NAEC Meeting Minutes
Department of Health and Human Services
National Institutes of Health
National Eye Institute
NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting
June 5-6, 2003
One Hundred Fourth MeetingThe National Advisory Eye Council (NAEC) convened for its one hundred third meeting at 8:30 a.m. on Thursday, June 5, 2003, in Conference Room H, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Paul A. Sieving, M.D., Ph.D., presided as Chair of the Council. The meeting was closed to the public from 8:30 a.m. until 1:30 p.m. for the review of grant and cooperative agreement applications and for the review of the NEI Intramural Research Program. The meeting was open to the public from 1:30 p.m. until adjournment at 3:55 p.m. On Friday, June 6, 2003, the meeting was open to the public from 8:30 a.m. until 11:30 p.m. Attachment A provides a roster of Council members.
Council Members Present:
Dr. Ruben Adler |
Dr. Lois E. Smith |
Council Members Absent:
Dr. Gordon E. Legge
Dr. P. Sarita Soni
NEI Staff Present:
|
Ms. Louise Amburgey |
Ms. Michele Lyles |
Other National Institutes of Health (NIH) Staff Present:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Mary Custer, CSR
Dr. Christine Melchoir, CSR
Dr. Michael Steinmitz, CSR
Other Federal Government Staff Present:
Dr. Wylie Chambers, Food and Drug Administration
Members of the General Public Present at the Open Session:
Mr. Andrew Brecher, Capitol Associates
Mr. Luke Condra, Salem Saxon, P.A.
Mr. Patrick G. Eddington, American Academy of Ophthalmology
Mr. Thomas Hoglund, Foundation Fighting Blindness (FFB)
Mr. Benjamin Lum, The Blue Sheet
Mr. Edward H. McManus, National Alliance for Vision and Eye Research
Mr. Robert Rupp, Association for Research in Vision and Ophthalmology
Dr. Santa Tumminia, FFB
Dr. John Whitener, American Optometric Association
Thursday, June 5, 2003
Closed Portion of the Meeting
The meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
Call to Order and Opening Remarks
Dr. Paul A. Sieving, Director, NEI, and Chair of the Council, called the meeting to order and welcomed the Council members to the one hundred fourth meeting of the National Advisory Eye Council. He announced that two members were not able to be present, Drs. Legge and Soni.
Introductions
Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council introduced Scientific Review Administrators (SRA) from the CSR: Dr. Michael Chaitin, Visual Sciences C, Dr. Mary Custer, Visual Sciences A, and Dr. Christine Melchoir, Chief of the Integrative, Functional, and Cognitive Neurosciences Integrated Review Group. Dr. Melchoir introduced Dr. Michael Steinmetz, who has been appointed as the new Scientific Review Administrator for the Visual Sciences B Study Section. Dr. Melchoir also announced a change in the names of the CSR study sections, starting with the October/November 2003 review cycle. Visual Sciences A will become Anterior Eye Diseases. Visual Sciences B will become Central Visual Processing. And Visual Sciences C will become Disease and Biology of the Posterior Eye.
Confidentiality / Avoidance of Conflict of Interest
Dr. McNicol reviewed policies and procedures regarding confidentiality and avoidance of conflict of interest situations. To avoid conflict of interest, members of federal advisory committees must not participate in the discussion of any application or proposal in which they, their spouse, minor child, close professional associate, or organization has a financial interest or affiliation. The Council members signed a statement certifying that they were absent during such discussions.
Electronic Grant Pilot
Dr. McNicol indicated that the DER staff had been able to mail council members most of the paper copies of background material two weeks in advance of the meeting. A few pieces of important late-arriving material were sent by Federal Express. Letters from applicants which arrived after the two week deadline were made available in the table folders. Dr. Richard S. Fisher, Director, Corneal Diseases Program, gave an update on the initiative to provide council review materials on CD. This round he introduced software to provide better file management for Macintosh users and organized material by program area code. Council members felt that the pilot was a complete success and asked that future meetings be paperless.
Review of Research and Training Applications
Council members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members signed a statement to this effect.
Review of the Intramural Research Program
Dr. Sheldon S. Miller, Scientific Director, presented the report of the NEI Board of Scientific Counselors.
Open Portion of the Metting
Welcome and Call to Order
Dr. Sieving welcomed guests attending the open portion of the meeting.
Introductions
Dr. McNicol introduced two new members of the DER Program staff.
Dr. Hemin R. Chin is the director of a new program on Ocular Genetics. Dr. Chin received his Ph.D. in neurobiology from Northwestern University on studies of the regulation of muscarinic acetylcholine receptors. He then did postdoctoral work in the National Heart Lung and Blood Institute's intramural Laboratory of Biochemical Genetics, studying Calcium channel regulation of parathyroid cell secretion. Dr. Chin was then recruited to the intramural program of the National Institute of Neurological Disorders and Stroke, where he did independent research cloning and sequencing genes involved in the structure, function, and regulation of Calcium channels and opioid receptors in a number of tissues, including Mueller's cells in the human retina. He next joined the extramural program of the National Institute of Mental Health, where he was Chief of the Genetic Basis of Neural Function Program. His duties included serving as Project Officer on the Brain Molecular Anatomy Project. We are very pleased to have recruited someone with Hemin's broad scientific and administrative experience. He will manage a portfolio of extramural grants and serve a liaison role in integrating and stimulating intramural/extramural ocular genetics resources.
Dr. Grace L. Shen is the director of a new program on Ocular Immunology, Inflammation, and Infection. Dr. Shen received her Ph.D. in biochemistry from the St. Louis University in the field of cancer genetics. She made her initial connection with immunology when she cloned the myc-IgA translocation in the mouse plasmacytoma. She then worked in the National Cancer Institute's intramural Laboratory of Genetics as a postdoctoral fellow and a senior staff fellow, with a focus on the myb gene and its involvement in myeloid leukemogenesis and development. Dr. Shen then joined the NCI extramural program as a program director. She managed a portfolio of grants in cancer immunology, basic cancer genetic research and functional genomics. Next, Dr. Shen was recruited to serve as Scientific Director for Oncology Product Development and Pharmacogenomics at Gene Logic Inc., a company focused on the generation of whole genome expression profile databases. Here she also served as the interim director for the Inflammation Program. We are very pleased to have recruited someone with Grace's strong scientific and administrative experience. She will manage a portfolio of grants and serve a liaison role in integrating studies of immunology, inflammation, and infection within the NEI extramural programs.
Consideration of Minutes of Previous Meeting
The minutes of the January 23-24, 2003, NAEC meeting were considered and approved as corrected.
Future Council Meeting Dates
Dr. McNicol indicated that future Council meetings are scheduled for two days, and that members are asked to free that time on their calendars. The NEI does not always need the second day, so members will be contacted as soon as the schedule is known.
The following dates were previously agreed upon for future Council meetings:
September 11-12, 2003
February 5-6, 2004
June 10-11, 2004
September 9-10, 2004
Council members were asked to continue to keep these dates reserved as they make future plans and obligations.
Budget Overview
Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the NEI budget. The NIH FY2003 budget represents the fifth year of a five-year "doubling period", FY1998 - FY2003. The NIH budget was $27.0B, which represents a 14.9% increase over the FY2002 level. The NEI FY2003 budget is $633.1M. This represents a 9.2% increase over the FY2002 level.
Ms. Fivozinsky indicated that the NEI FY2003 budget is distributed among the Division of Extramural Research (87.4%), the Intramural Research Program (9.9%), and Management (2.7%). Highlights of the FY2003 budget include an increase in the annual salary cap for investigators to $171,900; an increase in the Program/Evaluation tap from 1.25% to 2.1% (for the NEI this is an increase from $7 M to $12 M); and an across-the-board rescission of 0.65% ($4 M for the NEI).
The FY2004 President's budget request calls for a 3.4% increase for the NIH and a 2.4% increase for the NEI (to $648.3 M). The Citizen Witness hearings endorsed an NEI budget at a level of $711 M, which would allow the NEI to achieve a doubling of the budget from the FY1998 level. Dr. Zadnik discussed her citizens' testimony on behalf of the American Optometric Association, and indicated that she stressed the needs and opportunities for prevention research.
Extramural Budget Trends
Dr. McNicol reviewed the NEI FY2003 extramural research program operating policies. The NEI has funded non-competitive continuations (Type 5) at the recommended level. Competitive grants (Types 1 and 2) have been funded at a level determined by staff after a case-by-case review of the requested budget. The total number of funded research project grants is anticipated to be 1204, a 4.2% increase over the level of FY2002. The research project grant success rate will be 33.2% for FY2003, compared with 40.6% for FY2002. This decrease in the rate is due to a large increase in the number of grants submitted, 959 in FY2003 compared with 761 in FY2002 (a 26% increase).
Dr. McNicol reviewed the anticipated funding level of various extramural programs compared with the FY2002 levels. The center core grant program will have a 3.2% increase in funds. The Small Business programs will increase from 54 to 59 competitive awards. Collaborative Clinical Research will increase by 7.7%. And the Loan Repayment Programs will double.
Dr. McNicol discussed the new Vision Research Infrastructure Development Award program which was initiated this year. Eleven applications were submitted and eight were funded, for a total investment of $2.5 M.
New NIH Small Grant and Exploratory/Developmental Grant Programs
Dr. Fisher described two new NIH-wide grant programs in which the NEI will participate. The first is an R03 Small Research Grant program. Its purpose is to provide limited time and funds to explore a small project, two years and $50,000 annual direct costs. This will be a non-renewable award, which does not require preliminary data, and which will be reviewed in CSR study sections. In addition to the NIH R03, the NEI will continue to support both the NEI Small Grants for Pilot Research program (three years, $100,000 annual direct costs) and the NEI Small Research Grants for Data Analysis program (two years, $150,000 annual direct costs). These will be reviewed in study sections convened by the NEI.
Dr. Fisher indicated that the second new NIH program is one for high risk/high impact research. The NIH R21 Exploratory/Developmental Grant program is designed to provide funds to assess the feasibility of a novel area of research or a new experimental system; or the innovative use of existing technology to explore a new area of research. This mechanism will provide up to $275,000 direct costs over a two year period. The grant is not renewable, no preliminary data is required, and the application will be reviewed in a CSR study section. In addition to the NIH R21, the NEI will continue to support both the Clinical Study Planning Grant program and the Clinical Vision Research Development Award programs.
Concept Clearance: Joint NSF/NIH Program, Collaborative and Innovative Research in Computational Neuroscience
Dr. Michael D. Oberdorfer, Director, Strabismus, Amblyopia, and Visual Processing Program, described a new initiative which the NEI proposes to support. This will be a reissuance of an FY2002 Request for Applications, "Joint NSF/NIH Initiative to Support Collaborative Research in Computational Neuroscience". That program supported research that focused on integrating computational models and methods with neuroscience. Over 100 applications were submitted, and twenty-one were funded (two by the NEI). This year's program would emphasize both collaborative and innovative computational neuroscience research. Council was enthusiastic at the opportunities for continued vision research in this area and endorsed the concept of the revised program.
Guidelines for Use of Animals in Neuroscience and Behavioral Research
Dr. Oberdorfer informed Council members of NEI participation with seven other NIH Institutes and the Office of the Director, NIH, in funding a contract to prepare a report, "Guidelines for Use of Animals in Neuroscience and Behavioral Research". This document was prepared by the Institute for Laboratory Animal Research (ILAR), Commission on Life Sciences, the National Academies. ILAR appointed a committee of experts who held a series of workshops to identify common research themes in neuroscience and behavioral research, describe methods for recognizing and minimizing any negative impact the research might have on the health and welfare of animals, and discuss the innovations and limitations of each method. The committee has prepared a document which will be available in both print and Cdrom versions. The report presents a "best practices" approach to behavioral neuroscience research; it will be a valuable guide to the scientific community and to funding agencies. It replaces NIH Publication No. 94-3207, August, 1994, "Preparation and Maintenance of Higher Mammals during Neuroscience Experiments". The NEI will make copies widely available to all interested parties.
Workshop Report: Pathophysiology of the Optic Nerve and Ganglion Cell Degeneration
Dr. Ellen Liberman, Glaucoma Program Director, gave an update on this NEI-sponsored workshop held on November 12-13, 2002. The workshop examined current hypotheses of glaucoma pathophysiology, explored whether mechanisms of chronic neurodegeneration are relevant to the etiology of glaucoma, and discussed the key systems and models that might be explored in neuroprotection of retinal ganglion cells. The post-meeting report has been posted on a website for Council members to review.
Healthy Vision 2010 Community Awards Program
Ms. Rosie Janiszewski, Deputy Director, Office of Communication, Health Education, and Public Liaison (OCHEPL), NEI described this funding program. The NEI is the lead agency for the vision objectives of Healthy People 2010 (HP 2010), which include such topics as disease prevention, injury prevention, preschool vision screening, and rehabilitation. The Community Awards program was first implemented in FY2002. It was designed to provide $10,000 in seed money for community-based organizations to develop demonstration projects which further the HP 2010 goals. Over 500 hundred applications were submitted and reviewed; they came from all 50 states and covered all HP 2010 objectives. Thirty-four applications were funded. This year OCHEPL plans to streamline the program and increase its total funding.
Disseminating NEI Research Results
Ms. Judith Stein, Director, OCHEPL, summarized the activities her office undertakes to publicize the results of NEI-funded clinical research. She indicated that since 1976, her office has prepared 33 news releases, seven clinical alerts, and seven statements. She discussed the issues which are considered in planning a dissemination activity and described the types of products/activities which could be considered. She stressed the collaboration between the grantee institution, study personnel and NEI staff in the preparation and distribution of materials. As an example, she demonstrated the types of products that were prepared for the release of results from the NEI-funded Amblyopia Treatment Study. Key messages were identified and seven different products were developed. Evaluation results demonstrated that over 67 million people were exposed to the story, through a combination of print, internet, radio, and television coverage. Council members indicated their enthusiasm for the quality and accuracy of the material presented.
Adjournment
Dr. Sieving adjourned the meeting at 3:55 p.m. on June 5, 2003.
Friday, June 6, 2003
Open Portion of the Meeting
Welcome and Call to Order
Dr. Sieving re-convened the open portion of the meeting on Friday, June 6, 2003, at 8:30 a.m. in Conference Room H, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland.
Program Planning
Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, briefly reviewed the two-step program planning process. Phase I is the preparation of a streamlined document which identifies recent research progress, overarching programmatic goals, and program objectives. The second phase involves a continuous process in which workshops, symposia, and meetings are used to highlight emerging areas of science. These activities would produce reports to complement and update the document produced in Phase I.
Mr. Davis indicated that Council members are asked to review the Phase I material and send any comments or suggestions through an internet site. Following incorporation of Council member suggestions, the draft will be considered by the voluntary/professional/advocacy groups which make up the National Eye Health Education Partnership. Following incorporation of their suggestions, the finalized report will be published in both an internet and a print version in September, 2003.
Presentation of Phase I Program Panel Draft Reports
Dr. McNicol indicated that all six program panels have met and prepared draft documents. These drafts, along with rosters of the panel members, were sent to Council members in advance of the meeting.
Each program gave a brief overview of its Phase I report, which was followed by extensive Council discussion. Members identified topics which should be deleted, added, or expanded, and they suggested topics for Phase II workshops.
Dr. Sieving adjourned the meeting at 11:30 a.m. on June 6, 2003.
Certification
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Dr. Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute
Paul A. Sieving, M.D., Ph.D.
Chair
National Advisory Eye Council
Director
National Eye Institute
These minutes were approved by the Council at the September 11-12, 2003 meeting. A complete, printed copy of the Council minutes, including attachments, may be obtained from:
Ms. Karen R. Tolson
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: ktolson@nei.nih.gov
09/12/2003
Attachment A
NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE
Roster
(Terms end 11/30 of the designated year)
Ruben Adler, Ph.D. (05) Roy Beck, M.D., Ph.D. (05) Suraj P. Bhat, Ph.D. (06) Martha C Constantine-Paton, Ph.D. (03) Gordon E. Legge, Ph.D. (03) Mildred M. G. Olivier, M.D. (04) |
Richard J. Salem, J.D. (04) Lois E. Smith, M.D. (06) P. Sarita Soni, O.D. (03) J. Wayne Streilein, M.D. (04) Janey Wiggs, M.D., Ph.D. (06) Karla Zadnik, O.D., Ph.D. (04) |
Department of Defense Representative
Lt. Col. J. Brian Reed, M.D.
Chief, Vitreoretinal and Uveitis Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236
Department of Veterans Affairs Representative
Marco Z. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103
Ex Officio Members
Tommy G. Thompson
Secretary
Department of Health & Human Services
Washington, DC 20201
Elias A. Zerhouni, M.D.
Director
National Institutes of Health
Bethesda, MD 20892
Chair
Paul A. Sieving, M.D., Ph.D.
Director
National Eye Institute
National Institutes of Health
Bethesda MD 20892
Executive Secretary
Loré Anne McNicol, Ph.D.
Director
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892
