NINDS Advisory Council Meeting Minutes, May 27-28, 2004

1. Call to Order and Opening Remarks
2. Report of the Acting Director, Division of Extramural Research
3. Scientific Presentation: "Multimodality Brain Atlases of Mice and Men"
4. Update on Council Approved FY 2005 Proposed Initiatives
5. Council Subcommittee Reports
6. Caps and Large Grant Applications
7. Update on the NIH Roadmap as it Affects NINDS
8. Funding Strategy for Fiscal Year 2005
9. Council Review of Pending Applications
10. Adjournment

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

Summary of Meeting ¹
May 27-28, 2004

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 160th meeting on May 27-28, 2004, at Building 31, Conference Room 6, Bethesda, Maryland. Dr. Story Landis, 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 27, 2004 --10:30 a.m. to 5:00 p.m.
for the review and discussion of program development, needs, and policy; and
Closed:		May 28, 2004 - 8:00 a.m. to 11:25 a.m.
for the consideration of individual grant applications.

Council members present were:

Mr. Ronald Bartek
Dr. Bruce Bean
Dr. Keith Black
Dr. Alicia Conill
Dr. Raymond Dingledine
Dr. J. Donald Easton
Dr. Susan Hockfield
Dr. Daniel Lowenstein
Mr. Bradley Margus
Mr. Jeffrey Martin
Dr. William Mobley
Ms. Ellyn Phillips
Dr. Sally Shaywitz
Dr. Ira Shoulson
Dr. Lydia Villa-Komaroff
Mr. Robert Waterman
Dr. Huda Zoghbi

Council member absent was:

Dr. Patrick Pullicino

Council Roster (Attachment 1)

Ex Officio Members present:

Dr. Paul Hoffman, Department of Veterans Affairs
Dr. Geoffrey Ling, Department of Defense

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

Dr. Arthur Toga, UCLA
Ms. Beth Roy, Scientific Social Sciences
Dr. Tina Johnson, Epilepsy Foundation
Dr. Viviana Simon, Society for Women's Health Research
Ms. Elaine Young, University of Florida

NINDS employees present for portions of the meeting included:

Dr. Alan Willard
Ms. Ruth Linn
Dr. John Marler
Dr. Scott Janis
Dr. Mary Ellen Michel
Dr. Joanne Odenkirchen
Dr. Barbara Radziszewska
Dr. Frances Yee
Dr. Merrill Mitler
Dr. Claudia Moy
Dr. Robin Conwit
Mr. Michael Loewe
Dr. Melinda Kelley
Dr. Meena Hiremath
Dr. Bernard Ravina
Mr. Peter Gilbert
Dr. Raul Saavedra
Dr. Katrina Gwinn-Hardy
Ms. Nena Wells
Dr. Story Landis
Dr. Brandy Fureman
Dr. Linda Porter
Ms. Marian Emr
Dr. Dan Tagle
Dr. Paul Sheehy
Dr. Tom Jacobs
Mr. Gahan Breithaupt
Dr. Ronnie Horner
Dr. Yuan Liu
Dr. Alfred Gordon
Dr. Emmeline Edwards
Dr. Ernie Lyons
Dr. Eugene Oliver
Dr. Diane Murphy
Ms. Lorraine Fitzsimmons
Ms. Quandra Scudder
Mr. Jim Stables
Dr. Laura Mamounas
Dr. Robert Baughman
Mr. King Bond
Mr. Phillip Wiethorn
Ms. Diane Howden
Dr. Robert Finkelstein
Ms. Margaret Jacobs
Dr. Arlene Chiu
Dr. Maureen Beanan
Dr. Andrea Sawczuk
Dr. JoAnn McConnell
Dr. David Jett
Dr. Michael Nunn
Ms. Marvene Horwitz
Dr. Tom Miller
Dr. Naomi Kleitman
Dr. Audrey Penn
Dr. Yejun He
Dr. Christina Vert
Ms. Maureen Hambrecht
Dr. Daofen Chen
Dr. Paul Scott
Ms. Sylvia Parsons
Dr. Jill Heemskerk
Dr. Joe Pancrazio
Ms. Shannon Garnett
Mr. Paul Girolami
Dr. Gabrielle LeBlanc
Ms. Robin Latham
Mr. Paul Myers
Mr. Andy Baldus
Mr. George Bramhall
Dr. Karen Bateman
Dr. Richard Crosland
Dr. Randall Stewart
Ms. Cikena Reid
Ms. Janice Cordell
Ms. Lynn Morin
Dr. Heather Rieff
Ms. Joellen Harper
Mr. Patrick Moran
Dr. Robert Zalutsky
Dr. Katie Woodbury-Harris
Dr. Debra Hirtz
Dr. Kurt Fischbeck
Ms. Natalie Frazin

Other Federal employees present for portions of the meeting included:

Dr. Steve Foote, NIMH
Dr. Brent Stanfield, CSR
Dr. Rene Etcheberrigaray, CSR
Dr. Yingying Li-Smerin, CSR
Dr. Sherry Stuesse, CSR
Dr. Daniel Kenshalo, CSR
Dr. Peter Guthrie, CSR
Dr. Nicholas Steneck, ORI
Dr. Christine Melchior, CSR

1. Call to Order and Opening Remarks

   Dr. Story Landis, Director, NINDS, welcomed Council members, guests, and staff to the 160^th Council meeting. It is the last Council meeting for Mr. Margus and Drs. Black, Lowenstein, and Villa-Komaroff whose terms expire on July 31. Dr. Landis expressed appreciation for their service and contribution to the Council. Dr. Patrick Pullicino is unable to attend this meeting. She announced that the new slate of Council members had been approved and that the new members would be in attendance at the September 2004 Council meeting.

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2. Report of the Acting Director, Division of Extramural Research

   Government in the Sunshine Act and the Federal Advisory Committee Act

   Dr. Alan Willard, Acting Director, Division of 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 had not been involved in any conflict of interest situations during the review of grant applications. Council members were also reminded that they need to remove themselves from discussions of applications from any institution from which they have received an honorarium for one year from the time the honorarium was received. If the Council member's participation is deemed critical to the discussion, however, an authorization may be granted by the Institute.

   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. Alan Willard as the Council Executive Secretary, who will then refer the questions to the appropriate staff member for response. In response to questions from Council members, Dr. Willard clarified what are approved types of communication with potential applicants and what is disallowed.

   Consideration of Minutes of Previous Council Meeting

   The minutes of the Council meeting of February 12-13, 2004, were considered and accepted as written.

   Consideration of Dates for Future Council Meetings

   The following dates for future Council meetings were reconfirmed:

   September 9-10, 2004		(Thursday and Friday)
   February 10-11, 2005		(Thursday and Friday)
   May 26-27, 2005		(Thursday and Friday)
   September 15-16, 2005		(Thursday and Friday)
   February 9-10, 2006		(Thursday and Friday)
   May 25-26, 2006		(Thursday and Friday)
   September 14-15, 2006		(Thursday and Friday)

   Other Items

   Expedited Review Process--Dr. Willard reported that 116 out of 177 expedited applications were ready to be awarded.

   Reports Book--The Reports Book consists of applications that have been designated for funding since the last Council meeting. It includes a section on the status of applications that were identified for High Program Priority.

   Materials Produced by the Office of Communications and Public Liaison--Dr. Willard called attention to materials for the public produced by OCPL on stroke and other disorders.

   FY05 Approved Initiatives--The list of initiatives for which Council has given its concurrence was reviewed. Most of the announcements have been published in the NIH Guide, and the remainder will be published within the next few months.

   Staff Action--Dr. Emmeline Edwards is currently serving as Acting Deputy Director of the Division of Extramural Research (DER), while maintaining her portfolio in Systems and Cognitive Neuroscience; Dr. Yuan Liu has accepted the new position of Director of International Affairs within DER, which she will hold along with her duties as program director in Channels, Synapses, and Circuits; and Dr. Shanta Rajaram from NIMH is serving on a detail in the Scientific Review Branch.

   Report of the Director, NINDS

   Scientific Advances

   NINDS has enjoyed significant attention for two recent scientific advances: The first is a small trial conducted by Dr. Roland Martin and Dr. Henry McFarland in the Intramural Program which showed that for multiple sclerosis patients not responding to beta interferon therapy alone, adding the human antibody daclizumab to the patient's interferon therapy improved the patient's outcome. The second is a basic science pre-clinical finding released by the Miami Project, about which Dr. Naomi Kleitman, program director in the Repair and Plasticity Cluster, has been interviewed on television and elsewhere for her analysis. The studies showed that injected Schwann cells can form a bridge between distal and proximal lesions in the spinal cord. The investigators found improved motor function and found that many more axons crossed the lesion sites. These are two of many scientific advances in neurological disorders in which NINDS is making progress.

   Vacancies in NINDS

   Dr. Landis announced that there are currently several staff openings: Director of the Division of Intramural Research; Director of the Division of Extramural Research (DER); Deputy Director of DER; Executive Officer; Chief of the Training and Careers Office; and program directors in neurodegeneration, neuromuscular disease, and channels, synapses and circuits. Council members were invited to submit candidate names for any of the open positions. In response to a question about placing a part-time volunteer from a foundation in the institute, Dr. Landis responded that she would consider the candidate as long as there was no real or perceived conflict of interest or opportunity for undue influence.

   Porter Neuroscience Research Building

   The Porter Neuroscience Research Building is scheduled to open June 15. The concept was developed by Dr. Steven Hyman and Dr. Gerry Fischbach. The plan is for outstanding research scientists to be organized into areas of several enduring themes in both basic and clinical research. There will be a total of 56 scientists from eight different institutes and centers, who will be organized by program area. The expectation is that the collaboration and interaction that will result will fundamentally change the way intramural scientists do their work.

   Congressional Hearings

   Hearings on the NIH budget were held by the Senate Subcommittee on Appropriations and the House Subcommittee on Appropriations. In the Senate, there was one, two-hour hearing for NIH. Dr. Zerhouni testified, and the 27 institute and center directors were available to answer questions. Dr. Zerhouni talked about scientific advances, the Roadmap for Medical Research and management issues. Members of the Senate Subcommittee raised questions about the President's policy on stem cells and the President's FY05 budget. Individual I/C directors were asked specific questions of interest to their constituencies. The House Subcommittee held two hearings. The principle focus was on management, oversight, and priority-setting. An example that was used for management and priority-setting was the Parkinson's research agenda, led by Dr. Diane Murphy, with the assistance of Dr. Paul Sheehy and Dr. Eugene Oliver. Subcommittee members asked the I/C directors what was accomplished as a result of the budget doubling and what can and cannot be accomplished with the President's FY05 budget. Other questions were disease-specific.

   Blue Ribbon Panel on Conflict of Interest

   In response to questions about NIH staff consulting, Dr. Zerhouni created an NIH Ethics Advisory Committee, which is responsible for approving any outside activities over a certain level. Secondly, he assembled a Blue Ribbon Panel, which was responsible for analyzing NIH's conflict of interest and ethics policies. The Panel recently reported back to the NIH Director's Advisory Committee. The Panel strongly encouraged NIH staff to report any paid outside activities related to scientific research. They recommended that the senior management of the Intramural program and all Extramural staff be prohibited from all consulting to pharmaceutical or biotechnology companies. No more than 50 percent of the employee's salary could be generated by outside sources and no more than 25 percent from any one source, and no more than 400 hours per year could be devoted to paid consulting. Since the recommendations were issued, there have been several congressional hearings on the topic.

   Blueprint for the Brain

   A "Blueprint for the Brain" project has been launched by the 14 institutes involved in neuroscience research. The plan is to take advantage of the opportunities NIH has to revolutionize the way neuroscience research is conducted. The goal is to develop a "toolkit for the neuroscientist in the 21st Century," which will include projects such as a gene expression database, better imaging technologies, and other tools of broad applicability. The committee will build on some projects already underway, such as the GENSAT, etc. I/Cs not currently involved in these projects could sign on. This process will also help identify opportunities for multi-institute participation in the funding of clinical trials or the development of clinical trials based on resources already made available by another institute. NINDS will solicit ideas from the extramural community and voluntaries for what they would like to see included in the "toolkit." The Blueprint report is due to the NIH Director by the end of the fiscal year.

   Collaboration with the National Heart, Lung, and Blood Institute (NHLBI)

   NINDS has begun a partnership with NHLBI to advance the goals of the Stroke Progress Review Group. One of the first efforts in this regard is the joint development of an RFA entitled, "Novel Targets and Therapy Development for Ischemic Stroke." The two institutes have committed to working closer together to achieve common goals in stroke.

   Dr. Landis concluded her report by stating that one of her goals when appointed Director was to meet with health voluntary groups, to become better informed of their interests and needs. She has subsequently met with over 50 groups and has found the experience to be extremely informative and rewarding.

   In subsequent discussion, Council members raised concerns about the extra burden the HIPAA regulations have placed on human subjects research. Dr. Landis explained that the NIH Roadmap included the goal to review and consolidate all of the regulations related to human subjects research. She encouraged members of the public to serve on IRBs and animal care and use committees in order to have a voice on the projects that are reviewed by IRBs. Mr. Martin recommended that a subcommittee of Council be formed to articulate the major problems with the current rules and regulations. Lorraine Fitzsimmons informed Council that Dr. Zerhouni created a new sub-office within the NIH Office of Science Policy and Planning to address human subjects issues.

   Dr. Landis took the opportunity to announce that Lorraine Fitzsimmons, Chief of the Office of Science Policy and Planning, is leaving NINDS and has taken a job at the National Institute of Aging. Dr. Landis thanked her for her years of service, and said she will be missed.

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3. Scientific Presentation: "Multimodality Brain Atlases of Mice and Men"

   Dr. Arthur Toga, Professor, Department of Neurology, UCLA School of Medicine, reported that the ability to statistically and visually compare and contrast brain image data from multiple subjects is essential to understanding normal variability and differentiating normal from diseased populations. Dr. Toga's talk introduced the application of probabilistic atlases that describe specific subpopulations, measures their variability and characterizes the structural differences between them. Utilizing a variety of informatics approaches that incorporate statistical and mathematical models to represent the relationship between individuals and modalities, maps can be created that are both visual and quantitative. Utilizing data from structural MRI, atlases have been built with defined coordinate systems creating a framework for mapping data from functional, histological and other studies of the same population in several species. Dr. Toga described the basic approach and some of the underlying mathematical constructs that enable the calculation of probabilistic atlases and examples of their results from several different normal and diseased populations. The application of these approaches to create comprehensive maps of different strains of mice provides the ability to establish genotype - phenotype relationships in knockout or knockin strains. Gene expression maps relative to specific anatomies furthermore greatly facilitates the comparisons between several large-scale scientific projects devoted to mapping the genome of these animals. Thus, atlases have been built that are equivalent to databases and can be used as a dynamic reference enabling the calculation of new atlases as the answer to a particular query in several species.

   Dr. Toga illustrated some approaches useful in understanding multidimensional data and the relationships between them over time. Such four-dimensional representations capture longitudinal and/or cross sectional data for measurement of rates of change at any temporal scale. Functional data from milliseconds to seconds and structural from months to decades can be included in a 4D map. Dr. Toga discussed the use of animations as necessary vehicles for understanding some complex time varying data and the relative merits of other image attributes to enhance our understanding of and immersion into data volumes.

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4. Update on Council Approved FY 2005 Proposed Initiatives

   Dr. Willard directed Council's attention to the list of ten initiatives that Council had agreed could go forward for development in FY05. The list was included in the materials sent to Council before today's meeting. Most of the initiatives have been published in the NIH Guide; the remainder will be published by the end of the fiscal year.

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5. Council Subcommittee Reports

   Training and Career Development Subcommittee

   Dr. Bruce Bean, Chair of the Training and Career Development Subcommittee, announced the good news that the targeted success rate for F31 and F32 awardees of 25 percent had been met, and the targeted success rate of 30 percent for the K01program had been exceeded, reaching 38 percent. Many of the applicants who were not successful at first submission have resubmitted successful applications. Dr. Shaywitz suggested that the staff track the unsuccessful applicants as well as the successful ones.

   The subcommittee discussed the K programs at length and agreed that there needs to be more coordinated support for mentored research at academic institutions. It was also agreed that the K award programs need to be analyzed for distinctive features, qualifications, and possible overlap between programs. Does the K award lead to career development? Some of the K programs have very few applicants. A meeting of representatives from each I/C would be useful, to develop a consensus among the I/Cs that offer K awards. Subcommittee members felt that the institutional commitment required in K08 and K23 applications was unrealistic. Perhaps the wording can be changed in the Program Announcements to state that the institution needs to be committed to the "future independence" of the researcher. Dr. Mobley and Dr. Zoghbi offered to rewrite the guidelines and to bring the draft to the next Council subcommittee meeting.

   Dr. David Jett, program director in the Office of Minority Health and Research, updated the subcommittee on NIH changes to the definitions of "minority and disadvantaged applicants" and the status of the Career Development Award Program for Minority Scholars. The subcommittee was unanimous in expressing their strong support for the minority award program.

   Following Dr. Bean's presentation, the Council discussed what the institutions' requirements should be, both in terms of providing independent lab space and in providing mentors for the K08 and K23 awardees. It was questioned whether the K programs are leading to independent research. Suggestions that were made to help inform the discussion were: 1) Survey the other I/Cs' policies and expectations for the K programs; 2) compile the list of previous K08 and K23 awardees by mentor and determine what happened to awardees after their K08/K23 awards; and 3) meet with the mentors to learn their view of how the program is working.

   Clinical Trials Subcommittee

   Dr. Daniel Lowenstein, Chair of the Clinical Trials Subcommittee, reported thatthe Subcommittee heard reports on three recent workshops conducted by NINDS staff: 1) Priorities for Clinical Research in the Treatment of Intracerebral Hemorrhage, by Dr. Katherine Woodbury-Harris, 2) Priorities for Clinical Research in Emergency Neurology, organized by Dr. Robin Conwit, which explored the advantages to creating an Emergency Room Network, and 3) The Role of Neuroimaging in Clinical Trials for Parkinson's Disease, led by Dr. Bernard Ravina. The multi-institutional and multi-investigator approaches that were highlighted at the workshops led to a discussion of the advantages of collaborative grants: specifically, comparing an R01 investigator-initiated, multi-institutional grant that is led by an individual PI with a single-center grant that, in turn, makes grants to several sites. It was agreed that the latter arrangement is preferable and results in more cooperation. The institute should consider steps to make the multiple-grant arrangement more available to grantees. Lastly, the subcommittee discussed the potential relationship between NINDS/NIH and the pharmaceutical industry. As with the case in many large therapeutic trials, there exists the potential for partnerships with pharmaceutical companies that manufacture the drug in question. The subcommittee suggested that the NINDS consider writing a position paper that recognizes the Institute's interest in partnering with the pharmaceutical industry on clinical studies.

   Infrastructure and Neuroinformatics Subcommittee

   Dr. Susan Hockfield, Chair of the Infrastructure and Neuroinformatics Subcommittee, reported that the first topic the subcommittee discussed was the Sharing of Model Organisms for Biomedical Research policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html), which is a new NIH policy that applies to all grants or contracts that will produce animal models. As of October 1, all applications and proposals will be required to include a model-sharing plan, when animal models will be produced as part of the project. NIH provides support for model sharing by funding repositories, where models can be placed for subsequent distribution; and NINDS has a very successful administrative supplement program to support costs associated with sharing mouse models. Council members asked for data comparing the placement of models in a central repository with the development and sharing of models by individual institutions.

   The second topic discussed was how NINDS should handle non-clinical grant applications with budgets over one million dollars in any one year. The subcommittee reviewed recommendations formulated by a staff ad hoc committee, which included the suggestion that the PI contact staff three months before submission and that the Infrastructure Subcommittee advise whether the proposal fits the Institute's goals and mission. These recommendations were based on the process currently in place for large clinical trial grants. Council members discussed whether staff or the subcommittee should consider the large grant proposals, but a Council recommendation was deferred until the next agenda item was completed.

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6. Caps and Large Grant Applications

   Grants with budgets over one million dollars have a significant impact on the Institute's budget. Just as in the case of clinical trial grants, large, non-clinical applications need consideration before acceptance for relevance and to avoid overlap with other grants. Dr. Willard requested a recommendation from Council of a pre-submission process for large, non-clinical grants. Dr. Landis reminded Council that the peer review process and NINDS' policy of paying grants by percentile score help ensure quality and fairness in grant funding. Council voted (with one abstention) to recommend that staff, in consultation with Council members or other outside experts as appropriate, make recommendations to the Institute Director, who will make the final decision, on acceptance of large, non-clinical grant proposals and maintain the pre-submission requirement of six-weeks rather than lengthen the period to three months. There was no interest from Council in making pre-review decisions on whether to accept such applications. Staff was asked to report back to Council on the number of applications that come in for a decision, what the decisions were, and the results of the review.

   In the interest of time, Dr. Willard deferred discussion of whether to retain the budget caps on program project grants for another Council meeting. One proposal for Council to think about is to remove the cap but ask that the PI's contact staff before submission, in a process similar to the other large grant applications.

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7. Update on the NIH Roadmap as it Affects NINDS

   Dr. Emmeline Edwards, Acting Deputy Director, Division of Extramural Research, reported that when NIH found itself at the end of the budget doubling period, it became necessary to find a way to accelerate the pace of biological research and to move scientific advances to the translational phase. The NIH Roadmap for Medical Research was created to provide the framework for accomplishing these tasks. Over 300 outside scientists were consulted, as well as NIH staff, voluntary and patient groups. NINDS has been an active participant in the Roadmap development process. At the end of the process, three themes emerged: New Pathways to Discovery, Research Teams of the Future, and Re-Engineering the Clinical Research Enterprise. It was determined that multi- and inter-disciplinary research will be required to accomplish the specific goals within each of these research themes. RFAs have been or soon will be issued to invite research to meet these goals. One hundred twenty eight million dollars was designated for Roadmap projects in FY04, which comes from both the NIH Director's fund and a contribution from the I/Cs. NINDS benefits from the Roadmap in the following ways: it provides resources for NINDS researchers that address the broader NIH mission and fosters research not currently feasible, and it builds on existing NINDS programs in translational and clinical research. The Role of the NINDS Council will be to provide secondary review of applications for which NINDS is the lead, except for those considered for the NIH Director's Pioneer Award. NIH has asked that the Council members act as advisors to NIH rather than to the individual I/C on whose Council they participate. NINDS has taken the lead role in the Molecular Libraries and Imaging area, which has issued an RFA on High Throughput Molecular Screening Assays Development. The RFA uses the R03 Small Grant Award to fund the development and adaptation of biological assays for automated screening. There is $2 million set aside for this RFA, which will fund approximately 25 grants. The Roadmap interfaces with the Neuroscience Blueprint by providing: increased leveraging of NIH resources for Blueprint projects, an increased pool of interdisciplinary neuroscience applications for Blueprint goals, increased opportunity to explore synergy in scientific areas and support both small- and large-scale efforts, and in increased partnerships between I/C directors, which can be used to advance the Blueprint. The next steps in the Roadmap plan will involve NIH cooperation with extramural scientists and the private sector to identify roadblocks and refine solutions as well as continued effort by I/C directors to develop cross-cutting initiatives.

   Council members made several suggestions and comments regarding the NIH Roadmap following Dr. Edwards' presentation. There was support for programs that encouraged PIs from multiple disciplines to work together and for a greater emphasis on public-private partnerships. Dr. Ling noted that NIH could leverage partnerships with other government agencies to advance the goals of the Roadmap. Council discussed the details of the Roadmap initiative in which NINDS has the lead, the Molecular Libraries High Throughput Screening Centers RFA. Council also learned that the President's FY05 budget requests that 2 percent of each I/C's budget go toward the Roadmap. To avoid building a new infrastructure, each I/C has volunteered staff for formulation of the Roadmap initiatives and review. For future consideration, NINDS will need to think about balancing Roadmap and Institute priorities. Regarding evaluating the success of Roadmap initiatives, there was no evaluation plan built in to the Roadmap; however, the Institute can evaluate the results of our own initiatives. At the next Council meeting, Dr. Landis will answer the questions of what the criteria are for the evaluation, who will be conducting the evaluation, and what the consequences will be.

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8. Funding Strategy for Fiscal Year 2005

   Dr. Alan Willard and Mr. Andy Baldus, Chief, Financial Management Branch, NINDS, presented an interactive spreadsheet showing the NINDS budget from FY03, the current FY04 budget, and the President's FY05 budget. Council was asked to consider the amount available for competing applications, what changes would affect the payline, what would the consequences be for changing the amounts allocated for set-aside initiatives, the High Program Priority budget or the negotiated reduction percentages. Beginning with an estimated budget of $1.5 billion, a large fraction of the FY05 budget is already committed to non-competing awards, the intramural program, RMS, and center grants. Since the FY05 budget is unknown at this time, three assumptions were made for this model: a 12 percent increase in the total number of grant applications, the President's budget will be final (a 2.6 percent increase over FY04), the average cost of an application will increase by 3 percent. The model retains the cut strategy and payline. When Council considers changing the payline, they should know that 1 percent equals approximately $13 million. Council discussed several options, including whether there is flexibility in the commitment base or grants paid outside of the payline, looking at other I/Cs' funding strategies, lowering the payline, making bigger cuts, or reducing the increases for grant out-years.

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9. 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.

   Research Training and Career Development Programs

   The Council reviewed a total of 111 research career development grant applications; of this total, 81 applications had primary assignment to NINDS, and 60 of them (74.1 percent) were recommended for support in the amount of $8.8 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 $3.7 million.

   Research Grant Awards

   The Council reviewed a total of 2,267 research grant applications; of this total, 1,244 applications had primary assignment to NINDS, and 776 of them (62.4 percent) were recommended for support in the amount of $233.3 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 $72.6 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 four investigators as Javits awardees.

   Small Business Innovation Research and Small Technology Transfer Award Programs

   The Council reviewed a total of 191 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 98 applications had primary assignment to NINDS and 59 of them (60.2 percent) were recommended for support in the amount of $9.4 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 $6.0 million.

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10. Adjournment

    The meeting was adjourned at 11:25 a.m. on Friday, May 28.

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

Alan L. Willard, Ph.D.
Acting Executive Secretary
National Advisory Neurological Disorders and Stroke Council
Acting Director, Division of Extramural Research
National Institute of Neurological Disorders and Stroke

Story C. Landis, Ph.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.

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¹ For 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.

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