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NAEC Meeting Minutes - January 22, 2009

National Institutes of Health
National Eye Institute

Minutes of Meeting

January 22, 2009

The National Advisory Eye Council (NAEC) convened for its one hundred twenty-first meeting at 8:30 am on Thursday, January 22, 2009, at 5635 Fishers Lane, Rockville, 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 and from 4:00 pm until 4:15 pm for the review of grant and cooperative agreement applications, and to review the eyeGENE Network. On Thursday January 22, 2009 from 1:00 pm until 5:00 pm, the meeting was open to the public. Attachment A provides a roster of Council members.


Dr. Joseph Bonanno
Dr. James Chodosh
Dr. Scott W. Cousins
Dr. Ronald J. Gardner
Dr. Charles D. Gilbert
Dr. Mae O. Gordon
Dr. Gunilla Haegerstrom-Portnoy
Dr. Mary C. McGahan
Ms. Alberta Orr
Dr. Val Sheffield
Dr. Richard A. Stone
Dr. Marco A. Zarbin



Dr. Juan I. Korenbrot



Dr. David R. Copenhagen




Dr. Neeraj Agarwal
Ms. Rajnee Agarwal
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Dr. Mary Frances Cotch
Ms. Janet Craigie
Mr. William W. Darby
Ms. Linda Dingle
Mr. Donald Everett
Mr. Sean Finnegan
Dr. Richard Fisher
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Ms. Tina Jones
Mr. J. Kevin Keating
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Lisa Neuhold
Dr. Andrew P. Mariani
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Ms. Kathleen Moy
Dr. Michael D. Oberdorfer
Ms. Jessica Perez
Dr. Cesar Perez-Gonzalez
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Ms. Karen Robinson-Smith
Dr. Gordon Shefa
Dr. Grace L. Shen
Dr. Anne E. Schaffner
Dr. Paul A. Sieving
Dr. Sarah Sohraby
Dr. Michael A. Steinmetz
Ms. Chantel Stevenson
Dr. Santa Tumminia
Ms. Keturah Williams
Mr. David Whitmer
Dr. Jerome R. Wujek



Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Ms. Mary Frances Deutsch, Office of the NIH Director (OD)
Ms. Donna Holland, OD
Dr. Judith Finkelstein, CSR
Dr. Jerry Taylor, CSR



Dr. Wylie Chambers




Dr. Bobbie Austin, Association for Research in Vision and Ophthalmology (ARVO)
Ms. Joanne Angle, ARVO
Dr. Joseph Carroll, Medical College of Wisconsin
Ms. Adrianne Drollette, American Optometric Association (AOA)
Dr. Israel Goldberg, Health research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Ms. Elaine Richman, Richman Associates
Mr. Ted Shoneck, Tunnell Consulting


Thursday, January 22, 2009


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).


Dr. Andrew Mariani, 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.




1:00 pm



Dr. Paul A. Sieving, Director, NEI, and Chair of the Council welcomed Council members, staff, and guests to the one hundred twenty first session of the NAEC. He welcomed and introduced three new council members. Ms. Alberta Orr, is The Executive Director of The Disabilities Network, New York City and is experienced in disabilities. She served as the Director of The National Agenda on Vision and Aging Program of the American Foundation for the Blind and is currently working on her Ph.D. Dr. James Chodosh, MD, MPH, is a new faculty member at Harvard’s Massachusetts Eye & Ear Infirmary with clinical experience in corneal and related diseases. He is a new MPH, and previously served at the University of Oklahoma, moving to Mass Eye & Ear in July. Dr. Joseph Bonanno, O.D., Ph.D., is Associate Dean at the Indiana University School of Optometry.

Dr. Sieving also introduced and welcomed the two new NEI Staff. Dr. Lisa Neuhold is a new program director in Retinal Diseases, and Mr. Sean Finnegan is a new assistant in Office of the Director working with Dr. Sieving.

Dr. Sieving discussed several items of current interest. He noted that there is a new President and there will be a new Health and Human Services Secretary and a new NIH Director. NIH has prospered well under Dr. Zerhouni who worked to bring a number of new ventures to the NIH. When a new NIH Director comes, these areas will be rethought and recast and the NEI is ready to participate. The country is trying to dig out of economic problems. The stimulus package is being crafted at this point. The mechanism by which science will be funded and the size of such funding is under discussion but within the National Eye Institute, we’ve spent time thinking about how to approach the funds should they become available, distinguishing between one-time packages of money versus monies that will go into the base. The leadership at NEI will look carefully at how to foster success at the NEI in the best possible way.

Dr. Sieving commented on Comparative Effectiveness Research (CER) because there is considerable political interest in attending to the cost of medical costs in the country in light of effective health care. There is the expectation that there will be monies put into CER, and there is much speculation about what that will be, and if the NIH is to monitor this. NEI currently supports a trial of Lucentis vs. Avastin, compounds that are used to treat new vessels growing in the body and in the retina, noting there is a vast difference in price between the two compounds. The question that NIH is posing, is how to run trials comparing drug A to drug B in a way that will yield novel scientific information and produce knowledge that will bear on the national economy in terms of health care. Council members will have to be conscious of that over the next months and years.

Dr. Sieving noted that Dr. Zerhouni, the recent and former NIH Director, was not a native born US citizen and he recognized that global health concerns need to be addressed. In that regard, there was just a meeting who are working under the Indo-US Collaborative Research Initiative including the Director of the Department of Biotechnology (DBT). There are several grants under the DBT and 15 of those are vision. The intent of the Government of India is to increase the funding level 10-fold, a remarkable jump that tells of the commitment of the Government of India. At the level of due diligence, and opportunity, we must pay attention to what is happening in India regarding eye research. Also note that there is enthusiasm by the leadership in China for biomedical research.

The International Congress of Eye Research (ICER) meeting was held in Beijing in September and it is obvious there are opportunities developing in China at a very rapid pace. Also, in Europe, there is a very well organized vision community. These international opportunities demonstrate that we in the U.S. do not operate in isolation.


Presidential Transitions and Biomedical Science at NIH

Dr. Sheldon Miller, Director, Division of Intramural Research, NEI, began on a historical note and spoke about the evaluation of the intramural research program which has been an ongoing process. He noted there are periodic reviews going back several years. In addition, there are ongoing reviews of specific institutes on a rotating basis. In terms of presidential elections the transition always affects the intramural program. This provides an opportunity to review strengths and weaknesses and provide a vision going forward. Several goals are the encouragement of clinical trials and treatment targets, and optimizing clinical and translational research in the Intramural Research Program (IRP).

Another issue is the role of the Institutional Review Boards (IRB’s), the variety of different IRB’s, and the process of navigating those committees. One suggestion has been to eliminate some of the IRB’s. The NEI is a part of the NIH IRB process and there has been an enormous increase in efficiency including the creation of six new Protocol Service Centers (PSC’s) to allow support for protocol preparation.

He noted that the NEI is going forward in several areas in terms of research by expanding and developing a clinical presence in genetics, a new program in computational medicine, and translational methods. The NEI is participating with a wide range of NIH institutes in gene therapy methods and other areas to gain resources. It is making joint appointments across institutes. Training and mentoring are also being emphasized.


2009 Council Operating Procedures: Early Concurrence

Mr. William Darby, Chief, Grants Management Branch, Division of Extramural Research, NEI reviewed the current Council Operating Guidelines. He proposed adding Early En Bloc Concurrence to the existing Council Operating procedures and noted that the NEI is the only Institute that does not have early concurrence. Early concurrence allows the NEI to begin the process of funding those applications earlier resulting in more expeditious awards. The Executive Secretary would select at least three council members to review the selected applications and vote on early en bloc concurrence.

A Council Member stated that Members are usually assigned specific programs based on their expertise but with perhaps as few as three Council members voting on early concurrence, what would happen if expertise in a particular program is missing? Mr. Darby replied that any Council member may place a hold on an application for early concurrence in order to discuss the application at Council. Dr. Mariani stated that only a small percentage of applications would be designated for en bloc concurrence, these applications would not have any issues that require Council discussion or action. The number of applications designated for early en bloc concurrence would be in the range of perhaps 30. These applications would all be designated in the Electronic Council Book. A motion was made, and seconded, to add early en bloc concurrence to the current Council Operating Procedures. Council voted unanimously in favor of the motion.


2010 Council Dates

Dr. Mariani asked Council members to reserve the following dates in 2010 for Council meetings; January 14 and 15, June 10 and 11, and October 14 and 15.


Center for Excellence in Genomics of Eye Diseases

Dr. Hemin Chin, Ocular Genetics Program Director, Division of Extramural Research, NEI, discussed the rationale, policy, and modifications for the NIH Policy on Genome Wide Association Studies (GWAS) and the sharing of genetic data. He noted that it should advance our understanding of the molecular basis of disease, aid in discerning the inheritance patterns of genetic disorders, and clarify the implications of genetic factors that predispose to disease. He then reviewed NEI-sponsored GWAS studies including the AREDS samples, AMD, myopia and glaucoma. For the future of GWAS, Dr. Chin noted that these studies would better utilize existing population/patients cohorts with well-characterized phenotypes, bring new technologies and strategies for genomic analysis, and foster multi-disciplinary collaborations.

Dr. Chin then brought forward the Concept for a “Center for Excellence in Genomics of Eye Diseases” as a way to benefit from the rich resource of NEI-supported studies with population cohorts and identified phenotypes, and to take advantage of new and ever advancing technologies. This would be a U01 Cooperative Agreement mechanism with multiple PI’s.

Council expressed concern that for young investigators, sharing of data could be a detriment to career advancement, in the current academic setting. Staff responded that the NIH was aware of the issue and seeking solutions.

A motion was made, and seconded, to support the Concept in general terms. Council voted unanimously in favor of the motion.



Ms. Marilyn Laurie, Chief, Financial Management Branch, NEI reviewed the NEI budget, its appropriations history, and buying power. She noted that the NIH is currently operating under a continuing resolution. Ms. Laurie discussed the four components of the federal budget process: Congressional Action, Performance Review, Budget Formulation, and Budget Execution. She also summarized the effect of the Presidential Transition on the budget, the Economic Stimulus package being discussed in Congress, and Research Condition and Disease Categorization (RCDC) as a new tool to report funding amounts for Diseases and Research Areas.



Dr. Ellen Liberman, Acting Director, Vision Research Program, Division of Extramural Research, provided an update on types and numbers of grants funded and amounts expended during Fiscal Year 2008 that ended September 30, 2008.

In an overview of research project grants, Dr. Liberman noted that NEI followed central guidance on managing Research Project Grants (RPG’s) by making non-competitive awards at the 98% committed level and a case-by-case examination of competing awards. She stated that the success rate for RPG’s was 29.5% and the average total cost of an RPG was $364,636. In FY 2008, NEI funded 279 competing RPG’s and 780 non-competing RPG’s.

Dr. Liberman discussed the Institute’s strategy for new investigators and stated that NEI staff is encouraged to identify and give special consideration to new investigators in making funding recommendations, in keeping with NIH OD Policy. She also presented the newly-implemented strategy of identifying Early Stage Investigators (ESI’s).

Ongoing trans-NIH initiatives that the NEI is participating in are the NIH Roadmap for Biomedical Research, the NIH Neuroscience Blueprint, the NIH Genes and Environment Initiative, and the NIH Director’s Bridge Award. Future initiatives for the Institute include an RFA to solicit SBIR/STTR applications for screening for diabetic retinopathy and the NIH Roadmap-Transformative R01 Program.

Questions arose from Council on the new NIH policy of limiting resubmission (amended) applications. Dr Lore Anne McNicol, Acting Deputy Director, replied that beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009 due dates and beyond, the NIH will accept only a single amendment to the original application. Failure to receive funding after two submissions (i.e., the original and the single amendment) will mean that the applicant should substantially re-design the project rather than simply change the application in response to previous reviews.

It is expected that this policy will lead to funding high quality applications earlier, with fewer resubmissions. Applicants who fail to receive funding after two submissions may resubmit but only if the application is fundamentally revised to qualify as new. A new application is expected to be substantially different in content and scope with more significant differences than are normally encountered in an amended application. There is no time limit for the submission of the original and subsequent A1. This policy was implemented in response to the concern of the marked reduction in the number of awards made in response to original applications.

The Council had questions about New Investigators and ESI’s. Dr. Liberman stated that the category of “New Investigator” was previously by self identification by the applicant An ESI is a new investigator within ten years of his/her terminal research degree or is within 10 years of completing medical residency (or the equivalent).

Beginning with traditional R01 applications received for the February 2009 receipt dates, New Investigators and ESI’s will be identified using data within the NIH administrative database.


Biennial Advisory Council Report Certifying Compliance with the NIH Policy on Inclusion Guidelines

Mr. Donald Everett reported on the NIH compliance on women and minorities in clinical research studies as required every two years. He noted the Office of Research Women’s Health is coordinating the reporting efforts and discussed why NIH has this policy.

The Congress made what had previously been policy into public law through a section in the NIH Revitalization Act of 1993 (PL 103-43). The Revitalization Act essentially reinforced the existing NIH policies with four major differences:

  • NIH ensures that women and minorities are included in all human subject research;
  • Phase III clinical trials inclusion of women and minorities in numbers adequate to allow for valid analyses of differences in intervention effect;
  • Cost is not allowed as an acceptable reason for excluding these groups; and,
  • NIH initiates programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as volunteers in clinical studies.

Mr. Everett reported that the NEI was in full compliance with all requirements, had no data discrepancies between 2007 and 2008, and, was the first Institute to complete the training. There is good representation of women and minority participants in NEI Clinical Studies.

A motion was made, and seconded, to accept the Report. Council voted unanimously in favor of the motion.


Concept Clearance: NEI Administrative Supplements for Infrastructure Support

Dr. Michael Steinmetz, Program Director, DER, NEI, proposed a program of administrative supplements to provide infrastructure support for existing NEI research grants to introduce new technologies or upgrade current facilities.

Eligibility would require at least 2 years of funding remaining on an R01 grant. The work to be performed must be within the scope of the originally recommended and approved aims and the supplement would be for one year only. Institutions would be encouraged to participate in sharing in the costs and providing any future year support for maintenance. The maximum amount allowed would be $500,000. If council approved, a notice would be placed in the NIH Guide in a few weeks. July 1, 2009 would be the receipt deadline.

Council asked whether or not several investigators could share the request for more than a single grant. Dr. Steinmetz stated that the supplement would be made to only one grant but in the past have been for the use of several investigators.

A motion was made, and seconded, to accept the Concept. Council voted unanimously in favor of the motion.


Overview of the NEI Office of Administrative Management

Mr. David Whitmer, Executive Officer, NEI, presented an overview of the structure and function of the Office of Administrative Management (OAM), and the core purpose and core values of OAM in providing support for the mission of vision research of the NEI.

The OAM has four branches, Administrative Management (AMB), Financial Management (FMB), Management Policy and Analysis (MPAB), and Information and Technology Management (ITMB).

Mr. Whitmer discussed the improvement of services through the initiation of the Administrative Lab Manager position. He outlined the establishment of Standard Operating Procedures (SOPs) as a web based template for HR actions, travel, procurement, performance metrics for specific administrative actions, service level agreements with science areas, coordinated FY close-out with FMB for better financial management tracking, and centralized procurement, with a new procurement supervisor to more efficiently distribute work and identify better procurement approaches.

Annual goal setting with quarterly reporting on status to the Director and Deputy Director, technology enhancements to web based procurement and integration with NIH’s New Business System, new employee orientation, new human resources database to track federal, non-federal, contractor, and volunteer staff, development of Continuity of Operations Plan (COOP), configuration of all NEI desktops to new security standards and the creation of administrative user privileges for trained personnel, a risk management program, and the establishment of NEI “Green Team” for environmental awareness and to reduce energy use are some of the other initiatives of OAM.

Dr. Sieving thanked Mr. Whitmer for his contribution to the Institute and noted that OAM services are invaluable and that Mr. Whitmer is highly regarded within the NIH community.


Program Planning

Dr. Richard Fisher, Acting Director, Office of Program Planning and Analysis (OPPA) began his presentation by noting that OPPA is part of the NEI Director’s Office. He reviewed how funding decisions are made based on scientific merit, program priorities, and availability of funds and then reviewed the history of Program Planning at the NEI dating back to 1973. Dr. Fisher then spoke about the benefits of program planning for NEI Staff, the Scientific Community, and the public including individuals with visual disorders, professional organizations and patient advocate foundations, and for the business community including pharmaceutical and biotech industries.

NEI Program Planning should address the following questions. What are today’s scientific challenges? What are the barriers to progress? What are the scientific, administrative, and resource needs to overcome these barriers? What areas of investigation do not fit into existing programs? Should new program areas be developed? Are there opportunities that NEI should address with Funding Opportunity Announcements?

Implementation would occur with the NAEC overseeing the process, and NEI/OPPA Staff providing a Framework Document (March). Public comments would be solicited in a March – June timeframe. Program Panel Meetings would be held in May or June with Draft Reports ready in July. A second solicitation of Public Comment would be made in July and August before the Program reports are finalized.

A question arose from Council about how they were to become engaged and what their role was in oversight. Dr. Sieving replied that a Council subcommittee would be established including current and past members to meet, discuss, and present at Council meetings the status of Planning. The output, in a Planning Document would go to the council as soon as it was completed.

Further discussion centered on how the panels would be organized and around what topics or program areas. It was decide that this was an issue that would be addressed by the Council Subcommittee.



Dr. Sieving adjourned the meeting at 5:00 pm



I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Andrew P. Mariani, Ph.D.
Executive Secretary
National Advisory Eye Council
Division of Extramural Research
National Eye Institute

Paul A. Sieving, M.D., Ph.D.
National Advisory Eye Council
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


Attachment A


(Terms end 11/30 of the designated year)

Gunilla Haegerstrom-Portnoy, OD, PhD
Associate Dean Academic Affairs (09)
School of Optometry
University of California, Berkeley
Berkeley, CA

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

Mary C. McGahan, Ph.D. (10)
Professor and Department Head
Department Molecular
Biomedical Science
North Carolina State University
Raleigh, NC

Alberta Orr (12)
NYC Coalition on Vision and Aging
New York, NY

Val C. Sheffield, M.D., Ph.D. (10)
Department of Pediatrics
University of Iowa College of Medicine
Howard Hughes Medical Institute
Iowa City, IA

Richard Stone, M.D. (10)
Department of Ophthalmology
School of Medicine
University of Pennsylvania
Philadelphia, PA

Joseph Bonanno, O.D., Ph.D. (12)
School of Optometry
Indiana University
Bloomington, IN

James Chodosh, M.D. (12)
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Boston, MA 02114

Scott W. Cousins, M.D. (11)
Duke University Eye Center
Durham, NC

Ronald J. Gardner, J.D. (11)
Field Services
National Federation for the Blind
Bountiful, UT

Charles D. Gilbert, M.D., Ph.D. (11)
Department of Neurobiology
Rockefeller University
New York, NY

Mae O. Gordon, Ph.D. (10)
Department Ophthalmology &
Visual Sciences
Washington University School Medicine
St. Louis, MO


Department of Veterans Affiars Represenative
Marco A. Zarbin, M.D., Ph.D.
Professor and Chairman
Department of Ophthalmology
UMDNJ-New Jersey Medical School
Newark, NJ

Department of Defense Representative
Donald A. Gagliano, M.D. (Colonel)
Vision Center of Excellence
Washington, DC

Ex Officio Members
Kathleen Sebelius
Department of Health and Human Services
Washington, DC 20201

Francis S. Collins, M.D., Ph.D.
National Institutes of Health
Bethesda, MD 20892

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

Executive Secretary
Andrew P. Mariani, Ph.D.
Program Director
Fundamental Retinal Processes
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892