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Home » About NEI » The National Advisory Eye Council (NAEC), Minutes January 23, 2014

NAEC Meeting Minutes

National Institutes of Health
National Eye Institute
National Advisory Eye Council
One Hundred Thirty-sixth Meeting
January 23, 2014

The National Advisory Eye Council (NAEC) convened for its one hundred and thirty-sixth meeting at 8:30 am on Thursday, January 23, 2014, at 6701 Rockledge Drive, Bethesda, Maryland, 20817. 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 a.m. until 12:45 p.m. The meeting was closed to the public from 2:00 p.m. until adjournment at 5:00 p.m. for the review of grant and cooperative agreement applications. Attachment A provides a roster of Council Members.

COUNCIL MEMBERS PRESENT:
Dr. Laura Frishman
Dr. Jonathan Haines
Dr. John Morrison
Ms. Kathleen Petrillo
Dr. Eric Pierce
Dr. Krishna Sharma
Dr. Jayne Weiss
Dr. Sheila West
Dr. Rafael Yuste
Dr. Marco Zarbin

COUNCIL MEMBER ABSENT:
Dr. Hollis Cline

NEI STAFF PRESENT:
Dr. Houmam Araj
Dr. Neeraj Agarwal
Dr. Deborah Carper
Dr. Preethi Chander
Dr. Hemin Chin
Ms. Monique Clark
Mr. William Darby
Ms. Linda Dingle
Mr. Donald Everett
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Thomas Greenwell
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Mr. Kurt John
Ms. Tina Jones
Dr. Ellen Liberman
Dr. George McKie
Dr. Loré Anne McNicol
Ms. Kathleen Moy
Dr. Lisa Neuhold
Dr. Gyan Prakash
Dr. Maryann Redford
Ms. Karen Robinson-Smith
Dr. Gale Saunders
Dr. Anne Schaffner
Dr. Eleanor Schron
Dr. Paul Sieving
Dr. Michael Steinmetz
Dr. Santa Tumminia
Dr. Lisa Wei
Ms. Jennifer Wenger
Mr. David Whitmer
Dr. Louise Wideroff
Ms. Keturah Williams
Dr. Jerome Wujek

OTHER NIH STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Nataliya Gordiyenko, CSR
Dr. Paek Lee, CSR
Dr. Kirk Thompson, CSR

MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Dr. Richard Masland, Harvard University
Dr. Michael Oberdorfer, Consultant
Mr. Rodney Peele, American Optometric Association (AOA)
Ms. Kelli White, AOA
Dr. Matthew Windsor, Association for Research in Vision and Ophthalmology

OPEN SESSION OF THE MEETING
8:30 am

DIRECTOR'S REPORT AND OPENING REMARKS
Dr. Paul Sieving, Director of the National Eye Institute (NEI) and Chairman, National Advisory Eye Council (NAEC), welcomed all attending the meeting. He noted that due to the government shutdown last October, the scheduled October 2013 Council Meeting could not take place in person. He remarked on the current continuing resolution and the increase of $1 Billion in the NIH Budget. Dr. Sieving reviewed Fiscal Year 2013 (FY13) spending and the drop in the success rate for applications from 29 to 24% from the previous FY12 in large part to an increase in applications received. The NEI maintained the highest success rate for all Institutes at NIH.

The NIH Leadership Forum meets once a year to consider trans-NIH Initiatives and actions. The topics recently covered were the analysis of review group outputs; approaches to supporting science and scientists; maximizing efficiency of core facilities; changes to the biosketch; and the nature of the intramural research program. Dr. Sieving opined that these topics were being driven by a need for efficiencies in light of a flat budget.

We recently honored Dr. Jules Stein and were honored as the recipient of a bust of Dr. Stein by Jacques Lipchitz. The bust was presented by Dr. Brian Hofland, President of Research to Prevent Blindness which was founded by Dr. Stein, and Ambassador William vanden Heuvel, Dr. Stein's son-in-law, and Katrina vanden Heuven, Dr. Stein's granddaughter. Dr. Stein, an ophthalmologist, was the founder of Music Corporation of America, and his efforts were key to the creation of the National Eye Institute.

Dr. David Schneeweis has been appointed Deputy Scientific Director for the NEI Intramural Research Program replacing Dr. Sarah Sohraby. Dr. Schneeweis has a Ph.D. in Biomedical Engineering from the University of Michigan and he was a postdoctoral fellow with Dr. Julie Schnapf at the University of California, San Francisco studying phototransduction. He was then at the University of Illinois and subsequently Northwestern University where he administered the neuroscience program. His experience in teaching and administration will be an asset to the intramural program.

The NEI won a gold medal in June 2013 in the Web Health Awards. The award is a measure of the successes in communication by the communications office and particularly Ms. Kym Collins-Lee who manages the website.

Dr. Wei Li was honored as the Seventh Annual Sayer Vision Research Lecturer, and the first Young Intramural Investigator Awardee. His talk was on squirrels as a model for studying retinal neurobiology. Dr. Li is now a Senior Investigator in the NEI Intramural Research Program and Head of the Unit on Retinal Neurophysiology.

Drs. Frederick Ferris and Emily Chu will receive the 20th Helen Keller Prize and join a number of illustrious previous recipients.

In a modest note, Dr. Sieving announced that he has been elected to the German Academy of Sciences, the Leopoldina, and the first to represent the NIH on the world's oldest continuously existing academy for medicine and the natural sciences.

In the area of vision science, an important meeting of the Glaucoma Genetics Consortium was recently held and there has been progress in identifying risk genes for glaucoma. This has been a difficult undertaking but is feeding back into a more fundamental understanding of the disease.

The AMD Gene Consortium met last September and reported seven new genetic loci associated with AMD bringing the total to nineteen or twenty and pointing to the complexity of the disease.

The value of aquaporin in maintaining clarity of the lens is well known and quite recently the atomic view of that protein was derived by several groups. Knowing what the protein looks like is going to be important in understanding something about the structural biology and biological interplay in pathways maintaining lens clarity.

The NEI and the NIH Center for Regenerative Medicine are having a kick-off on an effort to move stem cells into a human clinical trial. Specifically, the start is to developing the materials for an IND (Investigational New Drug) application with the FDA for RPE-derived IPS cells. The NEI is the sole Institute that has competed successfully, five years running, for funds from NIH Director Francis Collins through the Common Fund, for IPS stem cells.

The BRAIN Initiative (Brain Research through Advancing Innovative Technologies), announced by the President last year, is moving ahead rapidly, with Dr. William Newsome as co-chair. Dr. Newsome will provide an update about the state of the initiative a later today.

Lastly, Drs. David Copenhagen and Bernard Godley were recognized by Dr. Sieving for their service on the Council as their terms of appointment ended last year.

Dr. West asked who will be running the clinical trial on stem cells and Dr. Sieving answered that a final decision has not been made but it could be handled within the NEI Intramural Program.

CONSIDERATION OF JUNE AND OCTOBER 2013 MINUTES
Dr. Loré Anne McNicol, Executive Secretary of the Council and Director, Division of Extramural Research, requested approval of the minutes of the June and October 2013 Council Meetings. A motion for approval was made and the minutes were accepted.

BUDGET UPDATE
Mr. Kurt John, Budget Analyst, Financial Management Branch, presented an overview and update on the NEI Fiscal Year (FY) 2014 budget. He reported that with regard to the FY 2014 Omnibus Funding Level, all 12 appropriation bills cleared Congress and have been signed by the President. The total NIH funding level is $30.15 billion. This is $1 billion over FY 2013, but still $0.71 billion below FY 2012. The total NEI funding level is $682 million, $25 million over FY 2013 operating level, but still $20 million below FY 2012. Pending issues are that OMB has to determine if the bill is within the discretionary spending caps. If not, the excess funding will be rescinded. There are also internal transfers to the Secretary and NIH. The NEI FY 2014 operating level will be the balance remaining after internal transfers.

The Omnibus Bill directs NIH Director to adopt a reasonable NIH-wide policy for noncompeting and competing inflation rates that is consistent with the overall funding increase, to review how the priority-setting affects program goals and the NIH research portfolio, and to develop a plan to reduce the administrative burden of organizations receiving support from NIH support. The Bill also specifies a trans-NIH Workshop to discuss clinical trial patient enrollment and retention challenges, the development of an NIH-wide process to reduce the cost of communications activities, and a resource shift from the extramural to intramural based on scientific merit and to include advance consultation with the extramural community. NIH should also apply the same additional level of scrutiny, planned for on extramural principal investigators with grants of $1,500,000 or more, to intramural researchers.

In an FY 2013 Budget recap, Mr. John reported that post sequester and transfers, NEI received $657 million to operate. This amount was $45 million below the FY 2012 operating level and approximately 25 percent below our FY 2003 appropriation buying power. Funding reductions impacted all program areas: extramural research -6 percent, intramural research -4 percent, and research management support -5 percent. NIH held the average cost of competing RPGs flat to FY 2012. NEI average costs remained constant at $404,300 per grant. Also, NIH allowed institutes flexibility with noncompeting RPG award policy. To balance resources, NEI funded noncompeting RPGs at 5% below the commitment amount noted on the most recent NGA. The President's Efficient Spending directives reduced travel, conference, printing, equipment, and supplies cost by 20% below the FY 2010 level.

Of the $657 million operating level, 86 percent funded extramural grants and R&D contracts, 11 percent supported intramural projects, and the remaining 3 percent was used for daily operations.

The extramural program funded 267 competing and 764 noncompeting RPGs, 40 core facilities, and 103 training awards. The NEI RPG success rate decreased from 29% in FY 2012 to 24% in FY 2013, but ranked the highest amongst the NIH ICs. In addition to reduced funding, NEI had a notable increase in competing RPG applications. The NIH success rate averaged approximately 16% and the other institutes ranged from 4.3% to 23%. The Intramural Program supported 108 research projects, and both the intramural program and the support offices achieved the President's Efficient Spending targets.

Operating considerations for the NEI in FY 2014 are based on a funding level that will be $682 million minus the likely internal transfers. With regard to RPGs, in FY 2013, NEI funded noncompeting grants at 5% below the commitment amount, which provided approximately $15 million to sustain other research priorities. If noncompeting grants are funded at the full commitment level in FY 2014, NEI costs would increase by approximately $16 million; from $295 million in FY 2014 to $311 million in FY 2014. Stipend increases are to be at a percent not below the federal pay policy. Program Evaluation is not to exceed 2.5 percent. Government-wide conference and travel restrictions also remain in place.

Moving forward the NEI has to establish an Operating Plan for FY 2014 according to our scientific priorities. The NEI must also formulate and submit the FY 2015 congressional justification that is due February 3, 2014, and revise the Mechanism Table to display funding provided to operate the NIH Clinical Center.

NEI LOAN REPAYMENT PROGRAM UPDATE
Dr. Neeraj Agarwal, NEI Training Officer, reported on the NIH Loan Repayment Program at NEI for fiscal year 2012. He noted that the NIH Loan Repayment Program (LRP) is intended to attract health professionals to careers in research. NIH Grant support is not required. The program is for two years and up to $35,000 payback of qualified educational debt is allowed, plus taxes. The loans are renewable, if eligibility criteria are met. The candidates must perform patient-oriented clinical research, devote a minimum of 50% effort for 2 years, be a US citizen, U.S. national, or, permanent resident. The application is available online. The NIH will repay educational loans backed by the U.S. Government and educational loans from accredited U.S. academic institutions and commercial lenders. The NIH will not repay home equity loans, loans consolidated with another individual (i.e. spouse, child), PLUS loans, delinquent loans, loans in default; or loans not current in repayment. Dr. Agarwal presented data on the number of applications received and the number of loans repaid by the NEI for the fiscal year 2013. A total of 28 applications were received and 25 applications were funded for an 89% success rate.

Dr. Haines praised the success of the program based on the comments of younger faculty who have received these awards but he questioned how this worked to attract clinically-trained individuals into research careers because these awardees never heard about the program until after they had already selected research careers. He did remark that the program certainly helped retain these individuals in their research careers.

COUNCIL OPERATING PROCEDURES
Mr. William Darby, Grants Management Officer, NEI, reviewed Council Operating Procedures for CY 2014. These guidelines provide an operating framework for the review of grant and cooperative agreement applications by the National Advisory Eye Council including the handling of appeals and the Special Council Review of Research Applications from PDs/PIs with more than $1.0 M Direct Costs in Annual NIH Support, and options for Council action. Included in the Council Operating Procedures are guidelines for staff negotiations and interim administrative actions. The Council operating procedures are available online at: http://www.nei.nih.gov/about/naec/procedures.asp

Dr. McNicol noted that there are no changes to the procedures and requested acceptance by Council. All were in favor of a motion to accept the Council Operating procedures for CY 2014.

CONCEPT CLEARANCE: NEI SBIR/STTR REGULATORY ASSISTANCE PROGRAM
Dr. Jerome Wujek, Research Resources Officer, NEI, reviewed the purpose of the SBIR/STTR Program, to turn knowledge into medical products with financial support for early-stage technologies with commercial potential. The goal is commercialization.

He noted that navigating the Federal Regulatory Pathway is a critical step towards the goal of commercialization.

The Federal Regulatory Pathway is through the Food and Drug Administration (FDA) which ensures the safety and quality of medical products, therapeutics and medical devices. The FDA sets regulations and standards for medical products. FDA approval is required before selling in the US.

Perceived as a hurdle to commercialization is that the regulations are complex, varied, changing, detailed, and equivocal. The problem is that small businesses often do not have or lack access to the expertise needed to navigate the process. A potential solution is for the NEI to establish a Regulatory Assistance Program to provide access to regulatory expertise.

A pilot program was initiated in 2011 and the NEI is now proposing to revise the Regulatory Assistance Program. The features of the pilot Regulatory Assistance Program were that it was a competitive application process that used a single regulatory consultant company with an initial meeting to cover the grantees questions and goals in order to develop a comprehensive regulatory strategy. There was subsequently a follow-up meeting for implementation.

The feedback from participants revealed that the pilot program filled an important need, provided good information and guidance, and was especially useful for start-up companies. On the negative side, it was noted that specialized ophthalmologic expertise was needed, and many expectations were not met.

The proposed Regulatory Assistance Program would offer administrative supplements. Ten supplements per year would be made with a single supplement to an individual company. The Program would allow each small business to choose a consultant based on the individual need, and the focus of the program would be on start-up/inexperienced companies. Availability of the Program would be announced through the NIH Guide, and on the NEI website.

Council queried Dr. Wujek on the oversight of consulting companies and possible conflict of interest issues. Dr. Wujek replied that these issues would be reviewed before an award would be made. Council also wanted to know about potential limitations of the Program in terms of financing and time to overcome the regulatory hurdles. Dr. Wujek stated that the duration and amount of the average award would meet the stated purpose. Council lastly asked about the success of pilot program. Dr. Wujek answered that ten awards were made and one company has gone on to get an IDE and a clinical trial is now in progress.

A motion was made, seconded, and approved by all Members of Council to move forward with the proposed concept for the Regulatory Assistance Program.

INITIATIVE TO ENHANCE REPRODUCIBILITY AND TRANSPARENCY OF RESEARCH FINDINGS
Dr. George McKie, Program Officer, NEI, reported on the issue of the reproducibility and transparency of research findings which have been noted as an issue in multiple publications and is a concern of the NIH. This is a problem in all areas of research and has been observed in both clinical and preclinical research.

As background, Dr. McKie noted NIH workshops held in 2012 that included the NINDS: "Optimizing the Predictive Value of Preclinical Research", summarized in the October 2012 issue of Nature, and the NCI: Reproducibility and data standards. The NIH Leadership discussed the underlying causes and developed "pilot" interventions in 2013

Possible causes in difficulties reproducing data include: "cartoon biology," an overemphasis on the "exciting, big picture" finding sometimes resulting in publications leaving out necessary experimental details; chance , where experiments are performed correctly, but without appropriate replication; difficulty in publication of "negative" findings; poor experimental design; failure to report of perform fundamental quality characteristics (e.g. blinded assessment, randomization, sample size calculations); and inadequate reporting of resources used and/or unexpected variability in resources.

Underlying issues contributing to irreproducibility may include poor training, poor evaluation, and perverse reward incentives. Principles for addressing the underlying issues could include raising community awareness, enhancing formal training, protecting the quality of funded and published research with a more systematic review process, and addressing issues of pressure and stability for investigators.

Trans-NIH actions planned are to discuss reproducibility of research findings with stakeholder communities, to create and pilot a new module on research integrity, as it relates to experimental biases and study design (once tested, the module will be available on the web), and to convene a meeting of Study Section Chairs, Boards of Scientific Counselors (BSC) Chairs and also to invite journal editors to discuss common opportunities.

NIH will implement pilots to address the key concerns such as to evaluate the "scientific premise" of grant applications, develop a checklist to ensure more systematic evaluation of grant applications, determine approaches needed to reduce "perverse incentives," e.g., design changes to bio-sketch requirements, longer-term support for investigators, and to support replication studies Important issues to consider as the pilots are developed are that one size does not fit all, the effects on experienced vs. early-career researchers, the costs of additional data, and the potential added burden to review process.

Ongoing projects separate from and/or complementary to the proposed pilots are that the NIH continues to collaborate with the Association for Psychological Science (APS) and the American Psychological Association (APA) on new and enhanced journal reporting standards, the NIA has an Interventions Testing Program, where preclinical studies are conducted with multi-site duplication, rigorous methodology and statistical analysis. The NHGRI has stated that the expectations of validation studies are an inherent part of the review of functional genomics studies and bioinformatics tool development. The NIDDK Mouse Metabolic Phenotyping Centers will provide standardized, high-quality phenotyping services. The NINDS has established a Scientific Rigor Working Group to forge action plans.

NEI efforts are to develop a checklist to give further guidance to reviewers for a more systematic evaluation. This will focus on the R24 mechanism, the NEI Translational Research Program on Therapy for Visual Disorders, and take into account the experimental design, minimization of bias, and interpretation of results.

Council acknowledged and discussed the problem and offered suggestions particularly with regard to the pressure to publish in high profile journals.

REPORT OF THE AUDACIOUS GOALS INITIATIVE TARGET DEVELOPMENT WORKING GROUP
Dr. Sieving reported that yesterday, a meeting of a group called the Target Identification Working Group consisting of Drs. Richard Masland, Larry Benowitz, Carlos Belmonte, Marco Zarbin, Jeremy Nathans, Laura Frishman, David Gamm, David Copenhagen, Ben Barres, and Rafael Yuste was held. Dr. Zarbin, co-chair of the Working Group, reminded Council that the work product of the original Audacious Goals meeting was the following objective: To restore vision by reconstructing the cells and connections in the eye and visual system. The two goals that are thought to be most appropriate are 1) to reintegrate into intact retina new photoreceptor cells and 2) to promote the regrowth of damaged axons of retinal ganglion cells. Both of those objectives are incorporated into the following current, more specific goal, which is, "To restore useful vision by regenerating or reconstructing the cells and connections of the retina after photoreceptor loss or ganglion cell injury."

There are many circumstances in which photoreceptors are lost through disease or injury and similarly with the optic nerve. The objective is to restore vision, useful vision. In other words, it's not an anatomic endpoint, it's a psychophysical endpoint, specifically pattern vision, not visual reflexsis. Two observations are that there's very important work that of course, remains to be done, and the usual way of doing things is not going to move this forward. There will need to be a review process that only allows proposals with scientific integrity to come forward. Then there would be an oversight panel to evaluate what should go forward and more importantly, to reevaluate progress as the work moves forward. Creating such a process is where this initiative is going to succeed or fail.

Dr. Masland, co-chair of the Working Group, amplified Dr. Zarbin's point about creating a process. He said that there needs to be some really smart people looking at what's happening and to advise where to place the resources.

UPDATE ON THE AUDACIOUS GOALS INITIATIVE
Dr. Sieving reminded Council that the Audacious Goals Initiative was launched here at an NAEC meeting. It has been receiving input from the NAEC, more specifically, direction from the NAEC. So the question is, what are the next steps? How do we jumpstart this process? How do we take a concept and create results? This can be a signature project for the NEI, one that the NEI can be recognized for, that Congress can pay attention to, and that other scientists in fields beyond vision alone can work on.

Council discussed the issues brought forward and agreed on the need to create a process for implementation of the Audacious Goals Initiative. This process would include a special study section/special review process, and an oversight group separate from the study section and with flexibility. There was also a suggestion that there is not a single target project and perhaps the goal is not audacious enough. It could be crisper and perhaps more focusses and reframed into a single overarching goal but most Council members did not agree with that suggestion.

BRAIN INITIATIVE
Dr. William Newsome, Stanford University, and Co-Chair, Advisory Council to the Director BRAIN Working Group, provided a report to Council on the status of the BRAIN Initiative.

The charge of the Working Group is to accelerate the development and application of innovative technologies to construct a dynamic picture of brain function that integrates neuronal and circuit activity over time and space and to build on neuroscience, genetics, physics, engineering, informatics, nanoscience, chemistry, and mathematics, to catalyze an interdisciplinary effort of unprecedented scope. The plan was to review the neuroscience landscape and articulate short-, mid- and long-range scientific goals, to develop a rigorous scientific plan, including high-priority research areas, principles and appropriate structures, collaboration opportunities, and timelines, milestones and cost estimates. The Working Group delivered an interim report on high-priority areas for NIH FY14 funding in September 2013, and will deliver a final report in June 2014. The process utilized four workshops in the spring and summer of 2013 that brought in 48 outside experts with opportunities for public commentary.

In order to have high impact and produce high-quality science, the BRAIN Initiative must accelerate other areas of neuroscience research. In 2014 NIH will spend $5.5B on neuroscience research, and BRAIN will be $40M (< 1%). It must focus, yet have broad impact. Technology is not an end in itself. The focus is on acquiring fundamental insight about nervous system function in health and disease. What tools and infrastructure are needed? Pose the problems, don't dictate the solutions. Allow the most compelling ideas to flourish — it is early and new approaches are still emerging. And encourage collaboration.

There will be a focus on circuits and networks, to map the circuits of the brain, measure the fluctuating patterns of electrical and chemical activity flowing within those circuits, and understand how their interplay creates our unique cognitive and behavioral capabilities. Maps of the brain will include cellular maps — with molecular components, activity maps — electrical and chemical, connectivity maps — local and long-range, functional maps — perturbations and behavior, and conceptual maps — theory and understanding. This will be an interdisciplinary effort for the discovery of fundamental circuit properties and principles with insight into circuits relevant to human brain function and disease and result in an acceleration of basic science, medicine, and technology.

The principles outlined in the interim report are to use appropriate experimental systems and models, cross boundaries in interdisciplinary collaborations, integrate spatial and temporal scales, establish platforms for sharing data, validate and disseminate technology, and consider ethical implications of neuroscience research. The high priority research areas identified in the interim report are to generate a census of cell types, create structural maps of the brain, develop new large-scale network recording capabilities, develop a suite of tools for circuit manipulation, link neuronal activity to behavior, integrate theory, modeling, statistics, and computation with experimentation and to delineate mechanisms underlying human imaging technologies. Also identified as high priority are to create mechanisms to enable collection of human data and to disseminate knowledge and training.

Actions needed in response to feedback from the interim report are to state explicitly how the BRAIN Initiative will positively impact multiple areas of neuroscience including cellular and molecular, genetics, developmental and stem cells, cognitive, and disease-focused research. Also needed is to address concerns about the NIH funding climate, e.g., will BRAIN generate new resources, and clarify how NIH and other BRAIN partners will cooperate with each other, with international efforts, and with private sector groups.

The next meeting of the Working Group will be March 5-6, 2014, in Washington D.C. It will include discussion with an NIH Big Data to Knowledge representative, identify core goals for a ten-year national BRAIN Initiative, and identify essential technologies for achieving these goals. Another topic will be the recommend mechanisms for achieving the goals, i.e., small scale collaborations, larger group efforts, national centers, and lastly to develop time-lines and specific milestones toward achieving the goals.

The Working Group will deliver a final report to the ACD on June 5, 2014 including goals, critical technologies, mechanisms, time-lines and milestones. There will a stakeholder meeting to coordinate national and international efforts and it will include BRAIN Initiative partners, public and private, NIH Neuroscience leadership, representatives of The Society for Neuroscience, representatives of clinical societies (Neurology, Psychiatry, Anesthesiology, Neurosurgery, Ophthalmology, Neuropsychology), and patient advocacy organizations.

Council discussed the idea of national centers versus individual efforts and the development of standards for implementation of the possible centers. They also asked about incentives to participate and recommended the need to partner with those with backgrounds in physics, math and statistics, and computation. Finally they discussed involvement with non-governmental organizations such as Bell Labs, Google, etc. because of technology development and big data capabilities and how the issue of intellectual property could be handled.

GENERAL COUNCIL DISCUSSION
Dr. Sieving redirected Council to their earlier discussion of the Audacious Goals Initiative and he posed two questions. Do the Audacious Goals need refocussing? And, how does the NEI move forward with the Initiative.

Council concurred that the Audacious Goals were appropriate and focused, a goal that is achievable and could restore vision. They recommended a process of soliciting ideas, sorting those ideas, asking for more complete proposals after that, then proceeding forward with a different kind of review, one that can look at balance between risk, opportunity and need as opposed to certainty, which often creeps into R01 reviews. Finally, to have some oversight group that will be monitoring this, providing feedback, and to actually change behavior in the groups that are working, but that may have drifted off target, or groups that are unaware of a new opportunity that really needs to be thoughtfully pursued.

BRAIN INITIATIVE UPDATE: NIH RESPONSE TO RECOMMENDATIONS FROM THE ADVISORY COMMITTEE TO THE DIRECTOR
Dr. Michael Steinmetz reported that for FY 2014 there will be a $40M NIH Investment with $10M from the NIH Director's Common Fund, $10M from the NIH Blueprint for Neuroscience, and $20M from individual Institute Contributions breaking down to $7.5M from NINDS, $7.5M from NIMH, $4.0M from NIDA, and $1.0Mfrom NIBIB. Funding for future years is unknown.

The Brain Initiative is currently managed by the Blueprint and there is an Executive Committee composed of representatives from those ICs which contribute their own funds. Workgroups were established for developing Funding Opportunity Announcements (FOAs) with NEI representation by Drs. Thomas Greenwell, Cheri Wiggs, Neeraj Agarwal, and Michael Steinmetz. There is significant oversight by Drs. Francis Collins and Kathy Hudson.

The Advisory Council to the Director established a number of High Prioritied and the NIH developed a number of initial responses including a census of cell types and structural maps (two U01 FOAs); large-scale recording, tools for circuit manipulation, linking activity to behavior; and theory, modeling, statistics, and computation (three U01 FOAs), and human imaging technology and collection of human data (one R24 FOA). A workgroup was formed to explore opportunities for disseminating knowledge and training.

FOAs have been issued on pilot classification strategies for a systematic inventory of cell types, integrating molecular identity with connectivity, morphology, and location, on developing tools to facilitate the analysis of complex circuits with emphasis on delivering genes, proteins and chemicals to specific cells of interest on developing new technologies and novel approaches for large scale recording and manipulation of neural activity, on optimizing existing and emerging technologies for recording and manipulation of neural activity, to perform pilot studies of the dynamic circuit activity in a specific neural system involving behavioral outcomes, and to establish interdisciplinary teams to plan for a new generation of non-invasive imaging techniques that would be used to understand human brain function.

The timeline for these FOAs under the BRAIN Initiative began December 17th when NIH Guide notices were published. Letters of intent will be due February 13th and 24th. The application deadlines are March 13th and 24th. Study Section Meetings will occur in June and July with Council review in August and awards to be issued in September.

Council asked is there any way that the NEI can be more involved in the planning and executing of the BRAIN initiative? Dr. Steinmetz replied that NEI Program Officers are on all of the committees, but the oversight is by the Institutes contributing funds. Dr. Sieving asked Council their opinion about NEI financial participation in the BRAIN Initiative. An initial response form Council was to fold the Audacious Goals into the Brain Initiative and to take the lead in that area? Dr. Sieving noted that the AGI predated the BRAIN Initiative and is standing on its own but he professed belief that the NEI also needed to be participating in the BRAIN Initiative.

Council discussed this issue including whether focus on other that a single goal, the Audacious Goal, would distract from the AGI, and possible areas of overlap between the BRAIN Initiative and the AGI but overall agreed that the NEI should have a financial stake in the Brain Initiative.

Dr. Sieving noted the sentiment at the table and expressed interest in finding ways that the NEI can participate, including financially, in the BRAIN initiative. He said he would explore this further in a sensible approach and in keeping with some of the comments made by Council.

The webcast of the Council Meeting may be viewed online at: http://videocast.nih.gov/summary.asp?Live=13396&bhcp=1

CLOSED SESSION OF THE MEETING — 2:00 pm
The meeting was closed to the public at 2:00 p.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 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.

REVIEW OF RESEARCH, RESEARCH TRAINING, AND COOPERATIVE AGREEMENT APPLICATIONS

ADJOURNMENT
The meeting was adjourned at 5:00 p.m.


CERTIFICATION
These minutes were submitted for the approval of the Council; all corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
National Eye Institute

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

ATTACHMENT A: NATIONAL ADVISORY EYE COUNCIL MEMBERS

Hollis T. Cline, Ph.D.
Professor
Departments of Molecular and Cellular Neuroscience and Chemical Physiology
The Scripps Research Institute
La Jolla, CA

Jonathan L. Haines, Ph.D.
Professor
Department of Molecular Physiology and Biophysics
Center for Human Genetics Research
Vanderbilt University School of Medicine
Nashville, TN

John C. Morrison, M.D.
Professor
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
Portland, OR

Kathleen M. Petrillo, J.D.
Partner
Senniger Powers, LLP
St. Louis, MO

Eric A. Pierce, Ph.D., M.D.
Director
Ocular Genomics Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Boston, MA

Krishna K. Sharma, Ph.D.
Professor
Departments of Ophthalmology and Biochemistry
Mason Eye Institute
University of Missouri-Columbia
Columbia, MO

Jayne S. Weiss, M.D.
Chairman and Professor
Department of Ophthalmology
Louisiana State University
School of Medicine
New Orleans, LA

Sheila K. West, Ph.D.
Professor
Department of Ophthalmology
Wilmer Eye Institute
Johns Hopkins University
Baltimore, MD

Rafael Yuste, M.D., Ph.D.
Professor
Departments of Biological Sciences and Neuroscience
Columbia University
New York, NY

Ex Officio
Marco A. Zarbin, M.D., Ph.D.
Professor and Chair
Institute of Ophthalmology and Visual Science
UNDNJ-New Jersey Medical School
Newark, NJ

Last Updated: February 2014

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