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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 9 , 2005

The National Advisory Eye Council (NAEC) convened for its one hundred tenth meeting at 8:30 am on Thursday, June 9, 2005, at the Holiday Inn Georgetown, Washington, DC. Paul A. Sieving. M.D., Ph.D, the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 8:30 am until 2:30 pm. The meeting was closed for the review of grant applications from 2:30 pm until adjournment at 5:00 pm. Attachment A provides a roster of Council members.

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COUNCIL MEMBERS PRESENT:

Dr. Ruben Adler
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. 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:

Dr. Houmam Araj
Ms. Glory Baldwin
Dr. Deborah Carper
Dr. Hemin R. Chin
Ms. Janet L. Craigie
Mr. William W. Darby
Mr. Michael P. Davis
Dr. Peter A. Dudley
Dr. Leon Ellwein
Mr. Donald F. Everett
Ms. Yemisi Faderin
Dr. Richard S. Fisher
Mr. Kenneth Frushour
Dr. Ralph J. Helmsen
Dr. Chyren Hunter
Dr. Natalie Kurinij
Dr. Santa Tumminia
Mr. John Whitaker
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Dr. Päivi H. Miskala
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Jean-Paul San Giovanni
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Ms. Judith Stein
Ms. M. Frances Strickler
Ms. Karen R. Tolson
Ms. Kelli Wilson

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OTHER NATIONAL INSTITUTES OF HEALTH (NIH) STAFF PRESENT:

Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Ms. Betsey Dean, Office of Science Policy and Planning, Office of the Director (OD), NIH
Mr. William Rosa, Office of Budget, OD, NIH
Dr. Daryn Wu, CSR
Dr. Jerome R. Wujek, CSR

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MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Eileen Resnick, Society for Women’s Health Research
Ms. Helen Viksnins, American Academy of Optometry
Dr. Sherry L. Ward, Physicians Committee for Responsible Medicine
Dr. John Whitener, American Optometric Association

THURSDAY, JUNE 9, 2005

OPEN PORTION OF THE MEETING

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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 tenth session of the NAEC. He reviewed current and emerging biomedical research issues from a perspective beyond the NEI, at the level of the NIH and above. He mentioned that chronic illness and obesity are major concerns. He described a recently briefing of NIH Institute and Center (IC) Directors by Dr. Richard Carmona, Surgeon General of the United States. Dr. Carmona stressed post-9/11 needs for increased preparedness and medical emergency planning; the continuing need to reach out to disenfranchised populations suffering from health disparities; better efforts to translate biomedical research results into health messages which can be understood by the general population; and health diplomacy at the global level.

Dr. Sieving next reviewed several important NIH-level issues. These included the February, 2005, issuance of interim final regulations regarding conflict of interest; discussions regarding the future of the Roadmap for Biomedical Research, particularly the transition of hospital bed-based research supported through the General Clinical Research Centers to a networked set of regional translational research centers with a more out-patient environment; and the expansion of activities under the NIH Neurosciences Blueprint.

Dr. Sieving described several recent NEI events. Dr. Rick Ferris, Clinical Director, NEI, will be the in-coming President of ARVO. The second Indo-US Collaborative Research Workshop was held before the ARVO annual meeting in April. The discussion included exploration of opportunities for collaborative research on the interplay of genes and environment. The National Ophthalmic Disease Genotyping Network is being established. Competitive grant supplements were awarded this spring in order to build capacity for Clinical Laboratory Improvement Amendments (CLIA)-based genotyping of ocular conditions. Dr. Carl Kupfer, past Director of the NEI, was honored at a reception at the Stone House inaugurating the David G. Cogan Ophthalmic Pathology Collection. Through Dr. Kupfer’s efforts, over 1000 of Dr. Cogan’s case reports and 3000 of the accompanying slides have been made available through an internet-accessible site which serves as a study and teaching tool.

Next, Dr. Sieving discussed the NEI response to issues raised by Council members at the February meeting regarding the role of Council. Dr. Sieving indicated that it is important to continue with portfolio analysis and to proceed with Phase II program planning. The Institute is working to evolve the series of small workgroups which can address the major agendas that impact on our science. Science issues include the content of stem cell work. Policy issues include how to fund stem cell work. Other workshop topics could involve cone cell survival. The Institute needs Council input to decide on the appropriate topics.

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NEI BUDGET OVERVIEW

Ms. Marilyn Laurie, Budget Officer, NEI, presented an overview of the three year cycle for developing and implementing 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 FY2005 and those proposed for FY2006 (0.7%) are relatively smaller: For FY2005 the enacted NEI budget is $669.1M, a 2.5% increase over the FY2004 level. The NEI FY2005 budget is distributed among the Extramural Research Program (86.5%), the Intramural Research Program (10.2%), and Research Management and Support (3.3%). Ms. Laurie described the distribution of the budget among various grant mechanisms and the Roadmap.

Ms. Laurie reviewed the schedule of events for the development of the FY2006 budget. The President’s budget calls for an NEI budget of $673.4M, a 0.7% increase over the FY2005 level. The House and Senate appropriation hearings began in April. Hearing topics included new ethics rules, the proposed NIH Office of Portfolio Analysis and Strategic Issues (OPASI), and NIH reauthorization. NEI-specific topics included diabetic retinopathy, ocular albinism, and age-related macular degeneration. Discussion regarding possible NIH reauthorization included expanded authority for the NIH Director to transfer funds between ICs in order to fund cross-cutting initiatives; the establishment of budget clusters, rather than 26 IC budget line items; and a more transparent disease reporting and tracking activity in OPASI which could focus on broad areas of interest rather than specific diseases. The FY2006 NIH budget is being developed this summer and will be submitted to the Office of Management and Budget in August/September.

Mr. James Jorkasky, Executive Director, NAEVR, summarized citizens’ activities regarding the FY2006 budget. He indicated that NAEVR and ARVO have produced a “white paper” responding to reauthorization issues, calling for a community of support for eye and vision research. Council member Dr. Earl Smith indicated that Dr. Zerhouni, Director, NIH, has been quoted in the press as supporting a reauthorization that would establish 10 IC “clusters”.

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NANOMEDICINE ROADMAP UPDATE

Dr. Richard S. Fisher, Director, Corneal Diseases Program, gave an update of the activities supported under 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, one of nine Roadmap initiatives, 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 ICs. In FY2004 all ICs contributed 0.34% of their budget to the Roadmap. In FY2005 the contributions rose to 0.63%. In FY2004 there were 19 Roadmap Requests for Applications (RFAs), leading to the funding of 193 grants. In FY2005 it is anticipated that there will be an additional 20 Roadmap RFAs.

The NEI is the lead Institute for the Nanomedicine Initiative. Its vision is to uncover novel properties of biomedical systems, understand engineering principles, and use nanomedicine to prevent and cure disease. Dr. Fisher stressed that Nanomedicine is distinct from Nanotechnology, which is focused on the physical sciences. 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 reviewed Nanomedicine activities. The initiative is managed under a novel Flexible Research Authority (FRA). FRA mandates transactions other than contracts, grants, or cooperative agreements; and it permits creative peer review procedures appropriate for the activity. The Nanomedicine team is using FRA to allow a rapid, intensive consultation with scientific experts in order to stimulate new partnerships and enhance peer review. Dr. Fisher reviewed the time line of the Nanomedicine planning process. In September, 2004, 20 planning grants were awarded. The grantees prepared Concept Development Plans and participated in an investigator meeting with the peer reviewers in March, 2005. On May 10, an RFA for a limited competition for Nanomedicine Centers was published. Applications are due July 12, will be reviewed in August, and four centers will be funded on September 30 2005. In FY2005 total program costs will be $6 M. In FY2006 it is anticipated that funds will be provided for an additional four or more centers. Additional details are available on the Roadmap web site http://www.nihroadmap.nih.gov.

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NIH NEUROSCIENCES BLUEPRINT UPDATE

Several NEI staff members contributed to a Council briefing on NEI participation in the NIH Neurosciences Blueprint. Dr. McNicol gave a general overview, indicating that this activity involves the 16 NIH ICs and Offices 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/repair. Each IC’s contribution is based on the budget level of its neuroscience inventory. For FY2005, the contribution is 0.15%, for a total of $6.86. The contributions are scheduled to increase by 0.15% yearly increments, reaching 0.75% in FY2009.

Dr. McNicol described the activities for FY2005: the inventory used to assess contributions, an RFA for R25 Education Project grants on the Neurobiology of Disease; expansion of the NIH Neuroscience Microarray Consortium which provides products and expert services on a fee-for-service basis, expansion of the NIH Pediatric MRI Initiative; and development of the International Neuroinformatics Consortium. She indicated that future activities would include neuroimaging, neuroepidemiology, core grants, training grants, Neuromouse driver lines, and Neuromouse repatriation.

Dr. Chyren Hunter, NEI Training Officer, described the training initiatives to be supported under the Blueprint. For FY2005 there is an RFA for supplements to active T32 Institutional Training grants to support the development, initiation, and expansion of courses in the neurobiology of disease. Seventeen applications were received, and they will be reviewed this summer for funding on September 30. Three possible training initiatives are under consideration for FY2006. The themes include a translational focus, training for both US and non-US citizens, partnering with the NIH Intramural Research Programs, and creating National Centers for neuroscience training. The topics being considered are neuroimaging, computational neuroscience, and translational research.

Council member Dr. Ruben Adler described the small NEI workgroup which met to consider opportunities under the Neurosciences Blueprint. That group suggested a requirement that training grants develop and offer a course on the neurobiology of disease. Council members indicated their endorsement for this new training activity.

Dr. Natalie Kurinij, Collaborative Clinical Research Program Director, described the Blueprint neuroepidemiology initiative which is being planned for FY2006. She said that its goal is to develop a standardized instrument for neuroepidemiologic studies and clinical trials. The instrument would cover motor, sensory, and cognitive function; be short and easily administered, with a low patient burden; and would harmonize measurements to permit meta-analyses. The five year initiative would be implemented in two phases. First, an expert group would develop the instrument, and then field testing would be performed.

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NEI BUDGET AND PROGRAM TRENDS

Dr. Jack A. McLaughlin, Deputy Director, NEI, gave an overview of NIH and NEI budget funding trends, in 1996 base year constant dollars. The NEI purchasing power has been dropping significantly since FY2003, and we are facing a future with the possibility of actual budget reductions. The distribution of grants funds among the NEI Program Areas has been quite stable over this period: Retinal Diseases 44%; Corneal Diseases 13%; Lens and Cataract 7%; Glaucoma and Optic Neuropathies 10%; Strabismus, Amblyopia, and Visual Processing 23%; and Low Vision 3%. The total number of Research Project Grants (RPG) funded peaked in FY2004 at 1214. In FY2005 this number is estimated to decline slightly to 1202, a 1% reduction. The FY2006 President’s Budget calls for the number of RPG awards to drop to 1172, a 2.5% reduction from the estimated FY2005 number.

Dr. McLaughlin presented the five year trends in RPG success rate (the number of grants funded divided by the number reviewed). The rate has fallen from 40.6% in FY2002 to an estimated 21.6% in the FY2006 President’s budget. This decline is due in part to an overwhelming increase in the number of grants submitted. In FY2002 761 grants were reviewed. The FY2006 estimate is for 1284, a 69% increase. Over this period, there was little variation in the success rates by program area. Council member Dr. Lenworth Johnson asked whether the NEI has data on success rates of new investigators versus established investigators. Dr. McLaughlin said that such information would be extremely difficult to obtain, but staff would look into the issue. Another factor which contributes to declining success rate is the increase in the average total costs. RPG average annual total costs have risen from $311,000 in FY2002 to $344,000 predicted for FY2006, a 6% increase.

Dr. McLaughlin presented a 10 year analysis of the mix of RPG grant mechanisms funded by the NEI. Historically, these have included R01, R03, R15, R21, R29, R33, R37, and U01 grants. Over the decade there has been a relative increase in the number of “small” RPG mechanisms awarded (R03, R15, R21, and R33). In FY1997 these represented 1.6% of the total. In FY2006, it is estimated that they will encompass 14.7% of the total. In the face of declining budgets, the NEI has eliminated its support for the Small Grant for Pilot Studies (R03) program.

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FUTURE COUNCIL MEETING DATES

Dr. McNicol indicated that future meetings are scheduled for a day and a half. She requested that members keep these times free on their calendars. The following dates were agreed upon:

September 22-23, 2005
January 19-20, 2006
June 8-9, 2006
September 14-15, 2006

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DIVISION OF EXTRAMURAL RESEARCH REPORT

Dr. McNicol provided additional information regarding the increased number of RPG submissions documented by Dr. McLaughlin. This is an NIH-wide phenomenon, with roughly a 50% increase in the past two years. 38% of grants submitted are revisions, 75% are A1 and 25% are A2. In addition, individual investigators are submitting multiple applications in the same fiscal year. For the NEI in FY2005, with 1125 RPGs submitted, 228 scientists had two or more applications (four individuals submitted four applications). Thirty-seven people had two applications submitted during the same review round.

She reviewed the details of funding for non-RPG grant mechanisms. The center core grant program (P30) will remain constant at 40 funded grants. The collaborative clinical research program will award $64M. Research Career Development awards will increase by five to a total of 64 awards at $12.8M. The small business programs will make 68 awards at a total of $15.8M. The Other Research category is expected to support five Bioengineering Research Partnerships, 3 collaborative translational research grants, and 15 Research Infrastructure Development Awards.

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PHASE II PROGRAM PLANNING

Mr. Michael P. Davis, Associate Director, Office of Science Policy and Legislation, NEI, presented an overview of the eight NEI Program Plans which were prepared from 1975 through 2004. These plans were coordinated through the Council, and involved extensive consultation with extramural and intramural scientists from both the vision research and the non-vision research communities.

Mr. Davis also reviewed the Government Performance and Results Act (GPRA) of 1993. Its purpose is to improve public confidence by making agencies accountable for results; initiating program performance reform; improving service delivery by planning for meeting program objectives; focusing on results, quality, and customer satisfaction; improving congressional decision-making; and improving internal management within the government. Mr. Davis described the NEI annual GPRA performance planning and reporting requirements. These fall in the areas of Research, Research Training and Career Development, and Research Facilities.

Next, Mr. Davis reviewed the President’s Management Agenda, (PMA) which presents five government-wide initiatives: strategic management of human capital, competitive sourcing, improved financial management, expanded electronic government, and budget and performance integration. The budget category mandates use of a Performance Assessment Rating Tool (PART) involving four measures: program purpose and design, strategic planning, program management, and program results.

Mr. Davis outlined the program planning activities that should underpin our responses to GPRA and PMA. These include identifying NEI priorities, assessing emerging areas of science, updating priorities on an ongoing basis, and developing a streamlined process and product. He indicated that staff has proposed a two phase planning process which involves developing a published plan and then identifying emerging areas of science/opportunities/policy issues. Phase I has been completed.

In considering Phase II, Mr. Davis emphasized the need for establishing appropriate workgroups, symposia, and meetings as well as the need to produce formal reports which feed into the process of Program Plan development. He presented possible science topics for discussion: cell biology of cone photoreceptor cells, neuroprotection, genetics of complex ocular diseases, development and congenital disease, angiogenesis, growth facts/cell division/differentiation, vision and imagine processing/low vision, and sensory awareness/visual attention. Possible policy topics included vision research training, mechanisms to support vision research, health services research, and vision research resources. Council members stressed the need to have appropriate outside scientists involved in the Phase II process.

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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).

CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

Dr. McNicol 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.

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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 5:00 pm.

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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 have been submitted for the approval of the Council. All corrections or notations have been 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

07/10/2006


Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

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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

Gunilla Haegerstrom-Portnoy
O.D., Ph.D. (05)
University of California
School of Optometry
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

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)
University of Houston
College of Optometry
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 Science
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

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

Ex Officio Members
Mike 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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