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NAEC Meeting Minutes - February 5-6, 2004

Department of Health and Human Services
National Institutes of Health

National Eye Institute

Minutes of Meeting

February 5-6, 2004

The National Advisory Eye Council (NAEC) convened for its one hundred sixth meeting at 8:30 am on Thursday, February 5, 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 1:00 pm. The meeting was closed for the review of grant applications and the report of the NEI Board of Scientific Counselors from 1:15 pm until adjournment at 5:00 pm. On Friday, February 6, 2004, the meeting was open to the public from 8:30 am until 11:30 am. Attachment A provides a roster of Council members.


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
Dr. Lois E. Smith
Dr. J. Wayne Streilein
Dr. Mriganka Sur
Dr. Janey L. Wiggs
Dr. Karla Zadnik
Dr. Marco A. Zarbin


Mr. Richard J. Salem


Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Dr. Samuel Rawlings
Dr. Maryann Redford
Dr. Grace L. Shen
Ms. Karen Robinson Smith
Dr. Annie E. Schaffner
Dr. Paul Sieving
Ms. Judy Stein
Ms. Mary Frances Tillman
Ms. Karen R. Tolson
Dr. Santa Tumminia
Mr. John Whitaker

Ms. Louise M. Amburgey
Dr. Deborah Carper
Dr. Hemin R. Chin
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. Tina Jones
Dr. Natalie Kurinij


Dr. David Armstrong, Center for Scientific Review (CSR)
Dr. Michael Chaitin, CSR
Dr. Christine Livingston, CSR
Dr. Christine Melchoir, CSR
Dr. Margaret Snyder, Office of Scientific Activities, Office of Extramural Research, Office of the Director, NIH


Dr. Wylie Chambers, Food and Drug Administration


Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Dr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Mr. Robert Rupp, ARVO
Patricia Smith, MasiMax Research, Inc.
Ms. Helen M. Viksnins
Dr. John Whitener, American Optometric Association




Dr. Paul A. Sieving, Director, NEI, and Chair of the Council welcomed Council members, staff, and guests to the one hundred sixth session of the National Advisory Eye Council. Dr. Sieving noted that Council member Richard Salem was not able to attend the meeting. He introduced three new Council members:

Dr. Eileen E. Birch is a Senior Research Scientist at the Retina Foundation of the Southwest and an Adjunct Professor of Ophthalmology at the University of Texas Southwest Medical Center in Dallas, Texas. She is an internationally recognized expert in the field of Strabismus, Ambylopia, and Visual Processing. Dr. Birch is an investigator in two NEI-sponsored clinical trials: the Pediatric Eye Disease Investigator Study and the Infant Aphakia Treatment Study.

Dr. Barrett G. Haik is the Hamilton Professor and Chair of Ophthalmology at the University of Tennessee Health Science Center College of Medicine in Memphis, Tennessee. Dr. Haik has had a distinguished career in the field of ophthalmic oncology and surgery and is a Fellow of the American College of Surgeons.

Dr. Mriganka Sur is the Fairchild Professor of Neuroscience and Head of the Department of Brain and Cognitive Sciences at the Massachusetts Institute of Technology in Cambridge, Massachusetts. He is internationally known for his work on neuronal plasticity and the development of the visual system, particularly in the organization of the somatosensory cortex.

Dr. Sieving thanked the new members for agreeing to join the Council. He noted that the success of the NEI is in very large measure due to the willingness of people who spend many hours in preparation for our meetings and other activities, and advise us on the planning and operation of our programs.


Dr. Loré Anne McNicol, Director, Division of Extramural Research, NEI, and Executive Secretary of the Council, 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.


Ms. Carol Fivozinsky, Budget Officer, NEI, presented an overview of the NEI budget. She indicated 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 described highlights of the FY2004 Consolidated Appropriations Act. The National Institute of Allergy and Infectious Diseases received $150M for the Global Fund to Fight HIV/AIDS, Malaria, and TB. The trans-NIH Roadmap for the Future will be funded at a level of $128M for FY2004 (the NEI share is $2.2M) and $237M in FY2005 (NEI share, $4.4M). The extramural annual salary cap remains equivalent to the Executive Level I salary, currently $175,200.

The President’s budget for FY2005 was transmitted to Congress on February 2, 2004, and appropriations hearings are scheduled for mid-March through April. The President’s budget calls for an NEI budget of $671.6M, a 2.9% increase over the FY2004 level, while the NIH President’s budget for FY2005 is $28.8B, a 2.6% increase. 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.


Dr. Loré Anne McNicol, Director, Division of Extramural Research (DER), NEI, indicated that after ten years at Executive Plaza, the DER has moved to the newly developed NIH Twinbrook complex. She indicated that the Divisions’ email, telephone, and fax contact information remains unchanged, and those Council member table materials include business cards with the new mailing address. The staff is very happy with the roomy new quarters.


Dr. McNicol asked for consideration of the minutes of the September meeting. The members voted to approve the minutes, subject to any additions or corrections that members might request in the next week.


Dr. McNicol indicated that future meetings are scheduled for a day and a half, and we ask that everyone keeps those times free on their calendars. The members’ table folders contain a list of dates already agreed upon:

June 10-11, 2004
September 9-10, 2004

Members selected the following dates for calendar year 2005:

February, 2005, to be determined
June 9-10, 2005
September 22-23, 2005


Dr. McNicol gave an overview of the NEI extramural FY2004 appropriation and funding plans. The enacted total budget is $652.7M, a 3.3% increase over the $632.3M 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 expected levels 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 number of competing RPGs will rise 2.3% compared to the number in FY2003. 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 similar to that of FY2003, 33.3% vs. 32.6%. The center core grant program will be 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.


Mr. William W. Darby, Grants Management Officer, NEI, discussed operating principles and procedures with the Council. Mr. Darby proposed one change to the existing policy: IRG-flagged concerns related to routine administrative issues, such as missing documentation, incorrect coding, or other minor issues, should be resolved by staff prior to the Council meeting and not be routinely presented. Council members approved this change and voted to accept the Council Operating Procedures as proposed.


Dr. McNicol indicated that at the last meeting Council members requested information regarding the outcomes for past staff requests for concept clearance of various initiatives. She first reviewed the number of special funding initiatives that had been presented to Council over the past seven years; these ranged from one in FY1997 to 23 in FY2003. She described the types of initiatives that staff routinely brings to the attention of Council. These include all Requests for Applications (RFA), Requests for Proposals, and Program Announcements; Intramural Research Program collaborations with extramural researchers; NEI-sponsored workshops, meetings, and symposia; and special high level DHHS programs such as Healthy People 2020. She indicated that staff uses several avenues to report outcomes to Councils. These include specific follow-up presentations at subsequent Council meetings and the publication of reports on the NEI extramural website. Over the seven year period, staff requested concept clearance for 67 initiatives and 66 were approved.

With smaller increases in the NEI budget, staff anticipates fewer special funding programs. Nevertheless, NEI intends to participate in those multidisciplinary NIH initiatives that support vision research objectives articulated in the “National Plan for Eye and Vision Research”. NEI will continue its policy of informing the community through publication in the NIH Guide to Grants and Contracts and posting on the NEI web page at http://www.nei.nih.gov In addition, whenever special set-aside funds are available for a specific initiative, ARVO has agreed to highlight the opportunity through its email alert network.


Dr. Peter A. Dudley, Director, Retinal Diseases Program, reviewed the FY2004 House Appropriations Committee Report Language (HR 108-188) which directed the NEI “…to focus on the development and application of scanning technologies to detect retinopathy that will be highly affordable and widely accessible to primary care physicians so that all Americans with diabetes may benefit from technologies that will allow of early detection.” The Committee further indicated that the web-based screening system should not require a significant new capital equipment investment on the part of the providers. Dr. Dudley recommended that Council approve the concept of publishing an RFA to support research in this area of technology development.

Council discussion endorsed the concept of supporting such an initiative. Members noted that early detection is critical for the prevention and treatment of blindness due to diabetic retinopathy, yet many Americans with the disease do not have regular screening eye examinations. Also, since diagnostic technologies constitute only one of many barriers to early detection, Council recommended that the NEI continue to support the development of surrogate markers, implementation and delivery strategies, and educational outreach programs.


Mr. Michael P. Davis, Associate Director for Science Policy and Legislation, NEI, announced the publication of “National Plan for Eye and Vision Research”. It is available on the NEI web site at http://www.nei.nih.gov/strategicplanning, or in print form. This volume marks the first phase of the new NEI strategic planning process. Panels of experts representing each of the NEI’s programmatic research areas were asked to assess progress made since publication of the previous plan, determine the most critical or promising areas of research need or opportunity, and develop goals and objects that address these areas.

The second phase of program planning is an ongoing effort to conduct workshops, conferences, and symposia in critical or emerging areas of science to explore how they might be applied to diseases of the eye and disorders of vision. Reports from such forms will be discussed with Council and posted on the NEI strategic planning website and will assist the refinement of the NEI’s goals and objectives.


Dr. McNicol gave an overview of the NIH Roadmap for the Future, a trans-NIH activity that was developed through consultation with experts from the broad biomedical research community. The Roadmap is designed to alleviate the barriers that exist in bringing the results of bench research to clinical practice. With an accelerated pace of discoveries in the life sciences, there is a need for their more rapid translation into practice. The Roadmap is founded on the principle that there is an opportunity to build an integrated system that is far more effective than current approaches. The criteria used to select Roadmap initiatives are that they be transforming, enhancing the ability of all Institutes and Centers to achieve their own missions, compelling to NIH stakeholders, and be something that no other entity can or will do. The Roadmap is organized into three core themes: New Pathways to Discovery, Research Teams of the Future, and Re-engineering Clinical Research. Several RFAs and RFPs have been issued under these thematic areas, with an anticipated total of 29 to be funded by the end of FY2004. Current and future Roadmap initiatives will be supported by a pool of resources which includes contributions from the NIH Director’s Discretionary Fund as well as joint investments committed by all Institutes and Centers. The FY2004 NIH investment will be $128M; the NEI share of the FY2004 Roadmap is $2.2M. By FY2209, the NIH will have invested over $2B in the program.


At 11:10 am, the meeting was closed to the public in accordance with the determination that t 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 grant review procedures. She described that pursuant to Public Law 92-463, today’s meeting will 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.

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, or close professional associate or organization have a financial interest or affiliation. The Council members will sign a statement certifying that they were absent during such discussions.


Dr. Sheldon Miller, Scientific Director, NEI, presented the September 30, 2003, report of the Board of Scientific Counselors (BSC), which reviewed the Ophthalmic Genetics and Visual Function Branch. Council concurred with the recommendations of BSC.


Dr. Sieving adjourned the meeting at 4:35 pm on February 5.




Dr. Sieving re-convened the open portion of the meeting on Friday, February 6, 2004, at 8:30 am in the Hyatt Regency Bethesda, One Bethesda Center, Bethesda, Maryland.


Ms. Judith Stein, Associate Director for Health Education and Communication, outlined the dissemination plan for distributing “National Plan for Eye and Vision Research”. Its availability in print and internet forms has been publicized through a press release, print ads in appropriate major journals, and slide presentations by NEI staff.


Ms. Joanne Angle, Executive Director, ARVO, announced that NIH Director Dr. Elias Zerhouni has accepted ARVO’s invitation to attend the 2005 annual meeting and address the ARVO membership.


Dr. Sieving presented an overview of NEI programs to support clinician scientists. He endorsed the need for strong programs to enhance the training and retention of clinician scientists in order to support translational research programs and ensure the successful and rapid transfer of research discoveries into therapies that can benefit those in need. He reviewed NEI participation in NIH Career Development Awards (K-series Awards) over the past decade, and presented data showing that 89 first time K-Awards have been funded by the NEI since 1996. This represents an investment of $42.1M. The overall success rate of applications for these awards was 68%. Since 1996, 49% of the K Awardees who applied for a subsequent grant were successful in obtaining funding.

Dr. Sieving next reviewed the NEI funding experience of MDs. In the period 1998 to 2002, MD applicants enjoyed a slightly higher success rate (47% vs. 44%) than non-MD applicants. In this period, successful MD applicants received significantly higher average total costs ($298,216) than did successful non-MD applicants ($233,909).

Dr. Sieving presented an overview of four new NEI funding programs for clinician scientists. The NIH Loan Repayment Programs (LRP) are designed to attract health professionals to careers in clinical, pediatric, health disparity, or contraceptive and infertility research by easing the burden of student loans for individuals involved in research. In exchange for a two-year commitment to a research career, the NEI will repay up to $35,000 per year of qualified educational debt for two years, pay an additional 39% of the repayments to cover Federal taxes, and may reimburse any state taxes that result from these benefits. LRP awards may be renewed once. Information regarding eligibility, application procedures, and other LRP programmatic policies is available at http://www.lrp.nih.gov

The NEI Institutional Clinical Scientist Development Program (K12) provides support to institutions with well-established vision research and clinical career development programs. The awards are intended to support the career development of clinician scientists and patient-oriented clinical investigators to conduct research related to all aspects of vision. Under this award, recently trained clinicians are selected and appointed to a structured, mentored, phased career program by the grantee institution. Typically a period of didactic training is followed by a period of mentored research experience. At the end of the career development period, appointees are expected to transition successfully into positions as independent investigators.

The David Cogan Clinician-Scientist Research Forum is a new activity designed to be held annually. It will bring young extramural clinician scientists to NEI facilities in Bethesda, MD. The program will include presentations, posters, and the opportunity to interact with NEI staff.

The NEI Intramural Research Program has announced a new Clinician-Scientist Development program designed to support board-eligible/certified clinicians seeking to develop an independent research program that involves patient-oriented research.

Dr. Sieving also reviewed a planned NEI initiative, the Career Transition Award (K22). This would support a phased career development program. A three year mentored scholar development phase would be followed by a two year independent faculty transition phase. Council members stressed the need to strengthen the transition and avoid too strong an emphasis on tenure-track status.


Dr. Leon B. Ellwein, Associate Director for Applications of Vision Research, gave an overview of initiatives to strengthen relationships between the NEI and private entities. First, the NEI has hosted five Eye Care Technology Forums, which highlighted translational research opportunities. These attracted over one hundred participants, including representatives from industry, FDA, AAO, and AOA. Published reports are available for three of the Forums. Second, the NEI developed the Vision Function Questionnaire, which has now been translated and linguistically validated in many languages. Council members noted that the Diabetic Retinopathy Research Network has recently developed an industry collaboration policy document which can serve as a model for future NEI-funded phase III clinical trials.


Dr. Sieving reviewed Congressional interest in this topic in Senate Report 108-081 and House Report 108-188 to the Departments of Labor, Health and Human Services, And Education, and Related Agencies Appropriation Bill, 2004. Areas of interest included diabetic retinopathy, degenerative eye diseases, glaucoma, health disparities, neurofibromatosis, ocular albinism, and genetics of retinopathy.

Dr. Sieving reported on NEI participation in a workshop supported by the Foundation Fighting Blindness entitled, “Retinal Gene Therapy: Regulatory, Product, and Clinical Issues for Diseases with Orphan Classification.”. This meeting between the FDA, NEI, and the vision research community took place on September 29, 2003. Attendees discussed the challenges and opportunities available in this field. Dr. Sieving stressed that success in this area requires access to patient families, and that diagnostic genotyping will encourage patients to participate. National core facilities are needed for the biologic resources necessary for translational research. He challenged the Council and staff to look at resources in a different framework, to network what we already have and to get industry involved.


Dr. Hemin Chin, Ocular Genetics Program Director, described a proposed initiative developed by an NEI-sponsored workshop, “A National Collaborative Network for Ophthalmic Research and Diagnostic Genotyping”, in November 2003. This initiative would support the formation of the National Ocular Disease Genotyping Network. The Network would encompass three activities: 1. Centralized repositories for receiving, processing, and archiving patient samples. 2. A genotype/phenotype database that would allow the analysis of larger datasets necessary to identify novel genetic risk factors for ocular diseases and provide standardized phenotypic descriptors. 3. A centralized ocular disease information and referral center to develop public and professional awareness and participation in NIH protocols. Overall, the Network would help prevent and treat genetic eye diseases by enabling vision researchers to use cutting-edge genomic technologies to diagnose ocular diseases, by refining phenotypic assessment, and by identifying and engaging broader patient populations for clinical trials.

Council members voted to endorse the concept for the Network. They discussed the issues surrounding selecting genes for study. Dr. Sieving indicated that the NEI would seek broad scientific input on such topics. Council members also noted that the database activity would have a tremendously useful effect in coalescing information already available.

Dr. Santa Tumminia, Special Assistant to the Director, presented an overview of existing NIH-supported genotyping and patient data organizing centers. Several of these initiatives incorporate features which might serve as appropriate models during the development and support of the NEI Network. Such aspects include tiered access for researchers/patients/industry and cost-recovery mechanisms tied to the availability of grant and/or industry funds.


Dr. Sieving informed Council that he has been meeting with Directors of other NIH Institutes and Centers which include a neuroscience focus in their research portfolios. They will be developing trans-NIH initiatives to stimulate research in this area.


Dr. Sieving adjourned the meeting at 12:00 pm on February 6, 2004.


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 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


Attachment A



(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

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

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

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
Department of Health & Human Services
Washington, DC 20201

Elias A. Zerhouni, M.D.
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