NINDS Advisory Council Meeting Minutes, September 12 - 13, 2002

• I. Call to Order and Opening Remarks
• II. Report of the Associate Director for Extramural Research
• III. Report of the Acting Director, NINDS
• IV. Scientific Presentation - "Individual Differences in Pain Responses: The Role of Gender and Ethnicity"
• V. Partnerships Between NINDS and Voluntary Organizations
• VI. Council Subcommittee Reports
• VII. Council Review of Pending Applications
• VIII. Adjournment

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

Summary of Meeting¹
September 12 - 13, 2002

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 154th meeting on September 12 - 13, 2002, in Building 31, Conference Room 10, National Institutes of Health, Bethesda, Maryland. Dr. Audrey Penn, Acting 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 12, 2002 --10:35 a.m. to 4:45 p.m.

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

Closed: September 12, 2002 - 4:45 p.m. to 5:20 p.m.
September 13, 2002 - 8:10 a.m. to 10:45 a.m.

for the consideration of individual grant applications.

Council members present were:

Mr. Ronald Bartek
Dr. Bruce Bean
Dr. Keith Black
Dr. J. Donald Easton
Dr. Apostolos Georgopoulos
Dr. John Griffin
Dr. Susan Hockfield
Dr. Daniel Lowenstein
Dr. Peter MacLeish
Mr. Brad Margus
Mr. Jeffrey Martin
Ms. Ellyn Phillips
Dr. Joshua Sanes
Dr. Ira Shoulson
Mr. Robert Waterman

Council members absent were:

Ms. Jeanne Carpenter
Dr. Lydia Villa-Komaroff
Dr. Sally Shaywitz

Council Roster (Attachment 1)

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.

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

Ms. Lucie Brujs - The ALS Association
Dr. James Grotta - University of Texas
Dr. Sid Gilman - University of Michigan
Mr. Andrew Kessler - American Psychological Society
Dr. Roger Fillingim - University of Florida
Dr. Grey Schuckman - University of Central Florida, NMSS-Mid Florida Chapter
Mr. Benjamin Lum - The Blue Sheet
Ms. Claudia Louis - American Heart Association
Ms. Michelle Schultz - Epilepsy Foundation
Dr. Perry Cohen-PDF

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NINDS employees present for portions of the meeting included:

Dr. Audrey S. Penn
Dr. Constance Atwell
Dr. Al Kerza
Dr. William Heetderks
Dr. Paul Nichols
Dr. Robert Baughman
Dr. Eugene Oliver
Dr. Alan Willard
Dr. Arlene Chiu
Dr. Toby Behar
Dr. Emmeline Edwards
Ms. Cikena Reid
Mr Lynn Morin
Dr. John Marler
Dr. Claudia Moy
Dr. Raul Saavedra
Ms. Marian Emr
Dr. Giovanna Spinella
Dr. Scott Janis
Dr. Naomi Kleitman
Dr. Danilo Tagle
Dr. Jill Heemskerk
Ms. Quandra Scudder
Dr. Story Landis
Dr. Thomas Miller
Dr. Ursula Utz
Ms. Rebecca Claycamp
Mr. Gahan Breithaupt
Ms. Nena Wells
Dr. David Eckstein
Dr. David Jett
Ms. Susan Free
Ms. Marvene Horwitz
Ms. Gladys Bohler
Dr. Eugene Major
Dr. Joanne Odenkirchen
Mr. Michael Loewe
Dr. Ronnie Horner
Ms. Christina King
Dr. Brandy Fureman
Mr. Gavin Wilkom
Ms. Debbie Jarman
Ms. Liz Eliott
Dr. Paul Sheehy
Ms. Ruth Linn
Mr. Andy Baldus
Dr. Robert Zalutsky
Dr. Paul Scott
Mr. Paul Girolami
Dr. Diane Murphy
Dr. Henry Khachaturian
Dr. Deborah Hirtz
Ms. Sylvia Parsons
Dr. Tom Jacobs
Dr. Yuan Liu
Dr. Meenaxi Hiremath
Ms. Karen Bateman
Dr. Ernest Lyons
Dr. Andrea Sawczuk
Dr. Bernard Ravina
Dr. Melinda Kelley
Dr. Katrina Gwinn-Hardy
Mr. Phillip Wiethorn
Ms. Liz Geiger
Ms. Margaret Jacobs
Mr. Levon Parker
Ms. Carol Rowan
Dr. Gaya Jeyarasasingam
Mr. Paul Myers
Dr. Susan Daniels
Dr. Gabriel Leblanc
Ms. Maureen Hambrecht
Dr. Robert Finkelstein
Dr. Alfred Gordon
Dr. Carlos Pena
Dr. Randall Stewart
Ms. Stephanie Clipper
Ms. Robin Latham
Dr. Frances Yee
Mr. Aaron Kinchen
Ms. Kimbery Campbell
Dr. Daofen Chen
Dr. Diane Lawrence
Mr. James Stable
Ms. Stacey Chambers
Ms. Pat Turner

Other Federal employees present for portions of the meeting included:

Dr. Cynthia McCormick, FDA
Dr. Cheryl Kitt, NIAMS
Ms. Sandra Talley, NIBIB
Dr. Michael Nunn, CSR
Dr. John Bishop, CSR
Dr. Bill Benzing, CSR
Dr. Sherry Stuesse, CSR
Dr. Jill Einstein, CSR
Dr. David Armstrong, CSR
Dr. Peter Guthrie, CSR

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I. Call to Order and Opening Remarks

Dr. Audrey Penn, Acting Director, NINDS, welcomed Council members, guests and staff to the 155th Council meeting and welcomed the new Council members: Ronald Bartek, reappointed for a full, four-year term, Dr. Bruce Bean, Dr. Donald Easton, Dr. Susan Hockfield, and Mr. Jeff Martin. Absent are Ms. Jeanne Carpenter, Dr. Geoffrey Ling, Dr. Sally Shaywitz, and Dr. Lydia Villa-Komaroff.

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II. Report of the Associate Director for Extramural Research

Government in the Sunshine Act and the Federal Advisory Committee Act

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 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.

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. Constance Atwell as Council Executive Secretary, who will then refer the questions to the appropriate staff member for response.

Consideration of Minutes of Previous Council Meeting

The minutes of the Council meeting of May 30-31, 2002, were considered and accepted as written.

Consideration of Dates for Future Council Meetings

The following dates for future Council meetings were reconfirmed:

• February 6-7, 2003 (Thursday and Friday)
• May 22-23, 2003, 2003 (Thursday and Friday)
• September 18-19, 2003 (Thursday and Friday)
• February 12-13, 2004 (Thursday and Friday)
• May 27-28, 2004 (Thursday and Friday)
• September 9-10, 2004 (Thursday and Friday)

Other Items

Reports Book -- The Reports Book consists of applications that have been designated for funding since the last Council meeting. It also includes the status of applications that were identified for High Program Priority (HPP). Dr. Atwell encouraged Council to communicate their preferences for funding to the staff. Following the Council discussion, the staff rank the applications, and the highest ranked are paid that fall within the HPP budget. The unfunded applications are kept for consideration at the next Council round, along with the new nominations. They are not carried over from one fiscal year to the next. The list of program announcements and requests for applications that have been published since the last Council meeting was sent to Council with the second mailing.

Expedited Review Process - Since NINDS has not been given a final FY03 budget, no expedited awards have been made. Twelve are ready for payment.

Loan Repayment Program

In the first year of the program, only NIH grantees were eligible. Most of the applications assigned to NINDS were paid, either by NINDS or by another institute. Twenty-seven were paid, which includes seven that had been assigned to other institutes. NINDS did not pay eight applications assigned to it. Four were paid by other institutes and four were not paid. For the next fiscal year, those eligible will include applicants with any outside research support. The applications will be reviewed by an NINDS Special Emphasis Panel for the potential of the principal investigator to make a significant contribution as an independent investigator. The results will be brought to the 2003 May Council meeting. The repayment agreement is made in the form of a contract, between NIH and the applicant's loan institution.

New Staff

Dr. Atwell introduced Dr. Cynthia McCormick, Division of Extramural Research Deputy Director; Dr. Alan Willard, not a new staff member but since Acting as DER Deputy Director he has been named Chief of the Scientific Review Branch; Michael Loewe, Chief of the Grants Management Branch; new Grants Management Specialists Aaron Kinchen, Gavin Wilkom, and Kimberly Campbell; Christina King, Program Analyst for Channels, Synapses, and Circuits; and Dr. Joanne Odenkirchen, Clinical Trials Research Project Manager.

Dr. Atwell welcomed Dr. Cheryl Kitt, former Program Director in the Systems and Cognitive Neuroscience Cluster and now Director of the Division of Extramural Program for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and thanked her for her significant contributions to NINDS.

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III. Report of the Acting Director, NINDS

Budget Overview

Dr. Audrey Penn presented a table which listed the budgets of the current fiscal year (FY02) and both the President's and the Senate's proposed FY03 budgets, for NIH and NINDS. In FY02, NIH's total budget was $23.456 billion and the NINDS budget was $1.313 billion. The President has proposed over $27 billion for NIH in FY03 and $1.4 billion for NINDS, representing a 15.8 percent increase for NIH and an 8.5 percent increase for NINDS. Part of the reason for the increase in the overall NIH budget is the need for additional spending on biodefense research.

New Directors

NIH Director, Dr. Elias Zerhouni, has appointed two new institute directors: Dr. Thomas Insel, National Institute of Mental Health; and Dr. Ting-Kai Li, National Institute on Alcohol Abuse and Alcoholism.

Extramural Retreat

The Division of Extramural Research held a retreat in July 2002 to review each cluster or group's current programs and future plans and priorities. The meeting was a very positive experience for all who participated, allowing the Director and each cluster/group's colleagues to become better informed of what each group is doing.

Parkinson's Disease Summit

Dr. Zerhouni requested a summit meeting, with a limited number of participants, to discuss the status of NIH support for research on Parkinson's disease. Dr. Zerhouni was concerned that all interested parties be involved in the discussion. His goal for the group was to establish benchmarks. One of the outcomes of the summit was the recommendation to host an international conference on Parkinson's disease.

NIH "Road Map" Project

The Road Map project, initiated by Dr. Zerhouni, involved several meetings with the institute directors and others from outside of NIH to brainstorm about priorities and areas of emphasis for NIH. Dr. Jack Griffin confirmed that the members of the groups were high caliber and representative of academia and the research and voluntary communities. The goal of the Road Map is to focus NIH's role for improving the nation's health. Dr. Zerhouni will issue a report with the results of the meetings.

Search for NINDS Director

A new search committee has been formed and several director candidates have been contacted for interviews. The goal is to have a new director selected by February Council.

Dr. Penn invited Dr. Cheryl Kitt to the podium, who introduced Dr. Roger Fillingim, Associate Professor, Department of Operative Dentistry of the University of Florida College of Dentistry and the North Florida/South Georgia VA Health System to give the scientific presentation.

A copy of Dr. Penn's presentation is attached as Appendix 1.

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IV. Scientific Presentation - "Individual Differences in Pain Responses: The Role of Gender and Ethnicity"

Dr. Roger Fillingim reported that pain is a complex experience sculpted by multiple biological, psychological, and sociocultural variables. One of the hallmark features of pain perception is dramatic inter-individual variability, and a better understanding of the factors responsible for such wide variability will enhance pain assessment and treatment. Recent evidence suggests that both gender and ethnicity substantially influence pain responses. Gender differences have been widely reported, with women at greater risk for many clinical pain conditions. Similarly, several studies indicate that ethnic minorities experience more severe pain than non-Hispanic whites. While these differences in clinical pain response are inevitably multiply determined, gender and ethnic differences in pain sensitivity represent one potentially important contributor. In this presentation, recent findings from studies addressing the influence of gender and ethnicity on experimental pain responses were reviewed. The results indicate that women exhibit greater pain sensitivity than men across multiple experimental pain tasks. Factors contributing to these differences, such as sex hormones and family history, were discussed. Regarding ethnicity, data were presented indicating that African Americans and Hispanic Americans show greater sensitivity to experimental pain tasks relative to non-Hispanic whites. Again, data concerning the contribution of psychological factors to the observed differences were reviewed. The clinical relevance of these findings was discussed.

Questions were raised about whether the physician's predisposition or the clinical environment may have influenced the results. Other questions included what types of groups were studied, whether the tests were conducted in predominantly minority settings, and how the ethnic groups were defined. Subjects self-identified their ethnic affiliation and self-reported pain acuity. In response to a question about the role of male hormones to explain the difference in pain thresholds between men and women, Dr. Fillingim stated that he had not studied that factor.

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V. Partnerships Between NINDS and Voluntary Organizations

Dr. Penn stated that NINDS has good relationships with voluntary organizations, and the voluntary groups make a valuable contribution to the institute's mission. There are many ways in which NINDS works with voluntaries, including staff and Council membership on boards of voluntary organizations. The senior staff believed it would be useful to share with Council the institute's experiences working with voluntaries. Dr. Penn introduced the first speaker, Marian Emr, Director, Office of Communications and Public Liaison, NINDS, to share her perspective.

Ms. Emr gave an overview of the importance of NINDS' partnerships with voluntary organizations, beginning in the late 1940s to the present. There are over 250 voluntary organizations known to NINDS that have a neurological disorder focus. She also described the NIH Council of Public Representatives, established in 1998 to facilitate interactions between NIH and the general public. NINDS, along with all other I/Cs, participates on the Council as another means of interacting with the public. NINDS' activities with voluntary health organizations are coordinated by the Office of Communications and Public Liaison, but program staff and Council members also play an important role in working with voluntaries. OCPL works with new groups that request assistance in their formulation, provides new health information to the voluntaries, and refers members of the public to non-profit resources. NINDS' goal is to maintain two-way communication with the voluntaries and cooperate on funding and/or planning research, educational programs, and conferences.

Dr. Penn thanked Ms. Emr for her remarks and introduced Dr. Paul Scott from the Office of Science Policy and Planning.

Dr. Scott discussed NINDS' work with voluntaries within the context of the Institute's Strategic Plan. As part of the development of the Strategic Plan, the NINDS director met with several voluntary group representatives, and comments from many organizations were incorporated into the final document. Dr. Scott gave an overview of the Neuroscience at the New Millennium report, the Parkinson's Disease Research Agenda, the Epilepsy Research Benchmarks, and the Stroke Progress Review Group. Different planning efforts have had different levels of voluntary involvement, and the process has evolved towards more active involvement. The Institute's goal is for disease research funding plans to be a joint collaborative activity between the scientific and voluntary communities.

Dr. Penn invited Dr. Deborah Hirtz, program director in the Clinical Trials Cluster, who works closely with the autism community, to speak about her experiences.

Dr. Hirtz discussed the five ways in which program directors work with voluntaries: 1) Establishing personal relationships and maintaining lines of communication, 2) Speaking to advocacy groups, 3) Providing scientific advice, 4) Assisting them with strategic planning, and 5) Promoting new and junior investigators into the groups' research areas of interest.

Dr. Hirtz introduced Council member Dr. Daniel Lowenstein, to discuss a Council member's involvement with voluntaries.

Dr. Lowenstein discussed his experience working with CURE, the Epilepsy Foundation, and the American Epilepsy Society, on a very successful plan to coordinate and direct epilepsy research. He presented the timeline of meetings that led to the current organizational structure. He noted that the joint effort began with a CURE Conference held in March 2000, which established benchmarks that researchers thought would ultimately lead to a cure for epilepsy. One key to the success of the process has been the concept of stewardship, i.e., the identification of individuals in the field of epilepsy research who are responsible for monitoring progress related to a specific benchmark. Stewards are to report back to the larger group about benchmark progress on at least an annual basis. Dr. Lowenstein described NINDS's initiatives on epilepsy, which were an integral part of the benchmark process. NINDS has clearly played a vital role in the development and implementation of the epilepsy cure plan.

Dr. Penn thanked Dr. Lowenstein for his important contribution and introduced Dr. Diane Murphy, program director in the Neurodegeneration Cluster.

Dr. Murphy presented a summary of the partnership between NINDS and voluntaries on the NINDS' Parkinson's disease initiative. A Parkinson's Disease Research Agenda was formulated in March 2000, with four components: 1) Understanding Parkinson's disease, 2) Treating Parkinson's disease, 3) Creating resources to support the field, and 4) Enhancing the research process. Enhancing the research process included adopting innovative funding mechanisms and bringing in new investigators to the field. One of the innovations in funding was to offer supplements to ongoing research, which would fund the inclusion of a specific Parkinson's disease project. The intent was to have the principal investigator with the supplement to follow up with a grant application that would build on the supplemental project.

The second innovation was the collaboration with several PD voluntary agencies to co-fund fast tracked grants for Parkinson's research. The mechanism used was the R21; these are short, two-year grants, which are predominantly to be used for high-impact, high-risk research ideas that do not require a large amount of preliminary data. In order to accelerate the process, the application was reduced to ten pages and used digital technology to provide the reviewers with copies of the grants, as well as using the council website for their approval of the highly meritorious applications. The solicitation was a large success in terms of the wide variety of excellent projects that were funded. It was also a success in that the NINDS formed beneficial collaborative relationships with the foundation groups involved, which carries over to other opportunities. A meeting will be held in spring of 2003 to discuss the research outcomes from these awards.

Dr. Penn next invited Council member Brad Margus to talk about the experiences of a small voluntary, which he directs, with NINDS.

Mr. Margus described Ataxia-Telangiectasia and the founding of the A-T Children's Project. He founded the A-T Children's Project in 1993 after two of his sons were diagnosed with A-T. The Project raises over $2 million annually, which funds a variety of efforts. There are approximately 380 A-T patients in the U.S. Mr. Margus reviewed the A-T Children's Project's fundraising methods, the approaches to research, and the current state of research on A-T. Because of the urgency of the need to find a cure, "short cuts to therapy," such as studying super antioxidants, gene therapy, neural stem cells, and potential therapeutic targets need to be explored. The A-T Children's Project also encourages researchers in related fields or basic science areas that have potential for affecting A-T to include A-T in their efforts. He suggested forms of collaboration and assistance that NINDS could provide small voluntaries such as the A-T Children's Project.

Dr. Penn thanked Mr. Margus for educating the audience on A-T and providing the Council and staff with important issues to think about and act on. She then introduced Council member Ron Bartek.

Mr. Bartek presented the collaborative relationship between the Friedreich's Ataxia Research Alliance (FARA) and NINDS as an example of NINDS successful work with voluntaries. Mr. Bartek formed the Friedreich's Ataxia Research Alliance, in consultation with Dr. Spinella, after his son was diagnosed with Friedreich's Ataxia in 1998. Since that time, FARA has been responsible for steering over $1 million to Friedreich's Ataxia research. FARA was a member of the voluntary group that was consulted on NINDS' Strategic Plan and works closely with NINDS on the institute's scientific conferences and clinical trials. With staff help, FARA has created a grant program to fund promising research.

Dr. Penn thanked Mr. Bartek and opened the floor for questions.

Jeff Martin expressed appreciation for the presentations, discussed his own experience working with voluntaries in Parkinson's disease, and offered his assistance to Council as a representative of a voluntary group. He suggested ways in which NINDS can work with voluntaries and described common goals.

Ellyn Phillips suggested that the Council lay members meet together to discuss the issue in more depth. Dr. Shoulson suggested that NINDS study the benefits that have been derived from working with voluntaries, which led to a discussion of measuring benefits and placing work with voluntaries within a broader planning process context. It was agreed that voluntaries have been helpful in NIH's work with the public and Congress.

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VI. Council Subcommittee Reports

Training and Career Development Subcommittee

Dr. Peter MacLeish, Chair of the Training and Career Development Subcommittee, named the members of the subcommittee and prefaced his report posing questions for future consideration: pointing out the need for more information about trainees, he asked three questions: 1. How many trainees are being supported by NINDS funding? 2. Are all neurological research areas represented? and 3. Is the distribution of pre-doctoral trainees and post-doctoral trainees adequate?

Dr. MacLeish reviewed the NRSA and K applications from 1996 to a projection for 2003, divided among F32, F31, and F30s. The numbers of all types of applications are increasing. He presented the success rates of the applications, which have declined in the last two years. Both declines are a result of a larger applicant pool. Dr. MacLeish asked the Council to think about whether the 25 percent - 30 percent success rate is acceptable. Data were presented showing the distribution of postdoctoral training grants and individual fellowship awards. NINDS' goal is a 50-50 distribution. The current postdoctoral distribution is 45 percent for individual fellowships and 55 percent for training grants.

In terms of policy issues, the first concerned the K02 (independent scientist) award. The institute requires that K02 awardees in their last two years apply for and obtain R01 grants. Currently this is not always the case. Dr. MacLeish asked that program directors communicate this goal more clearly to the K02 awardees and suggested that a successful R01 or equivalent application be a condition for the last two years of the K02 award. NINDS considers an R01- equivalent grant to be an independent, peer-reviewed, multi-year award with the K02 awardee as the principal investigator, and the total award must be for a minimum of $75,000 per year for three years or $100,000 per year for two years. The other policy issue concerned the K08, the mentored clinician scientist development award. This issue is one of the sponsoring institution's commitment to the grantee. The current language encouraging "Assistant Professor" appointments may be too restrictive as the sole indicator of commitment. The subcommittee suggested the following language be used in the new policy announcement: "In particular, institutions are urged to address the following commitments to the candidate, independent of the outcome of the career development award application: 1) Type of institutional appointment, 2) Sufficiency of funds available to carry out the proposed research, 3) Sufficiency of dedicated space for the candidate, and 4) Other resources available to the candidate." There was general Council support for the new institutional commitment language as suggested by the Training and Career Development Subcommittee.

Infrastructure Subcommittee Report

Dr. Joshua Sanes, Chair of the Infrastructure Subcommittee, summarized the plan for the NINDS Translational Research Program Management and Oversight Structure (see Appendix 2). The program was announced previously in the NIH Guide: NINDS Cooperative Program in Translational Research (PAR-02-139), NINDS Exploratory/Developmental Projects in Translational Research (PAR-02-138), and NINDS Mentored Research Scientist Development Awards in Translational Research (PAR-02-140). As is indicated in Appendix 2, management and oversight will be provided by a combination of Program staff, outside advisors, and Council. The first receipt date for the program is October 1, 2002.

Dr. Sanes related the subcommittee's discussion of how to encourage the availability of animal models to the research community, particularly transgenic and knockout models that have been developed with public funding. The subcommittee strongly supported the current NINDS program providing administrative supplements to grantees to fund the sharing and shipping of the animal models. In response to a question about how the research community will know about the mouse models, Dr. Baughman responded that the information was emailed to all NINDS grantees and will be available on the NINDS website.

There was a discussion about including language on mouse model sharing in the Terms and Conditions of Award. Dr. Atwell reminded Council that it is NIH policy that applicants state their intentions in respect to data or reagent sharing, and requirements for sharing can be included in the terms of the award, at the time the award is made. Dr. Finkelstein reported that NINDS and NIMH have formulated a policy, currently under consideration by NIH, for the sharing of reagents in genetics grants over $500,000.

Clinical Trials Subcommittee

Dr. Daniel Lowenstein, Chair of the Clinical Trials Subcommittee, reported that there were two broad issues that were discussed by the subcommittee. The first was procedural. Before an investigator is permitted to submit a large (greater than $1 million dollars in yearly direct costs) clinical research proposal, the clinical trials subcommittee evaluates the rationale of the proposal to see if the ideas fit into NINDS' overall planning and priorities. The subcommittee then makes a recommendation to NINDS as to whether the study should undergo peer review. If the study is then recommended for funding by the scientific peer review committee, it goes back to the subcommittee for review before the full council considers a funding recommendation. The second issue that came before the subcommittee was whether a clinical trial that requires additional years and funds beyond its award period to complete the trial should be required to submit a full application for continuation of the trial, which would then need to be evaluated by a scientific review committee. There are at least two common reasons for this situation. The first is that an NIH grant can only be awarded for a maximum of five years, which is sometimes not a sufficient length of time for a major trial to be completed. The other reason is slow patient recruitment into the trial. The subcommittee will discuss this issue and formulate a recommendation with the NINDS clinical trials group for the next Council meeting.

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VII. 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 74 research career development grant applications; of this total, 52 applications had primary assignment to NINDS, and 33 of them (63.5 percent) were recommended for support in the amount of $4.5 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 $1.6 million.

Research Grant Awards

The Council reviewed a total of 1,447 research grant applications; of this total, 896 applications had primary assignment to NINDS, and 571 of them (63.7 percent) were recommended for support in the amount of $152.0 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 $92.5 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 two investigators as Javits awardees.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 138 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 72 applications had primary assignment to NINDS and 43 of them (59.7 percent) were recommended for support in the amount of $7.3 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 $4.8 million.

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VIII. Adjournment

The meeting was adjourned at 10:45 a.m. on Friday, September 13.

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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.

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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