NAEC Meeting Minutes - June 7, 2007

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Eye Institute

NATIONAL ADVISORY EYE COUNCIL
Minutes of Meeting

One Hundred Sixteenth Meeting
June 7, 2007

The National Advisory Eye Council (NAEC) convened for its one hundred sixteenth meeting at 8:30 am on Thursday, June 7, 2007, at the Natcher Building Conference Center, 45 Center Drive, Bethesda, MD. Paul A. Sieving, M.D., PhD, 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 11:00 am for the review of grant and cooperative agreement applications. On Thursday, June 7, 2007, from 11:00 am until adjournment at 5:00 pm, the meeting was open to the public. Attachment A provides a roster of Council members.

COUNCIL MEMBERS PRESENT:

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

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NEI STAFF PRESENT:

Dr. Houmam Araj
Ms. Sylvia Braxton
Dr. Deborah Carper
Dr. Hemin R. Chin
Dr. Mary Frances Cotch
Mr. William W. Darby
Mr. Michael P. Davis
Mr. Donald F. Everett
Dr. Richard S. Fisher
Mr. Kenneth Frushour
Dr. Shefa Gordon
Dr. Ralph J. Helmsen
Mr. Tom Hoglund
Dr. Chyren Hunter
Ms. Rosemary Janiszewski
Dr. Natalie Kurinij
Ms. Marilyn Laurie
Dr. Ellen S. Liberman
Dr. Andrew P. Mariani
Dr. Jack A. McLaughlin
Dr. Loré Anne McNicol
Dr. Sheldon S. Miller
Dr. Päivi H. Miskala
Dr. Michael D. Oberdorfer
Dr. Samuel C. Rawlings
Dr. Maryann Redford
Ms. Gale Saunders
Dr. Annie E. Schaffner
Dr. Grace L. Shen
Dr. Paul A. Sieving
Ms. Patrice Singh
Mr. Arthur Stone
Dr. Santa Tumminia
Mr. David Whitmer
Ms. Romona Williams-Parker
Dr. Jerome R. Wujek

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OTHER NIH STAFF PRESENT:

Dr. Michael H. Chaitin, Center for Scientific Review (CSR)
Ms. Mary Frances Deusch, Office of Extramural Research, Office of the Director, NIH
Dr. Anthony Hayward, National Center for Research Resources (NCRR)
Dr. George McKie, CSR
Dr. Christine Melchior, CSR
Dr. Michael Steinmetz, CSR
Dr. Jerry Taylor, CSR

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MEMBERS OF THE GENERAL PUBLIC PRESENT AT THE OPEN SESSION:

Dr. Israel Goldberg, Health Research Associates
Mr. James Jorkasky, National Alliance for Eye and Vision Research
Ms. Lori Methia, Association for Research in Vision and Ophthalmology
Dr. Jeremy H. Nathans, Johns Hopkins University
Ms. Elaine Richman, Richman Associates
Dr. Karla Zadnik, Ohio State University

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THURSDAY, JUNE 7, 2007

CLOSED PORTION OF THE MEETING

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).

CONFIDENTIALITY / AVOIDANCE OF CONFLICT OF INTEREST

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.

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REVIEW OF RESEARCH AND RESEARCH TRAINING GRANT APPLICATIONS

OPEN PORTION OF THE MEETING

11:00 am

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CALL TO ORDER AND OPENING REMARKS

Dr. Paul A. Sieving, Director, NEI, and Chair of the Council welcomed Council members, staff and guests to the one hundred sixteenth session of the NAEC. He stated the meeting would convene with open session thoughts on activities involving NEI’s activities at NIH, pointing out areas of interest to the NEI. He described the NEI’s contribution to the Division of Public Health Challenge of Vision and Eye Care, which will appear in two issues in Archives of Ophthalmology for January and February, 2007. And he also discussed the status of ocular disease gene identification.

Dr. Sieving next reported on the Strategic Planning for Ocular Epidemiology Panel Report, headed by Dr. Sheila West of Johns Hopkins University. He stated that this panel has strong expertise in epidemiology and biostatistics and indicated that Mr. Michael Davis will present a report on the status of this study. The NAEC will take a look at the current state of planning, and over the summer will look at an interim status report. The panel plans to present at September’s council meeting. Dr. Sieving also discussed dbGap database: This public database is a vehicle which will make data regarding ophthalmic disease available both to researchers and to the general public.

Dr. Sieving discussed scientific manpower issues and noted that the NEI needs to prioritize funding for new investigators. At this time, the average first time NEI awardees are between 40-44 years of age. Dr. Sieving recognized Dr. Lore´ Anne McNicol, Director, Division of Extramural Research and Executive Secretary of the Council, who discussed the necessity for the vision community to anticipate training and develop ways to pull in young investigators and have them move into independent faculty/ industry positions. Dr. Sieving then discussed what appropriations have been designated for this area. He also discussed the Road Map: the vision research community has the opportunity to participate in the Microbiome and the Epigenetics initiatives. Some national efforts in future research areas were noted. He discussed the Senate appropriation hearings for 2007. The mood is positive right now. Senator Harkin highlighted the work vision community is doing. Dr. Sieving gave an update on the winner of the 2005 National Medal of Science—Dr. Torstein N. Wiesel, and welcomed two new staff members: Dr. Ian Macdonald, who is joining the NEI Intramural Research Program as Chief of the Ophthalmic Genetics and Visual Function Branch, and Dr. Shefa Gordon who will be a program analyst in the Office of Program Planning and Analysis.

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BUDGET OVERVIEW

The NEI Budget Officer, Ms. Marilyn Laurie, provided an overview of the NEI appropriations history. She indicated that the direct result of the joint resolution received in January increased NEI’s budget +0.1% ($8 M), which was a better increase than anticipated. Ms. Laurie stated that the NIH policy and focus was on stabilizing Research Project Grants (RPGs) at the expense of eliminating inflationary increases. She reviewed the trans-NIH initiatives: NIH Director’s awards funding is held in the NIH Office of the Director; other trans-NIH initiatives will either be built into the NEI budget or will be transferred into the Director’s budget but while remaining in the NEI base. Neuroscience Blueprint money was built into the budget. NEI contributed $1.1M and NIH gave a total of $40M. Two new programs will be discussed at the Senate Theme Hearing: A New Vision for Medical Research to be held on June 22nd and each IC director will be allowed two to five minutes to speak. With regards to the budget, Ms. Laurie stated that one of the things we hope to happen this year is that we actually receive appropriations on October 1. She then briefly discussed the Labor Appropriations Committee’s role to getting budget on time.

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CHANGE TO COUNCIL OPERATING PROCEDURES

Mr. William W. Darby, Chief, Grants Management Branch, provided an update on the Congressional passing of the NIH Reauthorization bill. It requires that all research grants and cooperative agreements be brought to council, regardless of the size of the award. Research training fellowship programs are one of the few exceptions. Dr. McNicol proposed that the Council accept this change and the motion to accept change was made by Dr. Haik and seconded by Dr. Holck, and passed by the Council.

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NIH ROADMAP CLINICAL AND TRANSLATIONAL SCIENCE AWARDS

Dr. Anthony Hayward, Director, Division for Clinical Research Resources, NCRR, who heads the NIH Roadmap for the Clinical and Translational Science Awards (CTSA), stated that the NCRR is the provider of shared resource resources, and the clinical & translation science award program falls under their purview. He stated that the NCRR has created a program that is more horizontal across the centers and that the CTSA application awardees collaborate across the NIH. A total of 60 awards have been made under this program, and NIH staff participate in the steering committees. The Institutional Clinician Scientist Training Award K12 is the training engine for these projects. Dr. Hayward provided an overview of CTSA funding, which includes over $500 million in awards per year.

Dr. Hayward described CTSA eligibility. The program has created a consortium within which educators provide degree programs. He also discussed CTSA’s key functions as well as the impact of the CTSA is to increase resources in different areas such as deploying web-based communications through the web site www.ctsa.web.org.

Council members had several questions regarding the organization and functioning of the CTSAs. Dr. Hayward noted that the goal is for the consortium to share a single, national Institutional Review Board as part of breaking down administrative barriers. And he discussed many details of the planned process for evaluating the program once it is completely implemented.

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EXTRAMURAL PROGRAM ACTIVITIES

Dr. Lore´ Anne McNicol gave an overview of the FY 2007 operating guidelines and stated that there is little flexibility with these rules. She discussed the consequences of a total cost cap for RPGs as having had a negative impact on translational research. Many investigators are forced spend time applying for several grants while ending up with multiple small grants to manage. She presented the time trend of the Biomedical Research and Development Price Index (BRDPI), which provides a snapshot of the current purchasing power. Over the past five years RPGs have lost nearly 17% of buying power through a combination of cost caps and inflation.

Dr. McNicol described the central operating guides for non-RPG grant mechanisms, and discussed policies regarding the support of new investigators. The NEI strives to provide new PIs with five years of funding on their first R01, and reminded the Council that many new investigators just out of post doc regard being awarded an R21 grant as a success. Dr. McNicol discussed the NIH Director’s Bridging Award (NDBA-R56). The NEI had submitted 10 nominations and all 10 were awarded for a total of $4,193,891. One other new program to be funded out of the NIH Director’s Office is the Director’s New Innovator Award. It provides up to $300,000 annual direct costs for a new investigator who has never had R01 funding to pursue highly innovative, high impact research. The program received over 2,000 applications for approximately 16 awards.

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FUTURE COUNCIL MEETING DATES

Dr. McNicol noted that future meetings are scheduled for a day and a half, and asked that everyone keep those times free on his or her calendar. The following dates have been agreed upon:

  • September 27-28, 2007
  • January 25-25, 2008
  • June 19-20, 2008
  • September 11-12, 2008

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REVIEW OF THE NEI CAREER DEVELOPMENT PROGRAMS

Dr. Chyren Hunter, Chief, Oculomotor Systems and Retinal Neurosciences Research, and NEI Training Officer, gave an overview of the NEI career development programs since 2000. She stated that the NEI has added career building mechanisms to our portfolios to honor our commitment to clinician scientists. She described the various mentored career development awards. She noted that the K22 NEI Career Transition Award is under-utilized. The K12 Mentored Clinical Scientist Development Program Award (Institutional) grants have limited applicant pools, have had difficulties filling positions, have accelerated out-year costs, and have resulted in a reduction in the number of individual K08 Mentored clinical Scientist Development Award and K23 Mentored Patient-Oriented Research Career Development Awards.

The NIH has established a new K99/R00 NIH Pathway to Independence (PI) Award to assist postdoctoral scientists in their transition into stable, independent research positions. The initial phase of the K99 provides one to two years of mentored support for advanced fellows ($90K TC including 8% F & A) and the R00 phase provides three years of independent research support once the individual has secured an independent research position. The NEI has a quota to fund four new K99/R00 awards each year, and anticipates having 20 active grants at steady state.

Dr. Hunter indicated that NEI’s operating plans included continued support for the individual career award programs. Support of the current K12 grants is assured through the end of 2009. The NEI will strongly encourage K12 Program directors to control costs by encouraging appointees to apply for individual K08 or K23 funding.

Council members asked about the relationship between the K22 and K99/R00 programs. Dr. Hunter said that their goals were similar. In 15 years, there has only been one K22 awardee. They also asked about the relationship between the NEI K12 program and the K12s incorporated into CTSAs. Dr. Hunter noted that there are currently no ophthalmology departments with a CTSA award.

Council members expressed their opinion that the NEI has not yet had sufficient experience with the K12 program to evaluate its long-term success. They recommended continuing the program.

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THE EVOLUTION OF COLOR VISION

Dr. Jeremy H. Nathans, Professor of Molecular Biology and Genetics, Neuroscience, and Ophthalmology, Johns Hopkins University, gave a presentation of his recent research into the evolution of color vision. He indicated that there are three general requirements for evolving a new dimension of color vision: a new visual pigment gene to encode a protein with a new absorbance spectrum, selective expression of this new visual pigment gene in a distinct class of retinal cone cells; and neural circuitry to extract chromatic information. Historically, the most recent step in the evolution of human color vision has been the acquisition of red-green color discrimination in the primate lineage. Dr. Nathans reviewed the photochemistry of retinals and the amino acid sequence differences responsible for spectral tuning among cone pigments. He noted that stochastic processes have played a surprising large role in the evolution of red-green color vision. It appears that tandem red and green pigment genes arose through an ancestral nonhomologous recombination event.

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NEI PUBLIC ACCESS POLICY REGARDING DATA FROM NEI-SUPPORTED STUDIES IN dbGaP

Dr. Hemin R. Chin, Chief, Ocular Genetics and Center Core Grant Programs, discussed the NEI Whole Genome Association (WGA) Study of AREDS-I samples and gave a short history. The dbGap is an acronym for the Database of Genotype and Phenotype. This database is extensively used as a tool to help the scientific community navigate through and have open access to the correlation between the genotype and phenotype data. Scientists can use dbGap to study gene variation in addition to being able to manipulate the data as necessary. All qualified investigator requests will be reviewed by the NIH before receiving the controlled access required to submit applications. The applicant can request application forms by going to the dbGap web site at http://dbGaP.nih.gov. All applicants will then require signatures from the qualifying officials within their institutions. Even those investigators who were involved in older studies would be able to access the data base to input information for future data as well. Although the open access will be open to everyone, the controlled data will be limited to the investigators. The investigator would have an exclusive period to their analysis until the investigator is ready to disclose the data. All the details are still a work in progress but will be finalized by the NIH sharing and data base policies.

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UPDATE ON 4TH NEI SYMPOSIUM ON THE EPIDEMIOLOGY OF EYE DISEASES

Dr. Natalie Kurinij, Chief, Epidemiology and Clinical Studies Program, gave an update on attending the Fourth U.S. Symposium on Ocular Epidemiology. With support from the National Eye Institute, this program was held January 29-31, 2007, in Sarasota, Florida. The attendees consisted of epidemiologists, ophthalmologists, optometrists, biostatisticians, health economists and ophthalmologists. The Keynote Speaker was Dr. Harvey M. Fineberg, M.D., Ph.D., President of the Institute of Medicine, US National Academy of Sciences. She included a program and other information and stated that the proceedings from the conference will be published this fall in the Journal of Ocular epidemiology. Dr. Kurinij stated that the symposium met its objectives of trying to chart forward the future needs and directions for epidemiology with regards to training and framing future questions. She stated that the meeting had great value for the field and was a success on a number of levels in addition it brought together both young and seasoned investigators.

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EPIDEMIOLOGY PROGRAM PLANNING ACTIVITIES UPDATE

Mr. Michael Davis, Director of the Office of Program Planning and Analysis gave an overview of the Strategic Planning for Ocular Epidemiology Panel, headed by Dr. Sheila West. The other panel members are Stanley Azen, Ph.D., Julie Burning, Sc.D., Jonathan Haines, Ph.D., Jonathan Holmes, M.D., Douglas Jabs, M.D., M.B.A., Paul Lee, M.D., J.D., Lance Liotta, M.D., Ph.D., Jerome Rotter, M.D., Rohit Varma, M.D., Ph.D., Daniel Weeks, Ph.D. and Karla Zadnik, O.D., Ph.D. NEI Program staff members were Donald F. Everett, M.A., Hemin R. Chin, Ph.D., Natalie Kurinij, Ph.D., Päivi H. Miskala, M.P.H., Ph.D., and Maryann Redford, D.D.S., M.P.H. Mr. Davis stated that the panel had been able to finish the draft report this spring as promised, and this draft is available for Council review. He stated that the draft would include many of the topics that Dr. Kurinij had discussed, but in greater detail. This is an excellent group; they focused on what they needed to do, and clearly articulated where the field should go. They held their first teleconference on March 21, 2007 and have held subsequent meetings and teleconferences consistently since that time.

Dr. Sieving invited council members to review this draft and submit any comments by June 22, 2007. The panel would revise the report in light of council input and place it on the web for public comment by July, 2007. He anticipates that the final report will be posted on the web by August, 2007.

Thank everyone for coming today. We will adjourn and Dr. Andrew Mariani will do his presentation on the Portfolio Overview at the next council.

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ADJOURNMENT

Dr. Sieving adjourned the meeting at 5:00 pm.

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CERTIFICATION

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

Dr. Loré Anne McNicol, Ph.D.
Executive Secretary
National Advisory Eye Council
Director, Division of Extramural Research
National Eye Institute

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

These minutes 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

06/25/2007


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Attachment A

NATIONAL ADVISORY EYE COUNCIL
NATIONAL EYE INSTITUTE

ROSTER

(Terms end 11/30 of the designated year)

Eileen E. Birch, Ph.D. (07)
Retina Foundation of the Southwest
Dallas TX 75231

Mae O. Gordon, Ph.D. (10)
Dept Ophthalmology & Visual Sciences
Washing University School of Medicine
660 South Euclid Campus
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

Barrett G. Haik, M.D. (07)
Department of Ophthalmology
College of Medicine
University of Tennessee Health Sci Ctr
Memphis TN 38163

Douglas H. Johnson, M.D. (10)
Department of Op9hthalmology
May Medical Center
200 First Street, SW
Rochester, MN 55905

Lenworth N. Johnson, M.D. (08)
Prof 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)
Department Molec Biomedical Sciences
North Caroline State University
4700 Hillsborough Street
Raleigh, NC 27606

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

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

Mriganka Sur, Ph.D. (07)
Depart Brain & Cognitive Sciences
Massachusetts Institute of Technology
Cambridge MA 02139

Department of Defense Representative
Lt. Col. David E. Holck M.D.
Chief, Reconstructive, Orbit, and Ocular Oncology Services
Wilford Hall Medical Center
Lackland Air Force Base, TX 78236

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
Secretary
Department of Health & Human Services
Washington, DC 20201

Elias A. Zerhouni, M.D.
Director
National Institutes of Health
Bethesda, MD 20892

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

Executive Secretary
Loré Anne McNicol, Ph.D.
Director
Division of Extramural Research
National Eye Institute
National Institutes of Health
Bethesda, MD 20892