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NAEC Meeting Minutes - January 24, 2008

National Institutes of Health
National Eye Institute

Minutes of Meeting

One Hundred Eighteenth Meeting
January 24, 2008
Terrace Level Conference Center
5635 Fishers Lane
Bethesda, Maryland

The National Advisory Eye Council (NAEC) convened for its one hundred eighteenth meeting at 8:30 am on Thursday, January 24, 2008, at the Terrace Level Conference Center, 5635 Fishers Lane, 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, January 24, 2008, from 1:30 pm until 4:50 pm, the meeting was open to the public. Attachment A provides a roster of Council members.


Dr. Mae O. Gordon
Dr. Gunilla Haegerstrom-Portnoy
Dr. David E. Holck
Dr. Lenworth N. Johnson
Dr. Juan I. Korenbrot
Dr. Todd P. Margolis
Dr. Mary C. McGahan
Dr. Earl L. Smith, III
Dr. Val C. Sheffield
Dr. Marco A. Zarbin



Dr. Scott W. Cousins, Dr. Ronald J. Gardner, Dr. Charles D. Gilbert, and Dr. Richard A. Stone



Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Deborah Carper
Dr. Hemin R. Chin
Dr. Mary Frances Cotch
Ms. Janet Craigie
Mr. William W. Darby
Mr. Kenneth Frushour
Ms. Jerusha Gittlen
Dr. Shefa Gordon
Dr. Chyren Hunter
Dr. Karl John
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Wei Li
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Dr. Grace L. Shen
Dr. Annie E. Schaffner
Dr. Paul A. Sieving
Dr. Michael A. Steinmetz
Dr. Santa Tumminia
Dr. Jerome R. Wujek



Ms. Sylvia Braxton, Division of Extramural Activities Support (DEAS)
Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Mr. Francis Costello, Office of Budget, Office of the Director (OD), NIH
Ms. Mary Frances Deusch, Office of Policy for Extramural Research Administration, Office of Extramural Research, OD, NIH
Dr. Judith Finkelstein, CSR
Dr. Holly Krull, National Heart Lung and Blood Institute
Dr. George McKie, CSR
Ms. Marilyn Smith, DEAS
Dr. Jerry Taylor, CSR



Mr. James Jorkasky, National Alliance for Eye and Vision Research (NAEVR)
Ms. Lori Methia, ARVO
Ms. Elaine Richman, Richman Associates




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. Loré Anne McNicol, Director, Division of Extramural Research (DER), 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.





1:30 pm



Dr. McNicol introduced Dr. Timothy Hayes, Chief of the Portfolio Analysis and Scientific Opportunities Branch, Office of Portfolio Analysis and Strategic Initiatives (OPASI), Office of the Director, NIH. Dr. Hayes gave an overview of the RCDC project. He indicated that it is designed to look at current NIH category spending, using a new system that will break down costs by Institute and Center (IC). NIH releases reports regarding over 240 diseases and disorders yearly, and past National Academy Sciences reports and congressional inquiries have been requesting more information. The material in these reports allows congress and the public to better understand NIH research spending and priorities. The need for a change in reporting came from the 2006 NIH Reauthorization bill. This law mandated an electric coding system referred to as Research, Condition, and Disease Categorization (RCDC) as a system that contains all the information for contracts, intramural and extramural data. The benefits of this system include consistency, transparency, efficiency, and opportunities for further portfolio analysis.

Mr. Hayes described RCDC as a methodology which breaks both disease categories and projects into “fingerprints” which are then matched. So RCDC develops a definition of each condition and disease and permits a reproducible, scientifically defensible match to funded projects. There will be a one-time discontinuity in the numbers NIH reports, given this change of methodology. But thereafter, it should be reproducible and coherent. The system will be introduced to the public this summer and will be launched in February of 2009.



Dr. McNicol introduced the NEI Director, Dr. Paul Sieving. Dr. Sieving outlined the background to NEI’s program planning activities regarding ocular epidemiology, as well as the Sarasota winter symposium. The planning initiative started in December, 2006, when he asked Dr. Sheila West, Johns Hopkins University, to agree to chair the panel. Dr. West convened a program planning group in 2007, held a meeting post ARVO, gave out a draft to get comments from the community and a final document was presented in 2007. I asked Sheila to come to this meeting and see the outcome of her panel’s vision.

Dr. West thanked Dr. Sieving and the superb committee that worked with her. These individuals were committed to move forward and quickly. The entire panel felt we were not in the business of doing the same old but wanted to take a long, hard, detailed look on how to use the opportunities in population studies to ask important questions regarding the two to three major issues in fundamental basic epidemiology. In uveitis there still can use some basic epidemiological approaches. In clinical trials where additional data is in the context of treatment or intervention, more data would add value to already expensive projects such as genetic and environmental type studies. The types such as smoking and AMD have shown powerful results when looked at in a population context. There is need for some important work in methodologies. The larger studies that are amassed we are looking at ways to get new approaches on how to handle that data. The NEI can identify it as a high priority area by taking the lead. There was a lot of concern about what was the future home for ocular epidemiology. It was an important impetus for us to go into the community to find out what needed to be done for future research. We were very pleased with responses that there are other areas such as genetics, etc. that need to be explored.



At this time, Dr. Sieving presented Dr. West with a plaque in recognition of her outstanding service. He noted that Dr. West was recently awarded a $10M grant from the Gates Foundation for research on the epidemiology of trachoma. He also congratulated Dr. McNicol for receiving the 2007 Presidential Rank Award for Meritorious Executive. He remarked that this is a very prestigious award in the government, thanked Dr. McNicol for her contributions to NEI extramural programs. Dr. Sieving also recognized the service of Council member Dr. Lenworth Johnson who represents NEI on the NIH Council of Councils (COC). This body provides oversight and advice to OPASI. It consists of members from each IC advisory councils.

Dr. Sieving sadly noted the deaths of two prominent members of the vision research community. Past Council member Dr. Rubin Adler, Johns Hopkins University, died recently after a short illness. He was a widely respected, universally liked, and very helpful advisory to the Institute. We are also saddened by the death of Dr. Muriel Kaiser-Kupfer who died two weeks ago following a long illness. Dr. Kaiser-Kupfer was the long-time chief of the Laboratory of Ophthalmic Genetics and also the NEI Clinical Director.

Dr. Sieving announced three new personnel changes in the NEI: Dr. Richard S. Fisher is the new Acting Director of the Office of Program Planning and Analysis, following the retirement of Mr. Michael Davis. Rick’s duties as the Corneal Diseases Program Director will be ably assumed by Dr. Grace L. Shen, presently the Ocular Infection, Inflammation, and Immunology Program Director. Dr. Sieving welcomed Rick Fisher’s scientific leadership to fuse science into all of the aspects of the NEI’s planning and reporting functions. Dr. Michael A. Steinmetz has joined the NEI as Director of the Development and Regeneration of Central Visual Pathways Program. Mike had been an extramural grantee at Johns Hopkins and then joined the Center for Scientific Review as Scientific Review Administrator for the Central Visual Processing Study Section. Dr. Neeraj Agarwal from the University of Texas Health Science Center, Fort Worth is now the Director of the Oculomotor Systems and Neuro-Ophthalmology Program. With these two appointments, the NEI now has four extramural neuroscience Program Directors: Drs. Chyren Hunter, Michael Oberdorfer, Michael Steinmetz, and Neeraj Agarwal. Dr. Sieving mentioned that NEI is now using a different definition; in the past “neuroscience” was focused on the central nervous system. Now, “neuroscience” includes the eye, so between these four people we now have a neuroscience group who can think about the molecular details of recognizing the color green in the cortex. It will take a while to put all this together.

The NIH Neurosciences Blueprint has had a very strong presence over the past five years. It incorporates translational, genetic and neuroscience approaches. The Blueprint includes 14 or so institutes with a total pot of $5B dollars. That puts neuroscience on par with the budgets of the National Cancer Institute or the National Heart Lung and Blood Institute. The leaders of the Blueprint are talking to each other about once a month, with far greater interest in topics such as mental health, vision, infectious diseases. One of the things reported is the knockout mouse project, a questionnaire is about to be added to that study that polls the visual community into a broader complex. New training programs in neuroscience and physiology helps to bring the neurosciences into the broader community. There will be money for the Blueprint as a leading idea put on the table by Neurology and NEI that is in the area of addressing some prototype disease for arresting macular degeneration and I thank Mike Oberdorfer for that. Neeraj and Mike are welcome additions to the program hat which brings NEI right in line with NIH.

Two and a half years ago the NEI and the government of India signed an agreement to collaborate on ocular research. Since that time, joint symposia were held in India and at ARVO to stimulate new collaborations. Such opportunities grow naturally out of resources available in both countries. The ARVO website will soon have more details on the pathways to submitting these applications.

Dr. Sieving announced that later this spring there will be an outside review of the administrative, financial, and management activities of the NEI scientific director, Dr. Sheldon Miller. Council member Juan Korenbrot will be the chair of the panel. The NIH has such periodic reviews for all of the IC senior staff, including Directors. You table books contain information describing the process.

Dr. Sieving mentioned that the NEI and NIH budgets are tight. Elias Zerhouni’s leadership is looking at a tight and flat budget for the foreseeable future. This is the 4th year running without an increase; the last increase was in FY2003. The NEI is trying as best we can to protect new investigators and provide new opportunities for outstanding vision research to be identified and supported. The NIH has undertaken efforts to revise peer review, shorten applications, speed the turn-around time for resubmission of applications which miss funding, limit the total number of submissions. But some of these ideas present very difficult trade offs. This is not an empty exercise as changes will have to be made. Len Johnson will say something about the Council of Councils (COC), his experiences and what he thinks of the exercise.



Dr. Johnson told the members that he was given the opportunity to participate and he was honored to have Dr. Sieving’s trust to represent the NEI. The meeting was chaired by the head of OPASI, Dr. Alan M. Krensky. The COC looked at the NIH Reform Act of 2006 since the function of COC is to initiate, review, and authorize new programs. He presented slides summarizing the key provisions of the Reform act.

The Reform Act increases the Common Fund, starting with 1.7% of NIH budget, or $500M. Its funds will increase annually. When they reach 5% of the NIH budget, the NIH Director will report back to Congress. These monies will allow the ICs to come together to do things that normally could not have done by any individual IC. OPASI uses portfolio analysis to identify areas in need of investment. Solid objectives can override lack of pilot studies if necessary.

Beyond the roadmap there are several categories that the COC is looking at. The past meeting discussed difficulties of R01 funding for new investigators; the dbGap initiative; AIDS related studies; and the National Children’s Study that is prospectively following 100,000 children from various centers throughout the country at both the genome and phenome level. Following this initial planning meeting, the COC will have two meetings per year in March and November.



Mr. Kenneth Frushour, Deputy Budget Office presented an overview of the FY2008 omnibus appropriation. He reviewed the 5-year appropriation history for the overall NEI budget. For FY2008 it is flat. However, considering the budget in constant dollars, shows that inflation means the flat budget is really a 4.6% decrease in buying power. The funds are distributed 86.3% to Extramural Research, 10.3% to Intramural Research, and 3.4% to administrative overhead. He reviewed the mechanism table, where there are very few increases, the 4.9% increase in salaries and the 5.7% increase in contracts was off-set by a 0.7% decrease in grants. This will result in a slight drop in the application success rate, from 26.6% in FY2007 to 26.3% in FY2008.

Mr. Frushour reviewed the Program Evaluation portion of the budget. These activities are paid from the Research and Development portfolio and represent funds transferred to HHS. The NIH is responsible for paying for the majority of funds into this program. We pay 85% and receive 2% of the funds back for evaluating NIH programs.

He ended the presentation by reviewing up coming events. The FY2009 President Budget will be available on February 4, 2008. We are still waiting for dates to be set for the House and Senate appropriation hearings. This information will be made available on the NEI website, www.nei.nih.gov on February 4.



Dr. McNicol talked about NEI plans to translate these budget numbers in funding activities. She summarized NEI actions during the Continuing resolution: In the Research Project Grant (RPG) category, awards have been made at 80% of the committed level from the FY2007 Notice of Grant Award. In February there will be upward adjustments, based on the final appropriation. NEI plans to use their flexibility to make all RPG award cohorts at the same adjustment level, most likely in the range of -1.35% to -2%. In terms of competing grants, Dr. McNicol remarked that there will be a -0.6% decrease in the RPG total, and funding for Center core Grants will be constant. She noted that she expects the number of Institutional Training grants NEI will be able to award will decrease by four to six awards.

There also has been central guidance concerning the funding of new investigators—individuals who have never been the Principal Investigator on a significant NIH independent research award (such as an R01 or U01). NEI has been given the goal to fund four new K99/R00 NIH Pathway to Independence Awards, at least two new K08 Individual Physician Scientist Awards, and 43 R01 Research Project Grants to new investigators. Dr. McNicol summarized expanded eligibility opportunities for the NIH Director’s Bridge Award program. She gave the definition of the new mandatory public access policy and explained its purpose. The database will provide “one-stop shopping” for the public and Congress to see the results of NIH supported research. Up until this year, entry of publications into the database was optional. Now the process is mandatory as only 12% of the papers funded by NIH investigators were submitted. Accession numbers must be recorded in competitive and continuing applications. Investigators can now fix electronic mistakes.



Mr. William W. Darby, grants Management Officer, NEI reviewed the 4-page revised NAEC operating procedures, by which Council grants staff the authority to perform a number of routine grant matters, such as approving requests for no-cost extensions, for orderly close-out of a project, etc. Council members voted unanimously to the operating document.



Dr. McNicol discussed the status of the NIH Peer Review Enhancement Study. Council had been given a briefing at the last meeting, by Dr. Jeremy Berg, Director of the National Institute of General Medical Sciences, who co-chairs the initiative. The charge developed by the committee is to find ways to fund the best science, by the best scientists, with the least administrative burden.

As background, Dr. McNicol pointed out that the major complaints which the NIH hears from members of the scientific community: the peer review process is slow. There are not enough senior researchers on the study section panels. The process favors predictable research. And the time and effort to write and review are a heavy burden on both applicants and reviewers. She noted that other drivers include the facts that funding success rates are falling, the number of applications has nearly doubled since FY1998, and that the number of grant mechanisms has expanded enormously. She stressed that peer review was originally developed to identify the 25% of grants that should not be funded. Peer review has not kept up with the times, even though the charge is the same.

Next, Dr. McNicol presented the suggestions for peer review enhancement that have been selected through the community consultation process. The committee was looking for “minority genius” ideas instead of taking a “village vote”. The problems to be solved were organized into eight categories, within which 35 solutions were grouped. These overarching categories include:

  • There are too many applications.
  • There are too many grant mechanisms.
  • Investigators spend too much time writing.
  • Scoring should be improved.
  • There should be less emphasis on preliminary data.
  • The quality of reviewers should be improved.
  • Stretch resources when funding grants.
  • Shorten the review cycle.

The next steps are that the report will be presented to the Steering Committee Working Group on Peer Review Enhancement, and the Committee will forward its recommendations to the parent Steering Committee (SC). The SC will forward its approved recommendations to Dr. Zerhouni. Council members discussed several of the proposals and the likely implications of their implementation. Several members indicated their opinion that many of the underlying problems would be solved if the NIH appropriation were increased.



Dr. McNicol noted that this January Council meeting is the time that Council meeting dates for Calendar Year 2009. She said that the table book included the range of dates that had been sent to all the members before the meeting. There was no clear consensus among the responses, so she suggested that she check with Dr. Sieving’s calendar and then email a set of dates to staff and Council members.



Council members indicated their concern regarding recent acts of violence against vision researchers who use vertebrate animals in their research. Dr. Oberdorfer said that the central NIH has been concerned about these activities. And he asked Council members whether they had specific issues or responses they would like to raise.

There was a general consensus that recent wave of violence directed at researchers is a serious problem. It is not always a problem that can be addressed by single IC, and there has not been much of a coordinated central NIH response. There was concern that the NIH should be doing more, and that the NIH should be quite forceful.

Dr. Oberdorfer informed Council that this issue is receiving more attention centrally at NIH. Dr. Ruiz-Bravo, the NIH Deputy Director for Extramural Research, has worked with a trans-NIH committee to develop a set of resources that would enable NIH extramural staff to become a kind of “swat team” in response to an event. It’s not clear to what extent the NIH can be prepared to answer all inquiries that come in, but some of the past issues raise concerns about being able to protect workers at their homes. This is more an institutional and law enforcement responsibility.

Council members next asked for an update regarding NEI policy toward the K12 Institutional Clinical Scientist Development Program. Dr. McNicol indicated that the staff had discussed the recommendations from previous council discussion. Clearly Council felt that this program had not operated for a sufficient time for staff to be able to judge its success and accomplishments. Therefore, the NEI will continue to accept applications for the K12 program. We are planning to issue an updated Funding Opportunity Announcement, hopefully in line with the transition to electronic submission for all NIH K grant mechanisms.

Council members were concerned that some of the individual K12 programs had been forced to drop positions that had previously been approved for funding. Dr. McNicol described some of the management analysis that takes place during the renewal of institutional training programs. If a grant comes in after its first year of funding and has not been able to fill all of its approved slots, staff would use the unexpended funds to off-set the award for the second year. And the PI would still be allowed the full number of slots for the second year. However, if the slot is not filled for three or four years in a row, the NEI staff would eliminate that position in future years.

A Council member raised the issue of the fate of individual vision researchers when the NIH enterprise has flat funding for several years. Against this backdrop, one sees that a scientist may lose grant funding for some period of time. Eventually that individual will have to close down their research program forever. It was hoped that Congress would consider this issue when dealing with the NIH budget.

Dr. McNicol responded that Dr. Sieving is a member of the NIH Steering Committee, and that this topic is clearly a large part of IC discussions with Dr. Zerhouni. Everyone at the NIH is aware of impact of flat funding and is concerned with future trends. Members suggested that given the financial situation, perhaps the NEI should have its own Roadmap. Staff could meet with focus groups of research specialists to determine areas of scientific opportunity. Instead of waiting for investigator-initiated research topics to be submitted to the NEI, the NEI could forecast the areas of research that were needed.

Dr. Sieving remarked that this was a very interesting and timely suggestion that he will refer to Rick Fisher who is the Director of Program Planning and Analysis. Individual grants go through a peer review, and the NEI has done some limited areas of program planning in recent years. Here at Council we have been examining the various grant portfolios, one per meeting, to analyze outcomes and opportunities. Some Council members disagreed with this approach, arguing in favor of investigator-initiated research. Others felt it would be good for the Institute to both proactive and reactive in its funding decisions. An NEI Roadmap could be a successful piece of this.

Dr. Sieving suggested that we take at face value that the NIH Roadmap process recognizes areas of scientific opportunity, but there needs to be a considerable consensus to make major investments using this route. He appreciated hearing the various sides of this discussion, and said that the NEI staff would be exploring whether we should have more proactive planning for short-term portfolio investments.



Dr. Sieving adjourned the meeting at 4:50 pm



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 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)

Mae O. Gordon, Ph.D. (10)
Dept Ophthalmology & Visual Sciences
Washington University School Medicine
St. Louis, MO 63110

Gunilla Haegerstrom-Portnoy, OD, Ph.D.
Associate Dean for Academic Affairs
School of Optometry (09)
University of California
Berkeley, CA 94720

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

Mary C. McGahan, Ph.D. (10)
Dept Molecular Biomedical Sciences
North Carolina State University
Raleigh, NC 27606

Val C. Sheffield, M.D., Ph.D. (10)
Department of Pediatrics
University of Iowa College of Medicine
Howard Hughes Medical Institute
Iowa City, IA 52242

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

Department of Defense Representative
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
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