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NAEC Meeting Minutes

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

June 8-9, 2006

The National Advisory Eye Council (NAEC) convened for its one hundred thirteenth meeting at 8:30 am on Thursday, June 8, 2006, at the Natcher Building, National Institutes of Health (NIH) Conference Center, 45 Center Drive, Bethesda, MD. Paul A. Sieving., M.D., Ph.D., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was closed to the public from 8:30 am until 12:00 pm for the review of grant and cooperative agreement applications. On Thursday, June 8, 2006, from 2:30 pm until 5:00 pm, and on Friday, June 9, 2006, from 8:30 pm until adjournment at 12:00 pm., the meeting was open to the public. Attachment A provides a roster of Council members.

COUNCIL MEMBERS PRESENT:

Dr. Roy W. Beck
Dr. Suraj P. Bhat
Dr. Eileen E. Birch
Dr. Gunilla Haegerstrom-Portnoy
Dr. Barrett G. Haik
Dr. David E. Holck
Dr. Lenworth N. Johnson
Dr. Juan I. Korenbrot
Dr. Todd P. Margolis
Dr. Earl L. Smith, III
Dr. Lois E. Smith
Dr. Mriganka Sur
Dr. Janey L. Wiggs
Dr. Marco A. Zarbin

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NEI STAFF PRESENT:

Ms. Louise M. Amburgey
Ms. Neyal Ammary
Dr. Houmam Araj
Ms. Sylvia Braxton
Dr. Deborah Carper
Dr. Rachel Caspi
Dr. Hemin R. Chin
Dr. Peter Colossi
Mr. Michael P. Davis
Ms. Linda Dingle
Dr. Peter A. Dudley
Dr. Leon Ellwein
Mr. Donald F. Everett
Dr. Richard S. Fisher
Mr. Kenneth Frushour
Dr. Ralph J. Helmsen
Mr. Tom Hoglund
Dr. Chyren Hunter
Ms. Rosemary Janiszewski
Ms. Tina E. Jones
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Dr. Päivi H. Miskala
Dr. Michael D. Obe
Mr. William O'Donnell
Dr. Lance Opticon
Ms. Felicia Powell
Dr. Maryann Redford
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Dr. Sarah Sohraby
Ms. Sylvia Speight
Ms. Judith Stein
Mr. Arthur Stone
Dr. Santa Tumminia
Dr. Eric Wawrousek
Mr. John Whitaker
Ms. Romona Williams-Parker

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OTHER NIH STAFF PRESENT:

Mr. John Burklow, Office of the Director (OD)
Ms. Rosemary Cerny, OD
Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Dr. Christine Livingston, CSR
Dr. Michael Steinmetz, CSR
Mr. David L. Whitmer, CSR
Dr. Jerome R. Wujek, CSR
Dr. Elias A. Zerhouni, Director, NIH

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MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Ms. Joanne Angle, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Adrienne Drollette, American Optometric Association
Dr. Israel Goldberg, Health Research Associates
Dr. Joseph Horwitz, University of California, Los Angeles
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Neala Marle
Ms. Lori Methia, ARVO
Ms. Elaine Richman, Richman Associates
Ms. Helen Viksnins, American Academy of Optometry

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THURSDAY, JUNE 8, 2006

CLOSED PORTION OF THE MEETING

8:30 am

The meeting was closed to the public at 8:30 a.m. 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).

CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

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.

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.

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REVIEW OF RESEARCH AND RESEARCH TRAINING APPLICATIONS

OPEN PORTION OF THE MEETING

2:30 pm

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CALL TO ORDER AND OPENING REMARKS

Dr. Paul A. Sieving, Director, NEI, and Chair of the Council welcomed Council members, staff, and guests to the one hundred thirteenth session of the NAEC. He indicated that it is important to continue with portfolio analysis and to proceed with Phase II program planning. He reviewed the portfolio analysis from the September, 2005, meeting and reported on the most recent evaluation of the human genome. Of the roughly 2,000 identified human disease-related genes, 400-500 are in the visual system.

Dr. Sieving next reported on recent NIH events, including budget development, electronic grant submission, and a new initiative to allow multiple Principal Investigators on research project grant applications. He mentioned that the NIH is examining possibilities for reducing the workload of study section reviewers, along with broader questions of where science should be reviewed. The NEI continues to have three captive study sections, which review approximately 60% of the applications submitted to the NEI. NEI staff has found that the award rates for applications reviewed in non-captive study sections are very similar to the award rates for those reviewed in captive study sections, indicating that NEI researchers are not disadvantaged by their locus of review. Dr. Sieving next discussed the role of Council, stressing that Council provides him with valuable advice regarding all aspects of Institute business.

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NIH AT THE CROSSROADS: MYTHS, REALITIES, AND STRATEGIES FOR THE FUTURE

Dr. Elias Zerhouni, Director, NIH, presented Council members with an overview of recent events and activities at the NIH as well as problems the organization is facing in the future. He noted that in an environment marked by the "perfect storm" of national challenges such as hurricane Katrina devastation, trade deficits, national defense, possibility of pandemic influenza, and the post-doubling ennui of "what has NIH done for us lately", the key for the NIH is to "manage forward". He noted some common misperceptions in the scientific community, and presented data which demonstrate that the NIH has not had too many RFAs, or too much translational research, or an over-investment in the NIH Roadmap. Instead, the drivers NIH faces include increased capacity in the scientific community, appropriations stagnation, and budget cycling. And he noted that the apparent FY2005 decrease in the award rate for individual applications (22.3%) is balanced by a higher award rate for individual scientists (27.6%). Overall, the NIH has found that the number of applications per applicant has increased from 1.2 to 1.5.

Dr. Zerhouni indicated that the adaptive strategies and guiding principles the NIH is following in FY2006 are to protect core values, never mortgage the future, manage the key drivers, and promote his vision for the future-to increase communications about the positive impact of NIH on science and health at local, regional, and national levels and to transform health through research. He is challenging biomedical researchers to pursue participatory medicine: the "3 Ps" of predictive, personalized, and pre-emptive.

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INTRAMURAL PROGRAM REPORT

Dr. Sheldon Miller, NEI Scientific Director, gave an overview of recent activities in the Intramural Research Program (IRP). Dr. Miller reviewed the mission, organization, and budget of the IRP. He indicated that the NIH Clinical Center is a unique resource for carrying out clinical research, and that it carries global responsibilities for pursing clinical research. Dr. Miller summarized staffing patterns within the IRP, recruiting efforts for three open positions, and recent progress towards such goals. He also described resource development, the status of the US-Indo Collaborative Agreement, and the NEI IRP Overseas Scholars Program.

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NANOMEDICINE ROADMAP UPDATE

Dr. Richard S. Fisher, Corneal Diseases Program Director, gave an overview of recent activities in the NIH Roadmap Nanomedicine Initiative, for which the NEI is the lead Institute. He described the context of this program, which is distinct from Nanomedicine and not simply nanotechnology applied to biomedical science. Instead, the Roadmap initiative emphasizes the development of strategies and tools-based on knowledge of the design of biological systems-for medical applications, and provides unique knowledge about biological system design that may be used to engineer devices for use in other fields.

Dr. Fisher reviewed the vision for the Roadmap Nanomedicine Initiative. It seeks to 1). Uncover novel properties of molecules and nanomachinery in cells and quantitatively characterize these; 2). Gain an understanding of the engineering principles used in living cells to "build" molecules, molecular complexes, organelles, cells, and tissues; and 3). Use this knowledge of properties and design principles to develop new technologies, and engineer devices and hybrid structures for repairing tissues as well as preventing and curing disease. Implementation of the initiative has been carried out through the establishment of a multidisciplinary network of Nanomedicine Development Centers, using Flexible Research Authority (FRA). FRA permits a rapid turnaround, flexibility in the management of awards, and an intensive consultation with the scientific community. Dr. Fisher directed Council members to the newly-established website for up-to-date information: http://www.nihroadmap.nih.gov/nanomedicine

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REPORT ON THE NEI WORKSHOP ON GLOBAL VISION RESEARCH NEEDS AND OPPORTUNITIES

Dr. Leon B. Ellwein, Associate Director for Applications of Vision Research, NEI, reviewed the outcomes of an NEI-sponsored workshop, held at the NIH Lawton Chiles International House on April 19-20, 2006. The scope and purpose of the workshop was to address three topical areas of vision research: 1). Basic, translational, and clinical vision research where international collaborations offer unique opportunity and leverage; 2). Research capacity and infrastructure development for enhancing global vision research productivity; and 3). Operations and health services research to bridge international disparities and improve eye care worldwide. The conferees concluded that the NEI should foster synergistic international collaborations by increasing the use of NIH Fogarty International Center grant mechanisms and issuing program project RFAs focused on translational research. The group agreed that NEI support should include international workshops, public health research and consultations in cooperation with the WHO, Research on the optimization of eye care delivery, global health economics research, development of international standards/classification, and collaborative international clinical trials. Dr. Ellwein directed Council member's attention to the conference summary on the NEI website: http://www.nei.nih.gov/strategicplanning/april06workshop.asp

Council members applauded NEI efforts to develop strategies and priorities for progress in this arena. They indicated their support for activities which can reduce costs through developing efficient international collaborations.

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NATIONAL EYE HEALTH EDUCATION PROGRAM (NEHEP) FIVE YEAR AGENDA

Ms. Rosemary Janiszewski, Deputy Director, Office of Communication, Health Education, and Public Liaison, NEI, presented Council with the new NEHEP strategic plan. She reminded members that Dr. Eve J. Higginbotham, Chair of the planning committee, had discussed the planning process with them at the January, 2006 meeting. At the March, 2006, NEHEP strategic planning conference, the group identified five priority areas for action: 1). The NEHEP program; 2). The NEHEP Partnership; 3). Glaucoma, Diabetic Eye Disease, and Low vision Programs; 4). New eye health education programs targeted to older adults; and 5). New evidence-based educational programs. The next step in the process is to convene subcommittees and workgroups, develop work plans, and work with our partners to implement the agenda.

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HEALTH VISION 2010 COMMUNITY AWARDS PROGRAM SUMMARY

Ms. Janiszewski summarized the results of this year's Community Awards program. These awards provide funding for community-based eye health education and promotion programs that will bring sight-saving information and vision-related care to children, older adults, and multi cultural populations. Fifty-two awards were funded, out of nearly 200 applications, for a total of $512,202. In FY2007, NEHEP anticipates funding another 50 awards.

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BUDGET OVERVIEW

The NEI Budget Officer, Marilyn Laurie, provided an update of the finalized FY2006 budget. The NIH received a 0.3% decrease in Budget Authority compared with FY2005 (including Roadmap funds). Central budget guidance has called for all NIH ICs to reduce FY2006 competing Research Project Grant (RPG) commitments by 2.35%. For competing RPGs, there will be no average total cost increase over the FY2005 competing level ($345,000). She indicated that the FY2007 President's Budget currently calls for a 0.8% decrease over the level for FY2006.

Ms. Laurie gave an overview of the provisions of the FY2007 President's budget. The $661.4M Budget Authority is divided among Extramural Research ($558.5M), Intramural Research ($67.2M), Administration ($22.0M), the NIH Roadmap ($8.0M), and NEHEP ($5.7M). The 2007 estimate calls for a decrease in the research project grant (RPG) success rate from 24.2% in 2006 to 20.1%. The number of competing RPGs funded will drop, and the estimated number of applications submitted will rise. She reviewed anticipated NEI contributions to trans-NIH initiatives: NIH Roadmap ($8.0M), Neuroscience Blueprint ($2.2M), Genes and Environment Initiative ($1.1M), and Pathway to Independence Awards ($360K).

Mr. James Jorkasky, Executive Director, NAEVR, summarized citizens' activities in support of the vision research budget. These included testimony by Dr. Peter J. McDonnell, Director, Wilmer Eye Institute, Johns Hopkins University School of Medicine, before the Senate Labor, Health and Human Services, and Education Appropriations Subcommittee. Dr. McDonnell highlighted recent examples of breakthroughs funded by the NEI in the area of research on Age Related Macular Degeneration (AMD), and pointed out missed opportunities where AMD research would suffer as a result of the proposed decrease in NEI funding.

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ADJOURNMENT

Dr. Sieving adjourned the meeting at 5:00 p.m. on Thursday, June 8, 2006

FRIDAY, JUNE 9, 2006 OPEN SESSION

8:30 AM

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NEI EXTRAMURAL REPORT

Dr. Loré Anne McNicol, Director, Division of Extramural Research and Executive Secretary of the Council, provided an overview of recent extramural activities. She noted that Dr. Ralph Helmsen, the NEI Research Resources Officer, is retiring after 40 years of government service. Dr. Helmsen has agreed to return as a contractor Extramural Program Analyst for six months in order to expedite the transition for his replacement. Dr. McNicol also mentioned that staff member Mr. Donald Everett, Program Director for Collaborative Clinical Research, had recently received a significant award from the NIH Office of Research on Women's Health. This award recognized his efforts in making the NEI one of only three ICs with complete and consistent reporting data on the inclusion of women and minorities in research for the past fiscal year.

Dr. McNicol gave an update regarding FY2006 extramural grant budget operations. She described NEI participation in three major trans-NIH programmatic initiatives, the Roadmap for Medical Research, the Neuroscience Blueprint, and the NIH Countermeasures Against Chemical Threats (CounterAct) Research Network. And she described the two pilot award mechanisms, R03 Small Grant and R21 Exploratory/Developmental Grant, employed by the NEI.

Dr. McNicol gave an overview of anticipated NIH grants initiatives. These included a pilot permitting multiple co-Principal Investigators on research grants, a pilot testing the feasibility of providing a one month turn-around from review to summary statement for new investigators (the R01* initiative), and electronic submission at Grants.gov using the new government-wide Standard Form 424 (Research & Resources) in place of the PHS SF398.

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FUTURE COUNCIL MEETING DATES

Dr. McNicol noted that future meetings are scheduled for a day and a half, and asked that members keep those dates free on his/her calendar. The following dates have been agreed upon:

September 14-15, 2006
January 18-19, 2007
June 7-8, 2007
September 27-28, 2007

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LENS AND CATARACT PROGRAM PORTFOLIO ANALYSIS

PROCESS OVERVIEW

Dr. Sieving thanked members for their support for the new NEI initiative of a regular cycle of review and analysis of the individual NEI portfolios. These activities will continue to include scientific presentation(s) by members of the vision research community as well as an administrative description by the appropriate Program Director. Portfolio analysis is designed to provide staff an opportunity for self-assessment, to give Council members a broad over-view, and to set the frame for specific Council actions in the future.

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INNOVATION IN LENS RESEARCH

Dr. Joseph Horwitz, Jules Stein Eye Center, UCLA, presented his research employing a genomics approach to the study of the ocular lens. He remarked that a typical question to him is why does the NEI need to invest in basic lens research when cataract surgery is so successful? He provided several answers. First, cataract surgery consumes 60% of the US medical budget for vision. Therefore, prevention strategies would be much more cost-effective than surgery. Second, there are complications to cataract surgery. The most serious and frequent is posterior capsular opacification. Current technologies and techniques cannot prevent this occurrence, and it highlights the need to understand the biology of the lens epithelium. Other complications include retinal detachment and endophthalmitis. A third issue is the incidence of childhood cataract, which varies from 1 to 6 per 10,000 live births. This highlights the need to understand lens growth and development.

Dr. Horwitz reviewed his own work on the cell biology and development of lens crystallin proteins. He has demonstrated that crystallins are ubiquitous proteins of multiple tissues, they have chaperone-like properties in controlling protein aggregation, and they are involved in much age-related disease. Overall, he has shown that the ocular lens is an ideal system for investigating crystallin functions, in and outside of vision.

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PORTFOLIO OVERVIEW

Dr. Ellen S. Liberman, Director, Lens and Cataract Program, described the background and history of the program. She gave a snapshot of the FY2005 goals, funding, and research areas. Next, she discussed time trends in the scientific sub-programs. Over the past decade there has been an increased number of RPGs focused on development, aging, and cell biology, with a concomitant decrease in grants in the areas of molecular biology, biochemistry and biophysics, and cataract pathogenesis. She stressed that lens tissue, which consists of only two cell types, is a beautifully simple model system for studies of developmental biology and of cell cycling, particularly since lens development is constantly repeated throughout the life of the individual. She highlighted recent exciting work which proposes the existence of a "circulatory system" within the lens, and described research needs in the areas of accommodation and presbyopia.

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COUNCIL DISCUSSION

Council members expressed their enthusiasm for the scientific presentation and for Dr. Liberman's stewardship of the program. They remarked that translational research should not be perceived as on a collision course with basic science. This field needs fundamental knowledge in order to do translational research. Although vision scientists tend to associate the non-transparency linked functions of crystalline with non-lens tissues, it is probably a mistake to compartmentalize like this.

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GENERAL COUNCIL DISCUSSION

Council members initiated an open discussion regarding novel scientific opportunities, concerns about the academic environment that affect progress in vision research, and suggestions to the NEI regarding the management of Council. Members felt that the issue of providing additional funding opportunities for first time investigators was a serious need. They questioned whether the Bridge to Independence Program would be sufficient, and requested that NEI staff pay attention to this problem when developing pay plans. Overall, Council expressed their concern with the impact of budget reductions and the effect that starting new trans-NIH programs has on the NEI R01 award rate.

ADJOURNMENT

Dr. Sieving adjourned the meeting at 11:04 a.m.

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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 were submitted for the approval of the Council; all corrections or notations were incorporated. 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

05/26/2007


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Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

ROSTER

(Terms end 11/30 of the designated year)

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

Gunilla Haegerstrom-Portnoy,OD, Ph.D.
Associate Dean for Academic Affairs
School of Optometry (05)
University of California
Berkeley, CA 94720

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

Lenworth N. Johnson, M.D. (08)
Professor of Ophthalmology & Neurology
University of Missouri
Columbia, MO 65212

Juan I. Korenbrot, Ph.D. (09)
Department of Physiology
University of California, San Francisco
San Francisco, DA 94143

Todd P. Margolis, M.D., Ph.D. (08)
Professor of Ophthalmology
Director, F. I. Proctor Foundation
San Francisco, CA 94122

Earl L. Smith, III, O.D., Ph.D. (08)
Dean, College of Optometry
University of Houston
Houston, TX 77204

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

Department of Defense Representative
Lt. Col. David E. Holck M.D.
Chief, Reconstructive, Orbit, and Ocular Oncology Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

Dept .of Veterans Affairs Representative
Marco A. Zarbin, M.D., Ph.D.
New Jersey Veterans Admin. Hospital
Newark, NJ 07103

Ex Officio Members
Michael O. Leavitt
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

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