National Institutes of Health
National Eye Institute
National Advisory Eye Council
One Hundred Thirty-second Meeting
October 4, 2012
The National Advisory Eye Council (NAEC) convened for its one hundred and thirty-second meeting at 8:30 am on Thursday, October 4, 2012, at 5635 Fishers Lane, Rockville, Maryland, 20852. Paul A. Sieving, M.D., PhD., the Director of the National Eye Institute (NEI), presided as Chair of the Council. The meeting was open to the public from 08:30 a.m. until 02:00 p.m. The meeting was closed to the public from 02:00 p.m. until adjournment for the review of grant and cooperative agreement applications and the report of the Board of Scientific Counselors. Attachment A provides a roster of Council Members.
COUNCIL MEMBERS PRESENT:
Dr. James Chodosh
Dr. David Copenhagen
Dr. Donald Gagliano
Dr. Bernard Godley
Dr. Jonathan Haines
Dr. John Morrison
Ms. Kathleen Petrillo
Dr. Eric Pierce
Dr. Krishna Sharma
Dr. Sheila West
COUNCIL MEMBERS ABSENT:
Dr. Joseph Bonanno
Dr. Hollis Cline
Ms. Alberta Orr
Dr. Marco Zarbin
NEI STAFF PRESENT:
Ms. Neyal Ammary-Risch
Dr. Houmam Araj
Dr. Neeraj Agarwal
Ms. Pamela Bobbitt
Dr. Deborah Carper
Dr. Hemin Chin
Ms. Monique Clark
Ms. Janet Craigie
Mr. William Darby
Mr. Donald Everett
Dr. Frederick Ferris
Dr. Richard Fisher
Dr. Shefa Gordon
Dr. Thomas Greenwell
Ms. Anna Harper
Mr. Dustin Hays
Ms. Jean Horrigan
Dr. Brian Hoshaw
Ms. Tina Jones
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen Liberman
Dr. Andrew Mariani
Dr. George McKie
Dr. Matthew McMahon
Dr. Loré Anne McNicol
Dr. Jennifer Mehren
Ms. Kathleen Moy
Mr. Christopher Nee
Dr. Lisa Neuhold
Mr. William O’Donnell
Dr. Steven Oversby
Mr. Trevor Peterson
Dr. Gyan Prakash
Ms. Karen Robinson Smith
Dr. Gale Saunders
Dr. Anne Schaffner
Dr. Eleanor Schron
Dr. Grace Shen
Dr. Paul Sieving
Mr. Mark Stevens
Ms. Chantell Stevenson
Dr. Michael Steinmetz
Ms. Sharon Taylor
Dr. Santa Tumminia
Ms. Donna Wells
Ms. Jennifer Wenger
Dr. Cheri Wiggs
Mr. David Whitmer
Dr. Jerome Wujek
OTHER NIH/DHHS STAFF PRESENT:
Dr. Michael Chaitin, Center for Scientific Review (CSR)
Dr. Roger Glass, Fogarty International Center
Dr. Nataliya Gordiyenko, CSR
Ms. Prabhjot Kaur, Office of Human Resources, Office of the Director
Dr. Paek Lee, CSR
Dr. Kirk Thompson, CSR
MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:
Ms. Shannon Curtis, American Academy of Ophthalmology
Dr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Ms. Beth Rada, Xoma Corporation
OPEN SESSION OF THE MEETING
CALL TO ORDER AND OPENING REMARKS
Dr. Paul Sieving, Director, NEI, and Chairman of the NAEC welcomed all attending the meeting. He presented Dr. James Chodosh a certificate from Secretary Sebelius for his term of service on Council and noted that Dr. Joseph Bonanno and Ms. Alberta Orr, unable to attend today’s meeting, were also leaving Council. Dr. Sieving welcomed Ms. Jennifer Wenger as the newly-appointed Associate Director of the NEI Office of Science Communications, Public Liaison, and Education. Dr. Sieving also welcomed Dr. Kapil Bharti, Stadtman Tenure-Track Investigator, in the Ophthalmic Genetics and Visual Function Branch and he announced the retirement of Dr. Daniel Kenshalo from the Scientific Review Branch.
Receiving NIH Director’s Awards recently were Dr. James Raber of the Veterinary Research and Resources Section, Dr. Sarah Sohraby from the Division of Intramural Research, Dr. Hemin Chin, Office of the Director, Team Save led by Mr. David Whitmer, and Drs. Neeraj Agarwal and Thomas Greenwell for their work as part of the NIH Blueprint Neurotherapeutics Grand Challenge. Dr. Sieving congratulated the recipients and thanked them for their work.
In vision research news, Dr. Sieving reported that the first retinal prosthesis has received approval from the FDA. The device was developed by Second Sight where Dr. Matthew McMahon was formerly a Principal Scientist. eyeGENE, the National Ophthalmic Disease Genotyping Network has entered a second phase in making genotyping available for research.
Dr. Sieving expressed uncertainty concerning the budget beyond the current continuing resolution. He noted that there may be difficulties ahead with decisions still to be made by the end of the year, and that $2.8 billion dollars, or 8.2% of the NIH budget, is at stake under the Budget Control Act of 2011.
Dr. Sieving thanked Mr. Donald Everett who agreed to head the Employee Workplace Advisory Group (EWAG) to solicit input from employees across the institute to gain insight into the current status and future of the institute.
Dr. Sieving reported that the recently held NIH Directors Leadership Forum was a complex discussion of a number of different topics.
Regarding extramural research activities, Dr. Sieving thanked Dr. McNicol for stewarding extramural research funds noting that the NEI lead the NIH in award rate which last fiscal year was a little over thirty percent. He remarked on the RFA on stem cells for developing new therapies for ocular diseases and that the applications received will be reviewed this fall. While on the topic of stem cells, Dr. Sieving also noted that the NIH had $50 million dollars available for intramural research and that the NEI Intramural Program had consistently received a high number of these awards. Lastly, Dr. Sieving announced that Dr. Christopher Austin was the newly appointed Director of NCATS.
Council queried Dr. Sieving on the specifics of the NIH Directors Leadership Forum and he replied that the issues discussed were the biomedical research workforce, training for a more diverse workforce and for non-traditional employment outside of the academic route, and repositories of large data sets including clinical trial data to increase availability.
CONSIDERATION OF FEBRUARY 2012 AND JUNE 2012 MINUTES
Dr. Loré Anne McNicol requested approval of the minutes of the January 2012 and June 2012 Council Meetings. A motion for approval was made and the minutes were accepted.
DEVELOPING A NATIONAL AGENDA FOR VISION RESEARCH
Dr. Richard Fisher announced the publication of the NEI Plan 2012 titled Vision Research: Needs, Gaps, and Opportunities which consists of an introduction, highlights of recent progress and statements of needs, gaps and opportunities. The Audacious Goals Initiative is to look at what is possible in 10 years and beyond. It is intended to develop a process to energize vision research efforts, be ambitious, not possible today but feasible later, compelling and motivating - capture the imagination, drive collaboration and multidisciplinary approaches, drive innovation, and cast a wide net. The 3 steps are to gather, develop, and select. He reviewed the announcement and publicity for the initiative. The deadline for submission of a one page goal is November 12, 2012. The submissions are to be reviewed in December 2012/January 2013 and winners notified January 7, 2013. The Audacious Goals Development meeting will be held February 24-26, 2013.
Council asked about the number of responses submitted to date. Dr. Sheila West reported that a group was organized at her institution to discuss the concept and invited Dr. Fisher to participate and there was an enthusiastic response. Other Council members reported some less than enthusiastic responses at other institutions.
Council inquired about the monetary support that was being planned for the initiative, for example, in the form of RFA(s). Dr. Fisher replied that since goals have not yet been identified a specific amount could not be specified. However, the NEI would support the achievement of the goals.
TRANS-NIH GLOBAL HEALTH ACTIVITIES AT THE FOGARTY INTERNATIONAL CENTER
Dr. Roger Glass, Director of the Fogarty International Center (FIC) and Associate Director for International Health, NIH spoke about global health in the 21st century from the perspective of the FIC. He noted a Presidential commitment to science and global health, that for the NIH Director global health is a major focus, there is enthusiasm on university campuses, many new global partnerships exist, and there are unique opportunities for new interventions and rapid advances. An Institute of Medicine report advocates the scaling up of existing interventions, the generation and sharing of knowledge, investing in people, institutions and capacity building, increasing U.S. financial commitments to global health, and engaging in respectful partnerships. The Fogarty Mission is to address global health challenges thru innovative & collaborative programs for research & training and to support and advance the NIH mission thru global partnerships. Rhode Island Congressman John E. Fogarty was “a man who, for more than a quarter of a century, worked tirelessly for a healthy America, in a healthier world (Congressman Melvin Laird (R-WI) 1967).
Dr. Glass reported that issues in Global Health in the 21st Century include changing patterns of disease - age, commonality of problems, dependence on new solutions, implementation strategies, information and communication technologies, and that multi-disciplinary approaches would be key. Also, the frontiers of biomedical research in the 21st Century may lie in global health because of unusual diseases, uncommon exposures, unique populations, and extraordinary partners. He asked, “How can FIC partner with NEI to support research in global eye disease?” The answer is through fellowships to train young researchers, BRICS Partnerships, and by building links to other NIH global initiatives.
Dr. West noted an interest in global health and asked what help was available. Dr. Glass replied that thinking about strategies and forming partnerships were important. Dr. Glass stated thinking about the strategy is important. Forming partnerships is important. Dr. Sieving thanked Dr. Glass for his interesting presentation.
NEI GLOBAL HEALTH AGENDA
Dr. Gyan Prakash reported that the NEI’s Office of International Programs-Global Health had the broad functions to coordinate and support collaborative international research programs that focus on selected eye diseases of substantial health importance to the US and other countries, maintain a knowledge base of the Institute’s research programs and policies in coordination with the National Institutes of Health - Fogarty International Center (FIC), identify relevant programs of other federal domestic agencies, bilateral research agencies, multilateral research organizations, and volunteer agencies involved in international health activities, and advise the NEI Director on program relationships and opportunities for collaboration.
The NEI Office of International Programs-Global Health is deeply committed to international research collaborations that are mutually beneficial and scientifically productive. The new business plan addresses the goals and priorities in the NEI International Programs and global health. The new business plan also takes in to consideration the NIH wide initiatives for establishing scientific collaborations with willing and collaborative partners around the world
Business Goals for NEI International Programs.
The three goals of the office are coordination, research collaboration, and training. The first is to establish a full-time International Program Office/Office of Global Health at the NEI to address the daily needs of international business and become an active participant in the NIH-wide programs that may affect vision research and training. The second is to foster a sustainable international research environment, expand collaborations in countries across the globe that are interested in the advancement of vision research, and support international partnerships providing scientific value to the NEI programs. The third is to develop human capital in the US to meet global health challenges to support the future needs of the US in the areas of vision research and training, support mentoring activities for the next generation of U.S. and international scientists and professionals interested in international vision research and global health programs.
An advisory panel is being planned to address many issues to determine focus of the long-term goals of the NEI International Programs/Global Health. Dr. Prakash summarized the latest international collaborative activities of the NEI Division of Intramural Research, and noted that NEI extramural programs funded NEI international grants: 26 grants and 36 foreign sites in 15 countries. He stated that “Good Eye Research Anywhere is Good Eye Research Everywhere.”
Council had questions about the grant tracking and whether that included contracts, motivation for trainees to come to the United States, how the challenge to treat global diseases would be met and what are the opportunities that are available.
CONCEPT CLEARANCE: NEI/NIDDK/NIAID JOINT WORKSHOP ON THE BIOLOGY OF COMPLEMENT RISK FACTORS FOR OPHTHALMIC AND RENAL DISEASE SYNDROMES
Dr. Lisa Neuhold discussed the concept of a joint workshop with NIDDK and NIAID to examine complement based therapeutics in age-related macular degeneration (AMD), atypical hemolytic uremic syndrome (aHUS), and dense deposit disease (DDD). In 2005, Genome wide scanning studies showed that Complement factor H (CFH) variations confer a higher risk for AMD. Studies have also shown similarities between AMD and certain kidney diseases associated with variants of CFH. Seven years later, despite the strong associations no successful therapies have been developed based on these risk factors for AMD, aHUS or DDD. The goal of the workshop would be to bring together experts in AMD, nephrology, and complement biology to generate new knowledge of these disease mechanisms and identify new therapeutic targets for the development of medications. Council liked the idea of the proposed workshop and was unanimous in endorsing the concept.
NEI BUDGET UPDATE
Ms. Marilyn Laurie provided an overview of the fiscal year (FY2012) budget expenditures and the status of the FY 2013 budget. In FY 2012 Intramural Research was $73M, Research Management and Support (RMS) was $25M, and the Extramural distribution was $604M. New operating policies implemented in FY 2012 were to promote efficient spending. The President issued Executive Order (E.O. 13589) on November 9, 2011 to reduce travel, printing costs, personal IT equipment, and conferences expenses, and to identify FY 2013 efficient spending targets. The Department of Health and Human Services (DHHS) implemented a new conference policy mandate in support of E.O. 13589. The NEI is evaluating all programs to identify research and administrative efficiencies.
For FY 2013 there is a Continuing Resolution (C.R.) from October 1, 2012 - March 27, 2013 and the NEI appropriation is $246M which equates to $707M in a one year annualized amount, a 0.612% increase over FY 2012. However, the full fiscal year appropriated amount is uncertain.
Operations during the C.R. are not specified. Usually in these circumstances, type 5 grants are historically funded at 90%, and new grants will be funded strategically. After the C.R., type 5 and new grants funding amounts would be revised as per NIH policy.
Regarding Sequestration, Congress needs to cut $1.2 trillion dollars or the Federal budget will face a sequestration starting on January 2, 2013. The impact could be an 8.2% or $57M decrease to the NEI budget. The NEI may need to reduce new awards, eliminate less significant programs or implement an cross-the-board cut, and reduce funding to commitments. However, no plans are being made because it is the Administration’s position that the sequestration was never meant to be implemented.
NEI NEHEP FILM CLIPS
Ms. Jennifer Wenger, Associate Director, Office of Science Communications, Public Liaison, and Education, reported on the Low Vision Education program implemented by the NEI and the National Eye Health Education Program (NEHEP). She described consumer materials such as an updated and revised booklet, “What you should know,” a companion video, “Stories of Hope and Independence,” a video for health professionals, the updated consumer website, www.nei.nih.gov/lowvision, and YouTube. A short trailer of the movie, “Going Blind,” and the NEI Low Vision Consumer video were presented. Council was laudatory of the educational materials and noted that earlier intervention for low vision is important. Ms. Wenger and Ms. Ammary-Risch agreed.
NEI LOAN REPAYMENT PROGRAM UPDATE
Dr. Neeraj Agarwal 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 United States 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 2012. A total of 37 applications were received and 35 applications were funded for a 95% success rate.
SPECIAL COUNCIL REVIEW OF RPG APPLICATIONS FROM PI/PDs WITH >$1.0M TOTAL DIRECT COSTS OF NIH RPG SUPPORT
Dr. Ellen Liberman briefed Council on the topic of Special Council Review. Under this policy Advisory Council members will provide additional consideration of new and renewal applications from well-supported investigators who currently receive $1 million or more annually in direct costs of NIH funding to support Research Project Grants (RPG). She presented a brief history of the policy. NOT-OD-12-110 was a Notice of NIH piloting of procedures for Special Council Review from PDs/PIs with more than $1.5 million total annual NIH support. NOT-OD-12-140 is the current Notice of NIH Special Council Review of research applications from PDs/PIs with more than $1.0 million direct costs in annual NIH support. The key points are that the policy applies to applications from Principal Investigators who currently have more than $1.0 million direct costs in annual NIH RPG support. It is not a cap on total NIH funding. The policy requires “additional consideration” by Advisory Councils. Council reviews the application not the Principal Investigator and the policy is intended to preserve innovation in an era of tight budgets. Dr. Liberman recounted the grant mechanisms included and excluded.
The process for the policy implementation will be a closed session discussion presented as a staff action. The staff action will include a table with a list of currently funded RPGs. The points to consider are, does this application afford a unique opportunity to advance research, is this project highly promising, is this project distinct from other funded work by this Principal Investigator, and does this field of research require higher levels of funding. Additional points to consider for competing renewals are, does this application continue a highly productive research endeavor, does this project play a critical role in the Principal Investigator’s research program, and does this project maintain the continuation of valuable research collaborations.
Council raised questions about the anticipated number of such special council reviews each Council round and had numerous comments and questions about the process.
GENERAL COUNCIL DISCUSSION
Council asked Dr. Sieving about the input received from the EWAG and he replied about some of the specifics and how the issues raised were being addressed. Council also asked if the Executive Order promoting Efficient Spending was affecting NEI Staff Travel.
Dr. Sieving raised the issue of the audacious goals initiative and noted that the process was moving faster than anticipated and that the NEI would support the achievement of these goals. Council commented on the need for personal outreach and publicity for the venture.
A final question from Council was about any feedback on the recent study section reorganization. Dr. McNicol noted that the distribution of scoring after reorganization seems indistinguishable from that before the reorganization.
CLOSED SESSION OF THE MEETING – 02:00 pm
The meeting was closed to the public at 02:00 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, 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.
REVIEW OF RESEARCH, RESEARCH TRAINING, AND COOPERATIVE AGREEMENT APPLICATIONS
REVIEW OF THE BOARD OF SCIENTIFIC COUNSELORS REPORT ON THE DIVISION OF EPIDEMIOLOGY AND CLINICAL APPLICATIONS, THE OPHTHALMIC MOLECULAR GENETICS SECTION, OPHTHALMIC GENETICS AND VISUAL FUNCTION BRANCH, AND THE CURE DISEASE PROPOSAL.
The meeting was adjourned at 05:30 pm
I hereby certify that, to the best of my knowledge, the foregoing minutes and attachment(s) are accurate and complete.
Loré Anne McNicol, Ph.D.
National Advisory Eye Council
Division of Extramural Research
National Eye Institute
Paul A. Sieving, M.D., Ph.D.
Chair, National Advisory Eye Council
Director, National Eye Institute
These minutes were submitted for the approval of the Council; all corrections or notations were incorporated. A complete, printed copy of the Council minutes, including attachments, may be obtained from:
Ms. Janet L. Craigie
National Eye Institute
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
FAX: (301) 402-0528
ATTACHMENT A: NATIONAL ADVISORY EYE COUNCIL MEMBERS
Joseph Bonanno, O.D., Ph.D.
Professor, School of Optometry
James Chodosh, M.D., MPH
Department of Ophthalmology
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Hollis T. Cline, Ph.D.
Dept Cell Biology & Chemical Physiol.
The Scripps Research Institute
La Jolla, CA
David R. Copenhagen, Ph.D.
Dept of Ophthalmology and Physiology
Univ of California, School of Medicine
San Francisco, CA
Bernard F. Godley, M.D., Ph.D.
Professor and Chair
Dept of Ophthalmology & Visual Sci
University of Texas Medical Branch
Jonathan L. Haines, Ph.D.
Dept of Molecular Physiology & Biophys
Center for Human Genetics Research
Vanderbilt University School of Medicine
John C. Morrison, M.D.
Department of Ophthalmology
Casey Eye Institute
Oregon Health and Science University
Rehabilitation Research and Training
Center on Blindness and Low Vision
Mississippi State University
Mississippi State, MS
Kathleen M. Petrillo, JD
Partner, Senniger Powers, LLP
St. Louis, MO
Pierce, Eric A., Ph.D, M.D.
Director, Ocular Genomics Institute
Massachusetts Eye and Ear Infirmary
Harvard Medical School
K. Krishna Sharma, Ph.D.
Dept of Ophthalmology & Biochemistry
Mason Eye Institute
Unviersity of Missouri - Columbia
Sheila K. West, Ph.D.
Professor, Dept Ophthalmology
Wilmer Eye Institute
Johns Hopkins University
Marco A. Zarbin, M.D., Ph.D.
Professor and Chairman
Department of Ophthalmology
Donald A. Gagliano, M.D. (Colonel)
Director, Vision Center of Excellence