NAEC Meeting Minutes - June 10, 2004

Department of Health and Human Services
National Institutes of Health

National Eye Institute

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

June 10, 2004

The National Advisory Eye Council (NAEC) convened for its one hundred seventh meeting at 8:30 am on Thursday, June 10, 2004, at the Hyatt Regency Bethesda, One Bethesda Center, Bethesda, 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 open to the public from 8:30 am until 1:30 pm. The meeting was closed for the review of grant applications and the report of the NEI Board of Scientific Counselors from 1:30 pm until adjournment at 5:00 pm. Attachment A provides a roster of Council members.

COUNCIL MEMBERS PRESENT:

Dr. Ruben Adler
Dr. Roy Beck
Dr. Suraj P. Bhat
Dr. Eileen E. Birch
Dr. Barrett G. Haik
Dr. Mildred M. G. Olivier
Dr. J. Brian Reed
Mr. Richard J. Salem
Dr. Lois E. Smith
Dr. Mriganka Sur
Dr. Janey L. Wiggs
Dr. Karla Zadnik
Dr. Marco A. Zarbin

SPECIAL CONSULTANT PRESENT:

Dr. Todd Margolis

NEI STAFF PRESENT:

Ms. Louise M. Amburgey
Mr. Robert Alexander
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Dr. Emily Chew
Ms. Janet L. Craigie
Mr. William W. Darby
Ms. Chris A. Davis
Mr. Michael Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Ms. Judith Duff
Dr. Leon Ellwein
Mr. Donald F. Everett
Dr. Richard S. Fisher
Ms. Carol Fivozinsky
Dr. Ralph J. Helmsen
Mr. Tom Hoglund
Dr. Chyren Hunter
Ms. Rosie Janiszewski
Ms. Tina Jones
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Ms. Michele D. Lyles
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Kathleen Moy
Ms. Angelia Neal
Dr. Michael D. Oberdorfer
Dr. Samuel Rawlings
Dr. Maryann Redford
Dr. Jean-Paul San Giovanni
Dr. Grace L. Shen
Ms. Karen Robinson Smith
Dr. Annie E. Schaffner
Dr. Paul Sieving
Ms. Karen Silver
Ms. Judy Stein
Ms. Mary Frances Tillman
Ms. Karen R. Tolson
Dr. Santa Tumminia
Mr. John Whitaker

OTHER NATIONAL INSTITUTES OF HEALTH (NIH) STAFF PRESENT:

Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Christine Livingston, CSR
Dr. Jerome Wujek, CSR

MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Kristen Bicenetti, SWHR
Mr. James Jorkasky, Alliance for Eye and Vision Research
Ms. Odunayo Obisesan, HUH
Ms. Kate Quinlan, Salem Law Group
Mr. Robert Rupp, ARVO
Ms. Eileen Resnick, SWHR
Dr. John Whitener, American Optometric Association
Dr. Elaine Young, University of Florida, Gainesville

THURSDAY, JUNE 10, 2004

OPEN PORTION OF THE MEETING

CALL TO ORDER AND OPENING REMARKS

Dr. Loré Anne McNicol, Director, NEI Division of Extramural Research, (DER) and Executive Secretary of the Council welcomed Council members, staff, and guests to the one hundred seventh session of the NAEC. Dr. McNicol noted the sudden and unexpected death of Council member Dr. Wayne Streilein. She indicated that that Wayne touched the lives of everyone in the room, as a colleague and a friend. He was an enormously gifted and warm person, and will be missed.

Dr. McNicol introduced Dr. Todd P. Margolis, who has graciously consented to act as an ad hoc member. Dr. Margolis is an M.D., Ph.D. clinician scientist who serves as Professor of Ophthalmology and Director of the Francis I. Proctor Institute at the University of California, San Francisco. He is an expert on herpes simplex virus infections of the cornea, and he is presently studying differential gene expression in a transgenic mouse model of HSV latency.

EXTRAMURAL ANNOUNCEMENTS

Dr. McNicol introduced two new staff members. The first, Dr. Houmam Araj, has joined the Scientific Review Branch of the NEI DER as a Scientific Review Administrator. Dr. Araj received his Ph.D. in Biological Sciences from Wayne State University on studies of DNA repair genes in Drosophila and Saccharomyces. He then did postdoctoral work in the Department of Neurosciences at Johns Hopkins, studying the cellular and molecular processes governing repulsive axon guidance mediated by the semaphorin and netrin protein families. Dr. Araj then joined the National Institute of Mental Health as a Scientific Review Administrator. In this position he was responsible for the review of trans-NIH neuroinformatics applications, as well as investigator-initiated grants in the areas of basic and clinical neuroscience and neurogenetics. The DER is very pleased to have recruited an individual with Dr. Araj’s broad scientific and administrative experience.

The second new employee is the new Committee Management Officer, Ms. Janet L. Craigie. Dr. McNicol noted that all Council members have already worked with her in getting to this meeting. Her background includes experience in support services in a private sector digital equipment production company. She also provided administrative support for the Department of Defense Computer Systems Command and the Ft. Belvoir Preventative Medicine Clinic, followed by twelve years at the National Heart Lung and Blood Institute. At NHLBI she worked in the Committee Management Service Center, which provided administrative support for eight different committees within three separate NIH Institutes. Ms. Craigie will have responsibility for support services and administration of the activities of the National Advisory Eye Council, the special emphasis panels convened by the DER Scientific Review Branch, and the NEI Board of Scientific Counselors.

CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

Dr. McNicol next reviewed policies and procedures regarding confidentiality and the 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.

CONSIDERATION OF MINUTES

Dr. McNicol asked for consideration of the minutes of the February meeting. The members voted to approve the minutes as written.

FUTURE COUNCIL MEETING DATES

Dr. McNicol indicated that future meetings are scheduled for a day and a half, and thanked members for their assistance in rescheduling the February meeting. Note that it will take place on a Monday and Tuesday. She requested that members keep these times free on their calendars. The following list of dates were agreed upon:

September 9-10, 2004
February 28-March 1, 2005
June 9-10, 2005
September 22-23, 2005

BUDGET OVERVIEW

Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the NEI budget. She reminded Council that FY2003 was the final year of a five year period of the doubling of the NIH budget, and that the budget increases for FY2004 and those proposed for FY2005 are relatively smaller: For FY2004 the enacted NEI budget is $652.7M, a 3.2% increase over the FY2003 level. For comparison, the FY2004 enacted NIH budget is $28.0B, a 3.1% increase over the FY2003 level. The NEI FY2004 budget is distributed among the Extramural Research Program (87.4%), the Intramural Research Program (9.9%), and Research Management and Support (2.7%).

Ms. Fivozinsky reviewed the schedule of events for the development of the FY2005 budget. The President’s budget calls for an NEI budget of $671.6M, a 2.9% increase over the FY2004 level, while the President’s NIH budget for FY2005 is $28.8B, a 2.6% increase. The House and Senate appropriation hearings began in April. There were no Citizens’ Witnesses hearings, but the National Alliance for Eye and Vision Research (NAEVR) and the American Optometric Association submitted written statements. The FY2005 Citizens’ budget for the NEI calls for a level of $711M, which would fully fund the NEI at the level originally proposed for the five year doubling. Senate Appropriations Subcommittee discussion topics at the FY2005 appropriation hearings included emphasis on topics including the NIH Roadmap for the Future, stem cell research, obesity, dietary supplements, and age-related macular degeneration (AMD).

The FY2006 NIH budget is being developed this summer and will be submitted to the Office of Management and Budget in August/September. Preliminary estimates for FY2006 are a 2% decrease below the level for FY2005.

Mr. James Jorkasky, Executive Director, NAEVR, summarized citizens’ activities regarding the FY2006 budget. He indicated that the new age-related eye disease prevalence data was released in April, and that updated cost data shows that eye disease consumes $68B annually in the United States. This information was part of an educational presentation to the congressional Aging, Women’s and Black caucuses, stressing the major public health issues involving eye disease. Council member Mr. Richard Salem reminded the group that there are still opportunities to increase the NEI budget, and that last year the Institute enjoyed the second highest relative funding increase at the NIH.
CONCEPT CLEARANCE: AGE-RELATED MACULAR DEGENERATION CLINICAL TRIAL

Dr. Emily Chew, Deputy Director, Division of Epidemiology and Clinical Research, NEI presented an overview of a proposed Intramural Research Program research and development contract for a Phase III clinical trial to determine whether xanthophyll/omega-3 fatty acid supplementation will delay the progression of AMD. This trial would follow the Age-Related Eye Disease Study (AREDS), which will end by 2005. The proposed study would be a “simple trial” which harmonizes clinical measurements (such as visual acuity) and study forms with those of other existing studies. This harmonization would simplify meta-analysis of the data and permit administrative efficiency. The proposed study would have approximately 50 clinical centers enrolling 4000 AREDS category three and four AMD patients into four arms. The research question is to determine whether oral supplementation with the xanthophylls lutein/zeaxanthin, the omega-3 fatty acids docosahexamenoic acid/eicosapentaenoic acid, or the combination of the two, decreases the incidence of vision loss associated with progression to advanced AMD. Dr. Chew reviewed the scientific literature supporting the rationale and feasibility of the study. Council members voted to approve the concept for this study.

EXTRAMURAL BUDGET TRENDS

Dr. McNicol gave an overview of the NEI extramural FY2004 appropriation and funding plans. The enacted extramural budget is $567.8M, a 3.3% increase over the level for FY2003. This increase is slightly below the Biomedical Research and Development Price Index, which the Department of Commerce estimates to be 3.8% for FY2004.

She reviewed the details of funding for various grant mechanisms. The total number of research project grants (RPGs) to be funded for FY2004 will be approximately 1205, an increase of 19 over FY2003. The NEI anticipates that this number will remain at 1205 for FY2005 with the President’s budget request. The number of competing RPGs funded in FY2004 will be 322, compared to 309 in FY2003, a 4.2% increase. For FY2005 the number of competing RPGs funded will fall to 308, a 4.4% decrease. The average total cost of RPGs will be $324,000 for FY2004. This is an increase of $10,000, or 3.2%, over the costs for FY2003. The award rate for competitive RPGs in FY2004 will be slightly lower than that of FY2003, 29.4% vs. 32.6%. This decrease is directly linked to a large increase in the number of RPG applications submitted in FY2004 (1094) compared to FY2003 (949), a 15.3% increase. This increased number of RPG submissions is comparable to that observed for the NIH as a whole this fiscal year. For the NEI, 74% of the RPG submissions are investigator-initiated new grant applications (Type 1), 3% are related to Requests for Applications, and 24% are related to the NEI Small Grants for Pilot Research Program Announcement.

The center core grant program (P30) has increased from 39 to 40 grants, with a rise in total average cost to $608,000, vs. $581,000 in FY2003, a 4.6% increase. The collaborative clinical research program will increase to $72.5M, from $68.1M in FY2003, a 6.5% increase.

NANOMEDICINE INITIATIVE OF THE NIH ROADMAP FOR THE FUTURE

Dr. Richard S. Fisher, Director, Corneal Diseases Program, gave an overview of the Nanomedicine Initiative, which is part of the NIH Roadmap for the Future. He reminded Council that the Roadmap is a trans-NIH activity, developed through consultation with experts from the broad biomedical research community. The Roadmap provides a framework of priorities which is designed to alleviate the barriers that exist in bringing the results of bench research to clinical practice. It is organized into three core themes: New Pathways to Discovery, Research Teams of the Future, and Re-engineering Clinical Research. The Nanomedicine Initiative is part of the New Pathways to Discovery theme. Roadmap activities are supported by a pool of resources which includes contributions from the NIH Director’s Discretionary Fund as well as funding from all Institutes and Centers.

The NEI is the lead Institute for the Nanomedicine Initiative. Dr. Sieving is co-chair of the Nanomedicine Implementation and Working Group, and NEI staff will be responsible for review and grants management of the Nanomedicine grants. The Council will receive information regarding all Roadmap applications, but will be the single body which provides a second level of review for all Nanomedicine Roadmap applications. Nanomedicine Initiative funding plans will be developed by the Working Group, based on initial review and Council input.

Dr. Fisher provided Council members with copies of the Nanomedicine Request for Applications which will solicit applications for the establishment of networked, multidisciplinary Nanomedicine Development Centers. The goal of the centers is to quantitate the physical and chemical properties of molecules and nanomachinery in cells; gain an understanding of the engineering principles used in living cells to assemble molecular-scale complexes, and use this knowledge for repairing damaged tissues as well as preventing and curing disease. The initiative will provide $1.5 M to fund planning grants in FY2004. In FY2005 and FY2006, $6 M per year will be provided to fund four or more centers. Additional details are available on the Roadmap web site http://www.nihroadmap.nih.gov.

SEVENTH ANNUAL NATIONAL EYE HEALTH EDUCATION CONFERENCE

Ms. Rosie Janiszewski, Deputy Director, Office of Communication, Health Education, and Public Liaison, NEI, reported on the 7th annual National Eye Health Education Conference, which was held in March, 2004. This meeting brings together representatives of the 70 national organizations which are partners with the NEI in the National Eye Health Education Program (NEHEP). This year’s meeting focused on four topics: diabetic retinopathy, health disparities, health literacy, and access to care. Council member Dr. Mildred Olivier, indicated that the diabetic retinopathy subcommittee recommended that the next step be a scientific study to determine the appropriate frequency of dilated eye examinations for patients with diabetes. The NEHEP Planning Committee will meet in November, 2004, to consider and prioritize all subcommittee recommendations.

HEALTHY VISION COMMUNITY AWARDS PROGRAM UPDATE

Ms. Janiszewski reviewed the Healthy Vision Community Awards Program, which was initiated in FY2003 to provide seed money to stimulate collaborative activities at the local level to achieve the Healthy People 2010 vision health goals. The individual awards are for up to $10,000 and applicants are encouraged to secure matching funds. Ms. Janiszewski described the process for reviewing applications submitted to the program; and Dr. Olivier, who served as one of the reviewers, indicated that over 500 applications were submitted. In FY2003 and FY2004, the program made 34 and 44 awards, respectively. In FY2005 the program proposes to provide 50 awards. Council members were provided with an abstract of the projects funded in FY2004. Council indicated its enthusiasm for the awards and encouraged NEI to implement plans to enlarge the program.

MIDCOURSE REVIEW FOR HEALTHY PEOPLE 2010

Ms. Janiszewski reported on progress made toward the vision objectives of the national health promotion and disease prevention initiative. NEHEP has established a database of community award recipients and developed base line data for nine of the ten Healthy People objectives using the 2002 National Health Interview Survey with “better than the best” methodology. Reporting regarding the occupational safety objective uses data from Bureau of Labor statistics, which lacks ethnicity data; analysis in this area will use “per cent improvement” methodology. Future steps in the review include a meeting of Department of Health and Human Services liaisons to discuss data issues, special populations, barriers, and strategies to move forward. October 20, 2004 is the NEI progress review date. Council members indicated their support for approach taken by the NEI.

REPORT ON NIH NEUROSCIENCE BLUEPRINT ACTIVITITIES

Dr. Michael Oberdorfer, Director, Strabismus, Ambylopia, and Visual Processing and Low Vision and Blindness Rehabilitation Programs, described NEI participation in the trans-NIH Neuroscience Blueprint. This activity involves the Institutes with a significant neuroscience portfolio and is designed to advance research in this area and encourage efficiency. The three theme areas of the Blueprint are development; plasticity; and degeneration, regeneration, and repair. The NIH Working Group is compiling an inventory of existing programs and initiatives and will review the available tools, resources, infrastructure, and needs.

Dr. Oberdorfer reported on a meeting of NEI staff and leaders of the visual neurosciences community to discuss the NEI role in the Blueprint. Issues identified by the group included the need to increase clinical participation in neuroscience research, the role for larger-scale neuroscience, and the role of the individual investigator. Council members expressed their enthusiasm for this activity and encouraged NEI to take a leadership role.

CLOSED PORTION OF THE MEETING

The meeting was closed to the public at 1:30 pm, 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. Appendix2). Dr. Sieving welcomed staff attending the closed portion of the meeting. Dr. McNicol reviewed Council procedures. She described that pursuant to Public Law 92-463, today’s meeting would be closed to the public until approximately 5:00 pm for the review of the Intramural Research Program and of grant and cooperative agreement applications.

REVIEW OF THE INTRAMURAL RESEARCH PROGRAM

Dr. Sheldon Miller, Scientific Director, NEI, presented the report of the December 7-9, 2003, meeting of the Board of Scientific Counselors (BSC), which reviewed the Section on Molecular Structure and Function. Dr. Emily Chew, Deputy Director, Division of Epidemiology and Clinical Research (DECR), presented the report of the December 7-9, 2003, BSC meeting which also reviewed DECR. Council concurred with the recommendations of the BSC and commended the Board for the clarity with which their report presented the complex review issues.

REVIEW OF RESEARCH AND RESEARCH 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.

ADJOURNMENT

Dr. Sieving adjourned the meeting at 4:35 pm.

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 will be submitted for the approval of the Council at the September 9-10, 2004, 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. Janet L. Craigie
National Eye Institute
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
e-mail: craigiej@nei.nih.gov

07/06/2004

Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

ROSTER
(Terms end 11/30 of the designated year)

Ruben Adler, M.D. (05)
Department of Ophthalmology
Johns Hopkins University School Med.
Baltimore MD 21287-9257

Roy W. Beck, M.D., Ph. D. (06)
Jaeb Center for Health Research
Tampa FL 33647

Suraj P. Bhat, Ph.D. (06)
Department of Ophthalmology
Jules Stein Eye Institute
University of California
Los Angeles CA 90095-7000

Eileen E. Birch, Ph.D. (07)
Retina Foundation of the Southwest
Dallas TX 75231

Barrett G. Haik, M.D. (07)
Department of Ophthalmology
College of Medicine
University of Tennessee Health Science Ctr
Memphis TN 38163

Todd P. Margolis, M.D., Ph.D. (*)
Professor of Ophthalmology
Director, F. I. Proctor Foundation
95 Kirkham Street
San Francisco, CA 94122

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

Richard J. Salem, J.D. (04)
Senior Partner
Salem Saxon, P.A.
Tampa, FL 33602

Lois E. H. Smith, M.D., Ph.D. (06)
Department of Ophthalmology
Harvard Medical School
300 Longwood Ave
Boston MA 02115

Mriganka Sur, Ph.D. (07)
Department of Brain & Cognitive Sciences
Massachusetts Institute of Technology
Cambridge MA 02139

Janey L. Wiggs, M.D., Ph.D. (06)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
Boston MA 02114

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

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

Dept .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