NAEC Meeting Minutes
Department of Health and Human Services
National Institutes of Health
National Eye Institute
September 12, 1996
The National Advisory Eye Council (NAEC) convened for its eighty-fourth meeting at 8:30 a.m. on Thursday, September 12, 1996, in Conference Room G, Executive Plaza North, National Institutes of Health (NIH), Rockville, Maryland. The Director of the National Eye Institute (NEI), Carl Kupfer, M.D., presided as Chair of the Council. The meeting was open to the public from 8:30 a.m. until 11:15 a.m., followed by the closed session until adjournment at approximately 5:00 p.m.
Council members present:
Dr. David C. Beebe
Ms. Sue Dauphin
Dr. Jeanette S. Felix
Dr. Marian R. Fisher
Dr. Diane L. Hatchell (Ex Officio)
Dr. Eve J. Higginbotham
Dr. David H. Hubel
Dr. Herbert E. Kaufman
Dr. Millicent L. Knight
Dr. Carl Kupfer (Ex Officio)
Capt. David O. Mazur (Ex Officio)
Dr. Ken Nakayama
Dr. Joseph P. Shovlin
Dr. David S. Zee
Council members absent: Dr. Roy H. Steinberg
Special Council Consultant: Dr. Richard H. Masland
NEI Staff Present:
Ms. Lilyan Atkinson
Ms. Margie Baritz
Dr. Mary Frances Cotch
Mr. Michael Davis
Dr. Peter A. Dudley
Ms. Lois Eggers
Dr. Leon B. Ellwein
Mr. Donald F. Everett
Ms. Carol L. Fivozinsky
Dr. Maria Y. Giovanni
Ms. Carolyn E. Grimes
Dr. Ralph J. Helmsen
Dr. Natalie Kurinij
Dr. Ellen Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Carmen P. Moten
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Ms. Maria Roos
Ms. Karen Robinson Smith
Ms. Judy Stein
Mr. John Whitaker
Other NIH Staff Present:
Dr. Luigi Giacometti, DRG
Dr. Leonard Jakubczak, DRG
Dr. Carole Jelsema, DRG
Dr. Samuel C. Rawlings, DRG
Dr. Michael Sesma, NIGMS
Ms. Peggy Schnoor, OD
Food and Drug Administration Staff Present:
Dr. Wiley A. Chambers
Dr. A. Ralph Rosenthal
The following members of the general public were present at the open session:
Ms. Joanne G. Angle, Association for Research in Vision and Ophthalmology
Dr. Israel Goldberg, Health Research Associates, Inc.
Mr. Steve Miller, American Academy of Ophthalmology
Mr. Frank Morris, AAO
Dr. Paul J. O'Brien, Health Research Associates, Inc
Dr. John Whitener, American Optometric Association
Open Portion of the Meeting
I. Call to Order and Opening Remarks
Dr. Kupfer called the meeting to order and welcomed the Council members and guests. He thanked Dr. Richard H. Masland who had agreed to participate in the meeting as a Special Council Consultant. Dr. Masland is Professor of Neuroscience and Professor of Ophthalmology at the Harvard Medical School in Boston. Dr. Kupfer thanked the retiring Council members, Drs. Felix, Kaufman, and Shovlin, for their outstanding service to the Institute.
II. Confidentiality / Avoidance of Conflict of Interest
Dr. Jack A. McLaughlin, Associate Director for Extramural Research, NEI, and Executive Secretary of the Council, reviewed policies and procedures regarding confidentiality and avoidance of conflict of interest situations.
III. Consideration of Minutes of Previous Meeting
The minutes of the Council meeting of June 6, 1996, were considered and approved as submitted.
IV. Future Meeting Dates
The following dates were agreed upon for future Council meetings:
January 23, 1997
June 12, 1997
September 11, 1997
V. Meeting of the National Advisory Council and Board Representatives
Earlier in the year, Dr. Harold Varmus, Director, NIH, had invited representatives from each of the Institute Advisory Councils and Boards to meet with him. He indicated that he would like to have a closer working relationship with the Councils and Boards and that future meetings would take place on an "as needed" basis. Dr. David C. Beebe represented the NAEC at the first meeting of this group, held on March 14. Dr. Diane L. Hatchell attended a second meeting, held on June 18, following the regular meeting of the Advisory Committee to the Director, NIH. She presented a summary of the meeting and led an NAEC discussion on the matter. Four working groups were established to address the role of Institute Councils and Boards in the following areas: (1) Intramural Research; (2) Grant Review; (3) Strategic Planning; and, (4) Advocacy. Dr. Hatchell reviewed the preliminary recommendations of each of the Working Groups. The NAEC expressed enthusiasm for the various recommendations to improve and expand NIH outreach and public information efforts. Members felt that the NAEC's track record of leading NEI's long-range planning activities could be a model for the strategic planning efforts of other NIH Councils and Boards. Some interest was expressed in receiving more feedback from NEI staff regarding the NAEC-reviewed applications that were ultimately funded. Dr. Hatchell finished her presentation by saying that this had been a very productive meeting and that the National Advisory Council and Board representatives had demonstrated a high level of energy and enthusiasm for getting things done. She said that the opportunity to discuss commonalities and differences in the function of Councils and Boards across the NIH, one of the goals of these meetings, had been a very positive experience.
VI. Extramural Research Program
Dr. McLaughlin's presentation covered the FY 1997 President's Budget (P.B.) request for NEI extramural programs and the latest funding estimates for FY 1996. He said that the P.B. request would allow for a 1.9% increase over the comparable FY 1996 level. This increase is less than the projected FY 1997 Biomedical Research and Development Price Index of 3.7%.
Dr. McLaughlin pointed out that the overall distribution of funds among the various extramural categories of support is similar to previous years, continuing a long tradition of emphasizing research project grants for individual investigators. He indicated that the budget for Small Business Innovation Research Awards and the Small Business Technology Transfer Grants is scheduled to increase from 2.0% to 2.5% of the extramural budget.
At the P.B. level of support, NEI would be able to fund approximately the same number of total research project grants in FY 1997 as it will in FY 1996. However, the underlying assumption in this estimate is that NIH would provide noncompeting grant increases of 2% on average, rather than the usual 4% increase to offset the costs of inflation, and that the average cost of competing grants would increase by no more than 2%. Dr. McLaughlin indicated that the NEI success rate at the P.B. level would be comparable to the FY 1996 figure, but to achieve this, NEI program directors would probably have to make larger cuts from recommended levels than has been the case in recent years.
VII. "Electronic Council Books"
Dr. Loré Anne McNicol, Program Director, Corneal Diseases, reported that the NEI had joined several other NIH Institutes in pilot testing an Internet-based "Electronic Council Book" system that provides access to summary statements. The hope is that this new system will simplify and reduce the costs of application-related communications with NAEC members. A prototype of this system was developed by staff at the National Institute on Aging and has been in use for about a year. The NIH Division of Computer Research and Technology has upgraded the system with a more powerful search engine and modified it for eventual NIH-wide use.
Because of the confidential nature of summary statements, the new system is access-restricted and password-protected. Council members will be able to read summary statement text on their computer screens, save text to a file or disk, and/or print out a hard copy. Summary statements can be accessed and sorted using a variety of search parameters.
Dr. McNicol concluded her remarks by saying that a demonstration of the new system would take place during the lunch break at the January 1997 Council meeting. All Council members will be given access to the system shortly thereafter. As needed, special application materials, staff action sheets, and letters from applicants will continue to be mailed to Council members. Complete table books of summary statements and related materials will continue to be made available to members at Council meetings.
VIII. Report on Rating of Grant Applications
Dr. Andrew P. Mariani, Chief, Scientific Review Branch, presented an overview of the "Report on Rating Grant Applications." This report was prepared by a subcommittee of the NIH Committee on Improving Peer Review. A summary of this report, the full text, and an update is available via an NIH Internet site (http://www.nih.gov/grants/peer/rga.htm). The subcommittee had been charged with the task of examining the process by which NIH scientific review groups rate grant applications and making recommendations to improve that process.
Dr. Mariani reviewed the series of recommendations contained in the report. The Council agreed with the conclusion that the current rating system works reasonably well. Some members expressed the opinion that most of the recommendations seemed trivial. There was strong, uniform support for retaining a reviewer-assigned "global" rating of scientific merit.
IX. Workshop on Neurotrophic Factors
Dr. Maria Y. Giovanni, Program Director, Fundamental Retinal Processes, presented a brief summary of a June 7 workshop entitled, "The Potential Therapeutic Use of Neurotrophic Factors for Ocular Diseases." Dr. Roy H. Steinberg was instrumental in organizing the workshop, and several other Council members also participated. The workshop brought together a group of basic scientists, clinicians, representatives from biotechnology companies, and NEI and FDA staff scientists to discuss the latest research on neurotrophic factors, their potential therapeutic use in various neurodegenerative retinal diseases, drug delivery systems, clinical trial design and conduct, and regulatory issues.
Dr. Giovanni thanked the NIH Office of Rare Diseases Research for providing funds to support the travel costs of the individuals who spoke at the workshop. She said that a summary of the workshop proceedings was in preparation. The Council members who had attended the workshop spoke very highly of it, and indicated that although this was a high-risk area of research, the potential payoff could be great.
X. Eye Care Technology Forum
Dr. Leon B. Ellwein, Special Advisor to the Director, NEI, briefed the Council on the preparation and tentative agenda for the fourth Eye Care Technology Forum that would be held on October 10-11, 1996. He related that the Forum had been established in 1992 to bring together various parties interested in improving upon the way in which ophthalmic drugs, devices, and procedures are developed, evaluated, and ultimately brought to the patient. Forums were held in 1992, 1993, and 1994, with representatives from industry, government, academia, and eye care provider organizations. The fourth Forum will address six topics: (1) Eye Irritation Testing: Issues and Opportunities; (2) Patient Reported Eye Care Outcomes: Measurement and Importance; (3) Intraocular Delivery of Therapeutic Molecules; (4) Regulation and Clinical Trials; (5) Off Label Use of Drugs and Devices: Issues in Aligning Product Labeling with Common Medical Practices; and, (6) Issues in Facilitating Availability of Safe and Effective Devices: Lasers for Refractive Surgery. Dr. Ellwein said that the Forum provides a "no fault" setting for improved communication among various constituencies along the complex technology chain linking research with eye care. The hope is that this improved communication can accelerate and make more efficient the processes of developing new eye care products and services.
XI. Update: Program Planning
Mr. Michael Davis, NEI Associate Director for Science Policy and Legislation, informed the Council that it was time to begin work on development of the next long-range plan for vision research. To that end, the Vision Research Program Planning Subcommittee of the NAEC has been reconstituted, and Dr. Beebe has agreed to serve its Chair. Dr. Higginbotham will also serve on the Subcommittee with additional members to be appointed at a later date. Mr. Davis invited any interested Council members to remain for a short meeting of the Subcommittee to plan the first steps in the development process.
Closed Portion of the Meeting
The next portion of 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).
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.
XII. Consideration of Research and Training Applications
The Council considered 284 research and training applications requesting $287.9 million in total costs. The Council recommended 263 applications with a total cost of $179.4 million.
Dr. Kupfer adjourned the meeting at approximately 5:00 p.m. on September 12, 1996.
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Jack A. McLaughlin, Ph.D. (01/03/97)
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute
Carl Kupfer, M.D. (01/09/97)
National Advisory Eye Council
National Eye Institute
These minutes will be submitted for the approval of the Council at the next meeting. Any corrections or notations will be incorporated in the minutes of that meeting.
This version of the Council minutes has been edited. A complete, printed copy of the official Council minutes, including attachments, may be obtained from:
Ms. Lois M. DeNinno
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-9110
FAX: (301) 402-0528