NINDS Advisory Council Meeting Minutes, October 8, 2001

• I. Call to Order and Opening Remarks
• II. Report of the Associate Director for Extramural Research
• III. Report of the Acting Director, NINDS
• IV. Update on Embryonic Stem Cell Research
• V. Update on Strategic Planning Process
• VI. Fiscal Year 2002 Funding Strategy
• VII. Council Subcommittee Reports
• VIII. Council Review of Pending Applications
• IX. Adjournment

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Neurological Disorders and Stroke Council

Summary of Meeting¹
October 8, 2001

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 152nd meeting on October 8, 2001, in Building 45, Conference Room D, National Institutes of Health, Bethesda, Maryland. Dr. Audrey Penn, Acting Director of the National Institute of Neurological Disorders and Stroke (NINDS), served as Chairperson. (This meeting had previously been scheduled for September 13-14 but was postponed to October 8 due to the tragic events of September 11.)

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

Open: October 8, 2001 -10:30 a.m. to 3:30 p.m.

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

Closed: October 8, 2001 - 3:30 a.m. to 3:55 p.m.

for the discussion and consideration of individual grant applications.

Council members present were:

Mr. Robert V. Abendroth
Dr. Martha Denckla
Dr. John Griffin
Dr. Julian Hoff
Ms. Kathy Hunter
Dr. Daniel Lowenstein
Dr. Peter MacLeish
Dr. Jerome Posner
Dr. Joshua Sanes

Council members absent were:

Dr. Keith Black
Ms. Jeanne Carpenter
Dr. Uta Francke
Mr. Bradley Margus
Dr. John Mazziotta
Dr. Richard Tsien
Dr. Lydia Villa-Komaroff

Ex Officio Members present:

Dr. Paul Hoffman, Department of Veterans Affairs

Ex Officio Members absent:

Dr. Geoffrey Ling, Department of Defense

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.

Top

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

Ms. Dianne Flescher-Epilepsy Foundation
Mr. Ronald Bartek--Friedreich's Ataxia Research Alliance
Ms. Adwoa Boahene, The Blue Sheet, F-D-C Reports, Inc.
Dr. Ira Shoulson, University of Rochester
Dr. Apostolos Georgopoulos, University of Minnesota Medical School
Dr. Sally Shaywitz, Yale University
Dr. Elizabeth Shuster - Mayo Clinic-Jacksonville
Ms. Pam Moore - Capital Publications
Ms. Lisa Cash - Spinal Cord Connections
Mr. Gregg Ukaegbu - Maryland Department of Health and Mental Hygiene

Top

NINDS employees present for portions of the meeting included:

Dr. Audrey S. Penn
Dr. Constance Atwell
Dr. Cheryl Kitt
Dr. Al Kerza
Dr. William Heetderks
Dr. Paul Nichols
Dr. Robert Baughman
Dr. Eugene Oliver
Dr. Alan Willard
Dr. Arlene Chiu
Ms. Joellen Harper
Dr. Toby Behar
Dr. Emmeline Edwards
Ms. Cikena Reid
Dr. Lynn Morin
Dr. John Marler
Dr. Claudia Moy
Dr. Raul Saavedra
Ms. Marian Emr
Dr. Giovanna Spinella
Dr. Scott Janis
Dr. Naomi Kleitman
Ms. Brandy Fureman
Dr. Danilo Tagle
Ms. Stephanie Clipper
Dr. Paul Sheehy
Dr. Lillian Pubols
Ms. Ruth Linn
Mr. Andy Baldus
Dr. Robert Zalutsky
Mr. Kevin Kirby
Dr. Paul Scott
Mr. Paul Girolami
Dr. Diane Murphy
Dr. Henry Khachaturian
Dr. Meredith Temple-O'Connor
Dr. Deborah Hirtz
Ms. Sylvia Parsons
Dr. Tom Jacobs
Ms. Patricia Turner
Ms. Margo Warren
Dr. Yuan Liu
Dr. Meenaxi Hiremath
Ms. Karen Bateman
Dr. Alfred Gordon
Dr. Laura Mamounas
Dr. Ernest Lyons
Dr. Andrea Sawczuk
Dr. Bernard Ravina
Dr. Randall Stewart
Dr. Melinda Kelley

Top

I. Call to Order and Opening Remarks

Dr. Audrey Penn, Acting Director, NINDS, welcomed Council members, guests and staff to the 152nd Council meeting. Dr. Penn introduced guests Dr. Ira Shoulson, University of Rochester; Dr. Apostolos Georgopoulos, University of Minnesota Medical Center; Mr. Ronald Bartek, Friedreich's Ataxia Research Alliance; and Dr. Elizabeth Shuster, Mayo Clinic. Dr. Penn announced that the nominees selected to replace the Council members whose terms had expired on July 31, 2001, had not been approved; therefore, she expressed her appreciation to Mr. Robert Abendroth; Dr. Martha Denckla, and Dr. Jerome Posner for extending their terms to include the current meeting.

Top

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 Act, 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 was open to the public, except during the 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. 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 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 24-25, 2001, were considered and accepted as written.

Consideration of Dates for Future Council Meetings

The following dates for future Council meetings were reconfirmed:

• February 14-15, 2002 (Thursday and Friday)
• May 30-31, 2002 (Thursday and Friday)
• September 12-13, 2002 (Thursday and Friday)
• February 6-7, 2003 (Thursday and Friday)
• May 22-23, 2003 (Thursday and Friday)
• September 18-19, 2003 (Thursday and Friday)

Other Items

Reports Book--Dr. Atwell called Council's attention to the Reports 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).

Program Announcements/Requests 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 prior to this meeting.

Expedited Review Process--Dr. Atwell reported that 18 applications that scored within the payline went through expedited review and have been paid with FY 01 funds, totaling $8.5 million. Six were Type 1s, five were amended Type 1s, one was a Type 2, and six were amended Type 2s.

Conference grants - Dr. Atwell reviewed the importance of NINDS-funded conferences and described the two primary types: 1) R13s that are investigator-initiated and are usually under $50,000, and 2) staff-initiated workshops. There is a third type whereby the conference is initiated outside of NINDS, but the staff is heavily involved. Dr. Atwell recommended using the cooperative agreement mechanism for these types of conferences. The cooperative agreement conference grant would only be available by invitation. The Council concurred. New guidelines will be issued to formalize this mechanism.

New Staff--Dr. Atwell introduced the following new staff members in the Division of Extramural Research, NINDS: Dr. Bernard Ravina, Program Director, Clinical Trials Cluster; Dr. Randall Stewart, Program Director, Channels, Synapses and Circuits Cluster; Dr. Laura Mamounas and Dr. Naomi Kleitman, Program Directors, Repair and Plasticity Cluster; Dr. Dan Tagle, Program Director, Neurogenetics Cluster; Dr. Andrea Sawczuk and Dr. Ernest Lyons, Scientific Review Administrators, Scientific Review Branch; Rebecca Claycamp, Deputy Grants Management Officer, Grants Management Branch; Dr. Meenaxi Hiremath, Program Analyst, Channels, Synapses and Circuits Cluster, and Ms. Karen Bateman, Program Analyst, Neural Environment Cluster. Dr. Daofen Chen, a new program director in the Channels, Synapses and Circuits Cluster, was unable to attend. Dr. Atwell also introduced Dr. Shaywitz from Yale University.

Top

III. Report of the Acting Director, NINDS

Dr. Penn announced that the President's FY 02 budget for NIH, which represents a 13 percent increase for NINDS, has not yet been through the Congressional appropriations process. Issues related to the budget and funding strategy will be raised for the Council's consideration later in the agenda.

The Secretary of the Department of Health and Human Services, Mr. Tommy Thompson, spent three and a half days at NIH this summer as part of his survey of each component of HHS. His visit included stops at the Bone Marrow Center, in which he has a special interest; the Clinical Center; the new Neuroscience Center, and the Stroke Center at Suburban Hospital. He was interested and engaged in NIH's work. The change in administrations has resulted in policy changes that have affected NIH, in particular the new travel policy. The most immediate impact is the restriction on travel to the annual Society for Neuroscience meeting this fall.

The NIH response to the events on September 11 went smoothly. The emergency evacuation plan, patient security, and other issues were handled successfully. The NINDS Advisory Council meeting was rescheduled; however, the 50th Anniversary Scientific Symposium on Brain Research, planned for October 10 and 11, remained on schedule. NIH personnel provided medical and testing assistance to New York, and several NIH staff were on call for emergency services.

The issue of translational research is gaining prominence at NIH. There is interest by the public and pharmaceutical industry for more emphasis in this area, largely driven by an increased understanding of the mechanisms for some neurological disorders. A committee has been formed to define the stages of disease from mechanism to therapy to delivery. This issue will be discussed in more detail at the next Council meeting.

The K08, K23 Career Development meeting at the American Neurological Association (ANA) meeting clearly demonstrated the success of the two mechanisms. With almost 100 percent attendance of the grant fellows, presentations were made of both the science that was conducted with the support of these grants, as well as administrative procedures. The next step is to promote the successful writing of an R01 grant application. Dr. Alan Willard's presentation on how to write an application was particularly well-received.

The Loan Repayment Program for extramural clinical research and extramural pediatric basic and clinical research has been published. The application will be available on the NIH public website. However, NINDS has not finalized decisions on its own qualifying criteria. NIH's general application requirements are similar to those for a senior fellowship: letters of recommendation, financial information, scientific interest, career goals, etc. The Scientific Review Branch will review the applications. The funds to support the Loan Repayment Program come from the overall budget; they are not a separate appropriation. Dr. Penn said she anticipates that approximately twelve awards will be made in FY02. The awardees must be engaged in patient-oriented research or pediatric research.

The Porter Neuroscience Research Center (PNRC) - The Office of Management and Budget has agreed to allow the demolition of the old building and to proceed with the new Porter Neuroscience Research Center building.

Directors' Searches - The NIH Director search has been postponed until early 2002. The NINDS Director search is near completion. The NIH Director nominee requires Senate confirmation; the individual I/C directors do not.

Budget Discussion - Dr. Penn presented a framework for the budget discussion. The portion of the budget for Research Project Grants is composed of two major parts: unsolicited grants that are paid according to percentile scores within the established payline; and grants that are received in response to a solicitation from NINDS or high program priority (HPP) grants that are outside the payline. Requests for Applications are written to encourage research in particular areas. After considerable deliberation, the senior and budget staff determined that the payline for FY 2002 will tentatively need to be 20 percent, in order to fund program initiatives and investigator-initiated research. Some of the influences on the amount available for distribution are the four-year average requirement for grant length, set by Congress, and the accumulation of large grants making their way through their four-year cycles. In addition, the average cost per grant has increased. The grantees have benefited from a 26 percent payline, as evidenced by the success rate for FY 00 of 37 percent. Some administrative cuts have been rescinded to 5 percent on non-modular and 0 for all others. Other factors influencing the reduced payline are the need for special initiatives, which include clinical trials, high program priority grants, and requests for applications and program announcements with a prescribed dollar set-aside.

Dr. Penn reviewed a chart showing the number of RFAs and PASs from FY 1992 - 2002, comparing the number of initiatives where NINDS was the primary institute versus the number where NINDS was a secondary institute. Until the last two years, NINDS co-sponsored initiatives at other institutes' request more often than it acted as primary sponsor. Recently, the numbers have shifted and NINDS has more often initiated the RFAs. Besides requests from other I/Cs, other influences on the selection of initiatives are the NIH designated areas of emphasis for research, the recommendations of the NINDS strategic plan and planning panels, the disease-specific progress review groups (PRGs), and the workshops. NINDS areas of special emphasis established in 1998 were: the biology of brain disorders, adult and pediatric neurodegenerative disorders, the genetics of brain disorders, therapeutics, drug and infrastructure development, the brain molecular anatomy project, pain research, brain imaging, CNS stem cell biology, and protein interactions. Dr. Penn explained that the institute is at the point at which it is reviewing the progress of its goals and deciding how to proceed in the future. She asked the Council and staff for assistance with prioritizing and providing direction.

Top

IV. Update on Embryonic Stem Cell Research

Dr. Arlene Chiu, Program Director, Repair and Plasticity Cluster, NINDS, reviewed the President's new policy on the use of human embryonic stem (ES) cells in research, which in turn has required NIH to change its policy. By way of background, the previous administration had approved the use of human ES cells in research under very specific conditions, but NIH had not fully implemented the NIH Guidelines on the use of human ES cells at the time the new administration took office. In February 2001, DHHS Secretary Tommy Thompson asked NIH to undertake a complete review of the state-of-the-science and policies related to all stem cell research (http://stemcells.nih.gov/). On August 9, 2001, President Bush announced that human ES cells derived on or before that date would be approved for research if they met certain criteria. Dr. Chiu reviewed the various sources and types of stem cells. Research related to all but human ES cells has always, and will continue to be, funded by NIH. She then defined ES cells and their uses in research; the President's criteria for funding work on human ES cells; and last, plans for the NIH Stem Cell Registry. She explained the advantages of ES cells compared with fetal tissue or adult stem cells. The Registry of approved human ES cell lines is being created and will be maintained by Dr. Judith Greenberg of NIGMS. It will be released in two phases: Phase I will be released soon and will contain basic information researchers need for grant applications. In Phase II, Dr. Greenberg will make available more detailed information about the approved cell lines. Dr. Chiu demonstrated a Registry page and the information that will be included. Dr. Chiu yielded the floor to Dr. Wendy Baldwin, Deputy Director, Office of Extramural Research (OER), who explained that NIH was close to issuing registry implementation guidelines but still had several difficult issues to resolve. The Guidelines will be posted on the NIH-OER website when they are complete. Dr. Baldwin explained, in response to a question about Material Transfer Agreements (MTAs), that individual institutions will have to work out their own MTAs, and the cell providers will have to include safeguards prohibiting the distribution of the cell lines to other investigators. Dr. Baldwin explained that it is anticipated that the focus will be on basic research initially, and clinical work will follow some time in the future.

Dr. Chiu was asked to speak briefly about the international ES cell conference she recently attended. She said some countries have research using ES cells already underway and discussed their preliminary findings.

Top

V. Update on Strategic Planning Process

Drs. Joshua Sanes and Constance Atwell each provided background for the discussion of priority setting by outlining the current status of the development and approval process for NINDS solicitations and initiatives.

After the lunch break, Dr. Paul Scott, Acting Chief, Science Policy and Analysis Branch, NINDS, gave an update on the strategic planning process. He described what has taken place since it began three years ago and where the process stands now. He explained the rationale for creating a strategic plan, the implementation and evaluation efforts, and plans for the future. Guiding principles were written to provide a framework for the process. Seven planning topic areas, with related planning panels and specific goals, were identified. The panels were asked to establish long-range goals and identify high-priority research areas and barriers to progress. The planning panels met and completed their work in 1998, which formed the basis for a strategic planning document. Dr. Scott referenced a handout that listed the major goals in the planning document and the subsequent initiatives and workshops that the clusters sponsored to meet these goals. Infrastructure needs were found to be a key priority for the Institute. Dr. Scott also summarized the disease-specific planning efforts, which included the Parkinson's Disease Research Agenda, the Five-Year Strategic Plan on Minority Health Disparities, the Brain Tumor Progress Review Group, the Epilepsy Benchmarks, and the Stroke Progress Review Group. The Institute has reached the point at which it will report on the progress of implementation and evaluate the success of the first phase of strategic planning. In terms of the future, the Institute is committed to continuing the effort, based on the results of the assessment and evaluation. Dr. Scott's branch is developing a set of recommendations for how to proceed with strategic planning to the Institute leadership and Council. Specific needs for the future include greater emphasis on setting priorities, greater involvement of the program staff, and thinking creatively about further engaging the extramural research and advocacy communities.

Dr. Scott was asked who would conduct the evaluation and he said they had planned to do it in-house, but that perhaps an outside evaluator would be more appropriate.

Dr. Atwell mentioned that the question was asked about the results of RFAs and their impact on the progress of research. She said that because RFAs were issued relatively recently, it is too soon to evaluate their success. Most of the awarded grants have not completed four years or have re-competed.

Top

VI. Fiscal Year 2002 Funding Strategy

Dr. Atwell presented the FY02 funding strategy and displayed a chart showing a breakdown of the budgets for FY98, FY99, FY00, FY01, and the proposed FY02 budget, by mechanism. She discussed each category in the budget, noting that the President's proposed budget was used for the FY02 figures. There are three components of research grants: 1) non-competing (the largest part of the budget), 2) administrative supplements, and 3) competing funds. The competing portion is what is discussed and decided upon by Council and staff.

The highlights of the presentation were as follows:

• The non-competing portion of the budget will increase over FY 01 due to the increase in the number and amount of previously awarded grants.
• The competing budget is comprised of payline grants and initiatives (RFAs/PASs, High Program Priorities (HPPs), and large scale clinical trials and epidemiological projects).
• The institute has flexibility among the components of the competing funds as well as payline level: the question presented to the Council was to determine which element had priority, and that will determine the levels of the other elements.

Dr. Atwell presented several budget models to serve as guides. Each varied the following components: payline versus initiatives, modular and nonmodular grant cuts (0 percent - 10 percent), and the President's budget plus or minus 5 percent. She opened it up to the floor for suggestions and recommendations. Among the ideas that were considered were to decrease the number of grants accepted for funding, shorten the average duration of grants, reduce the number of HPPs, decrease the percentage devoted to initiatives, move toward greater use of the R21 mechanism, or maintain the success rate and spend less than what was set aside for the initiatives. Some Council members were concerned about the impact of reducing the payline and/or the success rate.

Ultimately, Council recommended that the highest priority was to preserve the payline while still conducting initiatives in high priority areas (close to an 80 percent/20 percent split) and an average of 5 percent cuts in modular grants and 10 percent cuts in nonmodular grants.

Dr. Atwell then raised the issue of other-institute primary initiatives versus NS-primary initiatives. Initiatives proposed by other institutes require an expedited decision, thus raising the possibility of drawing a disproportionate amount from the set-aside budget. Therefore, Dr. Atwell proposed that a decision be made to cap the other-institute initiatives at a certain percentage of the set-aside budget. Currently, 66 - 75 percent of the budget goes to NS-primary initiatives, although we share in funding a greater number of initiatives sponsored by other I/Cs than our own. A consensus was reached that 75 percent of the set-aside budget should be devoted to NINDS-sponsored initiatives, leaving a quarter of the budget for other-I/C initiatives. Dr. Atwell thanked the Council for their participation and suggestions on the budget discussion.

Top

VII. Council Subcommittee Reports

Training and Career Development Subcommittee

Dr. Julian Hoff, Chairman of the Training and Career Development Subcommittee, presented the background and progress of the subcommittee. The Training and Career Development Committee was formed three years ago at the request of Dr. Gerald Fischbach. The purpose was to reverse the trend toward a decreasing number of physician-scientists and to develop a larger pool of independent investigators. The programs designed to meet these goals, spearheaded by Dr. Dennis Landis and Dr. Henry Khachaturian, are now in place or are nearly ready for implementation. These include the medical student program, the research fellowships, the career awards, summer fellowships, medical student scholarships, and support for postdoctoral fellows. In context of the budget, the NRSAs (fellowships and training grants) account for 2.3 percent of the NINDS budget, and the career awards (K08, K23, etc.) constitute 2.3 percent. The goal is to allocate 6 percent of the NINDS budget for training and career development. The subcommittee, which met the previous night, discussed the issue of loan suspension in some depth. The NIH, which has established qualifying criteria, has a loan repayment program that repays the educational loans to qualified grantees who agree to conduct clinical research (see: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-024.html). The program provides for the repayment of up to $35,000 of the principal and interest of the educational loans of extramural grantees or awardees for each year of obligated service. One question considered by the subcommittee was when in the medical student's or physician's career to offer the loan repayment opportunity. The subcommittee leaned toward starting the program in the middle of the researcher's grant term, i.e., a K08 grantee would be eligible in his or her third year. If the grantee were then awarded an R01 grant, the loan repayment agreement would stay in effect. The subcommittee did not reach consensus, however, and will continue to discuss this issue. Yet to be resolved is the issue of NINDS qualifying criteria; whether merit, financial need, or a combination of both should be required.

Before turning to the next subcommittee issue, Dr. Hoff mentioned that there was a mentoring session for K08 and K23 grantees at the recent ANA meeting. The program was sponsored by the ANA and NINDS and brought well-known investigators together with the K08 and K23 awardees in one-on-one sessions. Dr. Hoff asked Dr. John Griffin to summarize the session. Dr. Griffin explained that there were three components: 1) a presentation of research by the awardees, 2) a series of talks by NINDS leadership on the Institute's effort in career development, and 3) Dr. Alan Willard's presentation on how to apply for an NIH grant. The loan repayment issue attracted a great deal of attention, with many believing that the program should start during the K08 grant period. In regard to the mentor/mentee sessions, Dr. Griffin recommended creating a more formal process for evaluating the mentor's contribution. Dr. Penn seconded Dr. Griffin's description of the success of the program and expressed the need for a database of the K series grantees and their subsequent research application rate and success.

Returning to the subcommittee's report, Dr. Henry Khachaturian discussed the present state and future goals of training and career awards. Aside from the two new mechanisms: the MD/PhD mechanism and the new, short-term training grant mechanism, the rest have been in place for some time. The first analysis he presented was on F31s (pre-doctoral individual fellowships) and F32s (postdoctoral individual fellowships). The slide showed the number of applications, number of new awards, non-competing awards, and the total awards. He then analyzed the career development awards. There was a decrease in the number of applications from 1997 to 1999 followed by an increase in the last two years. The total number of applications is increasing. A study needs to be conducted to distinguish between applications sent in in response to new programs versus normal growth. An analysis of the K24s shows that there were a large number of applications in the first two years and a decrease in the last year. They began with a 50 percent success rate and ended last year with a 25 percent success rate. Dr. Khachaturian informed the Council that he is instituting a tracking system for K24 awardees.

Clinical Trials Subcommittee

Dr. Daniel Lowenstein reported that the subcommittee met once by teleconference between the last Council meeting and today's meeting. The general process for evaluating clinical research proposals exceeding $1 million in direct costs per year prior to submission for peer review is beginning to work smoothly. The purpose of the subcommittee's evaluation is to determine whether the rationale of the proposed study is fully justified and whether it is of significance to NINDS, and to make a recommendation to NINDS on whether the full application should be submitted. The subcommittee will continue to evaluate proposals at the regular meetings held during the Council meetings and at interim teleconference calls held between Council meetings to ensure that the applicant has a feasible timeline, from evaluation of the proposal to submission of the full application. The subcommittee also discussed a proposal from the NINDS clinical trials group to expedite scientific review of planning grants, which are one-year awards to allow the investigators to write the manual of operations for a Phase III clinical trial application. The subcommittee supported the proposal to allow the submission dates to be six weeks later than the typical application due dates. In addition, the subcommittee supported a second proposal to require that a completed manual of operations be included with the submission of an application for a Phase III clinical trial. Investigators who have not developed the manual of operations for the Phase III clinical trial would be encouraged to use the planning grant mechanism. Lastly, Dr. Scott Janis prepared an overview of all clinical trials for the subcommittee, thereby allowing the committee to analyze them in context and better plan the overall portfolio. Dr. Lowenstein thanked Dr. Janis for the report. Dr. Lowenstein also thanked Dr. Marler for his guidance and suggestions for the subcommittee.

Infrastructure, Neuroinformatics & Computational Neuroscience Subcommittee

Dr. Joshua Sanes presented the major issue of the subcommittee, which was the last meeting's approval for a P30 core grant program. The P30 program would help build up infrastructure, support maintenance of equipment, and address needs more directly by providing an alternative to center and project grant mechanisms. The subcommittee reached consensus on the following issues:

• The maximum allowable direct costs per year would be $600,000.
• Permit the awarding of funds in uneven amounts over the life of the grant, i.e., larger amounts would be granted in early years to purchase equipment, with smaller amounts in later years for maintenance.
• A cap of possibly $1.5 million maximum in any one year.
• The number of R01s needed to apply for a P30 would need to be at least five.
• The R01 would need to be active at the time of the application.
• One of the R01s could be funded by an institute or center other than NINDS, but would need to be within NIH.
• The P30 would work well with multiple institutions that are in proximity of one another, but would be difficult to approve for multiple centers spread across the country.
• The maximum number of core grants per applying institution would be one for the first three years, at which time the request for an additional grant would be reviewed.
• Program projects and center grants would be considered a single project in applying for the P30.
• Patient services and patient recruitment efforts would not qualify for the core grant.
• Recommendation that the applications be reviewed by study section module by module, so that one module could be funded and another not.

Two other issues considered by the subcommittee were: 1) A request by a number of neuroscientists for funding for large-scale neuroscience centers, which the subcommittee did not support, and 2) whether NINDS should provide funding for distributing animal models. There was a great deal of enthusiasm for this latter idea, and staff was asked to present at the next meeting a detailed proposal that would include small administrative supplements to individual labs, larger support for cores that can distribute animals, and ways to encourage institutes to share the models that were created with federal funds.

Dr. Penn thanked Dr. Sanes for his presentation.

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 other applications which needed specific discussion. All other applications were voted on through a mail ballot process prior to the end of the fiscal year as follows:

Research Training and Career Development Programs

The Council reviewed a total of 58 research career development applications; of this total, 37 applications had primary assignment to NINDS, and 27 of them (73.0 percent) were recommended for support in the amount of $3.2 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 $1.7 million.

Research Grant Awards

The Council reviewed a total of 1,175 research grant applications; of this total, 701 applications had primary assignment to NINDS, and 475 of them (67.8 percent) were recommended for support in the amount of $126.7 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 $65.1 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. However, there were no recommendations for a Javits Award this Council round.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 136 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 65 applications had primary assignment to NINDS and 44 of them (67.7 percent) were recommended for support in the amount of $6.9 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 $4.0 million.

Academic Research Enhancement Award Program

The Council reviewed a total of 9 Academic Research Enhancement Awards (AREA) applications; of this total, 5 applications had primary assignment to NINDS, and 4 of them (80.0 percent) were recommended for support in the amount of $0.4 million direct costs. It is anticipated that NINDS will be able to pay first-year direct costs of approximately $0.2 million.

Top

IX. Adjournment

The meeting was adjourned at 3:55 p.m. on Monday, October 8.

Top

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

_______________________________
Constance W. Atwell, Ph.D.
Executive Secretary
National Advisory Neurological Disorders
and Stroke Council
Associate Director for Extramural Research
National Institute of Neurological Disorders and Stroke

_______________________________
Audrey S. Penn, M.D.
Acting Chairperson
National Advisory Neurological Disorders
and Stroke Council
Acting 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.

Top

A complete, printed copy of the Council minutes, including attachments, may be obtained by contacting:

Mrs. Ruth Linn
Committee Management Specialist
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Suite 3309
6001 Executive Boulevard, MSC 9531
Rockville, MD 20852-9531
(301) 496-9248
(301) 402-4370 (FAX)
linnr@ninds.nih.gov