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NAEC Meeting Minutes - October 29, 1999

Department of Health and Human Services
National Institutes of Health

National Eye Institute

October 29, 1999

The National Advisory Eye Council (NAEC) convened for its ninety-third meeting at
8:30 a.m. on Friday, October 29, 1999, in Conference Room H, 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 10:45 a.m., followed by the closed session review of the intramural research program and grant applications until adjournment at 12:30 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. Anthony J. Adams
Dr. Constance Cepko
Lt. Col. William J. Flynn (Ex Officio)
Dr. M. Rosario Hernandez
Dr. David H. Hubel
Dr. Millicent Knight
Dr. Anthony B. Nesburn
Dr. Larry J. Takemoto (by teleconference)
Dr. Marco A. Zarbin (Ex Officio)
Dr. David S. Zee

Council members absent:

Dr. Dean Bok
Ms. Patricia A. Cleary
Mr. Sanford Cloud, Jr.
Mr. Richard T. Hellner

NEI Staff Present:

Ms. Margie Baritz
Dr. Mary Frances Cotch

Mr. Michael Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Ms. Judith A. Duff
Ms. Lois Eggers
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Maria Y. Giovanni
Dr. Ralph J. Helmsen
Dr. Chyren Hunter
Dr. Carl Kupfer
Dr. Natalie Kurinij
Dr. Ellen Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. LorÈ Anne McNicol
Ms. Kathleen Moy
Dr. Robert B. Nussenblatt
Dr. Michael Oberdorfer
Ms. Karen Robinson Smith
Ms. Judy Stein
Mr. John Whitaker

Other NIH Staff Present:

Dr. Luigi Giacometti, CSR
Dr. Len Jakubczak, CSR
Dr. Carole Jelsema, CSR
Mr. Richard Swaja, OD

Food and Drug Administration Staff Present: Dr. Wiley Chambers

The following members of the general public were present at the open session:

Dr. Israel A. Goldberg, Health Research Associates
Dr. Elaine Young, Juvenile Diabetes Foundation International

Open Portion of the Meeting

1. Call to Order and Opening Remarks

Dr. Carl Kupfer, Director, NEI, called the meeting to order and welcomed the Council members and guests. He noted that this would be the last Council meeting for Drs. Hubel, Knight, and Zee, the retiring members, and thanked them for their hard work and dedication.

Confidentiality / Avoidance of Conflict of Interest

Dr. Jack A. McLaughlin, Deputy Director, NEI, and Executive Secretary of the Council, 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 were later asked to sign a statement certifying that they were absent during such discussions.

2. Announcements

Dr. McLaughlin thanked the Council members for their patience and help in rescheduling the meeting. The original date for the Council meeting had been abandoned because of the immediate threat of hurricane Floyd in the Washington, D.C. area. He also thanked the extramural staff, who, from a logistical standpoint, had done “double duty” in getting ready for the meeting.

He announced that Dr. Scott Whitcup, Clinical Director, NEI, would be leaving the Institute at the end of December. Dr. Whitcup had accepted a senior position at Allergan, Inc. Dr. McLaughlin said that NEI would soon launch a major recruitment effort for Dr. Whitcup’s replacement.

Dr. McLaughlin said that the end of the fiscal year also marked the retirement of Ms. Carolyn Grimes, Grants Management Officer, NEI. Ms. Grimes had worked for the federal government for 31 years, most of that time at NEI. She was the focal point for the fiscal and administrative management of the NEI grants program. Dr. McLaughlin said that Ms. Grimes made a tremendous contribution to vision research, helping numerous extramural investigators by her prompt, efficient response to their requests for information and help.

Dr. McLaughlin announced that Mr. William W. Darby had been recruited to fill the position vacated by Ms. Grimes. Mr. Darby comes to NEI from the National Heart, Lung, and Blood Institute, where he had been chief Grants Management Officer, responsible for the business management and fiscal stewardship of its $1.3 billion extramural research program. Dr. McLaughlin said that Mr. Darby had considerable interest and experience in the development of NIH-wide grants management data automation initiatives, and that he was already hard at work at NEI on management information systems and other issues.

Consideration of Minutes of Previous Meeting

The minutes of the June 10, 1999, Council meeting were considered next and approved as submitted.

3. Future Council Meeting Dates

1. The following dates were agreed upon for future Council meetings:

February 10, 2000
June 8-9, 2000
September 14-15, 2000

4. Budget Overview

Ms. Carol Fivozinsky, Budget Officer, NEI, summarized the NEI budget for FY 1999 and reviewed the status of the FY 2000 appropriation. She said that in FY 1999, NIH had received an overall increase of almost 15% or $2 billion over the FY 1998 level. The NEI received a budget of about $397 million, an increase of 11.7% ($42 million) over FY 1998. With regard to the FY 2000 appropriation, Ms. Fivozinsky said that the Administration’s budget request proposed a 2% increase for both NIH and NEI. The House appropriations subcommittee subsequently proposed an 8% increase for NEI, and the Senate approved a 12.2% increase in its version of the bill. The comparable increases proposed for NIH were 8.7% and 12.8%, respectively. She said that a series of short term funding bills were needed to fund NEI and NIH during the budget negotiations. Ms. Fivozinsky said that a Conference Report that had been filed two days earlier would provide NEI with a 14.1% increase over FY 1999 level, but that the “compromise legislation” had not been approved by either the House or Senate.

5. Panel On Scientific Boundaries For Review

Dr. McLaughlin reviewed the current organization of the Center for Scientific Review (CSR), focusing on the Initial (now Integrated) Review Groups (IRGs) and associated study sections that review vision research applications. He then summarized the recommendations presented in the draft Phase I Report of the Panel on Scientific Boundaries for Review. Dr. McLaughlin said that it was his understanding (later confirmed directly by Dr. Ehrenfeld, Director, CSR) that no immediate changes were being proposed for the IRGs or study sections that review most vision research applications. He said that there had been little input into the CSR deliberations from vision scientists thus far. Council members said that the current vision-related study sections (VISA, VISB, and VISC) were doing an excellent job of identifying highly meritorious applications. Thus, the members were pleased to learn that no major changes were being proposed by CSR for the near term. Nonetheless, members expressed considerable concern that vision scientists had not participated in CSR deliberations and felt strongly that this situation should be remedied as soon as possible. The Council wished to bring this matter to the attention of the Director, NIH, and prepared and transmitted a statement (Attachment B) expressing its concern.

6. Modular Grant Awards

Dr. Lore Anne McNicol, Acting Director, Vision Research Program, reminded the Council that beginning with the April, 1999 receipt date, NIH introduced modular grant application and award procedures. Modular grants were designed to streamline the application process, reduce administrative burden, and disengage review from complex budget negotiations. Under these procedures all competing R01 (research project grants), R03 (small grants), R15 (Academic Research Enhancement Awards), R41 (Small Business Technology Transfer Research grants), and R43 (Small Business Innovative Research grants) which request no more than $250,000 direct costs in any one year will present the budget in $25,000 increments or modules.

She said that the NIH experience with the first round of modular grant applications was very satisfactory. Approximately 98% of applications that should have been presented in the modular format were indeed submitted that way. Reports from NIH staff attending initial review group meetings were also very positive. The reviews appeared to focus on broad budgetary issues rather than details, and most budgetary reductions were recommended on a module basis.

Dr. McNicol said that the Council would be considering the first summary statements from modular grant applications at its February, 2000, meeting. She said that while the level of the NEI FY2000 appropriation was still unknown, NEI extramural staff would generally make grant reductions, if necessary, in a manner which preserves the modular award concept. Dr. McNicol said that routine adjustments, e.g., to correct for overlap in support, would continue to be made in a detailed, specific manner, and on a grant-by-grant basis.

7. Functional Genomics Workshop

Dr. Maria Giovanni, program director, Division of Extramural Research, summarized the results of the NEI Functional Genomics Workshop held September 14-15, 1999, in Bethesda. The workshop was organized by NEI staff, Drs. Giovanni, Peter Dudley, and Robert Nussenblatt, with much input provided by Council members Drs. Dean Bok and Connie Cepko. The co-chairs of the workshop were Dr. Cepko and Dr. Val Sheffield. Dr. Bok chaired a breakout group. Council member Dr. Nesburn also attended the meeting. The goal of the workshop was to provide the Council with a set of recommendations for the development of the genomic resources that will facilitate understanding of the normal visual system and related disorders and diseases. The need for expanded access to genomic resources had been one of the top priorities established by the Council in Vision Research - A National Plan: 1999-2003.

The workshop participants included vision scientists with a working knowledge of genomics and scientists outside of the field of vision research with expertise in the area of functional genomics. Other participants included scientists with strong technological expertise from biotechnology and pharmaceutical companies. Presentations were made by a number of leading investigators in this area, including Dr. Eric Green, National Human Genome Research Institute (NHGRI), Dr. Bento Soares, University of Iowa, Dr. Jeffrey Trent, NHGRI, and Dr. Robert Strausberg, National Cancer Institute.

A number of recommendations emerged from the workshop. Strong support was expressed for the creation of a visual system web site that would enhance access to existing or newly created databases for genes expressed in the visual system, gene expression patterns, monoclonal antibodies, microarray data, cDNA clones and libraries, animal models with visual system mutations, etc. Another recommendation was to expand the generation cDNA libraries from various tissues in the visual system with the ultimate goal of identifying all of the genes expressed in the visual system. A third recommendation was to help support microarray centers for groups of investigators across the country. A recurrent theme during the workshop was that these resources should be made publicly available to the community in a timely manner. The Council was very supportive of these and other workshop recommendations and urged NEI staff to begin implementing them as soon as possible.

8. Genetics Of Eye Complications Of Diabetes

Dr. Peter A. Dudley, program director, Division of Extramural Research, proposed that NEI sponsor a workshop on the genetics of diabetic retinopathy. He informed the Council that there had been general interest on the part of the diabetic retinopathy research community for such a meeting, and that it was a scientific area highlighted in Vision Research - A National Plan: 1999-2003. Dr. Dudley said that the National Institute of Diabetes and Digestive and Kidney Diseases and the Epidemiology of Diabetes Interventions and Complications Study Group were also interested in expanding genetic research on the complications of diabetes. The Council was enthusiastic about a workshop on the genetics of diabetic retinopathy and endorsed the concept.

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).

9. Review of Intramural Research Program

The Council considered the recommendations of the Board Of Scientific Counselors (BSC) regarding their review of the Laboratory of Mechanisms of Ocular Diseases. Dr. Robert Nussenblatt, Director, Division of Intramural Research, was present during these discussions to give his response to these recommendations and to respond to questions from Council members.

10. Review of Research and Training Applications

The Council considered 459 research and training applications requesting $497.5 million in total costs. The Council recommended 429 applications with a total cost of $435.2 million. 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.

11. Adjournment

Dr. Kupfer adjourned the meeting at 12:45 p.m. on October 29, 1999.


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.
Executive Secretary
National Advisory Eye Council
Deputy Director
National Eye Institute

Carl Kupfer, M.D.
National Advisory Eye Council
National Eye Institute

These minutes will be submitted for the approval of the Council at the February 10, 2000, meeting. Any corrections or notations will be incorporated in the minutes of that meeting. A complete, printed copy of the 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
e-mail: lmd@nei.nih.gov


Attachment A

National Advisory Eye Council

National Eye Institute

(Terms end 11/30 of the designated year)


Adams, Anthony J., O.D., Ph.D. (00)
Dean and
Professor of Vision Science & Optometry
School of Optometry
University of California, Berkeley
Berkeley, CA 94720

Bok, Dean, Ph.D. (02)
Jules Stein Eye Institute
University of California, Los Angeles
Los Angeles, CA 90095

Cepko, Constance, Ph.D. (01)
Department of Genetics
Howard Hughes Medical Institute
Harvard Medical School
Boston, MA 02115

Cleary, Patricia A., M.S. (02)
Senior Research Staff Scientist
Biostatistics Center
The George Washington University
Rockville, MD 20852

Cloud, Jr., Sanford (01)
President and CEO
The National Conference
New York, NY 02115

Hellner, Richard T. (00)
President & CEO
Prevent Blindness America
Schaumburg, IL 60173
Hernandez, M. Rosario, D.D.S. (02)
Associate Professor
Ophthalmology & Visual Sciences
Washington University
St. Louis, MO 63110

Hubel, David H., M.D. (99)
John Franklin Enders
Professor of Neurobiology
Harvard Medical School
Boston, MA 02115

Knight, Millicent L., O.D. (99)
North Shore Eye Center
Evanston, IL 60201

Nesburn, Anthony B., M.D. (00)
Ophthalmology Research Laboratories
Cedars-Sinai Medical Center
Los Angeles, CA 90048

Takemoto, Larry J., Ph.D. (02)
Division of Biology
Kansas State University
Manhattan, KS 66506

Zee, David S., M.D. (99)
Professor of Neurology, Ophthalmology,
Otolaryngology & Neuroscience
Johns Hopkins University
School of Medicine
Baltimore, MD 21287

Ex Officio Members
Shalala, Donna E., Ph.D.
Department of Health and Human Services
Washington, D.C. 20201

Varmus, Harold, M.D.
National Institutes of Health
Bethesda, MD 20892

Kupfer, Carl, M.D. (Chair)
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

Department of Veterans Affairs Representative
Zarbin, Marco A., M.D., Ph.D.
Professor and Chairman
Department of Ophthalmology
UMDNJ-New Jersey Medical School
Newark, NJ 07103

Department of Defense Representative
Flynn, William J., Lt. Col., USAF, MC
Department of Ophthalmology
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Executive Secretary
McLaughlin, Jack A., Ph.D.
Deputy Director
National Eye Institute
National Institutes of Health
Bethesda, MD 20892

Attachment B

November 16, 1999

Harold E. Varmus, MD
National Institutes of Health

Dear Dr. Varmus,

At the meeting of the National Advisory Eye Council on October 29, 1999 the Council discussed the draft Phase 1 Report of the Panel on Scientific Boundaries for Review. While we appreciate the identification of many of the problems of the current scientific review process, such as the conservative review culture and the attention to methodological details at the expense of innovative science, we are troubled by some fundamental aspects of the report and have the following specific concerns.

First, we all know the importance of vision in all aspects of normal human behavior, and the devastating personal toll of blindness on individuals and the financial burden on society. We were astonished that no active vision scientists are members of the Panel on Scientific Boundaries. This deficiency should be rectified immediately.

Second, the proposals of the draft document do not recognize the unique interactions between the eye as a physical organ, the visual system, and the ability to see. The eye is a small organ with many different components. The function of one component always influences the function of the others. Consequently, any research on vision must be judged by scientists who are knowledgeable of how the eye and the visual system work as a whole in normal human beings, and how disorders of individual parts of the whole influence the function of others and lead to loss of vision. Certainly, any peer review group that evaluates research proposals on vision would have to consist of both clinical and basic scientists who represent a broad spectrum of disciplines and include experts on structures as disparate as the cornea, lens, aqueous, eye muscles, retina, optic nerve, etc.

The eye and vision are extraordinarily complex, and they require a special panel of experts to ensure that vision research is properly evaluated so that the best scientific proposals are funded. Many recent advances in health care have been in vision and by vision scientists, e.g., the development of effective treatments for blindness due to diabetic retinopathy and retinopathy of prematurity; the identification of genes involved in inherited retinal degenerations and the development of transgenic animal models and medical treatments for these conditions. Surely, a major reason has been the success of the visual science study sections in identifying the best proposals for funding. In the particular circumstance of vision research, the current system is working well. If the proposed restructuring of scientific review groups does not take these critical issues related to vision research into account, there will likely be a degradation in the quality of vision research which in turn would diminish our ability to improve the health and quality of life of Americans.

Thus, we ask that any restructuring of IRGs consider retaining the present organization in which vision-related proposals are reviewed together. Although we are open to suggestions wherein some vision proposals are reviewed by neuroscience study sections, we cannot accept a complete restructuring without representation. Thus, our most important request is the appointment of eye and vision researchers to the advisory groups and IRG panels who create or recommend changes in the scientific review sections. We urge continued consultation with groups, such as ARVO (Association for Research in Vision & Ophthalmology), who can assist in identifying outstanding individuals for service on these advisory groups and panels.

We thank you for considering our requests and look forward to the favor of a reply.


Members, National Advisory Eye Council