percent.

The discussion that ensued focused mostly on the benefit of mentoring. Council endorsed the implementation of the recommendations in the report.

Informatics Subcommittee

Dr. John Mazziotta, NANDS Council member, announced that the Biomedical Informatics Science and Technology Initiative (BISTI) had issued three program announcements: 1) Planning Grants for National Programs of Excellence in Biomedical Computing, 2) Innovations in Biomedical Information Science and Technology: Phased Innovation Award (R21/R33) and 3) Innovations in Biomedical Information Science and Technology: Phased Innovation Award (SBIR/STTR Initiative). He called Council's attention to several journal articles on informatics and recommendations from a workshop sponsored partly by the Neuroimaging Informatics Technology Initiative.

Council discussed the question of cross training in neuroscience and informatics and the need for appropriately trained reviewers for applications incorporating informatics.

<top>

VII. NINDS/NIMH Joint Session

The NIMH/NINDS Connection: The Value of Collaboration

Dr. Steven Hyman welcomed the group and introduced Dr. Ruth Kirschstein, Principal Deputy Director, NIH. Dr. Kirschstein endorsed the concept of collaboration among Institutes as was represented by this joint meeting. She reviewed congressional budget negotiations and announced a probable 15 percent or $2.7 billion increase in NIH's budget for the coming year.

In response to a question on construction, Dr. Kirschstein listed a new Clinical Center, the Lewis B. Stokes Laboratory Building, and a Vaccine Research Center as three projects that were underway to address the problem of aging facilities.

National Neuroscience Research Center

Dr. Fischbach provided background information on the discussions and planning meetings related to the Neuroscience Center. He underscored that the purpose of the new building would be to increase the pace of discovery and translation of fundamental science discoveries into effective therapies through an integration of efforts across Institutes. The estimated cost of the project is $260 - $270 million. He noted that the building would serve as a model of how neuroscience research should be conducted around the country.

In response to a question regarding staffing, Dr. Fischbach indicated that the new Center should reduce rather than increase costs, because of sharing and the elimination of duplicate work throughout NIH. Dr. Hyman and Dr. Fischbach described several areas of potential shared resources. Dr. Hyman listed as an additional benefit of the Center, better integration of the extramural and intramural communities at NIH.

Scientific Collaborations

Dr. Steven Hyman, Director, NIMH, introduced the presentation by describing the Healthy Brain Project, a longitudinal study on normal and pathological issues surrounding cognition and emotion with aging, that may potentially be sponsored by NIMH, NINDS and the National Institute on Aging (NIA). He described the fragmented research that should be integrated such as depression and cardiac mortality or mood disorders and Parkinson's as the focus of this new initiative.

As a second shared effort, Dr. Hyman described the NIfTI initiative, a multi-institute, intramural, extramural collaboration on imaging. The purpose is to develop common platforms to make data sharing easier. This effort is different from the national repository of MRI data supported partially by the National Science Foundation and discussed in a recent issue of Nature Neuroscience.

Data Sharing and the NIMH Human Genetics Initiative

Dr. Steven Moldin, Chief, Genetics Research Branch, Division of Neuroscience and Basic Behavioral Science, NIMH, introduced the presentation with a reiteration of the benefits - public health, cost and scientific - that can be achieved through data sharing. The goals of the NIMH initiative are to identify genes conferring vulnerability to mental disorders and to create a national resource of data and materials that would be available to the broader scientific community. The current focus is on schizophrenia, bipolar disorder, late onset Alzheimer's disease, recurrent early onset depression, and autism. This initiative has been implemented by having multiple teams of investigators at multiple sites work together to collect families, which contain multiple individuals affected with the disease of interest. As individual investigators generate results from this shared data, the information is incorporated into the shared resources. NIMH grantees and others within the extramural community have access to these shared resources through a required distribution agreement.

Dr. Moldin stated that the success of the program would be measured by utilization and acceleration of the process of gene discovery. He noted that over 20,000 samples have been distributed to 49 research groups. Progress in gene discovery has been realized in Alzheimer's research and schizophrenia.

At this point, Dr. Hyman introduced Dr. Manjuu Sharma, Secretary, Department of Biotechnology and Dr. S.K. Brachmachari, Director, Center for Biochemical Technology in India.

In the discussion that followed, Council members put forth the need for sharing of ideas as well as data. Dr. Hyman requested and received a joint endorsement from both Councils of the concept of sharing.

NINDS/NIMH 50^th Anniversary

Dr. Guy McKhann, Associate Director of Clinical Research, NINDS, announced that the 50^th Anniversary celebration would be held on October 9-11, 2001. The planned program represents a collaborative effort of scientists, voluntary organizations and industry. The agenda will address the history and the future of the Institutes with sessions directed primarily at scientists, but also with several offerings for the general public.

In the final questions and comments, Council members suggested a meeting addressing overlap in the portfolios of NINDS and NIMH. It was suggested that potential cost savings be explored in overlap among some centers and duplicate facilities. In the area of data sharing, Council warned that data sharing will not occur without incentives for investigators and a mechanism for making such sharing efficient.

<top>

VIII. Council Review of Pending Applications

This portion of the meeting, involving specific grant review, was closed to the public. The Council gave special attention to applications from foreign institutions and applications for which there were concerns about human subjects, including appropriate representation of women and minority subjects, or laboratory animals.

Research Training and Career Development Programs

The Council reviewed a total of 53 research career development grant applications; of this total, 37 applications had primary assignment to NINDS, and 26 of them (70.3 percent) were recommended for support in the amount of $2.6 million first-year direct costs. It is anticipated that, of the research career development grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $3.8 million.

Research Grant Awards

The Council reviewed a total of 1,309 research grant applications; of this total, 743 applications had primary assignment to NINDS, and 497 of them (66.9 percent) were recommended for support in the amount of $128.0 million first-year direct costs. It is anticipated that, of the research grants competing at thisCouncil, NINDS will be able to pay first-year direct costs of approximately $60.3 million.

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. At this meeting, the Council recommended five investigators as Javits awardees.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 134 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 71 applications had primary assignment to NINDS and 57 of them (80.3 percent) were recommended for support in the amount of $9.0 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 $2.7 million.

Academic Research Enhancement Award Program

The Council reviewed a total of 18 Academic Research Enhancement Awards (AREA) applications; of this total, 8 applications had primary assignment to NINDS, and 5 of them (62.5 percent) were recommended for support in the amount of $0.5 million direct costs. It is anticipated that NINDS will be able to pay first-year direct costs of approximately $0.3 million.

<top>

IX. Adjournment

The meeting was adjourned at 10:00 a.m. on Friday, September 15, 2000.

<top>

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

Ruth Linn
Committee Management Specialist

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.