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NINDS Advisory Council Meeting Minutes, May 24-25, 2001

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

Summary of Meeting1
May 24-25, 2001

The National Advisory Neurological Disorders and Stroke (NANDS) Council was convened for its 151th meeting on May 24, 2001 in Building 45, Conference Room E1/E2, 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: May 24, 2001 --10:40 a.m. to 5:15 p.m.

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

Closed: May 25, 2001 - 8:30 a.m. to 10:15 a.m.

for the discussion and consideration of individual grant applications.

Council members present were:

Mr. Robert V. Abendroth
Dr. Keith Black
Ms. Jeanne Carpenter
Dr. Martha Denckla
Dr. John Griffin
Dr. Julian Hoff
Dr. Daniel Lowenstein
Dr. Peter MacLeish
Mr. Bradley Margus
Dr. John Mazziotta
Dr. Jerome Posner
Dr. Joshua Sanes
Dr. Richard Tsien
Dr. Lydia Villa-Komaroff

Council members absent were:

Ms. Kathleen Hunter
Dr. Uta Francke
Dr. Lydia Villa-Komaroff
Council Roster

Ex Officio Members present:

Dr. Paul Hoffman, Department of Veterans Affairs

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. Dianne Flescher-Epilepsy Foundation
Ms. Elizabeth Schreiber--Epilepsy Foundation
T. J. Dunlap - JTx Co, Texas
Mr. Ron Bartek--Friedreich's Ataxia Research Alliance
Mr. Haimi Shiferaw, The Blue Sheet
Dr. Sid Gilman -The University of Michigan
Dr. John Miller - Montana State University
Dr. Elizabeth Shuster - Mayo Clinic-Jacksonville
Dr. Laura Ment - Yale University

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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
Ms. Margaret Jacobs
Dr. Katherine Woodbury-Harris
Dr. Robert Baughman
Dr. Eugene Oliver
Mr. Phillip Wiethorn
Ms. Shirley Broderick
Dr. Alan Willard
Dr. Arlene Chiu
Mr. Gahan Briethaupt
Dr. Mary Ellen Cheung
Dr. Yuan Liu
Ms. Mary Miers
Ms. Joellen Harper
Dr. Toby Behar
Dr. Emmeline Edwards
Ms. Quandra Scudder
Ms. Cikena Reid
Dr. Lynn Morin
Dr. Carlos Pena
Dr. Katrina Gwinn-Hardy
Dr. John Marler
Mr. Mark Salo
Dr. Claudia Moy
Mr. Peter Soltys
Dr. Raul Saavedra
Ms. Marian Emr
Dr. Giovanna Spinella
Ms. Salaama Wadud
Ms. Melissa Weener
Dr. Scott Janis
Dr. Barbara Radziszewska
Dr. Paul Sheehy
Dr. Lillian Pubols
Mr. Levon Parker
Ms. Nena Wells
Dr. Gabrielle Leblanc
Ms. Maureen Hambrecht
Ms. Ruth Linn
Mr. Andy Baldus
Dr. Robert Zalutsky
Mr. Kevin Kirby
Dr. Paul Scott
Dr. Story Landis
Mr. George Bramhall
Dr. David Eckstein
Mr. Paul Girolami
Dr. Diane Murphy
Dr. Henry Khachaturian
Dr. Robert Finkelstein
Mr. James Stables
Dr. Jill Heemskerk
Dr. Meredith Temple-O'Connor
Dr. Deborah Hirtz
Ms. Debbie Jarman
Ms. Marcia Vital
Dr. Jennifer Pinto-Martin
Mr. Kenny Bond
Dr. Piotr Kozlowski
Ms. Sylvia Parsons
Dr. Tom Jacobs
Dr. Tom Miller
Ms. Carol Rowan
Mr. Eric Fuller
Dr. Gaya Jeyarasasingam
Ms. Pat Turner
Dr. Richard Crosland
Ms. Robin Latham
Ms. Lorraine Fitzsimmons
Dr. Sussan Paydar
Mr. Peter Gilbert

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Other Federal employees present for portions of the meeting included:

Dr. David Armstrong, CSR
Dr. Christine Melchior, CSR
Dr. David Simpson, CSR
Dr. Joanne Fujii, CSR
Dr. Jay Joshi, CSR
Dr. Ursula Utz, FDA

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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 151st Council meeting. Dr. Penn introduced new Council member, Dr. Lydia Villa-Komaroff, who is Vice President for Research at Northwestern University. Dr. Penn also introduced the ad hoc members of Council Subcommittees. Dr. Uta Francke and Ms. Kathy Hunter were unavailable to attend this meeting. Dr. Penn announced the conclusion of the terms of the following Council members: Mr. Robert Abendroth; Dr. Martha Denckla; Dr. John Mazziotta; and Dr. Jerome Posner. Noting that replacements had not yet been appointed, she thanked them for their contributions and asked them to keep their calendars open for the September meeting.

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II. Report of the Associate Director for Extramural Research

Government in the Sunshine Act and the Federal Advisory Committee Acts

Dr. Constance Atwell, Associate Director for Extramural Research, NINDS, reviewed the Government in the Sunshine Act and the Federal Advisory Committee Acts, which require the Department of Health and Human Services to open to public observation as many advisory committee meetings as possible, including the National Advisory Councils. The NANDS Council meeting 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 February 15-16, 2001, were considered and accepted as written.

Consideration of Dates for Future Council Meetings

The following dates for future Council meetings were reconfirmed:

  • September 13-14, 2001 (Thursday and Friday)
  • September 13-14, 2001 (Thursday and Friday)
  • February 14-15, 2002 (Thursday and Friday)
  • May 30-31, 2002 (Thursday and Friday)
  • September 12-13, 2002 (Thursday and Friday)
  • 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).

Javits Neuroscience Investigator Award--Dr. Atwell noted that at a previous meeting it was decided that Council should limit the number of Javits Awards to 12 per year. That action had been taken in order to minimize the impact of these seven-year awards on the overall grant pool, for which an average target of four years has been set by NIH policy. Dr. Atwell informed the Council that ten Javits awards had been approved during the first two rounds and four were pending before this Council meeting. A motion was made and seconded to remove the limitation. Discussion brought out concerns about the implications of long grant awards. The motion was withdrawn and a new motion offered and passed. The new motion raises the limit to 15 for this year only and allowed the possibility of renewing a five-year award with a two-year award, with an annual review of proposed Javits awards and program impact.

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 the expedited review process is working well. One hundred eighty three applications have gone through expedited review and will be paid soon.

Retirement--Dr. Atwell announced the retirement of Ms. Shirley Broderick, Acting Chief, Information Resources Management Branch, and expressed appreciation for Ms. Broderick's leadership and contributions to information technology in NINDS.

New Staff--Dr. Atwell introduced the following new staff members in the Division of Extramural Research, NINDS: Dr. Claudia Moy and Mr. Peter Gilbert, Clinical Research Project Managers, in the Clinical Trials Cluster; Dr. Sussan Paydar, a Program Analyst, in the Neurogenetics Cluster, and Ms. Sylvia Parsons, Special Assistant to the Associate Director for Extramural Research.

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III. Report of the Acting Director, NINDS

Dr. Penn provided an overview of the pending budget requests for NINDS and for NIH as a whole. NIH funding appears to be continuing on a trajectory that will result in a doubling by FY 2003. NINDS has fared well. While the request for FY 2002 represents a lower percentage increase than NIH as a whole, due to the need to fund new organizations and smaller Institutes and Centers (ICs) that are still growing, it is still a significant increase over last year. NIH and individual ICs are working hard to anticipate and prepare for level funding in FY 2004 and beyond. One strategy employed by NINDS has been to identify productive use of funds, such as supplements, that do not create a commitment in future years.

This year brought important changes in the Congressional appropriations process. Representative Ralph Regula (R-OH), the new chairman of the House Subcommittee on Labor, Health and Human Services, Education, and Other Agencies, did not follow his predecessors' practice of holding individual hearings for the ICs. Instead, he convened an overview hearing similar to those held in the Senate in which the NIH Director presented a statement and IC Directors were available for questions. This hearing was supplemented by "theme hearings" addressing issues such as chronic diseases, health disparities, and infrastructure. A theme hearing on neuroscience was cancelled due to calendar constraints. The major focus of the Senate hearing was stem cell research and Chairman Specter's (R-PA) request for statements from each IC about current and future research. In response to Mr. Specter's questions, Dr. Penn discussed the use of embryonic stem cells in mouse models of Parkinson's disease and privately funded therapeutic studies in ALS.

Dr. Penn announced several personnel changes. Ms. Mary Miers, Chief, Science Policy and Analysis, will work with Dr. Gerald Fischbach on strategic planning for the Columbia University Health Sciences division. Dr. Guy McKhann, whose long association with NINDS most recently included a year as Acting Clinical Director, will step down from that position to devote more time to his research but will continue to serve as a consultant. Dr. Henry McFarland, Chief of the intramural Neuroimmunology Branch, will serve as Acting Clinical Director. Finally, Dr. Penn noted with sadness the death of Dr. Clarence J. "Joe" Gibbs in February. Dr. Gibbs had a long and distinguished research career with NINDS and was serving as Acting Chief of the Laboratory of Central Nervous System Studies at the time of his death. There will be a memorial service for Dr. Gibbs on July 24. Following Dr. Penn's remarks, Mr. Abendroth expressed Council's appreciation for Ms. Miers's work with the Institute and with Council.

Dr. Penn then discussed policy issues related to three major disorders confronting NINDS: transmissible spongiform encephalopathies (TSEs), Duchenne muscular dystrophy (DMD), and autism.

TSEs include scrapie in sheep, bovine spongiform encephalopathy (BSE) or "mad cow" disease, and other animal forms. Human TSEs include Kuru--once associated with ritual cannibalism but no longer seen-and a variety of rare, mostly genetic forms. The major human form, Creutzfeldt-Jacob disease (CJD) may be genetic, sporadic, or iatrogenic in origin. The current public health concern stems from the emergence of a variant form of CJD, vCJD, first observed in the mid 1990s and linked to BSE initially in Britain and now in other countries. There is widespread fear--though very little evidence-that CJD might be spread through the blood supply. NINDS has been heavily engaged in discussions within NIH and the Department of Health and Human Services seeking to identify and implement appropriate measures to prevent the spread of TSEs, to develop better measures to identify contaminated blood products and infected animals, and to improve understanding of the disease mechanism. Dr. Richard Johnson of The Johns Hopkins University School of Medicine is serving as a special consultant to the Directors of NIH and NINDS, and Dr. Paul Brown of the Division of Intramural Research continues to work as an investigator and policy advisor on TSE issues.

Most recently, Dr. Johnson and Dr. McKhann have visited the major laboratories in the U.S. where TSE research is being conducted to identify opportunities for expansion and collaboration. Dr. Ruth Kirschstein, Acting Director of NIH, has committed $4.8 million from her discretionary fund to NINDS and other ICs to ramp up research on TSEs. NINDS and NHLBI have awarded two major contracts to develop a rapid screening test. TSE research requires a P-3 containment facility and thus represents a substantial commitment of resources.

Duchenne muscular dystrophy has become a major focus of patient advocacy and Congressional interest. Concerns include the failure to develop an effective therapy despite the discovery of the disease gene in 1987; funding levels; and adequacy of the NIH peer review process for research related to muscle disease. Dr. Penn testified at a Senate Appropriations Committee hearing in February where other witnesses were critical of NIH efforts. Since then, there has been some progress on review issues with the formation of a new muscle biology study section, and efforts have been made to reach out to patient advocates and investigators concerned with the major muscular dystrophies. Legislation requiring the creation of centers and an expanded research effort has been introduced in both houses of Congress.

Autism research involves several ICs, primarily NIMH, NICHD, NIDCD, and NINDS. Legislation to expand NIH research efforts was enacted last year and is now being implemented. In addition, the House Government Reform Committee, chaired by Representative Dan Burton (R-IN), held several hearings to explore autism issues, including incidence and prevalence, and possible association of autism and childhood vaccinations.

Council members discussed the impact of disease advocacy activities on NIH programs. Mr. Abendroth described disease-focused legislation as a two-edged sword, especially when centers are involved. Our political system encourages advocacy groups to seek special treatment, and members of Congress are sympathetic to their concerns. Proliferation of centers will affect NINDS initiatives and payline, particularly if the budget does not continue to grow. Mr. Margus noted that while he advises advocates that it is not in the best interest of science to press for set asides, it is a hard position to sell when some groups are succeeding. He urged NIH to maintain a balanced position when discussing disease-specific legislation with the Congress.

Dr. Lowenstein observed that while the advocacy groups' contribution is important, they don't always see fundamental research as a high priority. Enactment of disease-specific legislation may increase disparities by skewing funds in the direction of those who have the resources to push for them. Dr. Mazziotta commented that many advocates are more likely to approach Congress than NIH. Dr. Griffin wondered if pivotal findings have ever emerged from Congressionally mandated initiatives and suggested a study of this issue. The overall challenge is to educate advocates and the Congress about the need for a strong science base and to respond creatively to disease-specific requests.

Prior to the break, Dr. Atwell introduced Mr. James Angus, the NINDS website project manager, and noted that he had previously served with the Los Angeles Museum of Natural History.

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IV. Presentation: "Novel Approaches Toward the Pathogenesis and Treatment of Multiple Sclerosis"

Training and Career Development Subcommittee

Dr. Julian Hoff, Chair of the Training Subcommittee, yielded the floor to Dr. Khachaturian, Training and Referral Officer, NINDS, who provided an update on training grants and K awards. The subcommittee has been working on a series of clinical programs for medical students through post-residency. These include medical student summer research, the scholars program, the MD/PhD or MD/MPH program, a postdoctoral program, the NINDS career transition award, mentored clinical scientist development award, and mid-career patient-oriented research career development award. Effective in FY 2002, there will be an upward revision of salaries and research costs from current level. Also, three new Program Announcements have been published. These are the Institutional National Research Service Awards (NRSA) to provide short-term research experience for medical students; the NINDS Medical Student Scholars Program, and a dual degree program. An RFA was recently published by NINDS, NIMH and NIDA for a national and regional NRSA institutional predoctoral and postdoctoral program to attract and retain minority investigators. Additionally, another program has been launched to encourage basic scientists to focus on translational research. Currently about 2.3 percent of the NINDS budget is allocated to training grants, and about 2.3 percent to K awards (4.6 percent combined). The subcommittee proposes raising this amount to 6 percent of the total budget. Although discussed at length, a definition for "translational research" was not agreed upon. Dr. Dennis Landis suggested that the role of mentors should be emphasized more. Therefore, at the ANA meetings in September, a group of K08 awardees and their mentors will meet the day before the main meeting to present abstracts of their research and discuss ways in which their future research careers can be facilitated.

Infrastructure, Neuroinformatics & Computational Neuroscience Subcommittee

Dr. John Mazziotta, Chair, Infrastructure, Neuroinformatics and Computational Neuroscience Subcommittee, presented a summary of the Subcommittee discussions.

Core grant--Developing programs for core grants to support infrastructure was deemed to be an effective use of funds. Other NIH Institutes have similar programs that usually include funding for career development and patient retention in studies, accounting to up to 4.5 percent of their total budgets. Since NINDS has career development grants as a separate mechanism, the committee proposed devoting no more than 1.5 percent of our budget to core grants for equipment, facilities, and operational costs to facilitate research. At an average capped cost of $350,000 per year, this would equate to about 20-30 grants. These resources could be shared by several investigators with NINDS or other NIH support. There is interest in this concept, but the details need to be refined.

Computational Neuroscience--A workshop on computational neuroscience has resulted in several recommendations and a joint initiative with the National Science Foundation and five other NIH institutes. The initiative will support collaborative research among the mathematics, theoretical physics, and computer science disciplines with the neurosciences. The subcommittee is very supportive of this initiative.

Neuroinformatics--The neuroinformatics-related programs called Biomedical Information Science and Technology Initiative (BISTI), Neuroinformatics Information Science and Technology Initiative (NIfTI), and the Human Brain Project, probably should be combined under one umbrella. BISTI is served by three types of mechanisms: P20, R21-R33 and the industry links, SBIR and STTR. A second workshop on NIfTI has been held, with the purpose of developing software tools to evaluate neurological data for the neuroscience and neurobehavioral research community.

Clinical Trials Subcommittee

Dr. Dan Lowenstein, Chair of the Clinical Trials Subcommittee, began his report by commenting that the morning's meeting was only the second for the Clinical Trials Subcommittee, with their continuing goal being to develop a strategy to manage the pool of incoming clinical trial applications. Dr. Lowenstein stated that the Subcommittee is attempting to bring more focused attention to individual grants as they come in for funding in order to advise the overall Council of the priorities that they should consider. To broaden the expertise of the group, several individuals have been asked to advise the Subcommittee on an ad hoc basis. Since its first meeting, the Subcommittee has begun to assemble a protocol for the pre-review of proposals which requires applicants to submit a short summary of their grant proposal three months before the due date of their application. This information will be used by the Subcommittee members to evaluate the relevance of each application to the Institute's interests and priorities. It was determined that this process would begin during the next Council round in order to give applicants sufficient notice as to whether their grant would be approved for submission. In these future grant rounds, applications will be discussed by the Subcommittee a minimum of two months prior to the grant application deadline so that information can be returned to the applicant in a useful time frame.

In addition to discussing the time frame for pre-approval of grant submissions, two other concerns were raised at the morning's meeting that will be addressed in later discussions: 1) co-funding of grants by multiple institutes, and 2) the process that will be used by planning grant recipients in submitting their clinical trial applications. Regarding the latter concern, the Subcommittee's suggestion was to require these investigators to participate in the same pre-review process as the other clinical trial applicants.

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V. Selection of Grants to Pay From Requests for Applications (RFAs)

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.

Dr. Sanes provided a broad overview of how the Institute's funds are expended into extramural research grants, intramural, contracts, and training activities, etc. Within these categories, extramural research is divided into two categories: standard investigator-initiated, peer-reviewed research that is funded by using a set payline (approximately 80 percent of funds), and other types of research that are also investigator-initiated and peer-reviewed, but are identified as high program priority projects (HPP), proposals submitted in response to a Requests for Applications (RFAs), or clinical trials (approximately 20 percent of funds). Within the RFA category - a focus of this discussion - some are disease-oriented and/or translational, others target an underfunded basic science area, while still others are center grants, awards for core facilities, etc. Following this overview, Dr. Sanes presented a number of points to consider including: 1) some grants are particularly difficult to curtail once funded, like center grants; 2) it would be prudent to consider how resources are allocated to different types of awards since the NINDS budget may not be as generous in the years ahead; 3) we need to respond to legitimate concerns of patient groups and Congress, which can be difficult to do via the standard investigator-initiated R01 mechanism; and 4) good science emerges from the "marketplace" of ideas, and micromanagement of science is not usually beneficial. He also noted that if the RFA mechanism continues to be used, a modified peer review of each RFA developed might be considered, and/or they should be broadened as much as possible.

Following Dr. Sanes' presentation, Dr. Atwell reviewed several topics that will be discussed in greater detail at the upcoming September Council meeting. These topics include: the balance between investigator-initiated grants (R01s, etc.) and other categories of proposals (RFAs, HPPs, clinical trials, etc.), determination of an acceptable payline, negotiated reductions in awards, and the funding of high program priority grants. Dr. Atwell continued her presentation by discussing how funding decisions are made regarding HPP grants and proposals submitted in response to RFAs. For example, factors that are considered in selecting grants for HPP designation include: program balance and needs, the creativity and innovation of the proposal, the level of funds that have already been invested in the project, and the potential to aid a new investigator by funding the proposal. The criteria used to rank and select proposals submitted in response to an RFA are similar and include: merit/priority score, program balance within the RFA topic, the potential to bring a new investigator into the field, and overlap with existing grants held by the principal investigator.

Following these presentations, a number of issues were raised in a general discussion session including:

  • Responding to Congressional mandates with funding/research programs that are of high quality.
  • Identifying the best means of ensuring that RFAs are designed to benefit a wide range of fields (if possible), that the process by which ideas for RFAs are reviewed is made more transparent, and that the standards used to review proposals submitted in response to RFAs are as rigorous as those used to review other investigator-initiated proposals.
  • Determining the success and impact of projects funded through HPPs, PAs, etc.
  • Ensuring that our program balance, ongoing level of solicitations, and current review criteria, etc. will work well in either good, or less favorable, financial times.

Further discussion of these issues is planned for the September 2001 Council meeting.

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VI. Update on the Stroke PRG

Dr. Thomas Jacobs, Program Director, Neural Environment Cluster, NINDS, reported that several factors provided impetus for the Stroke PRG, including increases in overall biomedical funding, the growth of knowledge in fundamental neurobiology, and a recognition that more research in stroke is needed. After examining several planning mechanisms, it was decided to use the "Program Review Group" model that has been successful for brain tumor research. The Brain Tumor PRG (BT-PRG) set a comprehensive research agenda, but it also broadened for scientific community and Congress the concept of research progress. The BT-PRG switched the focus from concentrating only on funding to the larger picture of scientific achievement and the next research questions to address.

The stroke PRG process started last October with a leadership meeting of Dr. Gerald Fischbach, NINDS staff, and the two appointed co-chairs. The co-chairs, Dr. Jim Grotta from the University of Texas, Houston, and Dr. Michael Moskowitz from Harvard, have complementing interests that will enhance the process. A planning meeting that included 32 co-chairs who will lead 15 topic areas was held in March 2001. The agenda for the Stroke PRG Roundtable was formulated and leading experts who could participate were identified. The Roundtable, to be held July 15-17, 2001, will bring together 150 of these leaders in the field, including representatives from other Institutes and agencies, as well as patient advocates. Several overarching themes, such as health disparities and pediatric stroke, will be included in the discussions of most of the topic areas. The Roundtable will not be a traditional conference or workshop with presentations, but a working meeting, by the end of which a draft of recommendations and priorities will be produced. The draft report will be presented at the September 2001 council. If accepted by the Council, and approved by Dr. Penn, it will move forward to implementation.

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VII. Electronic Research Administration

Dr. John McGowan, Director, Division of Extramural Activities, NIAID, and the Project Manager for Electronic Research Administration (eRA), gave an overview of the system. eRA is the paperless electronic transfer of application and administrative data. NIH hopes to adopt this system institute-wide. eRA is NIH's infrastructure for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of NIH grant awards to biomedical investigators worldwide. eRA integrates two parallel systems, the NIH Commons and IMPAC II. The Commons interfaces with NIH's partners in the research community, whereas IMPAC II is used by NIH staff. NIH Commons is slated to mesh with Federal Commons, the central electronic face of the government to the public.

eRA is built from an Oracle relational database management system. The system is divided into modules (programs) that come into play for each application and administrative process for NIH awards. eRA has modules for specific business functions, modules that cut across business areas, and query tools for reporting.

In addition to a congressional mandate requiring agencies to migrate from paper-based to electronic systems, NIH is pursuing eRA to lower costs and administrative effort, speed up process, and provide better quality data. Ultimately, all parties involved will conduct seamless, secure, interactive business. The potential benefit to the extramural community is immense.

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VIII. National Institute of Biomedical Imaging and Bioengineering

Dr. William Heetderks, Program Director, NINDS Repair and Plasticity Cluster, discussed the history, status, and implications of the newest NIH component, the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

NIBIB grows out of various NIH activities in bioengineering and imaging. The NIH Revitalization Act of 1993 directed NIH to conduct a study of bioengineering research. The study recommended that NIH establish a high-level, central focus for basic bioengineering research, significantly expand representation of the engineering community on advisory groups, and establish an intramural bioengineering program. NIH has received similar input on biomedical imaging. To meet its goals, NIH established the NIH bioengineering consortium (BECON). BECON activities include Bioengineering Research Partnership Awards, Bioengineering Research Grants, and Mentored Quantitative Research Career Development Awards. For FY1999 NIH estimated $697.5 million in funding for bioengineering at all ICs, though the definition of bioengineering was quite broad.

Congress, noting the importance of research in imaging, bioengineering, computer science, informatics, and related fields to improving health care, established the National Institute of Biomedical Imaging and Bioengineering with the last bill of the 106th Congress (PL 106-560). The president signed the bill in December 2000 and in April 2001 the DHHS Secretary approved a plan for implementation which is now underway.

Dr. Steven Hyman, Director of NIMH, led a committee that developed a mission statement for NIBIB following the guidance of PL 106-560. The statement says the goal of the Institute is to "improve health by promoting fundamental discoveries, design, and development, and translation and assessment of technological capabilities in biomedical imaging and bioengineering...." The focus of NIBIB is on research and training "that can be applied to a broad spectrum of biological processes, disorders, diseases, and across organ systems." Although the Institute will engage in a full range of activities in support of research, partnership with other NIH Institutes and Centers will play a significant part.

NIBIB-related activities, beyond formulation of the mission statement, include: Submission of an FY2002 budget request; appointment of Dr. Donna J. Dean as Acting Director of NIBIB; identification of a funding code (EB); efforts to identify NIH grants appropriate for transfer to the new Institute; development of interim operating guidelines; development of grant referral guidelines; recruitment of a Director; development of a candidate list for an advisory council; and recruitment of program staff. Until the advisory council is established, FY2002 applications will be handled as dual assignments with other ICs or other IC councils will handle Council level review as "foster parents." Council members may direct suggestions regarding the new institute to the Acting Director, Donna J. Dean, Ph.D. at dd49p@nih.gov or phone 301-435-6138 or fax 301-435-7268.

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IX. U.S. Japan Cooperative Brain Research Program

Dr. Mark Hallett, Chief, Medical Neurology Branch, Clinical Neurosciences Program, DIR, NINDS, described a cooperative program that was established by a Memorandum of Understanding (MOU) signed in November 2000 between the NINDS, on behalf of the United States, and the National Institute for Physiological Sciences at Okazaki, representing Japan. The program is open to all neuroscientists in both countries. Associated activities may include collaborative research projects, information sharing (workshops and seminars), short-term exchanges of scientists, and other relevant activities. Each country will fund its own scientists' exchanges and attendance at meetings. There are already several U.S. laboratories working with Japanese scientists under the auspices of the MOU. A U.S.-Japanese cooperative workshop, "Multimodal Neuroimaging," is planned as a satellite session to the Society of Neuroscience meeting in San Diego this fall. Dr. Hallett has been designated chair of an oversight committee for the U.S., which will publicize and guide the program. It is anticipated that five to ten U.S. scientists will be supported under this program each year.

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X. Council Review of Pending Applications

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

Research Training and Career Development Programs

The Council reviewed a total of 73 research career development applications; of this total, 50 applications had primary assignment to NINDS, and 38 of them (76.0 percent) were recommended for support in the amount of $4.1 million first-year direct costs. It is anticipated that, of the research career development grants competing at this Council, NINDS will be able to pay first-year direct costs of approximately $3.3 million.

Senator Jacob Javits Neuroscience Investigator Awards

The Senator Jacob Javits Neuroscience Investigator Awards are made to distinguished investigators who have a record of scientific excellence and productivity, who are actively pursuing an area of research of strategic importance, and who can be expected to continue to be highly productive for a seven-year period. Candidates are nominated and selected at each Council meeting. At this meeting, the Council recommended four investigators as Javits awardees.

Research Grant Awards

The Council reviewed a total of 1,220 research grant applications; of this total, 768 applications had primary assignment to NINDS, and 515 of them (67.1 percent) were recommended for support in the amount of $159.7 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 $70.7 million.

Small Business Innovation Research and Small Technology Transfer Award Programs

The Council reviewed a total of 145 Small Business Innovation Research (SBIR) and Small Technology Transfer Award (STTR) grant applications; of this total, 73 applications had primary assignment to NINDS and 47 of them (64.4 percent) were recommended for support in the amount of $7.4 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 $3.2 million.

Academic Research Enhancement Award Program

The Council reviewed a total of 22 Academic Research Enhancement Awards (AREA) applications; of this total, 8 applications had primary assignment to NINDS, and 6 of them (75.0 percent) were recommended for support in the amount of $0.6 million direct costs. It is anticipated that NINDS will be able to pay first-year direct costs of approximately $0.4 million.

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XI. Adjournment

The meeting was adjourned at 10:15 a.m. on Friday, May 25.

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

Last updated August 12, 2008