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NAEC Meeting Minutes - February 14, 2002

National Institutes of Health
National Eye Institute

Minutes of Meeting

February 14, 2002

The National Advisory Eye Council (NAEC) convened for its one hundredth meeting at 8:30 a.m. on Thursday, February 14, 2002, in Conference Room G, 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 12:15 p.m. for the review of grant applications and the review of the report of the Board of Scientific Counselors. The meeting was open to the public from 1:15 p.m. until adjournment at 4:10 p.m. Attachment A provides a roster of Council members.

Council members present:

Dr. Ruben Adler
Dr. Mildred M. G. Olivier
Dr. Roy W. Beck (ad hoc)
Dr. P.Sarita Soni
Dr. Dean Bok
Dr. J. Wayne Streilein

Dr. Martha C. Constantine-Paton
Dr. Larry J. Takemoto
Dr. M. Rosario Hernandez
Dr. Karla Zadnik
Dr. Gordon E. Legge
Dr. Marco A. Zarbin (Ex Officio)

Council members absent:

Ms. Patricia Cleary
Mr. Richard J. Salem
Lt. Col. William J. Flynn (Ex Officio)

NEI staff present:

Ms. Louise Amburgey
Dr. Natalie Kurinij
Ms. Margie Baritz
Dr. Ellen S. Liberman
Dr. Mary Frances Cotch
Dr. Andrew P. Mariani
Mr. William W. Darby
Ms. Michele Lyles
Mr. Michael Davis
Dr. Jack A. McLaughlin
Ms. Linda Dingle
Dr. Loré Anne McNicol
Dr. Peter A. Dudley
Dr. Richard Mowery
Ms. Judith Duff
Ms. Kathleen Moy
Ms. Lois Eggers
Dr. Michael D. Oberdorfer

Mr. Donald F. Everett
Dr. Samuel Rawlings
Dr. Richard S. Fisher
Dr. Maryann Redford
Ms. Carol Fivozinsky
Ms. Karen Robinson Smith
Dr. Ralph J. Helmsen
Dr. John Paul SanGiovanni
Dr. Jeanette Hosseini
Dr. Paul Sieving
Dr. Chyren Hunter
Ms. Marie Watkins
Ms. Rosie Janiszewski
Mr. John Whitaker
Ms. Tina Jones

Other National Institutes of Health (NIH) staff present:

Dr. Michael Chaitin, CSR
Dr. Christine Melchior, CSR
Dr. Mary Custer, CSR
Ms. Marie Willet, OER, OD, NIH
Dr. Carole L. Jelsema, CSR

Members of the general public present at the open session:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology
Ms. Carrie Kovar, American Academy of Ophthalmology
Ms. Sarah Milo, National Alliance for Vision Research
Dr. Santa Tumminia, Foundation Fighting Blindness
Dr. John Whitener, American Optometric Association

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).


Dr. Paul A. Sieving, Director, NEI, and Chair of the Council, called the meeting to order and welcomed the Council members to the one hundredth meeting of the National Advisory Eye Council.


Dr. Sieving introduced a new member present for his first meeting of the National Advisory Eye Council (NAEC), Dr. Ruben Adler, the Arnall Patz Distinguished Professor of Ophthalmology, Johns Hopkins University School of Medicine. Dr. Adler received his M.D. degree from the University of Buenos Aires, and pursued postgraduate training in embryology and development in the Institute of Anatomy at the University of Buenos Aires, and in the Hubrect Laboratory at the University of Utrecht. He held faculty positions at the University of Buenos Aires and the University of California, San Diego, before joining Johns Hopkins. Dr. Adler’s outstanding research on neurotrophic factors and the development of the visual system has garnered many awards and honors, including the Alcon Award for outstanding contributions to vision research.

Dr. Sieving noted that Council members Patricia Cleary and Richard Salem were unable to attend this meeting. He introduced Dr. Roy W. Beck, Professor of Ophthalmology, Epidemiology, and Biostatistics at the University of South Florida and Executive Director of the Jaeb Center for Health Research. Dr. Beck graciously agreed to serve as an ad hoc member for this meeting. Dr. Beck received his M.D. from the University of Pennsylvania and his Ph.D. in Epidemiology from the University of South Florida. He then served as Assistant Professor of Ophthalmology, Neurology, and Neurosurgery and Director of the Neuro-ophthalmology Service at the University of Michigan before returning to Florida. Dr. Beck is well known for his clinical trials research experience.

Dr. Sieving indicated that the NEI recently had word that Department of Defense liaison member to the NAEC, Dr. William Flynn, has been reassigned. Institute staff has appreciated his insight and knowledge. A replacement has not yet been appointed.

Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, and Executive Secretary of the Council introduced Scientific Review Administrators from the Center for Scientific Review (CSR): Dr. Michael Chaitin (VISC), Dr. Mary Custer (VISA), Dr. Carole Jelsema (Chief, Molecular, Cellular, and Developmental Neuroscience Integrated Review Group), and Dr. Chris Melchior (Chief, Integrative, Functional, and Cognitive Neuroscience Integrated Review Group).

Dr. McNicol also introduced Ms. Marie Willet, a visitor from the Office of Extramural Programs, Office of Extramural Research, OD, NIH.


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.


The Council considered 345 research and training applications requesting $413.1 million in total all year costs. The Council recommended 334 applications with a total all year cost of $400.2 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.


As required by the Public Health Service Act, each NIH Institute annually provides its Council a written description of the research reviewed by its Board of Scientific Counselors (BSC), and the results of that review. The Council may make recommendations to the Director, NEI, regarding this research. The Council first considered the June 3-4, 2001, BSC report on the Laboratory of Molecular and Developmental Biology (LMDB) and the Tenure Review of Dr. Stanislav I. Tomarev, LMDB. Dr. Joram Piatigorsky, Chief, LMDB, gave a presentation on his work involving investigations of lens and corneal epithelial crystallins and the refracton hypothesis. Next, Council considered the December 3-4, 2001, BSC report on the Laboratory of Retinal cell and Molecular Biology (LRCMB) and the tenure review of Dr. Karl Csaky of the Laboratory of Immunology. Dr. Barbara Wiggert, Chief, LRCMB, gave a presentation on her work involving the elucidation and the control of gene expression in the neural retina and retinal pigmentary epithelium. Dr. Robert Wurtz, Acting Scientific Director, NEI, was available to present his response to the reports and to answer questions regarding implementation of the BSC recommendations.

Open Portion of the Meeting


Dr. Sieving welcomed guests attending the open portion of the meeting. Dr. McNicol announced that the Division of Extramural Research has a new single point of telephone contact: 301-451-2020. Members and guests were urged to make note and change the number in their personal directories.


The minutes of the November 20, 2001, NAEC meeting were considered and approved as submitted.


The following dates were agreed upon for future Council meetings:

June 13-14, 2002 (the 14th will be a half day meeting for program planning)
September 12-13, 2002
January 23-24, 2003
June 12-13, 2003
September 11-12, 2003

Council members were asked to keep these dates reserved as they make future plans and obligations.


Dr. McNicol noted that this is the 100th meeting of the NAEC. To mark the occasion, she briefly reviewed a document presenting highlights from the history of the Council in order to recognize and illustrate its contributions to the mission of the NEI and field of vision research.


Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the FY2002 NEI and NIH budgets. After operating under a series of continuing resolutions, the NIH received an FY2002 appropriation of $23.6 billion, which is a 15.0% increase over FY2001. Within this budget, NEI received a $582.9 million appropriation, which is a 14.4% increase over FY2001. This marks the fourth year of double digit increases, and the NEI received the second highest percentage increase of the categorical NIH Institutes and Centers, lagging behind only the large increases for the National Institute of Allergy and Infectious Diseases designated for bioterrorism and for international funds for AIDS, tuberculosis, and malaria control. Despite this welcome news, the NEI is still behind in achieving the goal of a doubling of the budget over a five year period.

The FY2002 NIH appropriation bills and conference reports stressed the importance of genetic approaches to retinal and other blinding eye diseases. Legislation raised the salary cap for extramural investigators, provided increased funds for new National Institute of Biomedical Imaging and Bioengineering, and raised the Program Evaluation tap from 1% to 1.25%.

The $582.9 million NEI FY2002 appropriation is distributed among extramural grants and research and development contracts 87.6%), the Division of Intramural Research (9.5%), and Research Management and Support (2.9%).

The FY2003 budgets for the NEI and NIH are being prepared. The administration’s budget calls for a 15.7% increase in the NIH budget, from $23.6 to $27.3 billion. The NEI budget is recommended for an 8.4% increase from $582.9 to $631.8 million. NIH House budget testimony will be held in March/April with five theme panels. The NEI will participate in the panel on health promotion and disease prevention. Senate overview hearings are scheduled for April 11, possibly to be followed by a few panels. Citizen witness hearings will follow after the appropriations hearings.


Dr. McNicol reviewed budget trends for the extramural research program in FY2002. During the series of continuing resolutions, no new program initiatives were funded and no supplemental awards were made. Competitive grants, on average, were funded at the FY2001 level. Continuing grants, on a grant-by-grant basis, were issued at or below the FY2001 level. With the final appropriation, the continuing grants were revised to the committed level.

Dr. McNicol reviewed the history of the extramural budget authority, and described expected funding actions for FY2002. The NEI anticipates funding approximately 1727 grants, compared with 1631 grants in FY2001, an increase of 96. The double-digit budget increase which the NEI received for FY2002 will permit an increase in the annual total cost of grants by an average of 5% ($14,717). The NEI intends to fund a number of new scientific initiatives. These include a shared technology enhancement supplement program, Vision Research Infrastructure Development Grants, strategies to identify the genetic basis of diabetic retinopathy, novel approaches to corneal tissue engineering, a diabetic macular edema network, an SBIR/STTR technology initiative, and an ocular albinism initiative. In addition, the NEI will collaborate with other NIH Institutes and Centers in co-funding research opportunities in studies of ocular melanoma, diabetic complications, bioengineering, autoimmunity, computational neuroscience, global health research, and the social and cultural dimensions of health.


Mr. William W. Darby, Grants Management Officer, reviewed the NAEC operating guidelines and directed attention to the section with the recommended response to deflect personal contacts from applicants. No changes to the document were proposed. Council members approved the guidelines.


Mr. Michael Davis, Associate Director for Science Policy and Legislation, NEI, reviewed the Government Performance and Results Act (GPRA) requirements for yearly performance plans and assessments. At the June, 2002, meeting, the staff will present Council with an outline for Program Planning and GPRA activities.


Dr. Natalie Kurinij, Group Leader, Epidemiology and Clinical Studies, NEI, presented recently published results from the NEI-supported Age Related Eye Disease Study (AREDS). The purpose of the study was two-fold: to assess the clinical course, prognosis, and risk factors of age-related macular degeneration (AMD) and cataract; and to evaluate through randomized clinical trials the effects of pharmacologic doses of (1) antioxidants and zinc on the progression of AMD, and (2) antioxidants on the development and progression of lens opacities. Men and women between the ages of 55 and 80 years whose macular status ranged from no evidence of AMD in either eye to relatively severe disease with vision loss in one eye but good vision in the fellow eye were eligible for the study, provided that their ocular media were sufficiently clear to allow good fundus photography. A total of 4,757 patients were randomized to treatment with placebo, antioxidants, zinc, or antioxidants and zinc and followed for a minimum of five years.

Results to date indicate that people at high risk of developing advanced stage AMD lowered their risk by about 25% when treated with a high-dose combination of vitamin C, vitamin E, beta-carotene, and zinc. In the same high risk group, the nutrients reduced the risk of vision loss caused by advanced AMD by about 19%. For those study participants who had either no AMD or early AMD, the supplements did not provide an apparent benefit.

In the cataract portion of the study, researchers discovered that the same nutrients had no significant effect on the development or progression of age-related cataract.

Council members commended the study, and noted that although the nutrients would not cure AMD nor restore lost vision, they may play a key role in helping people at high risk for developing advanced AMD keep their vision.


Dr. Chyren Hunter, NEI Training Officer, reviewed the past history of NEI support for conference grants and proposed policy changes for the next fiscal year. The purpose of conference grants would be to support meetings which address high impact and cutting edge scientific areas of research; to bring vision researchers together with scientists from other disciplines; to provide training opportunities for students and new investigators; and to increase the visibility of opportunities in vision research and the NEI in the broader scientific community. The highest priority for funding would continue to be the U13 cooperative agreement conference grant mechanism. New U13 guidelines would require prior involvement of NEI staff in the planning and development of the meeting and application; multi-year funding would be permitted; and the application would be reviewed in NEI-organized initial review groups. Meeting outcomes would frequently be published as reports on the NEI web site. Investigator-initiated R13 conference grant applications would be a lower priority. R13s could not receive multi-year funding, NEI support would be credited in advertising and publications related to the meeting, and the applications would be reviewed in Center for Scientific Review initial review groups.

Council members enthusiastically passed a motion to change the conference grant guidelines and to permit expedited funding through staff administrative review of applications for less than $50,000 annual direct costs.


Dr. McNicol described NEI participation in the NIH Clinical Research and Pediatric Research Loan Repayment Programs, which is available on the internet at http://lrp.info.nih.gov Initiated by PL 106-310, these programs will repay up to $35,000 per year of eligible educational loans, plus the accompanying income tax burden, for two years; they may be renewed. Eligible candidates must be US citizens, permanent residents, or non-citizen nationals with a doctoral-level degree who are pursuing patient-oriented clinical research and are carrying total qualifying educational debt in excess of 20% of annual income. For FY2002 the eligible NEI affiliation includes first-time support as Principal Investigator on an R01, R03, R21, or U01 research grant; first-time support as director of a subproject on a U10 cooperative clinical research grant; support on an F32 or T32 postdoctoral training grant; or support on a K08 or K23 physician scientist training grant. For FY2003 and beyond eligible individuals may be supported by any Federal Agency or non-profit organization as well as the NEI.

Application is made yearly, on line to the NIH Office of Loan Repayment, with review performed by a panel of outside scientists convened by the NEI. The review criteria are a personal statement of career goals, current research, proposed research, and letters of recommendation. Applicants will be notified by July 31 and the contracts awarded in August/September.

An overview of the first competition will be presented to Council at their June 13-14, 2002, meeting.


Dr. Sieving adjourned the meeting at 3:45 p.m. on February 14, 2002.


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.
National Advisory Eye Council
National Eye Institute

These minutes will be submitted for the approval of the Council at the June 13-14, 2002, meeting. Any corrections or notations will be incorporated into the minutes of that meeting. A complete, printed copy of the Council minutes, including attachments, may be obtained from:

Ms. Marie E. Watkins
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: mew@nei.nih.gov


Attachment A


(Terms end 11/30 of the designated year)

Dean Bok, Ph.D. (02)
Professor of Neurobiology and Ophthalmology
University of California, Los Angeles
Los Angeles, CA 90095-1763

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

Martha C Constantine-Paton, Ph.D. (03)
Professor of Biology
Massachusetts Institute of Technology
Cambridge, MA 02139

M. Rosario Hernandez, D.D.S. (02)
Associate Professor of Ophthalmology
Washington University
St. Louis, MO 63110

Gordon E. Legge, Ph.D. (03)
McKnight Distinguished University Professor of Psychology
University of Minnesota Twin Cities
Minneapolis, MN 55455-0344

Mildred M. G. Olivier, M.D. (04)
President and CEO
Midwest Glaucoma Center, P.C.
Hoffman Estates, IL 60194

Richard J. Salem, J.D. (01)
Senior Partner
Salem, Saxon, and Nielsen, P.A.
Tampa, FL 33602

P. Sarita Soni, O.D. (03)
Professor of Optometry & Visual Science
Indiana University
Bloomington, IN 47405

J. Wayne Streilein, M.D. (04)
President and Director of Research
Schepens Eye Research Institute
20 Staniford ST
Boston, MA 02114

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

Karla Zadnik, O.D., Ph.D. (04)
College of Optometry
Ohio State University
Columbus OH 43210-1240

Department of Defense Representative


Department of Veterans Affairs Representative

Marco Z. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103
Ad Hoc Member

Roy W. Beck, M.D.
Jaeb Center for Health Research
Tampa, FL 33613

Ex Officio Members

Tommy G. Thompson
Department of Health & Human Services
Washington, DC 20201

Ruth L. Kirschstein, M.D.
Principal Deputy Director
National Institutes of Health
Bethesda, MD 20892


Paul A. Sieving, M.D., Ph.D.
National Eye Institute
National Institutes of Health
Bethesda MD 20892

Executive Secretary

Loré Anne McNicol, Ph.D.
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892